[Federal Register: March 24, 2004 (Volume 69, Number 57)]
[Page 13855-13856]
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

[[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 
    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 
    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 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]