[Federal Register Volume 63, Number 22 (Tuesday, February 3, 1998)]
[Notices]
[Pages 5562-5563]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-2576]
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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 regulatory issues.
Date and Time: The meeting will be held on February 19, 1998, 8:30
a.m. to 5:30 p.m.
Location: Holiday Inn, Versailles Ballrooms III and IV, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Karen M. Templeton-Somers, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-4090, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12535. Please call the Information Line for
up-to-date information on this meeting.
Agenda: The committee will discuss the scientific evidence for
initiating a scheduling action for ULTRAM (tramadol
hydrochloride), R. W. Johnson Pharmaceutical Research Institute, under
the Controlled Substances Act. The committee will also evaluate the
effectiveness of the independent steering committee in detecting,
moderating, and preventing the physical dependence and abuse of
ULTRAM and make suggestions for improving the surveillance of
its misuse.
Procedure: On February 19, 1998, from 8:30 a.m. to 3:45 p.m., the
meeting is open to the public. Interested persons may present data,
information, or views,
[[Page 5563]]
orally or in writing, on issues pending before the committee. Written
submissions may be made to the contact person by February 11, 1998.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before February 11, 1998, 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 February 19, 1998, from 3:45
p.m. to 5:30 p.m., the meeting will be closed to permit discussion and
review of trade secret and/or confidential information (5 U.S.C.
552b(c)(4)). The investigational new drug and Phase I and II drug
products in process will be presented and recent action on selected new
drug applications will be discussed.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: January 27, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-2576 Filed 2-2-98; 8:45 am]
BILLING CODE 4160-01-F
