[Federal Register: February 12, 2003 (Volume 68, Number 29)]
[Notices]               
[Page 7128]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe03-51]                         


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Food and Drug Administration


 
Manufacturing Subcommittee of the Advisory Committee for 
Pharmaceutical Science; Notice of Meeting


AGENCY: Food and Drug Administration, HHS.


ACTION: Notice.


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    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 March 21, 2003, from 8 
a.m. to 4:30 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Kathleen Reedy or Carolyn Jones, 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: 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: The subcommittee will: (1) Discuss the mission of the 
subcommittee, (2) discuss the direction of the initiative entitled 
``Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach'' 
(see the FDA Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/guidance/gmp.html), 
and (3) receive an update on the regulatory approaches regarding 
aseptic manufacturing.
    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 March 7, 2003. 
Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. to 12:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before March 7, 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 Carolyn Jones 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: February 3, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-3431 Filed 2-11-03; 8:45 am]

BILLING CODE 4160-01-S