[Federal Register Volume 73, Number 199 (Tuesday, October 14, 2008)]
[Notices]
[Pages 60705-60706]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24264]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-N-0448]
International Drug Scheduling; Convention of Psychotropic
Substances; Single Convention on Narcotic Drugs; Gamma-hydroxybutyric
acid; Ketamine; Dextromethorphan; N-benzylpiperazine; 1-(3-
trifluoromethylphenyl) piperazine; 1-(3-chlorophenyl) piperazine; 1-(4-
Methoxyphenyl) piperazine; 1-(3,4-methylenedioxybenzyl) piperazine;
Gamma-butyrolactone; 1,4-Butanediol; Reopening of Comment Period
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; reopening of comment period.
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SUMMARY: The Food and Drug Administration (FDA) is reopening until
October 20, 2008, the comment period for the notice on ``International
Drug Scheduling; Convention on Psychotropic Substances; Single
Convention on Narcotic Drugs,'' published in the Federal Register of
September 5, 2008 (73 FR 51823), requesting comments on abuse
potential, actual abuse, medical usefulness, trafficking, and impact of
scheduling changes on availability for medical use of 10 drug
substances. FDA is taking this action in response to a request for a
reopening of the comment period to allow interested persons additional
time to review the notice and submit comments.
[[Page 60706]]
DATES: Submit written or electronic comments by October 20, 2008.
ADDRESSES: Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: James R. Hunter, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 5146, Silver Spring, MD 20993-0002, 301-
796-3156, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
The United States is a party to the 1971 Convention on Psychotropic
Substances (the Psychotropic Convention). Article 2 of the Psychotropic
Convention provides that if a party to the convention or the World
Health Organization (WHO) has information about a substance, which in
its opinion may require international control or changes in such
control, it should notify the Secretary-General of the United Nations
(the Secretary-General) and provide the Secretary-General with
information in support of its opinion.
The Controlled Substances Act (21 U.S.C. 811 et seq.) (Title II of
the Comprehensive Drug Abuse Prevention and Control Act of 1970)
provides that when WHO notifies the United States under Article 2 of
the Psychotropic Convention that it has information that may justify:
(1) Adding a drug or other substance to one of the schedules of the
convention, (2) transferring a drug or substance from one schedule to
another, or (3) deleting it from the schedules, the Secretary of State
must transmit the notice to the Secretary of Health and Human Services
(the Secretary of HHS). The Secretary of HHS must then publish the
notice in the Federal Register and provide opportunity for interested
persons to submit comments that HHS will consider in its preparation of
the scientific and medical evaluations of the drug or substance.
In the Federal Register of September 5, 2008 (73 FR 51823), FDA
published a notice requesting comments on the abuse potential, actual
abuse, medical usefulness, trafficking, and impact of scheduling
changes on availability for medical use of 10 drug substances. These
comments will be considered in preparing the United States' response to
WHO regarding the abuse liability and diversion of these drugs. WHO
will use this information to consider whether to recommend that certain
international restrictions be placed on these drugs.
Interested persons were originally given until October 6, 2008, to
comment on the 10 named drug substances.
II. Request for Comments
Following publication of the September 5, 2008, notice, FDA
received a request to allow interested persons additional time to
comment. The requester asserted that the time period for comments was
insufficient to respond fully to FDA's specific request for comments
and to allow potential respondents to thoroughly evaluate and address
pertinent issues. Therefore, FDA has decided to reopen the comment
period on the notice until October 20, 2008, to allow the public more
time to review and comment on its contents.
III. How to Submit Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding the ten drug
substances. Submit a single copy of electronic comments to http://www.regulations.gov or two paper copies of any mailed comments, except
that individuals may submit one paper copy. Comments are to be
identified with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.
Dated: October 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-24264 Filed 10-10-08; 8:45 am]
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