[Federal Register: August 29, 2006 (Volume 71, Number 167)]
[Notices]
[Page 51198]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29au06-46]
[[Page 51198]]
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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 Committee for Pharmaceutical Science on FDA's
regulatory issues.
Date and Time: The meeting will be held on October 18, 2006, from
8:30 a.m. to 5:30 p.m. and on October 19, 2006, from 8:30 a.m. to 1
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: 301-827-6801, e-mail: mimi.phan@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1-800-741-8138 (301-443-0572) in
Washington, DC area), code 3014512539. Please call the Information Line
for up-to-date information on this meeting. 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 (ACPS).'' (Click on the year 2006 and scroll down to ACPS
meetings.)
Agenda: On October 18, 2006, the subcommittee will: (1) Receive an
update on previous Clinical Pharmacology Subcommittee meeting
recommendations and an introduction to three new topics of this
meeting; (2) discuss and provide comments on the first new topic: The
scope and strength of evidence to support the inclusion of
pharmacogenetic information on Cytochrome P2D6 polymorphisms in a
revision of the label for tamoxifen to improve the benefit/risk of the
drug; and (3) discuss and provide comments on the second new topic:
evaluation of transporter-based drug interactions. On October 19, 2006,
the subcommittee will consider the third new topic: The impact of using
prior knowledge on drug development and regulatory decisions. Prior
knowledge of disease change over time and covariates, placebo variation
and drug effects can be used to make better decisions and design more
informative clinical trials. Examples will be used to demonstrate these
principles.
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 on or before
October 3, 2006. Oral presentations from the public will be scheduled
between approximately 11:15 a.m. and 11:45 a.m. on both days. Time
allotted for each presentation may be limited. Those desiring to make
formal oral presentation should notify the contact person 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 on or before October 3, 2006.
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: August 23, 2006.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E6-14296 Filed 8-28-06; 8:45 am]
BILLING CODE 4160-01-S