[Federal Register: August 29, 2006 (Volume 71, Number 167)]
[Page 51198]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[[Page 51198]]



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 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 
    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 
    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 
    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 
    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]