[Federal Register: February 3, 2003 (Volume 68, Number 22)]
[Notices]
[Page 5297-5298]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03fe03-60]
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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.
Date and Time: The meeting will be held on March 12, 2003, from
8:30 a.m. to 5 p.m. and March 13, 2003, from 8:30 a.m. to 5 p.m.
Location: Center for Drug Evaluation and Research Advisory
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
Contact Person: Kathleen Reedy or Carolyn Jones, 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
[[Page 5298]]
Washington, DC area), code 12539. Please call the Information Line for
up-to-date information on this meeting.
Agenda: On March 12, 2003, the committee will: (1) Receive a final
report from the Process Analytical Technology Subcommittee and provide
direction to the Manufacturing Subcommittee; (2) receive an update on
sterile products produced by aseptic processing; (3) discuss and
provide direction for future subcommittees: Biopharmaceutics
Subcommittee and Microbiology Subcommittee; (4) discuss and provide
comments on topical dermatological drug product nomenclature; and (5)
discuss and provide comments on topical dermatological bioequivalence,
methods development. On March 13, 2003, the committee will: (1) Discuss
and provide direction for future subcommittee: Pharmacology/Toxicology
Subcommittee; (2) receive an update on the Office of Pharmaceutical
Science research projects; (3) discuss and provide comments on dose
content uniformity, parametric interval test for aerosol products; (4)
discuss and provide comments on levothyroxine bioequivalence; and (5)
discuss and provide comments on comparability protocols.
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 March 3, 2003.
Oral presentations from the public will be scheduled between
approximately 1:30 p.m. to 2 p.m. on March 12, 2003, and 11:30 a.m. to
12 noon on March 13, 2003. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before March 3, 2003, 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 Carolyn Jones 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: January 27, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-2459 Filed 1-31-03; 8:45 am]
BILLING CODE 4160-01-S