[Federal Register Volume 69, Number 191 (Monday, October 4, 2004)]
[Notices]
[Pages 59238-59239]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-22214]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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: [email protected] 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a draft guidance for industry being prepared by FDA.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
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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
outlets.
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]
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