Meetings: Pharmaceutical Science Advisory Committee,

[Federal Register: September 21, 1998 (Volume 63, Number 182)]

[Notices]

[Page 50250]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr21se98-72]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Advisory Committee for Pharmaceutical Science; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

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's regulatory issues.

Date and Time: The meeting will be held on October 22, 1998, 8:30 a.m. to 5 p.m.

Location: Advisory Committee conference room, rm. 1066, 5630 Fishers Lane, Rockville, MD 20852.

Contact Person: Kimberly L. Topper or Angie Whitacre, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-1000, 301-827-7001, or e-mail ``Topperk@cder.fda.gov'', 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: The committee will discuss: (1) Bioavailability/ bioequivalence (BA/BE) issues related to solid oral dosage forms; (2) progress reports on guidances pertaining to the biopharmaceutical classification system, other BA/BE guidances; and (3) criteria (average, population, and individual) to allow comparison of BE measures/parameters.

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 October 5, 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 October 5, 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.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: September 11, 1998. Sharon Smith Holston, Acting Commissioner of Food and Drugs.

[FR Doc. 98-25106Filed9-18-98; 8:45 am]

BILLING CODE 4160-01-F