Meetings:

Federal Register: December 28, 2010 (Volume 75, Number 248)

Notices

Page 81618

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

DOCID:fr28de10-118

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Docket No. FDA-2010-N-0001

Anesthetic and Life Support Drugs Advisory Committee; 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: Anesthetic and Life Support Drugs Advisory

Committee.

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 10, 2011, from 8 a.m. to 4:30 p.m.

Location: FDA White Oak Campus, 10903 New Hampshire Ave.,

Building 31 Conference Center, the Great Room (rm. 1503), Silver

Spring, MD 20993-0002. Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/default.htm; under the heading ``Resources for You'', click on ``White Oak

Conference Center Parking and Transportation Information for FDA

Advisory Committee Meetings''. Please note that visitors to the

White Oak Campus must enter through Building 1.

Contact Person: Kalyani Bhatt, 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, e-mail: kalyani.bhatt@fda.hhs.gov, or FDA Advisory

Committee Information Line, 1-800-741-8138 (301-443-0572 in the

Washington, DC area), and follow the 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: On March 10, 2011, the committee will: (1) Receive updates regarding neurodegenerative findings (findings related to degeneration in the nervous system) in juvenile animals exposed to anesthetic drugs, as well as results from human epidemiological studies using anesthesia in children (information related to studies of patterns and causes of disease); (2) discuss the relevance of these findings to pediatric patients and provide guidance for future preclinical and clinical studies; and (3) discuss the potential implications of these data upon the practice of pediatric anesthesia as well as the communication of the risk of sedative/anesthetic agents to prescribers and parents.

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 24, 2011. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.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 15, 2011. 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 16, 2011.

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 Kalyani Bhatt 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: December 21, 2010.

Jill Hartzler Warner,

Acting Associate Commissioner for Special Medical Programs.

FR Doc. 2010-32591 Filed 12-27-10; 8:45 am

BILLING CODE 4160-01-P