[Federal Register Volume 69, Number 147 (Monday, August 2, 2004)]
[Rules and Regulations]
[Pages 46098-46099]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-17543]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14


Advisory Committee; Pediatric Advisory Committee; Establishment

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Final rule.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
establishment of a Pediatric Advisory Committee in the Office of the 
Commissioner. Elsewhere in this issue of the Federal Register, FDA is 
publishing a document requesting nominations for the membership on this 
committee. This document adds the Pediatric Advisory Committee to the 
agency's list of standing advisory committees in 21 CFR 14.100.

DATES:  This rule is effective August 2, 2004. Authority for the 
committee being established will end on June 18, 2006, unless the 
Commissioner formally determines that renewal is in the public 
interest.

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: Under the Federal Advisory Committee Act of 
October 6, 1972 (Pubic Law 92-463) (5 U.S.C. app. 2); section 904 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 394), as amended by 
the Food and Drug Administration Revitalization Act (Public Law 101-
635); section 14 of the Best Pharmaceuticals for Children Act (Public 
Law 107-109), as amended by section 3(b)(2) of the Pediatric Research 
Equity Act of 2003 (Public Law 108-155), and 21 CFR 14.40(b),

[[Page 46099]]

FDA is announcing the establishment of the Pediatric Advisory Committee 
by the Commissioner. The Best Pharmaceuticals for Children Act, as 
amended by the Pediatric Research Equity Act of 2003, provides for the 
establishment of this committee. This committee will provide advice and 
make recommendations to the Commissioner of Food and Drugs on matters 
relating to pediatric therapeutics, pediatric research, and any other 
matter involving pediatrics for which the Food and Drug Administration 
has regulatory responsibility. The committee will also advise and make 
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.
    The Pediatric Advisory Committee will be composed of a core of 12 
voting members including the chair. Members and the chair are selected 
by the Commissioner of Food and Drugs (the Commissioner) or designee 
from among the authorities knowledgeable in pediatric research, 
pediatric subspecialties, statistics, and/or biomedical ethics. The 
core of voting members shall also include one member from a relevant 
patient or patient family organization and may include one technically 
qualified member, selected by the Commissioner or designee who is 
identified with consumer interests and is recommended by either a 
consortium of consumer-oriented organizations or other interested 
persons. In addition to the voting members, the committee may include 
one nonvoting member who is identified with industry interests and one 
nonvoting member who represents a pediatric health organization.
    Therefore, the agency is amending 21 CFR 14.100(a) as set forth 
below.

List of Subjects in 21 CFR Part 14

    Administrative practice and procedure, Advisory committees, Color 
additives, Drugs, Radiation protection.

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Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
14 is amended as follows:

PART 14--PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE:

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1. The authority citation for 21 CFR part 14 is revised to read as 
follows:

    Authority: 5 U.S.C. App. 2; 15 U.S.C. 1451-1461, 21 U.S.C. 41-
50, 141-149, 321-394, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b 264; Pub. L. 107-109; Pub. L. 108-155.

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2. Section 14.100 is amended by adding paragraph (a)(3).


Sec.  14.100   List of standing advisory committees.

* * * * *
    (a) * * *
    (3) Pediatric Advisory Committee.
    (i) Date established: June 18, 2004.
    (ii) Function: Advises on pediatric therapeutics, pediatric 
research, and other matters involving pediatrics for which the Food and 
Drug Administration has regulatory responsibility.

    Dated: July 27, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-17543 Filed 7-29-04; 10:30 am]
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