[Federal Register: October 4, 2004 (Volume 69, Number 191)]
[Page 59238-59239]
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 Subcommittee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on November 3, 2004, from 8 
a.m. to 5:30 p.m., and on November 4, 2004, from 8 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, FAX 301-827-6776, 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 November 3, 2004, the subcommittee will: (1) Receive 
topic updates for ongoing FDA activities previously presented to the 
subcommittee; (2) discuss and provide comments on the evidence for 
updating labels of approved drugs to include integrating 
pharmacogenetic, pharmacokinetic, and prognostic biomarkers for the 
purpose of optimizing therapeutic response and reducing risks of 
toxicity; and (3) discuss and provide comments on metabolism- and 
transporter-based drug-drug interactions included as recommendations in 
a draft guidance for industry being prepared by FDA. On November 4, 
2004, the subcommittee will discuss and provide comments on a new 
critical path project related to general aspects of the transition of 
biomarkers to surrogate endpoints, with a focus on planning and 
process, rather than on specific biomarkers or surrogate endpoints.
    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 25, 
2004. Oral presentations from the public will be scheduled between 
approximately 12:30 p.m. and 1 p.m. on November 3, 2004, and between 1 
p.m. and 1:30 p.m. on November 4, 2004. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before October 25, 2004, 
and submit a brief statement of the general nature of the evidence or 
arguments they wish to present, the names and

[[Page 59239]]

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: September 24, 2004.
Sheila Dearybury Walcoff,
Associate Commissioner for External Relations.
[FR Doc. 04-22214 Filed 10-1-04; 8:45 am]