[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