[Federal Register: May 24, 2002 (Volume 67, Number 101)]
[Page 36615-36616]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


    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 
    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 
    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 
[FR Doc. 02-13107 Filed 5-23-02; 8:45 am]