[Federal Register Volume 64, Number 66 (Wednesday, April 7, 1999)]
[Notices]
[Pages 16976-16977]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8590]
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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
