[Federal Register: April 14, 2003 (Volume 68, Number 71)]
[Page 17959]
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 May 21 and 22, 2003, 
from 8:30 a.m. to 5 p.m.
    Location: Marriott Washingtonian Center, Ballrooms A, B, C, and D, 
9751 Washingtonian Blvd., Gaithersburg, MD.
    Contact Person: Kathleen Reedy, 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: REEDYK@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 May 21, 2003, the subcommittee will discuss: (1) The 
mission of the subcommittee; and (2) direction of the Pharmaceutical 
Current Good Manufacturing Practices (CGMPs) for the 21st Century: A 
Risk-Based Approach. On May 22, 2003, the subcommittee will discuss: 
(1) The regulatory approaches regarding aseptic manufacturing; and (2) 
process analytical technologies and transition from the Advisory 
Committee for Pharmaceutical Science--Process Analytical Technologies 
Subcommittee to Manufacturing Subcommittee.
    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 May 13, 2003. 
Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 12:30 p.m. on both days. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before May 13, 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 Kathleen Reedy 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: April 7, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-9029 Filed 4-11-03; 8:45 am]