[Federal Register: March 5, 2007 (Volume 72, Number 42)]
[Rules and Regulations]
[Page 9674-9675]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05mr07-9]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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]
BILLING CODE 4160-01-S