[Federal Register: January 31, 2008 (Volume 73, Number 21)]
[Proposed Rules]
[Page 5778-5781]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31ja08-25]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
21 CFR Part 1308
[Docket No. DEA-283P]
Schedules of Controlled Substances: Placement of Indiplon Into
Schedule IV
AGENCY: Drug Enforcement Administration, Department of Justice.
ACTION: Notice of proposed rulemaking.
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SUMMARY: This proposed rule is issued by the Deputy Administrator of
the Drug Enforcement Administration (DEA) to place the substance
indiplon (N-methyl-N-[3-[3-(2-thienylcarbonyl)-pyrazolo[1,5-
a]pyrimidin-7-
[[Page 5779]]
yl]phenyl]acetamide), including its salts, and all products containing
indiplon into schedule IV of the Controlled Substances Act (CSA). This
proposed action is based on a recommendation from the Assistant
Secretary for Health of the Department of Health and Human Services
(DHHS) and an evaluation of the relevant data by DEA. This scheduling
of indiplon in schedule IV will not be finalized until a New Drug
Application (NDA) for an indiplon product is approved by the Food and
Drug Administration (FDA). If finalized, this action will impose the
regulatory controls and criminal sanctions applicable to schedule IV
non-narcotics on those who handle indiplon and products containing
indiplon.
DATES: Written comments must be postmarked, and electronic comments
must be sent, on or before March 3, 2008.
ADDRESSES: To ensure proper handling of comments, please reference
``Docket No. DEA-283'' on all written and electronic correspondence.
Written comments being sent via regular mail should be sent to the
Deputy Administrator, Drug Enforcement Administration, Washington, DC
20537, Attention: DEA Federal Register Representative/ODL. Written
comments sent via express mail should be sent to the Deputy
Administrator, Drug Enforcement Administration, Attention: DEA Federal
Register Representative/ODL, 8701 Morrissette Drive, Springfield, VA
22152. Comments may be directly sent to DEA electronically by sending
an electronic message to dea.diversion.policy@usdoj.gov. Comments may
also be sent electronically through http://www.regulations.gov using
the electronic comment form provided on that site. However, persons
wishing to request a hearing should note that such requests must be
written and manually signed; requests for a hearing will not be
accepted via electronic means. DEA will accept electronic comments
containing MS Word, WordPerfect, Adobe PDF, or Excel file formats only.
DEA will not accept any file format other than those specifically
listed here.
Posting of Public Comments: Please note that all comments received
are considered part of the public record and made available for public
inspection online at http://www.regulations.gov and in the Drug
Enforcement Administration's public docket. Such information includes
personal identifying information (such as your name, address, etc.)
voluntarily submitted by the commenter.
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 posted online or made available in the public docket, you must
include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the first
paragraph of your comment. You must also place all the personal
identifying information you do not want posted online or made available
in the public docket 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 posted online or made available
in the public docket, you must include the phrase ``CONFIDENTIAL
BUSINESS INFORMATION'' in the first paragraph of your comment. You must
also prominently identify confidential business information to be
redacted within the comment. If a comment has so much confidential
business information that it cannot be effectively redacted, all or
part of that comment may not be posted online or made available in the
public docket.
Personal identifying information and confidential business
information identified and located as set forth above will be redacted
and the comment, in redacted form, will be posted online and placed in
the Drug Enforcement Administration's public docket file. If you wish
to inspect the agency's public docket file in person by appointment,
please see the FOR FURTHER INFORMATION paragraph.
FOR FURTHER INFORMATION CONTACT: Christine A. Sannerud, PhD, Chief,
Drug and Chemical Evaluation Section, Drug Enforcement Administration,
Washington, DC 20537, (202) 307-7183.
SUPPLEMENTARY INFORMATION:
Note Regarding This Proposed Scheduling Action
In accordance with the provisions of the Controlled Substances Act
(21 U.S.C. 811(a)), this action is a formal rulemaking ``on the record
after opportunity for a hearing.'' Such proceedings are conducted
pursuant to the provisions of the Administrative Procedure Act (5
U.S.C. 556 and 557). Interested persons are invited to submit their
comments, objections or requests for a hearing with regard to this
proposal. Persons wishing to request a hearing should note that such
requests must be written and manually signed; requests for a hearing
will not be accepted via electronic means. Requests for a hearing
should be made in accordance with 21 CFR 1308.44 and should state, with
particularity, the issues concerning which the person desires to be
heard. All correspondence regarding this matter should be submitted to
the DEA using the address information provided above.
