35516 Federal Register / Vol. 63, No. 125 /Tuesday, June 30, 1998 /Rules and Regulations

regulatory authority beginning July 1,

1998, to have OHA attorney advisors

conduct certain prehearing proceedings

and issue fully favorable decisions

where appropriate under the rules. In

order to provide for an uninterrupted

continuance of that authority for the

additional period we believe

appropriate, and to ensure that we

retain the ability to manage the hearings

process appropriately, we find that it is

in the public interest to make these

rules effective upon publication.

Executive Order 12866

We have consulted with the Office of

Management and Budget (OMB) and

determined that these rules do not meet

the criteria for a significant regulatory

action under Executive Order 12866.

Thus, the rules are not subject to OMB

review.

Regulatory Flexibility Act

We certify that these regulations will

not have a significant economic impact

on a substantial number of small entities

because they affect only individuals.

Therefore, a regulatory flexibility

analysis as provided in the Regulatory

Flexibility Act, as amended, is not

required.

Paperwork Reduction Act

These regulations impose no

reporting/recordkeeping requirements

necessitating clearance by OMB.

(Catalog of Federal Domestic Assistance

Program Nos. 96.001, Social SecurityDisability Insurance; 96.006, Supplemental

Security Income)

List of Subjects

20 CFR Part 404

Administrative practice and

procedure, Death benefits, Disability

benefits, Old-Age, Survivors and

Disability Insurance, Reporting and

recordkeeping requirements, Social

Security.

20 CFR Part 416

Administrative practice and

procedure, Aged, Blind, Disability

benefits, Public assistance programs,

Supplemental Security Income (SSI),

Reporting and recordkeeping

requirements.

Dated: June 23, 1998.

Kenneth S. Apfel,

Commissioner of Social Security.

For the reasons set out in the

preamble, subpart J of part 404 and

subpart N of part 416 of chapter III of

title 20 of the Code of Federal

Regulations are amended as set forth

below.

PART 404—FEDERAL OLD-AGE,

SURVIVORS AND DISABILITY

INSURANCE (1950– )

Subpart J is amended as follows:

1. The authority citation for subpart J

of part 404 continues to read as follows:

Authority: Secs. 201(j), 205(a), (b), (d)-(h),

and (j), 221, 225, and 702(a)(5) of the Social

Security Act (42 U.S.C. 401(j), 405(a), (b), (d)-

(h), and (j), 421, 425, and 902(a)(5)); 31 U.S.C.

3720A; sec. 5, Pub. L. 97–455, 96 Stat. 2500

(42 U.S.C. 405 note); secs. 5, 6(c)-(e), and 15,

Pub. L. 98–460, 98 Stat. 1802 (42 U.S.C. 421

note).

2. Section 404.942 is amended by

revising paragraph (g), to read as

follows:

§ 404.942 Prehearing proceedings and

decisions by attorney advisors.

* * * * *

(g) Sunset provision. The provisions

of this section will no longer be effective

on April 1, 1999, unless they are

extended by the Commissioner of Social

Security by publication of a final rule in

the Federal Register.

PART 416—SUPPLEMENTAL

SECURITY INCOME FOR THE AGED,

BLIND, AND DISABLED

Subpart N is amended as follows:

1. The authority citation for subpart N

continues to read as follows:

Authority: Sec. 702(a)(5), 1631, and 1633

of the Social Security Act (42 U.S.C.

902(a)(5), 1383, and 1383b).

2. Section 416.1442 is amended by

revising paragraph (g), to read as

follows:

§ 416.1442 Prehearing proceedings and

decisions by attorney advisors.

* * * * *

(g) Sunset provision. The provisions

of this section will no longer be effective

on April 1, 1999, unless they are

extended by the Commissioner of Social

Security by publication of a final rule in

the Federal Register.

[FR Doc. 98–17343 Filed 6–29–98; 8:45 am]

BILLING CODE 4190–29–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 868, 884, and 890

[Docket No. 94N–0418]

Medical Devices; Retention of Three

Preamendment Class III Devices in

Class III

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is retaining the

following three preamendments class III

devices in class III: Lung water monitor,

powered vaginal muscle stimulator for

therapeutic use, and stair-climbing

wheelchair. The agency is taking this

action because insufficient information

exists to determine that special controls

would provide reasonable assurance of

their safety and effectiveness, and/or

these devices present a potential

unreasonable risk of illness or injury.

