[Federal Register Volume 79, Number 61 (Monday, March 31, 2014)]
[Notices]
[Pages 18034-18035]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07112]
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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 April 21, 2014, from 8
a.m. to 5 p.m. This is a reschedule of a postponed meeting announced in
the Federal Register of January 14, 2014 (79 FR 2452), originally
scheduled for March 3, 2014.
Location: Bethesda Marriott, 5151 Pooks Hill Rd., Bethesda, MD
20814, 301-897-9400 or visit the hotel's Web site at http://www.marriott.com/hotels/travel/wasbt-bethesda-marriott/.
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:
[email protected], 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 April 21, 2014, 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
Pediatric Research Equity Act (Pub. L. 108-155). The PAC will meet to
discuss Activa Dystonia Therapy, ADVATE (antihemophilic factor
(recombinant)), FAMVIR (famciclovir), INTELENCE (etravirine), KEPPRA
(levetiracetam), MAXALT and MAXALT MLT (rizatriptan), NATAZIA
(estradiol valerate and estradiol valerate/dienogest), PERTZYE
(pancrelipase), PERZISTA (darunavir), REYATAZ (atazanavir), SKLICE
(ivermectin), TISSEEL (fibrin sealant), TORISEL (temsirolimus), ULTRESA
(pancrelipase), Vertical Expandable Prosthetic Titanium Rib (VEPTR),
and VIREAD (tenofovir disoproxil fumarate).
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 committee.
Written submissions may be made to the contact person on or before
April 14, 2014. Oral presentations from the public will be scheduled on
April 21, 2014, between approximately 11:30 a.m. and 12:30 p.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
[[Page 18035]]
requested to make their presentation on or before April 4, 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 April 7, 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: March 26, 2014.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-07112 Filed 3-28-14; 8:45 am]
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