[Federal Register: October 1, 2002 (Volume 67, Number 190)]
[Page 61639-61640]
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.
    Dates and Time: The meeting will be held on October 21, 2002, from 
8:30 a.m. to 5 p.m. and October 22, 2002, from 8:30 a.m. to 5 p.m.

[[Page 61640]]

    Location: Center for Drug Evaluation and Research Advisory 
Committee conference rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Kathleen Reedy, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for 
express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 
301-827-7001, or e-mail: REEDYK@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 October 21, 2002, the committee will: (1) Receive 
summary reports and provide direction for the Nonclinical Studies 
Subcommittee and the Process Analytical Technologies Subcommittee; (2) 
receive updates on risk-based chemistry manufacturing control review 
and blend uniformity; and (3) discuss and provide comments on 
regulatory issues related to crystal habits--polymorphism. On October 
22, 2002, the committee will: (1) Discuss and provide direction for 
future subcommittee--Good Manufacturing Practices/Manufacturing 
Subcommittee; and (2) discuss manufacturing issues; sterile drug 
products produced by aseptic processing.
    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 14, 
2002. Oral presentations from the public will be scheduled between 
approximately 11:45 a.m. and 12:45 p.m. on October 21, 2002, and 1 p.m. 
and 2 p.m. on October 22, 2002. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 14, 2002, 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    FDA welcomes the attendance of the public at its advisory committee 
meetings and will make every effort to accommodate persons with 
physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Kathleen Reedy at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 22, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-24812 Filed 9-30-02; 8:45 am]