[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
