[Federal Register Volume 61, Number 108 (Tuesday, June 4, 1996)]
[Rules and Regulations]
[Page 28048]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-13979]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 14
Standing Advisory Committees; 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 the
function of the Generic Drugs Advisory Committee to the Advisory
Committee for Pharmaceutical Science. This action is being taken to
more accurately describe this committee.
EFFECTIVE DATE: June 4, 1996.
FOR FURTHER INFORMATION CONTACT: Donna M. Combs, Committee Management
Office (HFA-306), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-443-2765.
SUPPLEMENTARY INFORMATION: FDA is announcing that the name of the
Generic Drugs Advisory Committee has been changed. After establishment
of this committee, on January 22, 1990, the agency decided that the
name ``Advisory Committee for Pharmaceutical Science'' would more
accurately describe the committee. The Committee reviews primary
scientific issues dealing with pharmaceutical science including
testing, research, biopharmaceutics, pharmacology, and new chemistry.
The Committee also gives advice on scientific and technical issues
concerning the safety and effectiveness of human generic drug products
for use in the treatment of a broad spectrum of human diseases.
Therefore, the agency feels the name change will more accurately
describe this Committee to the public. In the Federal Register of
February 21, 1996 (61 FR 6644 at 6645), FDA published a notice that
indicated that the name of the Generic Drugs Advisory Committee had
been changed in the charter renewal dated January 22, 1996. In this
document, FDA is hereby formally changing the name and function of the
committee by revising 21 CFR 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)(3)(B) and (d) and under 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 a clarifying amendment to existing regulations
and when effective will reflect the current committee charter.
List of Subjects in 21 CFR Part 14
Administrative practice and procedure, Advisory committees, Color
additives, Drugs, Radiation protection.
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
1. The authority citation for 21 CFR part 14 continues to read as
follows:
Authority: Secs. 201-903 of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321-394; 21 U.S.C. 41-50, 141-149, 467f, 679, 821,
1034; secs. 2, 351, 354, 361 of the Public Health Service Act (42
U.S.C. 201, 262, 263b, 264); secs. 2-12 of the Fair Packaging and
Labeling Act (15 U.S.C. 1451-1461); 5 U.S.C. App. 2; 28 U.S.C. 2112.
2. Section 14.100 is amended by revising the heading for 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.
* * * * *
(ii) Function: Gives advice on scientific and technical issues
concerning the safety and effectiveness of human generic drug products
for use in the treatment of a broad spectrum of human diseases.
* * * * *
Dated: May 28, 1996.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 96-13979 Filed 6-3-96; 8:45 am]
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