[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11655-11656]
[FR Doc No: 2013-03613]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Neonatal Subcommittee of the Pediatric 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: Neonatal Subcommittee of the Pediatric 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 Friday, March 15, 2013,
from 8 a.m. to 4 p.m.
    Location: Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver
Spring, MD 20910,<PHONE_NUMBER>, www.sheratonsilverspring.com.

    Contact Person: Walter Ellenberg, Office of the Commissioner, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154,
Silver Spring, MD 20993,<PHONE_NUMBER><EMAIL_ADDRESS>or
FDA Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER>
in the Washington, DC area). 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
at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.
    Agenda: The Food and Drug Administration Safety and Innovation Act
identified the need to expand current pediatric science to include the
neonatal population. On March 15, 2013, FDA's Neonatal Subcommittee of
the Pediatric Advisory Committee will convene a non-voting session to
establish an operational framework for the subcommittee as well as
discuss and comment on nonspecific matters pertaining to neonatology.
The subcommittee will also comment on ways to approach the challenges
and identify different programmatic strategies for advancing the
knowledge necessary to developing neonatal regulatory science.
    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 meeting
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 7, 2013. Oral presentations from the public will be scheduled
between approximately 11 a.m. and 12 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 27, 2013. 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, 2013.
    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 Walter Ellenberg,
301-796-0885, 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 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-03613 Filed 2-15-13; 8:45 am]
BILLING CODE 4160-01-P


Comment Info: =================

General Comment:DOCKET # USCG-2009-0101, SABINE RIVER MILE 19.3, NPRM
LA DEPT OF WILDLIFE AND FISHERIES LETTER, 1 PAGE
NATIONAL MARINE FISHERIES LETTER, 1 PAGE