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Schedules of Controlled Substances: Placement of Indiplon
Into Schedule IV
8
FR Doc E8-1692[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]
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.
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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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