Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Rules and Regulations 28047

Thereafter, on December 6, 1993 (58 FR

64121), the expiration date of the

musculoskeletal system listings in both

parts A and B was extended, as were the

expiration dates for several other body

system listings. That rule provided that

the musculoskeletal system listings

would no longer be effective on June 6,

1996.

Also, we published a notice of

proposed rulemaking (NPRM) on

December 21, 1993 (58 FR 67574) that

included proposed revisions to these

listings. We will publish any changes to

the listings based on that NPRM in a

subsequent final rule.

In this final regulation, we are

extending for one year, to June 6, 1997,

the date on which the musculoskeletal

system listings will no longer be

effective. We believe that the

requirements in these listings are still

valid for our program purposes.

Specifically, if we find that an

individual has an impairment that

meets the statutory duration

requirement and also meets or is

equivalent in severity to an impairment

in the listings, we will find that the

individual is disabled without

completing the remaining steps of the

sequential evaluation process. We do

not use the listings to find that an

individual is not disabled. Individuals

whose impairments do not meet or

equal the criteria of the listings receive

individualized assessments at the

subsequent steps of the sequential

evaluation process.

Regulatory Procedures

Pursuant to section 702(a)(5) of the

Social Security Act, 42 U.S.C. 902(a)(5),

as amended by section 102 of Public

Law 103–296, SSA follows the

Administrative Procedure Act (APA)

rulemaking procedures specified in 5

U.S.C. 553 in the development of its

regulations. The APA provides

exceptions to its notice and public

comment procedures when an agency

finds there is good cause for dispensing

with such procedures on the basis that

they are impracticable, unnecessary, or

contrary to the public interest. We have

determined that, under 5 U.S.C.

553(b)(B), good cause exists for

dispensing with the notice and public

comment procedures in this case. Good

cause exists because this regulation only

extends the date on which the

musculoskeletal system listings will no

longer be effective. It makes no

substantive changes to the listings. The

current regulations expressly provide

that the listings may be extended, as

well as revised and promulgated again.

Therefore, opportunity for prior

comment is unnecessary, and we are

issuing this regulation as a final rule.

In addition, we find good cause for

dispensing with the 30-day delay in the

effective date of a substantive rule,

provided for by 5 U.S.C. 553(d). As

explained above, we are not making any

substantive changes in the listings.

However, without an extension of the

expiration date for the musculoskeletal

system listings, we will lack regulatory

guidelines for assessing musculoskeletal

system impairments at the third step of

the sequential evaluation processes after

the current expiration date of the

listings. In order to ensure that we

continue to have regulatory criteria for

assessing these impairments under the

listings, we find that it is in the public

interest to make this rule effective upon

publication.

Executive Order 12866

We have consulted with the Office of

Management and Budget (OMB) and

determined that this rule does not meet

the criteria for a significant regulatory

action under Executive Order 12866.

Thus, it was not subject to OMB review.

Regulatory Flexibility Act

We certify that this regulation will not

have a significant economic impact on

a substantial number of small entities.

Therefore, a regulatory flexibility

analysis as provided in Public Law 96–

354, the Regulatory Flexibility Act, is

not required.

Paperwork Reduction Act

This regulation imposes no reporting/

recordkeeping requirements

necessitating clearance by OMB.

(Catalog of Federal Domestic Assistance

Program Nos. 96.001, Social SecurityDisability Insurance; 96.002, Social SecurityRetirement Insurance; 96.004, Social

Security-Survivors Insurance; 96.006,

Supplemental Security Income)

List of Subjects in 20 CFR Part 404

Administrative practice and

procedure, Blind, Disability benefits,

Old-Age, Survivors and Disability

Insurance, Reporting and recordkeeping

requirements, Social Security.

Dated: May 20, 1996.

Shirley S. Chater,

Commissioner of Social Security.

For the reasons set forth in the

preamble, part 404, subpart P, chapter

III of title 20 of the Code of Federal

Regulations is amended as set forth

below.

PART 404—FEDERAL OLD-AGE,

SURVIVORS AND DISABILITY

INSURANCE (1950– )

Subpart P—[Amended]

1. The authority citation for subpart P

of part 404 continues to read as follows:

Authority: Secs. 202, 205(a), (b), and (d)–

(h), 216(i), 221(a) and (i), 222(c), 223, 225,

and 702(a)(5) of the Social Security Act (42

U.S.C. 402, 405(a), (b), and (d)–(h), 416(i),

421(a) and (i), 422(c), 423, 425, and

902(a)(5)).

2. Appendix 1 to subpart P of part 404

is amended by revising item 2 of the

introductory text before part A to read

as follows:

Appendix 1 to Subpart P—Listing of

Impairments

* * * * *

2. Musculoskeletal System (1.00 and

101.00): June 6, 1997.

* * * * *

[FR Doc. 96–13882 Filed 6–3–96; 8:45 am]

BILLING CODE 4190–29–P

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 the

function of the Fertility and Maternal

Health Drugs Advisory Committee. 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

Fertility and Maternal Health Drugs

Advisory Committee has been changed.

After reestablishment of this committee,

on March 23, 1978, the agency decided

that the name ‘‘Advisory Committee for

Reproductive Health Drugs’’ would

more accurately describe the subject

areas for which the committee is
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.

* * * * *