[Federal Register Volume 78, Number 37 (Monday, February 25, 2013)]
[Notices]
[Page 12763]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04256]
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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 Thursday, March 14, 2013
from 8 a.m. to 5:30 p.m.
Location: Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver
Spring, MD 20910, 301-589-0800 or visit the hotel's Web site at http://www.sheratonsilverspring.com/.
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 Thursday, March 14, 2013, the Pediatric Advisory
Committee will meet to discuss pediatric-focused safety reviews, as
mandated by the Best Pharmaceuticals for Children Act (Public Law 107-
109) and the for Pediatric Research Equity Act (Public Law 108-155)
for: ACTEMRA (tocilizumab), ALIMTA (Pemetrexed disodium), CREON
(pancrelipase), GADAVIST (gadobutrol), HIZENTRA [Immune Globulin
Subcutaneous (Human), 20% Liquid], INOMAX (nitric oxide), INVEGA
(paliperidone), KEDBUMIN (albumin human), KYTRIL Injection (granisetron
hydrochloride), LAMICTAL XR (lamotrigine), MENACTRA [Meningococcal
(Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate
Vaccine], MOXEZA (moxifloxacin ophthalmic solution 0.5%), NATROBA
(spinosad), NEXIUM (esomeprazole magnesium), NEXIUM IV (esomeprazole
sodium), UROXATRAL (alfuzosin hydrochloride), and ZENPEP
(pancrelipase). Also, there will be an Informational Update on Codeine.
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
March 7, 2013. Oral presentations from the public will be scheduled
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
requested to make their presentation on or before February 27, 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 February 28, 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 [email protected], 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: February 19, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-04256 Filed 2-22-13; 8:45 am]
BILLING CODE 4160-01-P