[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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