2011-19481. Pediatric Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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.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.