Document ID: FDA-2013-N-0001-0010
Agency: fda
Document Type: Notice
Title: Neonatal Subcommittee of the Pediatric Advisory Committee Meeting
Posted Date: 2013-02-19T05:00Z

[Federal Register Volume 78, Number 33 (Tuesday, February 19, 2013)]
[Notices]
[Pages 11655-11656]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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, 301-589-0800, www.sheratonsilverspring.com.

[[Page 11656]]

    Contact Person: Walter Ellenberg, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154, 
Silver Spring, MD 20993, 301-796-0885, walter.ellenberg@fda.hhs.gov, or 
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 
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