[Federal Register Volume 69, Number 147 (Monday, August 2, 2004)]
[Notices]
[Page 46153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17542]



[[Page 46153]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Advisory Committee; Pediatric Advisory Committee; Formation of a 
Pediatric Ethics Subcommittee

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
formation of a subcommittee of the Pediatric Advisory Committee. This 
subcommittee has been established to address pediatric ethical issues, 
as well as IRB referrals related to clinical investigations involving 
children as subjects and IRB referrals that involve both FDA regulated 
products and research involving children as subjects that is conducted 
or supported by the Department of Health and Human Services. The 
subcommittee's preliminary recommendations will be presented to the FDA 
Pediatric Advisory Committee.

FOR FURTHER INFORMATION CONTACT:  Jan Johannessen, Office of Science 
and Health Coordination (HF-33), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-6687.

SUPPLEMENTARY INFORMATION: FDA is announcing the formation of a 
subcommittee of the Pediatric Advisory Committee. This subcommittee has 
been established to address pediatric ethical issues, as well as IRB 
referrals related to clinical investigations involving children as 
subjects as specified in Sec.  50.54 (21 CFR 50.54) and IRB referrals 
that involve both FDA regulated products under Sec.  50.54 and research 
involving children as subjects that is conducted or supported by the 
Department of Health and Human Services as specified in 45 CFR 46.407.
    The subcommittee's preliminary recommendations will be presented to 
the FDA Pediatric Advisory Committee. The subcommittee will meet 
approximately two times a year. Meetings of the subcommittee will be 
open to the public. All meetings will be announced in the Federal 
Register at least 15 days prior to each scheduled public meeting.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2).

    Dated: July 27, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-17542 Filed 7-22-04; 10:30 am]
BILLING CODE 4160-01-S