Document ID: FDA-2010-N-0553-0001
Agency: fda
Document Type: Notice
Title: Meetings: Pediatric Advisory Committee
Posted Date: 2010-10-28T04:00Z

[Federal Register: October 28, 2010 (Volume 75, Number 208)]
[Notices]               
[Page 66381-66382]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28oc10-47]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0553]

 
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 Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the Agency on FDA's regulatory issues.

DATES: The meeting will be held on December 6, 2010, from 8 a.m. to 6 
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 Advisory 
Committee. Submit either electronic or written comments by January 6, 
2011.

ADDRESSES: The meeting will be held at the Bethesda Marriott, 5151 
Pooks Hill Rd., Bethesda, MD 20814.
    Submit electronic comments to http:[sol][sol]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 20852.
    Contact Person: Walter Ellenberg, Office of Pediatric Therapeutics, 
Office of Special Medical Programs, Office of the Commissioner, Food 
and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm. 5154, 
Silver Spring, MD 20993, 301-796-0885, or FDA

[[Page 66382]]

Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in 
the Washington, DC area), code 8732310001. Please call the 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 hot line/phone line to learn about possible 
modifications before coming to the meeting.
    Agenda: The Pediatric Advisory Committee (PAC) will meet to discuss 
donor and banked human milk. FDA is convening the meeting to obtain and 
discuss information and data that will provide the Agency with a better 
understanding of current practices, and potential benefits and risks 
associated with the donation and banking of human milk.
    FDA recognizes the benefits associated with breastfeeding, and is 
focusing this meeting on issues related to banking human milk. Human 
milk is banked for use by infants in need of donated milk. The agenda 
for the meeting will include presentations and discussions on the 
benefits and risks of human milk banking practices as they relate to 
pre-term and term infant populations. Topics will include, but not be 
limited to, infectious disease risks, State regulations and current 
practices in donor and human milk banking.
    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:[sol][sol]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 committee. 
Written submissions may be made to the contact person on or before 
November 29, 2010. Oral presentations from the public will be scheduled 
between approximately 1 p.m. and 2 p.m. Those individuals interesting 
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 November 18, 2010. 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 November 19, 2010.
    Comments: FDA is opening a docket to allow for additional public 
comments to be submitted to the Agency on the issues before the 
Pediatric Advisory Committee beginning October 28, 2010, and closing 
January 6, 2011. All comments received on or before November 29, 2010, 
will be provided to the committee members. All comments received after 
November 29, 2010, 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:[sol][sol]www.regulations.gov. 
Submit written comments to the Division of Dockets Management, Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
It is only necessary to send 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 
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:[sol][sol]www.fda.gov/
AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.[hairsp]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: October 25, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-27283 Filed 10-27-10; 8:45 am]
BILLING CODE 4160-01-P