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[Federal Register: October 1, 2002 (Volume 67, Number 190)]
[Notices]               
[Page 61640]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01oc02-90]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Process Analytical Technologies 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: Process Analytical Technologies 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 October 23, 2002, from 
8:30 a.m. to 5 p.m.
    Location: Ramada Inn, Georgetown and Montrose Conference Rooms, 
1775 Rockville Pike, Rockville, 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, or e-mail: <A HREF="mailto:REEDYK@cder.fda.gov">REEDYK@cder.fda.gov</A>, 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 discuss: (1) Computer systems 
validation--21 CFR part 11 issues pertinent to process analytical 
technologies (PAT), (2) a PAT case study, and (3) rapid microbiology 
testing.
    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 14, 
2002. Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 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 October 14, 2002, 
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 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: September 22, 2002.
Linda Arey Skladany,
Senior Associate Commissioner for External Relations.
[FR Doc. 02-24813 Filed 9-30-02; 8:45 am]
BILLING CODE 4160-01-S

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