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Food and Drug Administration, HHS.
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: email@example.com, 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).Start Signature
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