[Federal Register Volume 67, Number 190 (Tuesday, October 1, 2002)]
[Notices]
[Pages 61639-61640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24812]
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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'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: [email protected], 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
presentation.
Persons attending FDA's advisory committee meetings are advised
that the agency is not responsible for providing access to electrical
outlets.
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]
BILLING CODE 4160-01-S
