Document ID: FDA-2015-N-0001-0020
Agency: fda
Document Type: Notice
Title: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice
of Meeting
Posted Date: 2015-02-25T05:00Z

[Federal Register Volume 80, Number 37 (Wednesday, February 25, 2015)]
[Notices]
[Pages 10123-10124]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-03900]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-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 public advisory 
committee of the Food and Drug Administration (FDA). The meeting will 
be open to the public.
    Name of Committee: Pediatric Ethics Subcommittee of the Pediatric 
Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency regarding ethical protections for 
children in FDA-regulated clinical trials.
    Date and Time: The meeting will be held on Monday, March 23, 2015 
from 8:30 a.m. to 4:30 p.m.
    Location: Doubletree by Hilton Hotel, 8727 Colesville Rd., Silver 
Spring, MD 20910. Answers to commonly asked questions, including 
information regarding special accommodations due to a disability, 
visitor parking, and transportation, may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.
    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 
walter.ellenberg@fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-

[[Page 10124]]

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 Pediatric Ethics Subcommittee of the Pediatric Advisory 
Committee will meet to discuss the general topic of how procedural 
sedation for nontherapeutic (research) interventions or procedures in 
the pediatric population should be considered under the Additional 
Safeguards for Children in Clinical Investigations at 21 CFR 50 subpart 
D. A brief summary of the subcommittee's discussion will then be 
presented to the FDA Pediatric Advisory Committee on Tuesday, March 24, 
2015.
    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 9, 2014. Oral presentations from the public will be scheduled 
between 11:30 a.m. and 12:30 p.m. on March 23, 2015. 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 26, 2015. 
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 March 2, 2015.
    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 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 20, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03900 Filed 2-24-15; 8:45 am]
BILLING CODE 4164-01-P