[Federal Register Volume 76, Number 73 (Friday, April 15, 2011)]
[Pages 21382-21383]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-9149]



Food and Drug Administration

[Docket No. FDA-2011-N-0184]

Pediatric Ethics Subcommittee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


    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 Pediatric Advisory Committee on FDA and certain 
Department of Health and Human Services regulatory issues.

DATES: The meeting will be held on Wednesday, May 11, 2011, from 8 a.m. 
to 3 p.m.
    FDA is opening a docket to allow for additional public comments to 
be submitted to the Agency on the issues before the Pediatric Ethics 
Subcommittee. Submit either electronic or written comments by May 5, 

ADDRESSES: The meeting will be held at the North Marriott Hotel & 
Conference Center, 5701 Marinelli Rd., Bethesda, MD 20852.
    Submit electronic comments to http://www.regulations.gov. Submit 
written comments to the Division of Dockets Management (HFA-305), Food 
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 
    Contact Person: Walter Ellenberg, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154, 
Silver Spring, MD 20993-0002, 301-796-0885, or by e-mail: 
Walter.Ellenberg @fda.hhs.gov, or FDA Advisory Committee Information 
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area). Please 
call the

[[Page 21383]]

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 hotline/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: On May 11, 2011, the Pediatric Ethics Subcommittee of the 
Pediatric Advisory Committee will meet to discuss the general topic of 
the ethics of administering subtherapeutic doses of investigational 
products to children for the purpose of determining, for example, drug 
metabolism, disposition, and targeting (e.g., exploratory 
investigational new drug (IND) studies). In this context, the 
subcommittee will also discuss the referral of such protocols by an 
Institutional Review Board for review by a Federal panel under 21 CFR 
    The subcommittee's recommendations will then be presented to the 
FDA Pediatric Advisory Committee on Monday, May 16, 2011. The 
announcement of the May 16, 2011, Pediatric Advisory Committee meeting 
can be found elsewhere in this issue of the Federal Register.
    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 subcommittee. 
Written submissions may be made to the contact person on or before 
April 28, 2011. Oral presentations from the public will be scheduled 
between approximately 11 a.m. and 12 noon on May 11, 2011. Those 
desiring to make 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 April 20, 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 April 21, 2011.
    Comments: FDA is opening a docket to allow for additional public 
comments to be submitted to the Agency on issues before the Pediatric 
Ethics Subcommittee beginning April 15, 2011, and closing May 5, 2011. 
All comments received on or before May 5, 2011, will be provided to the 
committee members. All comments received after May 5, 2011, will be 
taken into consideration by the Agency. Interested persons are 
encouraged to use the docket to submit either electronic or written 
comments regarding this meeting (see ADDRESSES). Submit electronic 
comments to http://www.regulations.gov. Submit written comments to 
Division of Dockets Management (see ADDRESSES). It is necessary to 
submit only one set of comments. It is no longer necessary to send two 
copies of mailed comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets management between 9 a.m. and 4 
p.m. Monday through Friday.
    Persons attending FDA's advisory committee meetings are advised 
that the Agency is not responsible for providing access to electrical 
    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: April 11, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-9149 Filed 4-14-11; 8:45 am]