Background
Indiplon acts as an agonist at benzodiazepine sites of the
GABAA receptor-channel complex. It has comparable sedative/
hypnotic action to that of the benzodiazepines, diazepam and triazolam,
and non-benzodiazepines that bind to the GABAA complex, such
as zolpidem, zaleplon and zopiclone, all of which are controlled as
depressants in schedule IV of the CSA. Indiplon has a similar
pharmacological profile as these substances in addition to a short
plasma half-life and short duration of action. In a human abuse-
liability study in individuals with known histories of sedative abuse,
oral administration of indiplon (30 mg, 50 mg and 80 mg) produced dose-
dependent increases in drug-liking and decreases in psychomotor and
cognitive functioning comparable to those produced by the schedule IV
benzodiazepine, triazolam. Indiplon is likely to be diverted and abused
in the same manner as other schedule IV depressants.
The FDA has received two NDAs for indiplon products,
Somposure[supreg] and Somposure[supreg] MR. These products are
currently under review for the treatment of insomnia, as characterized
by difficulty in sleep onset or sleep maintenance. Indiplon is a new
chemical entity and has not been marketed in the United States or in
other countries.
On January 23, 2006, the Assistant Secretary for Health of the DHHS
sent the Administrator of the DEA a scientific and medical evaluation
and a letter recommending that indiplon be placed into schedule IV of
the CSA. Enclosed with the January 23, 2006, letter was a document
prepared by the FDA entitled, ``Basis for the Recommendation for
Control of Indiplon in Schedule IV of the Controlled Substances Act
(CSA).'' The document contained a review of the factors which the CSA
requires the Secretary to consider (21 U.S.C. 811(b)).
The factors considered by the Assistant Secretary of Health and DEA
with respect to Indiplon were:
(1) Its actual or relative potential for abuse;
(2) Scientific evidence of its pharmacological effects;
(3) The state of current scientific knowledge regarding the drug;
(4) Its history and current pattern of abuse;
[[Page 5780]]
(5) The scope, duration, and significance of abuse;
(6) What, if any, risk there is to the public health;
(7) Its psychic or physiological dependence liability; and
(8) Whether the substance is an immediate precursor of a substance
already controlled under this subchapter (21 U.S.C. 811(c)).
Based on the recommendation of the Assistant Secretary for Health,
received in accordance with section 201(b) of the Act (21 U.S.C.
811(b)), and the independent review of the available data by the DEA,
the Deputy Administrator of the DEA, pursuant to section 201(a) and
201(b) of the Act (21 U.S.C. 811(a) and 811(b)), finds that:
(1) Based on information now available, indiplon has a low
potential for abuse relative to the drugs or other substances in
schedule III;
(2) Once approved for marketing, indiplon will have a currently
accepted medical use in treatment in the United States; and
(3) Abuse of indiplon may lead to limited physical dependence or
psychological dependence relative to the drugs or other substances in
schedule III.
Based on these findings, the Deputy Administrator of the DEA
concludes that indiplon, including its salts, and all products
containing indiplon, warrant control in schedule IV of the CSA, if and
when a NDA for indiplon is approved.
Interested persons are invited to submit their comments, objections
or requests for a hearing with regard to this proposal. Requests for a
hearing should state, with particularity, the issues concerning which
the person desires to be heard. All correspondence regarding this
matter should be submitted to the Drug Enforcement Administration using
the address information provided above. Persons wishing to request a
hearing should note that such requests must be written and manually
signed; requests for a hearing will not be accepted via electronic
means. In the event that comments, objections, or requests for a
hearing raise one or more issues which the Deputy Administrator finds
warrant a hearing, the Deputy Administrator shall order a public
hearing by notice in the Federal Register, summarizing the issues to be
heard and setting the time for the hearing.
Requirements for Handling Indiplon
If this rule is finalized as proposed, indiplon and all products
containing indiplon would be subject to the Controlled Substances Act
and the Controlled Substances Import and Export Act regulatory controls
and administrative, civil and criminal sanctions applicable to the
manufacture, distribution, dispensing, importing and exporting of a
schedule IV controlled substance, including the following:
Registration. Any person who manufactures, distributes, dispenses,
imports, exports, engages in research or conducts instructional
activities with indiplon, or who desires to manufacture, distribute,
dispense, import, export, engage in instructional activities or conduct
research with indiplon, would need to register with the DEA to conduct
such activities in accordance with part 1301 of Title 21 of the Code of
Federal Regulations.
