Document ID: FDA-2013-N-0001-0075
Agency: fda
Document Type: Notice
Title: Pediatric Advisory Committee; Notice of Meeting
Posted Date: 2013-08-13T04:00Z

[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Page 49272]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19522]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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.
    Date and Time: The meeting will be held on September 19, 2013, from 
10 a.m. to 5:30 p.m. and September 20, 2013, from 8 a.m. to 1 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 
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: On September 19, 2013, and September 20, 2013, the 
Pediatric Advisory Committee (PAC) will meet to discuss pediatric-
focused safety reviews, as mandated by the Best Pharmaceuticals for 
Children Act (Pub. L. 107-109) and the for Pediatric Research Equity 
Act (Pub. L. 108-155).
    On September 19, 2013, the PAC will meet to discuss Cervarix (human 
papillomavirus Bivalent (Types 16 and 18) vaccine); Gammagard Liquid 
(Immune Globulin Infusion (human)); Hemacord (hematopoietic progenitor 
cells, cord blood); Copegus and Pegasys (rivabirin and peginterferon 
alfa-2a); Chantix (varenicline tartrate); Isentress (raltegravir 
potassium); Intuniv (guanfacine), Topamax (topiramate); Faslodex 
(fulvestrant); Ixempra Kit (ixabepilone); and Plavix (clopidogrel 
bisulfate). An update on the drug program for KidNet will be provided. 
On September 20, 2013, the PAC will meet to discuss the Berlin Heart 
EXCOR Pediatric Ventricular Assist Device; Melody Transcatheter 
Pulmonary Heart Valve (TPV); and Elana Surgical Kit (HUD). On September 
20, 2013, the committee will also receive and discuss a report on the 
September 9 and 10, 2013, meeting of the Pediatric Ethics Subcommittee 
of the PAC concerning their discussion of the ethical issues involved 
in the development of pediatric medical countermeasures.
    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 
August 30, 2013. Oral presentations from the public will be scheduled 
on September 19, 2013, between approximately 11:30 a.m. and 12 noon, 
and on September 20, 2013, between 10:30 a.m. and 11 a.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 
August 22, 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 August 26, 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 at 
301-796-0885, email walter.ellenberg@fda.hhs.gov, 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 6, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-19522 Filed 8-12-13; 8:45 am]
BILLING CODE 4160-01-P