[Federal Register: October 25, 2005 (Volume 70, Number 205)]
[Notices]
[Page 61625]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr25oc05-58]
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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 Committee: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on November 14, 2005, from
8:30 a.m. to 5:30 p.m. and on November 15, 2005, from 8:30 a.m. to 1:30
p.m.
Location: Food and Drug Administration, Center for Drug Evaluation
and Research Advisory Committee Conference Room, rm. 1066, 5630 Fishers
Lane, Rockville, MD.
Contact Person: Mimi Phan, 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: phanm@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 14, 2005, the subcommittee will: (1) Receive an
update on previous Clinical Pharmacology Subcommittee meeting
recommendations and an introduction to the topics of this meeting, (2)
discuss and provide comments on the evidence and process for
translation of pharmacogenetic information (e.g., Cytochrome P 2C9
polymorphisms) into label updates for approved products, (3) discuss
current evidence related to the pharmacogenetics of warfarin as a
potential basis for label updates, and (4) discuss and provide comments
on the critical path pilot project, the End-of-Phase 2A meetings which
will include a case study. On November 15, 2005, the subcommittee will
discuss and and provide comments on: (1) An update on the critical path
biomarker-surrogate endpoint project, (2) the use of biomarker
information in labels to facilitate individualizing pharmacotherapy,
and (3) the analytical and clinical validation criteria for approving a
clinical assay (``diagnostic test''). The background material will
become available no later than the day before the meeting and will be
posted on FDA's Web site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm
under the heading ``Advisory Committee for Pharmaceutical
Science.'' (Click on the year 2005 and scroll down to the Advisory
Committee for Pharmaceutical Science meetings.)
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 4,
2005. Oral presentations from the public will be scheduled between
approximately 11:15 a.m. and 11:30 a.m. and 3:35 p.m. and 3:50 p.m. on
November 14, 2005, and between approximately 11:20 a.m. and 11:50 a.m.
on November 15, 2005. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before November 4, 2005, 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
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 Mimi Phan 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 18, 2005.
Jason Brodsky,
Acting Associate Commissioner for External Relations.
[FR Doc. 05-21241 Filed 10-24-05; 8:45 am]
BILLING CODE 4160-01-S