[Federal Register: April 3, 2003 (Volume 68, Number 64)]
[Page 16292]
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 April 22, 2003, from 
8:30 a.m. to 5 p.m. and April 23, 2003, from 8:30 a.m. to 12:30 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5600 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, e-mail: REEDYK@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 April 22, 2003, the subcommittee will discuss: (1) 
Quantitative risk-benefit analysis using exposure-response for 
determining dose adjustment for special populations; and (2) pediatric 
population pharmacokinetics study design template and analyses of the 
FDA pediatric database. On April 23, 2003, the subcommittee will 
discuss: (1) Pharmacogenetics: improvement of existing drug treatments, 
and (2) drug interactions: metabolism and transport-based.
    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 April 15, 
2003. Oral presentations from the public will be scheduled between 
approximately 12:45 p.m. and 1:15 p.m. on April 22, 2003, and 11:30 
a.m. to 12 noon on April 23, 2003. Time allotted for each presentation 
may be limited. Those desiring to make formal oral presentations should 
notify the contact person before April 15, 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 
    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 Kathleen Reedy at 
least 7 days in advance of the meeting.
    FDA regrets that it was unable to publish this notice 15 days prior 
to the Clinical Pharmacology Subcommittee of the Advisory Committee for 
Pharmaceutical Science meeting. Because the agency believes there is 
some urgency to bring these issues to public discussion and qualified 
members of the Clinical Pharmacology Subcommittee of the Advisory 
Committee for Pharmaceutical Science were available at this time, the 
Commissioner of Food and Drugs concluded that it was in the public 
interest to hold this meeting even if there was not sufficient time for 
the customary 15-day public notice.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 25, 2003.
Linda Arey Skladany,
Associate Commissioner for External Relations.
[FR Doc. 03-8011 Filed 4-2-03; 8:45 am]