[Federal Register: August 4, 2004 (Volume 69, Number 149)]
[Notices]               
[Page 47156]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au04-79]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
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 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 (DHHS).
    Date and Time: The meeting will be held on September 15, 2004, from 
8 a.m. to 1 p.m.
    Location: Center for Drug Evaluation and Research Advisory 
Committee Conference Room, rm. 1066, 5630 Fishers Lane, Rockville, MD.
    Contact Person: Jan N. Johannessen, Office of the Commissioner (HF-
33), Food and Drug Administration, 5600 Fishers Lane (for express 
delivery, rm. 17-51), Rockville, MD 20857, 301-827-6687, e-mail: 
jjohannessen@fda.gov, or FDA Advisory 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.
    Agenda: The committee will discuss: (1) The recommendation of the 
Pediatric Ethics Subcommittee from its meeting on September 10, 2004, 
regarding a referral by an Institution Review Board under 21 CFR 50.54 
and 45 CFR 46.407 of a proposed clinical investigation that involves 
both an FDA-regulated product and research involving children as 
subjects that is conducted or supported by the DHHS, and (2) a report 
by the agency on Adverse Event Reporting, as mandated in section 17 of 
the Best Pharmaceuticals for Children Act, for PULMICORT/RHINOCORT 
(budesonide), CLARINEX (desloratadine), CUTIVATE/FLONASE/FLOVENT 
(fluticasone), OCULFOX (ofloxacin), FLUDARA (fludarabine), and FOSAMAX 
(alendronate).
    The background material will become available no later than the day 
before the meeting and will be posted under the Pediatric Advisory 
Committee (PAC) docket Web site 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 2004 and scroll down to PAC meetings.)

    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 by September 1, 
2004. Oral presentations from the public will be scheduled between 
approximately 11:30 a.m. and 12:30 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before September 1, 
2004, 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.
    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 Jan N. Johannessen 
at least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: July 29, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-17823 Filed 7-30-04; 3:41 pm]

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