On Tuesday, September 11, 2012, 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 Kapvay (clonidine hydrochloride), Vyvanse (lisdexamfetamine dimesylate), Ofirmev (acetaminophen), ella (ulipristal acetate), Beyaz (drospirenone/ethinyl estradiol/levomefolate calcium tablets and levomefolate calcium tablets), LoLoestrin 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 the complete set of 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 website prior to the meeting, all efforts will be made to try and provide the background material at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

 

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 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 for procedures on public conduct during advisory committee meetings.

 

Walter Ellenberg, Ph.D.
Office of Pediatric Therapeutics
Office of the Commissioner
Food and Drug Administration
Bldg. 32, Room 5154
10903 New Hampshire Ave..
Silver Spring, Maryland 20993

 

Phone: 301–796-0885
Fax: 301-847-8640
 

E-mail: walter.ellenberg@fda.hhs.gov

 

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).