[Federal Register: September 30, 2002 (Volume 67, Number 189)]
[Page 61344-61345]
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 
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 23, 2002, from 8 
a.m. to 5 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee conference room 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Kathleen Reedy, 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 FDA Advisory Committee 
Information Line, 1-800-741-8138

[[Page 61345]]

(301-443-0572 in the Washington, DC area), code 12539. Please call the 
Information Line for up-to-date information on this meeting.
    Agenda: The subcommittee will discuss: (1) Consideration of 
investigational pharmacokinetic studies to identify patient populations 
at risk, (2) methods used to adjust dosing given the availability of 
exposure-response information, (3) use of exposure-response 
relationships in the Pediatric Study Decision Tree, (4) questions to be 
asked of the pediatric database, and (5) scientific and practical 
considerations in the use of pharmacogenetic tests to determine drug 
dosage and administration.
    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 October 14, 
2002. Oral presentations from the public will be scheduled between 
approximately 12 noon and 1 p.m. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 14, 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 
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electric 
    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 Kathleen Reedy 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 20, 2002.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 02-24678 Filed 9-27-02; 8:45 am]