[Federal Register Volume 72, Number 42 (Monday, March 5, 2007)]
[Rules and Regulations]
[Pages 9674-9675]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3716]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 14


Advisory Committee: Change of Name and Function

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the 
standing advisory committees' regulations to change the name and 
function of the Advisory Committee for Pharmaceutical Science. This 
action is being taken to reflect changes made to the charter for this 
advisory committee.

DATES: This rule is effective March 5, 2007.

FOR FURTHER INFORMATION CONTACT: Theresa Green, Committee Management 
Officer (HF-4), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-1220.

SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the 
Advisory Committee for Pharmaceutical Science, which was established on 
January 22, 1990, has been changed. The name Advisory Committee for 
Pharmaceutical Science and Clinical Pharmacology more accurately 
describes the subject areas for which the committee is responsible. The 
committee shall provide advice on scientific, clinical and technical 
issues related to safety and effectiveness of drug products for use in 
the treatment of a broad spectrum of human diseases, the quality 
characteristics which such drugs purport or are represented to have and 
as required, any other product for which FDA has regulatory 
responsibility, and make appropriate recommendations to the 
Commissioner of Food and Drugs. The Committee may also review agency 
sponsored intramural and extramural biomedical research programs in 
support of FDA's drug regulatory responsibilities and its critical path 
initiatives related to improving the efficacy and safety of drugs and 
improving the efficiency of drug development.
    FDA is revising Sec.  14.100(c)(16) (21 CFR 14.100(c)(16)) to 
reflect these changes. In this document, FDA is hereby formally 
changing the name and the function of the committee by revising Sec.  
14.100(c)(16). Publication of this final rule constitutes a final 
action on this change under the Administrative Procedure Act. Under 5 
U.S.C. 553(b)(B)

[[Page 9675]]

and (d) and 21 CFR 10.40(d) and (e), the agency finds good cause to 
dispense with notice and public procedure and to proceed to an 
immediately effective regulation. Such notice and procedures are 
unnecessary and are not in the public interest, because the final rule 
is merely codifying the new name and expanded function of the advisory 
committee to reflect the current committee charter.

List of Subjects in 21 CFR Part 14

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

0
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

0
1. The authority citation for 21 CFR part 14 continues 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.

0
2. Section 14.100 is amended by revising the heading of paragraph 
(c)(16) and paragraph (c)(16)(ii) to read as follows:


Sec.  14.100  List of standing advisory committees.

* * * * *
    (c) * * *
    (16) Advisory Committee for Pharmaceutical Science and Clinical 
Pharmacology.
    (i) * * *
    (ii) Function: The committee shall provide advice on scientific, 
clinical and technical issues related to safety and effectiveness of 
drug products for use in the treatment of a broad spectrum of human 
diseases, the quality characteristics which such drugs purport or are 
represented to have and as required, any other product for which the 
Food and Drug Administration has regulatory responsibility, and make 
appropriate recommendations to the Commissioner of Food and Drugs. The 
Committee may also review agency sponsored intramural and extramural 
biomedical research programs in support of FDA's drug regulatory 
responsibilities and its critical path initiatives related to improving 
the efficacy and safety of drugs and improving the efficiency of drug 
development.
* * * * *

    Dated: February 26, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-3716 Filed 3-2-07; 8:45 am]
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