

[Federal Register: February 12, 2008 (Volume 73, Number 29)]
[Notices]               
[Page 8047]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12fe08-32]                         


[[Page 8047]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology; 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: Advisory Committee for Pharmaceutical Science 
and Clinical Pharmacology.
    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 March 18, 2008, from 
8:30 a.m. to 5 p.m. and on March 19, 2008, from 8:30 a.m. to 12:30 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: 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. A notice in the Federal Register 
about last minute modifications that impact a previously announced 
advisory committee meeting cannot always be published quickly enough to 
provide timely notice. Therefore, you should always check the agency's 
Web site and call the appropriate advisory committee hot line/phone 
line to learn about possible modifications before coming to the 
meeting.
    Agenda: On March 18, 2008, the committee will: (1) Discuss and 
provide comments on three new topics of this meeting; first new topic: 
The new clinical pharmacogenomics (PGx) concept paper. Key issues in 
the concept paper include an industry survey on the collection of PGx 
samples, and the applications of PGx in clinical development will be 
presented and (2) discuss and provide comments on the second new topic: 
Quantitative clinical pharmacology: Critical path opportunities. An 
example of a disease model and its applications will be presented. The 
regulatory experience, designs, and implications of pediatric studies 
will be discussed. On March 19, 2008, the committee will consider the 
third new topic: Renal impairment concept paper. The effects of renal 
impairment on Cytochrom P (CYP)/transporter, methods of evaluation of 
renal function, and the effects of hemodialysis on drug clearance will 
be discussed.
    FDA intends to make background material available to the public no 
later than 2 business days before the meeting. If FDA is unable to post 
the background material on its Web site prior to the meeting, the 
background material will be made publicly available at the location of 
the advisory committee meeting, and the background material will be 
posted on FDA's Web site after the meeting. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2008 and scroll down to the appropriate advisory committee 
link.
    Procedure: Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person on or before 
March 4, 2008. Oral presentations from the public will be scheduled 
between approximately 10:30 a.m. and 11 a.m. each day. Those desiring 
to make formal oral presentations 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 February 27, 2008. Time allotted 
for each presentation may be limited. If the number of registrants 
requesting to speak is greater than can be reasonably accommodated 
during the scheduled open public hearing session, FDA may conduct a 
lottery to determine the speakers for the scheduled open public hearing 
session. The contact person will notify interested persons regarding 
their request to speak by February 28, 2008.
    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.
    FDA is committed to the orderly conduct of its advisory committee 
meetings. Please visit our Web site at http://www.fda.gov/oc/advisory/default.htm
 for procedures on public conduct during advisory committee 

meetings.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: February 4, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-2540 Filed 2-11-08; 8:45 am]

BILLING CODE 4160-01-S
