[Federal Register Volume 73, Number 200 (Wednesday, October 15, 2008)]
[Notices]
[Pages 61139-61140]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-24356]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0038]


Pediatric Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    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 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 18, 
2008, from 8 a.m. to 5 p.m.
    Location: Holiday Inn Gaithersburg, 2 Montgomery Village Rd., 
Gaithersburg, MD 20877.
    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 href="/cdn-cgi/l/email-protection#ec8dac8a888dc284849fc28b839a"><span class="__cf_email__" data-cfemail="167756707277387e7e6538717960">[email protected]</span></a>, 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 18, 2008, the Pediatric Advisory Committee will 
hear and discuss reports by the agency, as mandated in section 17 of 
the Best Pharmaceuticals for Children Act (BPCA), on adverse event 
reports for BETOPTIC S (betaxolol), ALDARA (imiquimod), LAMICTAL 
(lamotrigine), LEVAQUIN (levofloxacin), SANDOSTATIN (octreotide), 
ZYPREXA (olanzapine), RISPERDAL (risperidone), LAMISIL (terbinafine), 
TIMOLOL GFS (timolol), and AMBIEN (zolpidem). The committee will be 
provided a written followup report on ZYVOX (linezolid), as requested 
by the committee at the November 16, 2006, Pediatric Advisory Committee 
meeting. The committee will also be updated on other activities, 
including the June 9 and 10, 2008, Pediatric Ethics Subcommittee 
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. Background material is 
available at http://www.fda.gov/ohrms/dockets/ac/acmenu.htm, click on 
the year 2008 and 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 
October 27, 2008. Oral presentations from the public will be scheduled 
between approximately 1:30 p.m. and 2:30 p.m. on November 18, 2008. 
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 17, 2008. 
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 20, 2008.
    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 Pe[ntilde]a

[[Page 61140]]

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/oc/advisory/default.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: October 7, 2008.
Randall W. Lutter,
Deputy Commissioner for Policy.
[FR Doc. E8-24356 Filed 10-14-08; 8:45 am]
BILLING CODE 4160-01-S


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