[Federal Register: October 8, 2003 (Volume 68, Number 195)]
[Page 58118-58119]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

Clinical Pharmacology 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: Clinical Pharmacology Subcommittee of the

[[Page 58119]]

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 November 17, 2003, from 
8:30 a.m. to 5:30 p.m.; and on November 18, 2003, from 8:30 a.m. to 
1:30 p.m.
    Location: 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, or 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 12539. Please call the Information Line for 
up-to-date information on this meeting.
    Agenda: On November 17, 2003, the subcommittee will discuss: (1) 
Quantitative analysis using exposure-response: Proposal for End-of-
Phase2A (EOP2A) meeting and use of clinical trial simulation for PK-QT 
study design; and (2) pediatric decision tree: Examples for applying 
the pediatric decision tree. On November 18, 2003, the subcommittee 
will discuss the pediatric decision tree: (1) Use of clinical trial 
simulation in pediatric population pharmacokinetics study design; (2) 
drug interactions; and (3) pharmacogenetics: Integration into new drug 
    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 November 6, 
2003. Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 12 noon on November 17, 2003, and 12:30 
p.m. and 1 p.m. on November 18, 2003. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before November 6, 2003, 
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: October 2, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-25446 Filed 10-7-03; 8:45 am]