[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]
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