September 19, 2013: Pediatric Advisory Committee Meeting Announcement
|OC||September 19, 2013|
September 20, 2013
|10:00 a.m. - 5:30 p.m.|
8:00 a.m. - 1:00 p.m.
|Doubletree Hilton Hotel |
8727 Colesville Rd.
Silver Spring, MD 20910
On Thursday, September 19, 2013, the Pediatric Advisory Committee (PAC) will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (Public Law 107-109) and the for Pediatric Research Equity Act (Public Law 108-155) for Cervarix [human papillomavirus Bivalent (Types 16 and 18) vaccine]; Gammagard Liquid [Immune Globulin Infusion (human)]; Hemacord (hematopoietic progenitor cells, cord blood); Copegus & Pegasys (rivabirin and peginterferon alfa-2a); Chantix (varenicline tartrate); Isentress (raltegravir potassium); Intuniv (guanfacine), Topamax (topiramate); Faslodex (fulvestrant); Ixempra Kit (ixabepilone); and Plavix (clopidogrel bisulfate). An update on the pediatric trials for the drug program for Kidnet will be provided.
On September 20, 2013 the PAC will meet to discuss, 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 Berlin Heart EXCOR Pediatric Ventricular Assist Device; Melody Transcatheter Pulmonary Heart Valve (TPV); and Elana Surgical Kit (HUD). The committee will also receive and discuss a report on the September 9-10, 2013 meeting of the Pediatric Ethics Subcommittee of the PAC concerning their discussion of the ethical issues involved in the development of pediatric medical countermeasures.
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.
- Background material
Public Participation and Sponsor Information
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 August 30, 2013. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:00 p.m. on September 19, 2013, and between 10:30 a.m. and 11:00 p.m. on September 20, 2013. 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 22, 2013.
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 26, 2013.
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
- FDA Advisory Committee Information Line
(301-443-0572 in the Washington DC area)
Please call the Information Line for up-to-date information on this meeting.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app.2).