28048 Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Rules and Regulations

responsible. The mandate of the

committee has expanded significantly in

recent years to include drugs for

menopausal women and drugs used in

the practice of andrology. The change is

consistent with the growing use of this

term by specialists in the field of

reproductive health, which includes

obstetrics, gynecology, endocrinology,

andrology, epidemiology, and related

specialties. The committee reviews and

evaluates data on the safety and

effectiveness of marketed and

investigational human drugs for use in

the practice of obstetrics, gynecology,

and related specialties.

The Fertility and Maternal Health

Drugs Advisory Committee’s name was

changed in the charter renewal dated

March 23, 1996. In this document, FDA

is hereby formally changing the name

and the function of the committee by

revising 21 CFR 14.100(c)(9).

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 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 of paragraph (c)(9)

and paragraph (c)(9)(ii) to read as

follows:

§ 14.100 List of standing advisory

committees.

* * * * *

(c) * * *

(9) Advisory Committee for

Reproductive Health Drugs.

* * * * *

(ii) Function: Reviews and evaluates

data on the safety and effectiveness of

marketed and investigational human

drugs for use in the practice of

obstetrics, gynecology, and related

specialties.

* * * * *

Dated: May 28, 1996.

Michael A. Friedman,

Deputy Commissioner for Operations.

[FR Doc. 96–13978 Filed 6–3–96; 8:45 am]

BILLING CODE 4160–01–F

21 CFR Part 14

Standing Advisory Committees;

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 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:

§ 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.

* * * * *