Document ID: FDA-2008-N-0448-0009
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2008-10-14T04:00Z

[Federal Register: October 14, 2008 (Volume 73, Number 199)]
[Notices]               
[Page 60705-60706]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14oc08-56]                         

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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: james.hunter@fda.hhs.gov.

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]

BILLING CODE 4160-01-S