[Federal Register: October 15, 2007 (Volume 72, Number 198)]
[Page 58310-58311]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

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. The committee 
also advises and makes recommendations to the Secretary of Health and 
Human Services under 45 CFR 46.407 on research involving children as 
subjects that is conducted or supported by the Department of Health and 
Human Services, when that research is also regulated by FDA.
    Date and Time: The meeting will be held on Tuesday, November 27, 
2007, from 8 a.m. to 5:30 p.m. and Wednesday, November 28, 2007, from 8 
a.m. to 6 p.m.
    Location: Hilton, Washington DC North/Gaithersburg, Grand Ballroom, 
620 Perry Pkwy., Gaithersburg, MD.
    Contact Person: Carlos Pe[ntilde]a, Office of Science and Health 
Coordination, Office of the Commissioner (HF-33), Food and Drug 
Administration, 5600 Fishers Lane (for express delivery, rm. 14B-08), 
Rockville, MD 20857, 301-827-3340, e-
mail:Carlos.Pe[ntilde]a@fda.hhs.gov, or FDA Advisory Committee 
Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC 
area), code 8732310001. 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 November 27, 2007, in response to the Pediatric Advisory 
Committee's 2005 request for specific updates after 2 additional years 
of influenza seasons, the committee will receive information on adverse 
event reports, focusing on neuropsychiatric and behavioral events, for 
Tamiflu (OSELTAMIVIR). On November 28, 2007, the Pediatric Advisory 
Committee will hear and discuss reports by the agency, as mandated in 
Section 17 of

[[Page 58311]]

the Best Pharmaceuticals for Children Act (BPCA), on adverse event 
reports for Serevent (SALMETEROL), Provigil (MODAFINIL), Azopt 
Gleevec (IMATINAB MESYLATE). The Pediatric Advisory Committee will also 
hear about and discuss the Pediatric Initiatives between FDA and the 
European Medicines Agency.
    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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 

the year 2007 and scroll down to the appropriate advisory committee 
    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 
November 5, 2007. Oral presentations from the public will be scheduled 
between approximately 1 p.m. to 2: p.m. on November 27, 2007 and 11 
a.m. to 11:30 a.m. and 3 p.m. to 3:30 p.m. on November 28, 2007. 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 October 26, 2007. 
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 October 29, 2007.
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to electrical 
    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 Dr. Carlos 
Pe[ntilde]a 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 athttp://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/oc/advisory/default.htm
 for procedures on public conduct during advisory committee 

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

    Dated: October 8, 2007.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E7-20302 Filed 10-12-07; 8:45 am]