[Federal Register: February 6, 2002 (Volume 67, Number 25)]
[Page 5603]
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 February 25, 2002, from 
8:30 a.m. to 5:30 p.m., and February 26, 2002, from 8 a.m. to 5 p.m.:
    Location: Holiday Inn, The Ballrooms, Two Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Nancy Chamberlin, 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: CHAMBERLINN@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 February 25, 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, use and validation of chemometric tools, and 
feasibility of parametric release concept; and (3) discuss the need for 
a general FDA guidance to facilitate the implementation of PATs.
    On February 26, 2002, the subcommittee will discuss strategies to 
explore issues in the following four focus areas: (1) Product and 
process development, (2) process and analytical validation, (3) 
chemometrics, and (4) process analytical technologies, applications and 
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the subcommittee. 
Written submissions maybe made to the contact person by February 15, 
2002. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. on February 25, 2002, and between 
approximately 1:30 p.m. and 2 p.m. on February 26, 2002. Time allotted 
for each presentation may be limited. Those desiring to make formal 
oral presentations should notify the contact person before February 15, 
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 Nancy Chamberlin 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: January 31, 2002.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 02-2882 Filed 2-5-02; 8:45 am]