[Federal Register: April 11, 2005 (Volume 70, Number 68)]
[Page 18407]
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 3 and 4, 2005, from 
8:30 a.m. to 5 p.m.
    Location: Food and Drug Administration, Center for Drug Evaluation 
and Research Advisory Committee Conference Room, 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, e-mail: scharenh@cder.fda.gov, or FDA Advisory 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 May 3, 2005, the committee will: (1) Receive an update 
from the Clinical Pharmacology Subcommittee and (2) discuss and provide 
comments on the general topic of establishing drug release or 
dissolution specifications. On May 4, 2005, the committee will: (1) 
Receive an update on current activities of the Parametric Tolerance 
Interval Test Workgroup, (2) discuss and provide comments on the 
general topic of considerations for assessment of pharmaceutical 
equivalence and product design, and (3) discuss criteria for 
establishing a working group for review and assessment of Office of 
Pharmaceutical Science research programs.
    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 25, 
2005. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. each day. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before April 25, 2005, 
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 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: April 1, 2005.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 05-7129 Filed 4-8-05; 8:45 am]