[Federal Register Volume 77, Number 7 (Wednesday, January 11, 2012)]
[Notices]
[Pages 1696-1697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-324]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0001]


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 14, 2012, from 
7:30 a.m. to 3 p.m.
    Location: Gaylord National Hotel and Convention Center, Maryland 
Ballroom C, 201 Waterfront St., National Harbor, MD 20745. The hotel's 
phone number is (301) 965-4000.
    Contact Person: Yvette Waples, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
31, Rm. 2417, Silver Spring, MD 20993-0002, (301) 796-9001, FAX: (301) 
847-8533, email: <a href="/cdn-cgi/l/email-protection#e2a3a1b2b1cfa1b2a2848683cc8a8a91cc858d94"><span class="__cf_email__" data-cfemail="acedeffcff81effceccac8cd82c4c4df82cbc3da">[email protected]</span></a>, or FDA Advisory Committee 
Information Line, 1-(800) 741-8138 ((301) 443-0572 in the Washington, 
DC area), and follow prompts to the desired center or product area. 
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: The committee will discuss the clinical pharmacology 
aspects of pediatric clinical trial design and dosing to optimize 
pediatric drug development. FDA will seek input on how to strategically 
inform pediatric clinical trial design and dosing by utilizing existing 
knowledge, including available adult and nonclinical data. The 
discussion will include the role of modeling and simulation including 
physiologically-based pharmacokinetic modeling in pediatric drug 
development. Modeling and simulation is the application of mathematical 
approaches to predicting what will happen in a clinical trial with 
pediatric patients when a particular dose of a drug is used.
    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 
February 29, 2012. Oral presentations from the public will be scheduled 
between approximately 10:45 a.m. and 11:45 a.m. Those individuals 
interested in making 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 21, 2012. 
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 22, 2012.
    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

[[Page 1697]]

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: January 5, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-324 Filed 1-10-12; 8:45 am]
BILLING CODE 4160-01-P


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