[Federal Register Volume 67, Number 190 (Tuesday, October 1, 2002)]
[Notices]
[Page 61640]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-24813]
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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: [email protected], 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
