[Federal Register Volume 62, Number 156 (Wednesday, August 13, 1997)]
[Notices]
[Pages 43332-43333]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-21434]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
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). The meeting will
be open to the public.
Name of Committee: Dermatologic and Ophthalmic Drugs 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 September 4 and 5, 1997,
8:30 a.m. to 5:30 p.m.
Location: Holiday Inn, Versailles Ballrooms I, II, and III, 8120
Wisconsin Ave., Bethesda, MD.
Contact Person: Tracy Riley or John B. Schupp, Center for Drug
Evaluation and Research (HFD-21), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-443-5455, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572 in the
Washington, DC area), code 12534. Please call the Information Line for
up-to-date information on this meeting.
Agenda: The committee will hear presentations and discuss data
submitted regarding the new drug application (NDA) 20-785,
SynovirTM (thalidomide capsules, Celgene Corp.), for
treatment of erythema nodosum leprosum.
Procedure: Interested persons may present data, information, or
views,
[[Page 43333]]
orally or in writing, on issues pending before the committee. Written
submissions may be made to the contact person by August 22, 1997. Oral
presentations from the public will be scheduled between approximately
8:30 a.m. to 9 a.m., and between approximately 1 p.m. to 2 p.m. on
September 4, 1997. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person before August 22, 1997, 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. The agency
encourages investigators, academicians, members of the pharmaceutical
industry, consumer groups, and others with information relevant to the
topic to respond to the contact person.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: August 7, 1997.
William B. Schultz,
Acting Lead Deputy Commissioner.
[FR Doc. 97-21434 Filed 8-12-97; 8:45 am]
BILLING CODE 4160-01-F
