[Federal Register Volume 78, Number 153 (Thursday, August 8, 2013)]
[Notices]
[Pages 48438-48439]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-19138]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Pediatric Ethics 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 subcommittee of a 
public advisory committee of the Food and Drug Administration (FDA). 
The meeting will be open to the public.
    Name of Subcommittee: Pediatric Ethics Subcommittee of the 
Pediatric Advisory Committee.
    General Function of the Subcommittee: To advise and make 
recommendations to the Pediatric Advisory Committee on pediatric 
ethical issues.
    Date and Time: The meeting will be held on September 9, 2013, from 
8 a.m. to 5:30 p.m. and September 10, 2013, from 8 a.m. to 3 p.m.
    Location: Doubletree Hilton Hotel, 8727 Colesville Rd., Silver 
Spring, MD 20910, 301-589-5200 or visit the hotel's Web site at http://doubletree3.hilton.com/en/hotels/maryland/doubletree-by-hilton-hotel-washington-dc-silver-spring-DCASSDT/index.html.
    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, email 
[email protected] 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 subcommittee 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: On September 9 and 10, 2013, the Pediatric Ethics 
Subcommittee of the Pediatric Advisory Committee will meet to discuss 
ethical issues in pediatric product development, including medical 
counter measures, focusing on the concepts of minimal risk, disorder or 
condition, and exposure of pediatric subjects to risks under 21 CFR 
50.54.
    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 subcommittee 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 
September 9, 2013. Oral presentations from the public will be scheduled 
between approximately 2 p.m. and 3 p.m. Those individuals interested in 
making formal oral presentations should notify the contact

[[Page 48439]]

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 August 30, 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 September 3, 2013.
    Persons attending FDA's subcommittee meetings are advised that the 
Agency is not responsible for providing access to electrical outlets.
    FDA welcomes the attendance of the public at this meeting 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 at 301-796-0885, email 
[email protected], 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: August 2, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19138 Filed 8-7-13; 8:45 am]
BILLING CODE 4160-01-P