[Federal Register Volume 63, Number 96 (Tuesday, May 19, 1998)]
[Notices]
[Pages 27583-27584]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-13314]


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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.

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 June 23, 1998, 8 a.m. to 
5 p.m., and on June 24, 1998, 8:30 a.m. to 5:30 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Kimberly L. Topper, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration 5600 Fishers Lane, 
Rockville, MD 20857, 301-443-5455, (For Federal Express Deliveries-- 
Chapman Bldg., 801 Thompson Ave., rm. 200, Rockville, MD 20857) or FDA 
Advisory Committee Information Line,

[[Page 27584]]

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 June 23 and 24, 1998, the committee will focus on both 
safety/efficacy and quality topics with a bridging topic (exposure). 
Specific topics to be discussed include: (1) Nonclinical/nonhuman 
pharmacology/toxicology research programs to support the drug 
development and registration process, (2) in vitro drug metabolism to 
support guidance updating, (3) the revision of the guidance for scale-
up and post-approval changes for immediate release drug products, and 
(4) complex drug substances.
    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 June 16, 1998. 
Oral presentations from the public will be scheduled between 
approximately 10:30 a.m. and 11 a.m. on June 23, 1998, and between 
approximately 10:15 a.m. and 10:45 a.m. on June 24, 1998. Time allotted 
for each presentation may be limited. Those desiring to make formal 
presentations should notify the contact person before June 16, 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: May 11, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-13314 Filed 5-18-98; 8:45 am]
BILLING CODE 4160-01-F