[Federal Register: October 2, 2003 (Volume 68, Number 191)]
[Page 56846]
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 
    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 October 21, 2003, 
from 8:30 a.m. to 4:30 p.m., and October 22, 2003, from 8:30 a.m. to 
5 p.m.
    Location: Best Western Washington Gateway Hotel, 1251 West 
Montgomery Ave., Rockville, MD.
    Contact Person: Hilda Scharen, 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 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 
    Agenda: On October 21, 2003, the committee will do the 
following: (1) Receive updates from the Manufacturing, Clinical 
Pharmacology, and Pharmacology/Toxicology Subcommittees, (2) discuss 
and provide comments on the FDA draft guidance for industry entitled 
``Process Analytical Technologies (PAT), a Framework for Innovative 
Pharmaceutical Manufacturing and Quality Assurance,'' (see the FDA 
Internet Web address http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cder/guidance/5815dft.htm), 
and (3) discuss and provide comments on parametric tolerance 
interval test for dose content uniformity. On October 22, 2003, the 
committee will do the following: (1) Discuss and provide comments on 
risk based Chemistry Manufacturing and Control (CMC) review 
proposals, (2) discuss and provide comments on nomenclature, and (3) 
discuss and provide direction to the research plan for generics.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the 
subcommittee. Written submissions may be made to the contact person 
by October 10, 2003. Oral presentations from the public will be 
scheduled between approximately 11:30 a.m. and 12:30 p.m. on October 
21, 2003, and between approximately 1 p.m. and 2 p.m. on October 22, 
2003. Time allotted for each presentation may be limited. Those 
desiring to make formal oral presentations should notify the contact 
person before October 10, 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 Hilda Scharen 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 25, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-24927 Filed 10-1-03; 8:45 am]