[Federal Register Volume 73, Number 21 (Thursday, January 31, 2008)]
[Proposed Rules]
[Pages 5778-5781]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-1692]


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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 [email protected]. 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