[Federal Register: August 30, 1999 (Volume 64, Number 167)]
[Notices]
[Page 47194-47195]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30au99-76]

-----------------------------------------------------------------------

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 September 23 and 24,
1999, 8:30 a.m. to 5 p.m.
    Location: Center for Drug Evaluation and Research Advisory
Committee conference room, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Kimberly Littleton Topper at topperk@cder.fda.gov
or Angie Whitacre at whitacre@cder.fda.gov, Center for Drug Evaluation
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-7001, 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 September 23, 1999, the committee will discuss
individual bioequivalence-criteria for equivalence comparisons. On
September 24, 1999, the committee will discuss clinical pharmacology-
pharmacokinetic/pharmacodynamic issues in drug development and research
issues in nonclinical studies.
    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 September 8,
1999. Oral

[[Page 47195]]

presentations from the public will be scheduled between approximately 1
p.m. to 2 p.m. Time allotted for each presentation may be limited.
Those desiring to make formal oral presentations should notify the
contact person before September 8, 1999, 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:August 23, 1999.
Linda A. Suydam
Senior Associate Commissioner
[FR Doc. 99-22479 Filed 8-27-99; 8:45 am]
BILLING CODE 4160-01-F