[Federal Register: April 7, 1999 (Volume 64, Number 66)]
[Notices]               
[Page 16976-16977]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07ap99-84]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Drug Abuse Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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     This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.
    Name of Committee: Drug Abuse Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on April 20, 1999, from 
8:30 a.m. to 4 p.m.
    Location: Center for Drug Evaluation and Research/Advisory 
Committee Conference Room, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Karen M. Templeton-Somers, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20057, 301-827-7001, or

[[Page 16977]]

FDA Advisory Committee Information Line, 1-800-741-8138 (301-439-0572 
in the Washington, DC area), code 12535. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: The committee will be discussing appropriate patient 
populations and outcome measures for clinical trials for drugs to treat 
alcohol use disorders.
    Procedure: On April 20, 1999, from 8:30 a.m. to 1:30 p.m., the 
meeting is open to the public. Interested persons may present data, 
information, or views, orally or in writing, on issues pending before 
the committee. Written submissions may be made to the contact person by 
April 6, 1999. Oral presentations from the public will be scheduled 
between approximately 8:30 a.m. to 9:30 a.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before April 13, 1999, 
and submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and addresses of proposed 
participants, and an indication of the approximate time requested to 
make their presentation.
    Closed Committee Deliberations: On April 20, 1999, from 1:30 p.m. 
to 4 p.m., the committee will review trade secret and/or confidential 
information relevant to pending investigational new drugs or new drug 
applications. This portion of the meeting will be closed to permit 
discussion of this information (5 U.S.C. 552b(c)(4)).
    FDA regrets that it was unable to publish this notice 15 days prior 
to the April 20, 1999, Drug Abuse Advisory Committee meeting. Because 
the agency believes there is some urgency to bring these issues to 
public discussion and qualified members of the Drug Abuse Advisory 
Committee were available at this time, the Commissioner concluded that 
it was in the public interest to hold this meeting even if there was 
not sufficient time for the customary 15-day public notice.
     Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 30, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-8590 Filed 4-6-99; 8:45 am]
BILLING CODE 4160-01-F