[Federal Register: August 14, 2003 (Volume 68, Number 157)]
[Page 48614]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Manufacturing Subcommittee of the 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: Manufacturing Subcommittee of the 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 September 17, 2003, from 
8:30 a.m. to 5 p.m. and on September 18, 2003, from 8:30 a.m. to 3 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, 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 e-mail: SCHARENH@cder.fda.gov, 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 September 17, 2003, the subcommittee will discuss 
quality by design and how it is distinct from approaches that attempt 
to test in quality. On September 18, 2003, the subcommittee will 
discuss and define principles by which risk management is integrated 
into decisionmaking.
    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 September 10, 
2003. Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 12:30 p.m. on September 18, 2003. Time 
allotted for each presentation may be limited. Those desiring to make 
formal oral presentations should notify the contact person before 
September 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 
    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: August 7, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-20683 Filed 8-13-03; 8:45 am]