[Federal Register: May 27, 2004 (Volume 69, Number 103)]
[Page 30321]
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 Subcommittee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on July 20 and 21, 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, 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 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 July 20, 2004, the subcommittee will address the 
following issues: (1) Receive topic updates for ongoing activities 
pertaining to manufacturing science and quality by design; and (2) 
discuss and provide comment on a Current Good Manufacturing Practice 
(cGMP) risk model being developed at FDA. On July 21, 2004, the 
subcommittee will address the following issues: (1) Discuss and provide 
comments on a cGMP and quality system approach for the production of 
investigational new drugs (INDs) and (2) discuss and provide comments 
on manufacturing science and risk-based questions for new drug 
application chemistry, manufacturing and controls (NDA CMC) review 
    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 July 13, 2004. 
Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 1:30 p.m. on July 20, 2004, and between 
approximately 11:30 a.m. and 12 noon on July 21, 2004. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before July 13, 
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 
    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: May 20, 2004.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 04-11945 Filed 5-26-04; 8:45 am]