[Federal Register: September 17, 2004 (Volume 69, Number 180)]
[Page 56070-56071]
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 October 19 and 20, 2004, 
from 8:30 a.m. to 5 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Advisory Committee conference rm. 1066, 5630 Fishers Lane, 
Rockville, MD.
    Contact Person: Hilda Scharen, 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, FAX: 301-827-6776, e-mail: SCHARENH@cder.fda.gov, or 
FDAAdvisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 3014512539. Please call the Information 
Line for up-to-date information on this meeting.
    Agenda: On October 19, 2004, the committee will do the following: 
(1) receive updates pertaining to the Manufacturing Subcommittee, the 
Parametric Tolerance Interval Test (PTIT) Workgroup, and the Good 
Manufacturing Practices (GMPs) for the 21st Century Initiative, and (2) 
review and discuss research opportunities under the Critical Path 
Initiative. On October 20, 2004, the committee will do the following: 
(1) review and discuss the Office of Pharmaceutical Science (OPS) plans 
and activities designed to take the organization towards the ``desired 
state'' of science and risk-based regulatory policies and practices as 
articulated under the GMPs for the 21st Century Initiative, and (2) 
review and discuss specific topics related to pharmaceutical 
equivalence and bioequivalence of generic drugs.
    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 October 12, 
2004. 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 October 12, 2004, 
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.

[[Page 56071]]

    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 Hilda Scharen 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 9, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-20934 Filed 9-16-04; 8:45 am]