Document ID: FDA-2012-N-0001-0090
Agency: fda
Document Type: Notice
Title: Pediatric Advisory Committee Meeting
Posted Date: 2012-07-30T04:00Z

[Federal Register Volume 77, Number 146 (Monday, July 30, 2012)]
[Notices]
[Pages 44639-44640]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18509]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-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 11, 2012, from 
8:30 a.m. to 4 p.m.
    Location: DoubleTree by Hilton Hotel, 8727 Colesville Rd., Silver 
Spring, MD 20910. The hotel's telephone number is 301-589-5200.
    Contact Person: Walter Ellenberg, Office of Pediatric Therapeutics, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 
5154, Silver Spring, MD. 20993, 301-796-0885, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), to find out further information regarding FDA advisory committee 
information. 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 11, 2012, 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 
Pediatric Research Equity Act (Public Law 108-155), for Kapvay 
(clonidine hydrochloride), Vyvanse (lisdexamfetamine dimesylate), 
Ofirmev (acetaminophen), ella (ulipristal acetate), Beyaz 
(drospirenone/ethinyl estradiol/levomefolate calcium tablets and 
levomefolate calcium tablets), Lo

[[Page 44640]]

Loestrin Fe (norethindrone acetate and ethinyl estradiol ethinyl 
estradiol and ferrous fumarate), Aridol (mannitol inhalation powder), 
Augmentin XR (amoxicillin/clavulanate potassium), Afinitor 
(everolimus), Moxeza (moxifloxacin hydrochloride), and Lastacaft 
(alcaftadine).
    As mandated by the Food and Drug Administration Amendments Act, 
Title III, Pediatric Medical Device Safety and Improvement Act of 2007 
(Public Law 110-85), the committee will discuss the safety of and the 
ongoing propriety of the humanitarian device exemption for the Melody 
Transcatheter Pulmonary Valve and Ensemble Delivery System and the 
Elana Surgical Kit.
    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 
September 4, 2012. Oral presentations from the public will be scheduled 
between approximately 11:30 a.m. and 12:30 p.m. on September 11, 2012. 
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 24, 2012. 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 27, 2012.
    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 
(walter.ellenberg@fda.hhs.gov) or 301-796-0885 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: July 24, 2012.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2012-18509 Filed 7-27-12; 8:45 am]
BILLING CODE 4160-01-P