June 23, 2009: Meeting of the Pediatric Advisory Committee Meeting Announcement
|OC||June 23, 2009||8:30 a.m. - 5:00 p.m.|
Hilton, WashingtonDC/Rockville Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland, 20852
On June 23, 2009, the Pediatric Advisory Committee will review and discuss reports by the Agency, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act, for Alvesco (ciclesonide), Androgel (testosterone), Asmanex (mometasone furoate), Combigan (brimonidine/timolol), Depakote (divalproex sodium), Derma-Smoothe F/S (fluocinolone acetate), Diovan (valsartan), Hepsera (adefovir dipivoxil), Inspra (eplerenone), Moxatag (amoxicillin), Omnaris (ciclesonide), and Zometa (zoledronic acid).
More complete information about the topics on which FDA will seek public input will be available by or around June 19, 2009 at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm, click on the year 2009 and scroll down to the appropriate advisory committee link.
FDA intends to make the complete 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 (http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm)
Public Participation and Sponsor Information
Interested persons and Sponsors (representatives from industry) 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 June 9, 2009. Comments received on or before June 19, 2009, will be provided to the committee before the meeting.
- Oral presentations from the public (excluding Sponsors) will be scheduled between approximately 1 p.m. and 2 p.m on June 23, 2009. Those desiring to make 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 June 1, 2009. 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 June 2, 2009.
- Martha Monser
10903 New Hampshire Ave.
Silver Spring, MD
- 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.
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 Website and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.
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.
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 Carlos Peña, PhD, MS at (301) 827-3340 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).