[Federal Register: October 19, 2001 (Volume 66, Number 203)]
[Page 53225-53226]
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 November 28 and 29, 
2001, from 8:30 a.m. to 5:30 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, 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 November 28, 2001, the committee will: (1) Discuss the 
current status of, and future plans for, the FDA draft guidance 
entitled ``ANDAs: Blend Uniformity Analysis;'' (2) discuss and provide 
direction for the Process Analytical Technology Subcommittee; (3) 
discuss and provide comments on stability testing and shelf life; and 
(4) receive updates from subcommittees and on other Center for Drug 
Evaluation and Research guidance documents. On November 29, 2001, the 
committee will: (1) Receive updates on FDA research in 
dermatopharmacokinetics, and (2) discuss and provide comments on 
bioequivalence issues.
    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 November 15, 
2001. Oral presentations from the public will be scheduled between 
approximately 1:30 p.m. and 2:30 p.m. on November 28, 2001, and between 
approximately 11 a.m. and 12 noon on November 29,

[[Page 53226]]

2001. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before November 15, 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: October 12, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-26370 Filed 10-18-01; 8:45 am]