[Federal Register Volume 62, Number 201 (Friday, October 17, 1997)]
[Notices]
[Pages 54118-54119]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-27531]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committee for Pharmaceutical Science; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.


[[Page 54119]]


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: Advisory Committee for Pharmaceutical Science.
    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 December 11 and 12, 
1997, 8:30 a.m. to 5:30 p.m.
    Location: Quality Hotel, Maryland Room, 8727 Colesville Rd., Silver 
Spring, MD.
    Contact Person: Kimberly Littleton Topper, Center for Drug 
Evaluation and Research (HFD-21), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-443-5455, (FedEx--Chapman Bldg., 
801 Thompson Ave., rm. 200, Rockville, MD 20852), or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12539. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On December 11, 1997, the committee will discuss the 
Biopharmaceutics Classification System, topicals-dermatological drug 
products, and Narrow Therapeutic Index Drugs and relevance to product 
quality testing. On December 12, 1997, the committee will discuss the 
drug-drug interaction studies, and bioequivalence studies that fail to 
meet established confidence intervals.
    Procedure: 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 December 1, 
1997. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on December 11, 1997, and between 
approximately 1:30 p.m. and 2 p.m. on December 12, 1997. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before December 1, 
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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 9, 1997.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 97-27531 Filed 10-16-97; 8:45 am]
BILLING CODE 4160-01-F