Document ID: FDA-2010-N-0067-0001
Agency: fda
Document Type: Notice
Title: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology; Notice of Meeting
Posted Date: 2010-02-24T05:00Z

[Federal Register: February 24, 2010 (Volume 75, Number 36)]
[Notices]               
[Page 8368-8369]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24fe10-96]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0067]

 
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 17, 2010, from 
7:30 a.m. to 3 p.m.
    Location: Atlanta Marriott Marquis, 265 Peachtree Center Ave., 
Atlanta, GA 30303. The hotel phone number is 404-521-0000.
    Addresses: Submit electronic comments on this document to http://
www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Submit a single copy of electronic 
comments or two paper copies of any mailed comments, except that 
individuals may submit one paper copy. Comments should be identified 
with the docket number found in brackets in the heading of this 
document. Comments received on or before March 8, 2010, will be 
provided to the committee before the meeting. Received comments may be 
seen in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.
    Contact Person: Yvette Waples, 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: yvette.waples@fda.hhs.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. 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 17, 2010, the committee will discuss and provide 
comments on the following topics: (1) General scientific issues related 
to the application of pharmacogenomics in the early stages of drug 
development. Pharmacogenomics examines the genetic differences that 
influence a person's responses, both beneficial and harmful, to certain 
drugs; (2) a new patient-centric clinical pharmacology approach to drug 
safety; (3) the design and analysis of clinical pharmacology studies 
focusing on how the renal function changes in the way the body absorbs, 
distributes, metabolizes, and excretes a drug in patients with kidney 
impairment; and (4) scientific considerations and recent developments 
in transporter-mediated drug interactions. These interactions are 
between two or more drugs that either inhibit or enhance the roles of 
specialized proteins known as ``transporters'' and, in turn, the 
interactions can affect a drug's safety and/or efficacy.
    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/AdvisoryCommittees/Calendar/
default.htm. 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 8, 2010. Oral presentations from the public will be scheduled 
between approximately 9:25 a.m. and 10 a.m., and 1:15 p.m. and 1:45 
p.m. 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

[[Page 8369]]

participants, and an indication of the approximate time requested to 
make their presentation on or before March 1, 2010. 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 March 2, 2010.
    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 Yvette Waples 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/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.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 18, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-3594 Filed 2-23-10; 8:45 am]
BILLING CODE 4160-01-S