[Federal Register: June 14, 2001 (Volume 66, Number 115)]
[Page 32359]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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 July 19, 2001, from 8:30 
a.m. to 5:30 p.m. and July 20, 2001, from 8:30 a.m. to 3 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee conference room 1066, 5630 Fishers Lane, Rockville, MD.
    Contact: Nancy Chamberlin, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, 5630 Fishers Lane, rm. 1076), Rockville, MD 20857, 301-827-
7001, or e-mail: CHAMBERLINN@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: On July 19, 2001, the committee will: (1) Discuss specific 
recommendations of the Orally Inhaled and Nasal Drug Products 
Subcommittee regarding dose response of locally acting nasal sprays and 
nasal aerosols, with particular application to bioequivalence studies; 
(2) hear reports and provide direction to the Nonclinical Studies 
Subcommittee; (3) provide comments and advice to the Risk-Based 
Chemistry, Manufacturing, and Controls Review Working Group for 
establishment of a list of low risk drugs; (4) discuss and provide 
direction on optimal applications of inline process controls in 
pharmaceutical production; and (5) discuss problems and provide 
comments to form a scientific basis for establishment of acceptance 
limits for microbiological tests that use newly developed technologies 
that do not rely on colony counts, and their application as process 
controls and product release criteria. On July 20, 2001, the committee 
will: (1) Provide comments and advice on methods to determine drug 
transfer into breast milk and interpretation of data; and (2) discuss 
and provide comments on the feasibility, scientific challenges, and 
approaches for establishment of pharmaceutical equivalence, 
bioavailability, and bioequivalence of liposome drug products.
    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 July 12, 2001. 
Oral presentations from the public will be scheduled between 
approximately 1:15 p.m. to 2:15 p.m. on July 19, 2001, and between 
approximately 10:15 a.m. to 11:15 a.m. on July 20, 2001. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before July 12, 
2001, 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: June 6, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-14928 Filed 6-13-01; 8:45 am]