[Federal Register Volume 76, Number 148 (Tuesday, August 2, 2011)]
[Notices]
[Pages 46304-46305]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0002]


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, September 22, 
2011, from 2 p.m. to 6:30 p.m. and on Friday, September 23, 2011, from 
8 a.m. to 5:30 p.m.
    Location: Hilton Washington DC North/Gaithersburg, 620 Perry Pkwy., 
Gaithersburg, MD 20877.
    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), and follow the prompts to the desired center or product area. 
Please call the Information Line for up-to-date information on this 
meeting. 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 and 
call the appropriate advisory committee hot line/phone line to learn 
about possible modifications before coming to the meeting.
    Agenda: On Thursday, September 22, 2011, the Pediatric Advisory 
Committee 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), for Fluarix 
(influenza virus vaccine), Afluria (influenza virus vaccine), and 
Abilify (aripiprazole). There will also be an update on a study jointly 
funded by the Agency for Healthcare Research and Quality (AHRQ) and FDA 
on antipsychotic use and metabolic effects in children.
    On Friday, September 23, 2011, 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 Akten (lidocaine hydrochloride), Famvir (famciclovir), 
Levaquin (levofloxacin), Navstel (balanced salt ophthalmic solution 
with hypromellose, dextrose, and glutathione), Retrovir (zidovudine), 
Topamax (topiramate), Triesence (triamcinolone acetonide injectable 
suspension), Videx EC (didanosine), Ziagen (abacavir sulfate), and 
Zomig Nasal Spray (zolmitriptan). There will be an informational update 
on Kaletra (lopinavir/ritonavir) oral solution and tablets.
    As mandated by the Food and Drug Administration Amendments Act, 
Title III, Pediatric Medical Device Safety and Improvement Act of 2007 
(Pub. L. 110-85), the committee will discuss the safety of and profit-
making waiver for the pediatric humanitarian device, Melody 
Transcatheter Pulmonary Valve and Ensemble Delivery System.
    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.

[[Page 46305]]

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 
Friday, September 16, 2011. Oral presentations from the public will be 
scheduled between approximately 2 p.m. and 3 p.m on Friday, September 
23, 2011. 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 Friday, September 2, 2011. 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 Tuesday, September 6, 2011.
    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 notify 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: July 28, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-19481 Filed 8-1-11; 8:45 am]
BILLING CODE 4160-01-P