Document ID: FDA-2014-N-0001-0052
Agency: fda
Document Type: Notice
Title: Pediatric Advisory Committee; Notice of Meeting
Posted Date: 2014-07-07T04:00Z

[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38320-38321]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15683]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-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 23, 2014, from 
8 a.m. to 5:30 p.m.
    Location: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD 
20814.
    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 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 link, or call the advisory committee information 
line to learn about possible modifications before coming to the 
meeting.
    Agenda: The Pediatric Advisory Committee will meet to discuss 
pediatric-focused safety reviews, as mandated by the Best 
Pharmaceuticals for Children Act and the Pediatric Research Equity Act 
for: AFINITOR DISPERZ (everolimus); Berlin Heart EXCOR[supreg] 
Pediatric Ventricular Assist Device; CONTEGRA[supreg] Pulmonary Valved 
Conduit; DYMISTA (azelastine hydrochloride; fluticasone propionate); 
Elana Surgical Kit; ENTERRA Therapy System; LEVAQUIN (levofloxacin); 
LEXIVA (fosamprenavir calcium); QNASL (beclomethasone diproprionate), 
Medtronic Melody[supreg] Transcatheter Pulmonary Valve; MENHIBRIX 
(Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid 
Conjugate Vaccine); SINGULAIR (montelukast sodium); TREANDA 
(bendamustine hydrochloride); VERAMYST (fluticasone furoate); VIREAD 
(tenofovirdisoproxil fumarate); and VOLUVEN (6% hydroxyethyl starch 
130/0.4 in 0.9% sodium chloride injection).
    FDA intends to make background material available to the public no 
later

[[Page 38321]]

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 committee. 
Written submissions may be made to the contact person on or before 
August 25, 2014. Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 12:30 p.m. on September 23, 2014. 
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 15, 2014. 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 18, 2014.
    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: June 30, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15683 Filed 7-3-14; 8:45 am]
BILLING CODE 4164-01-P