[Federal Register Volume 63, Number 67 (Wednesday, April 8, 1998)]
[Notices]
[Pages 17185-17186]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9102]
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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 April 27, 1998, 1:30
p.m. to 5 p.m. and April 28, 1998, 8:30 a.m. to 5:30 p.m.
Location: Holiday Inn, Two Montgomery Village Ave., Gaithersburg,
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: On April 27, 1998, the committee will discuss and review
trade secret and/or confidential information. On April 28, 1998, the
committee will: (1) Discuss the scientific evidence for initiating a
scheduling action for ULTRAM (tramadol hydrochloride), R. W.
Johnson Pharmaceutical Research Institute, under the Controlled
Substances Act; (2) evaluate the effectiveness of the independent
steering committee in detecting, moderating, and preventing the
physical
[[Page 17186]]
dependence and abuse of ULTRAM; and (3) suggest improvements
for surveillance of misuse.
Procedure: On April 28, 1998, from 8:30 a.m. to 5:30 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 17, 1998. Oral presentations from the public will be scheduled
between approximately 1 p.m. and 2 p.m. on April 28, 1998. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentations should notify the contact person before April
17, 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 April 27, 1998, from 1:30 p.m.
to 5 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 application (IND) and Phase I and Phase II
drug products in process will be presented, and recent action on
selected new drug applications (NDA's) will be discussed. This portion
of the meeting will be closed to permit discussion of this information.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 1, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-9102 Filed 4-7-98; 8:45 am]
BILLING CODE 4160-01-F