Security. Indiplon would be subject to schedule III-V security
requirements and must be manufactured, distributed and stored in
accordance with 21 CFR 1301.71, 1301.72(b), (c), and (d), 1301.73,
1301.74, 1301.75(b) and (c), 1301.76, and 1301.77.
Labeling and Packaging. All labels and labeling for commercial
containers of indiplon which are distributed on or after finalization
of this rule would need to comply with requirements of 21 CFR 1302.03-
1302.07.
Inventory. Every registrant required to keep records and who
possesses any quantity of indiplon would be required to keep an
inventory of all stocks of indiplon on hand pursuant to 21 CFR 1304.03,
1304.04 and 1304.11. Every registrant who desires registration in
schedule IV for indiplon would be required to conduct an inventory of
all stocks of the substance on hand at the time of registration.
Records. All registrants would be required to keep records pursuant
to 21 CFR 1304.03, 1304.04, 1304.05, 1304.21, 1304.22, and 1304.23.
Prescriptions. All prescriptions for indiplon or prescriptions for
products containing indiplon would be required to be issued pursuant to
21 CFR 1306.03-1306.06, 1306.21-1306.27.
Importation and Exportation. All importation and exportation of
indiplon would need to be in compliance with 21 CFR Part 1312.
Criminal Liability. Any activity with indiplon not authorized by,
or in violation of, the Controlled Substances Act or the Controlled
Substances Import and Export Act occurring on or after finalization of
this proposed rule would be unlawful.
Regulatory Certifications
Executive Order 12866
In accordance with the provisions of the CSA (21 U.S.C. 811(a)),
this action is a formal rulemaking ``on the record after opportunity
for a hearing.'' Such proceedings are conducted pursuant to the
provisions of 5 U.S.C. 556 and 557 and, as such, are exempt from review
by the Office of Management and Budget pursuant to Executive Order
12866, section 3(d)(1).
Regulatory Flexibility Act
The Deputy Administrator, in accordance with the Regulatory
Flexibility Act (5 U.S.C. 601-612), has reviewed this proposed rule and
by approving it certifies that it will not have a significant economic
impact on a substantial number of small entities. Indiplon products
will be prescription drugs used for the treatment of insomnia. Handlers
of indiplon often handle other controlled substances which are already
subject to the regulatory requirements of the CSA.
Executive Order 12988
This regulation meets the applicable standards set forth in section
3(a) and 3(b)(2) of Executive Order 12988 Civil Justice Reform.
Executive Order 13132
This rulemaking does not preempt or modify any provision of state
law; nor does it impose enforcement responsibilities on any state; nor
does it diminish the power of any state to enforce its own laws.
Accordingly, this rulemaking does not have federalism implications
warranting the application of Executive Order 13132.
Unfunded Mandates Reform Act of 1995
This rule will not result in the expenditure by state, local and
tribal governments, in the aggregate, or by the private sector, of
$120,000,000 or more (adjusted for inflation) in any one year, and will
not significantly or uniquely affect small governments. Therefore, no
actions were deemed necessary under provisions of the Unfunded Mandates
Reform Act of 1995.
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). 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; 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.
[[Page 5781]]
List of Subjects in 21 CFR Part 1308
Administrative practice and procedure, Drug traffic control,
Narcotics, Prescription drugs.
Under the authority vested in the Attorney General by Sec. 201(a)
of the CSA (21 U.S.C. 811(a)), and delegated to the Administrator of
DEA by Department of Justice regulations (28 CFR 0.100), and
redelegated to the Deputy Administrator pursuant to 28 CFR 0.104, the
Deputy Administrator hereby proposes that 21 CFR part 1308 be amended
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. Section 1308.14 is amended by redesignating paragraphs (c)(25)
through (c)(51) as (c)(26) through (c)(52) and adding a new paragraph
(c)(25) to read as follows:
Sec. 1308.14 Schedule IV.
* * * * *
(c) * * *
(25) indiplon (N-methyl-N-[3-[3-(2-thienylcarbonyl)-pyrazolo[1,5-
a]pyrimidin-7-yl]phenyl]-acetamide)--2726
* * * * *
Dated: January 22, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-1692 Filed 1-30-08; 8:45 am]
BILLING CODE 4410-09-P