[Federal Register: April 22, 2002 (Volume 67, Number 77)]
[Page 19577-19578]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

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: 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 May 7 and 8, 2002, from 
8:30 a.m. to 5 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Kathleen Reedy or 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, or 
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 May 7, 2002, the committee will: (1) Discuss the current 
status of, and future plans for, the draft FDA guidance entitled 
``Guidance for Industry, Food-Effect Bioavailability and Fed 
Bioequivalence Studies: Study Design, Data Analysis, and Labeling'' 
(see the FDA Internet address www.fda.gov/cder/guidance/4613dft.PDF 
under ``Biopharmaceutics (Draft) Guidances''); (2) discuss and provide 
comments on the biopharmaceutic classification system; and (3) discuss 
and provide direction for future subcommittees. On May 8, 2002, the 
committee will: (1) Receive summary reports and provide direction for 
the Process Analytical Technology Subcommittee; (2) discuss and provide 
comments on regulatory issues related to crystal habits-polymorphism; 
(3) discuss problems and provide comments to form a scientific basis 
for establishment of acceptance limits for microbiological tests that 
use newly developed technologies that do not rely on colony counts and 
their application as process controls and product release criteria; and 
(4) discuss the current status of, and future plans for, the draft FDA 
guidance entitled ``Guidance for Industry, ANDAs: Blend Uniformity 
Analysis'' (see FDA Internet address www.fda.gov/cder/guidance/
2882dft.PDF under ``Generics (Draft) Guidances'').
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by April 26, 
2002. Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. to 12:30 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 April 26, 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

[[Page 19578]]

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 or 
Jayne Peterson 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: April 11, 2002.
Linda A. Suydam,
Senior Associate Commissioner for Communications and Constituent 
[FR Doc. 02-9734 Filed 4-19-02; 8:45 am]