[Federal Register: March 24, 2004 (Volume 69, Number 57)]
[Notices]
[Page 13855-13856]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24mr04-64]
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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
[[Page 13856]]
(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 April 13 and 14, 2004,
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: Hilda Scharen or Kimberly Topper, 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, e-mail:
SCHARENH@cder.fda.gov or TOPPERK@cder.fda.gov, or FDA Advisory Committee Information Line, 1-
800-741-8138 (301-443-0572 in the Washington, DC area), code
3014512539. Please call the Information Line for up-to-date information
on this meeting.
Agenda: On April 13, 2004, the committee will receive an update
from the Clinical Pharmacology Subcommittee. The committee will also
discuss and provide comments on the following topics: (1) A proposal
for resolving the issues related to the parametric tolerance interval
test for dose content uniformity for inhalation products, (2) the
Process Analytical Technologies progress and next steps, and (3)
process analytical technology for products in the Office of
Biotechnology Products, Center for Drug Evaluation and Research and in
the Center for Biologics Evaluation and Research. On April 14, 2004,
the committee will discuss and provide comments on the following
topics: (1) Bioequivalence testing/methods strategy for products
exhibiting high variability and (2) bioinequivalence concepts and
definition.
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 April 6, 2004.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 p.m. on April 13, 2004, and 1 p.m. and 2
p.m. on April 14, 2004. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before April 6, 2004, 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 Hilda Scharen or
Kimberly Topper 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: March 17, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-6484 Filed 3-23-04; 8:45 am]
BILLING CODE 4160-01-S