[Federal Register Volume 75, Number 248 (Tuesday, December 28, 2010)]
[Notices]
[Page 81618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-32591]
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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.
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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: 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: [email protected], 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]
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