[Federal Register: May 24, 2002 (Volume 67, Number 101)]
[Notices]
[Page 36615-36616]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24my02-88]
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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 June 12, 2002, from 8:30
a.m. to 5:30 p.m., and June 13, 2002, from 8 a.m. to 5 p.m.
Location: Hilton DC North--Gaithersburg, The Ballrooms, 620 Perry
Pkwy., Gaithersburg, MD.
Contact Person: Kathleen Reedy and Jayne Peterson, 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,
petersonj@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 June 12, 2002, the subcommittee will: (1) Identify and
define technology and regulatory uncertainties/hurdles, possible
solutions, and strategies for the successful implementation of process
analytical technologies (PATs) in pharmaceutical development and
manufacturing; (2) discuss general principles for regulatory
application of PATs including principles of method validation,
specifications, and feasibility of the parametric release concept; and
(3) discuss necessary general FDA
[[Page 36616]]
guidance to facilitate the implementation of PATs. On June 13, 2002,
the focus will be on the following two working groups: (1) Product and
process development, and (2) process and analytical validation. The two
working groups will be formed from the merging of the previous four PAT
working groups, which included: (1) Product and process development;
(2) process and analytical validation; (3) chemometrics; and (4)
process analytical technologies, applications, and benefits.
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 31, 2002.
Oral presentations from the public will be scheduled between
approximately 1 p.m. and 2 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 31, 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 Carolyn Jones at
301-827-7001 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, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent
Relations.
[FR Doc. 02-13107 Filed 5-23-02; 8:45 am]
BILLING CODE 4160-01-S