EFFECTIVE DATE: July 30, 1998.

FOR FURTHER INFORMATION CONTACT:

Janet L. Scudiero, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1184.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of June 18,

1997 (62 FR 33044), FDA issued a

proposed rule to retain the lung water

monitor, the powered vaginal muscle

stimulator for therapeutic use, and the

stair-climbing wheelchair in class III.

This proposed retention in class III was

based on a lack of information

submitted in response to the section

515(i) of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C.

360e(i)) order to determine whether or

not special controls could be established

to reasonably assure the safety and

effectiveness of these devices.

Interested persons were given until

September 16, 1997, to comment on the

proposed rule. During the comment

period, FDA received no comments on

the proposed rule.

II. FDA’s Conclusion

FDA has concluded that insufficient

information exists to establish special

controls to provide reasonable assurance

of the safety and effectiveness of the

lung water monitor, the powered

vaginal muscle stimulator for

therapeutic use, and the stair-climbing

wheelchair and/or that these devices

present a potential unreasonable risk of

illness or injury.

III. Environmental Impact

The agency has determined under 21

CFR 25.30(h) that this action is of a type

that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.
Federal Register / Vol. 63, No. 125 /Tuesday, June 30, 1998 /Rules and Regulations 35517

IV. Analysis of Impacts

FDA has examined the impacts of the

final rule under Executive Order 12866

and the Regulatory Flexibility Act (Pub.

L. 96–354), as amended by subtitle D of

the Small Business Regulatory Fairness

Act of 1996 (Pub. L. 104–121) and the

Unfunded Mandates Reform Act of 1995

(Pub. L. 104–4). Executive Order 12866

directs agencies to assess all costs and

benefits of available regulatory

alternatives and, when regulation is

necessary, to select regulatory

approaches that maximize net benefits

(including potential economic,

environmental, public health and safety,

and other advantages; distributive

impacts; and equity). The agency

believes that this final rule is consistent

with the regulatory philosophy and

principles identified in the Executive

Order. In addition, the final rule is not

a significant regulatory action as defined

by the Executive Order and so is not

subject to review under the Executive

Order.

If a rule has a significant economic

impact on a substantial number of small

entities, the Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because FDA believes that

there is little or no interest in marketing

these devices, and because this rule

retains these devices as previously

classified, the agency certifies that this

final rule will not have a significant

impact on a substantial number of small

entities. Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

V. Paperwork Reduction Act of 1995

This rule contains no collections of

information. Therefore, clearance by the

Office of Management and Budget under

the Paperwork Reduction Act of 1995 is

not required.

This final rule is issued under

sections 513, 515(i), and 701(a) of the

act (21 U.S.C. 360c, 360e(i), and 371(a))

and under authority of the

Commissioner of Food and Drugs.

Dated: June 17, 1998.

D.B. Burlington,

Director, Center for Devices and Radiological

Health.

[FR Doc. 98–17290 Filed 6–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1 and 301

[TD 8772]

RIN 1545–AU08

Magnetic Media Filing Requirements

for Information Returns

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Final and temporary

regulations.

SUMMARY: This document contains final

and temporary regulations relating to

the requirements for filing information

returns on magnetic media or in other

machine-readable form under section

6011(e) of the Internal Revenue Code

(Code). These regulations affect persons

filing information returns. These

regulations prescribe magnetic media

filing requirements for employers filing

wage and tax statements for employees

in Puerto Rico, U.S. Virgin Islands,

Guam, and American Samoa. In

addition, these regulations provide

taxpayers with the guidance to comply

with the changes made to the Code and

to the administrative practices with

respect to filing on magnetic media or

in other machine-readable form.

DATES: Effective date: These regulations

are effective June 30, 1998.

Applicability date: These regulations

apply to information returns required to

be filed on or after January 1, 1997.

FOR FURTHER INFORMATION CONTACT:

Donna Joy Welch, (202) 622–4910 (not

a toll-free call), if the inquiry relates to

provisions of these regulations. For

further information, see the telephone

numbers listed at the beginning of

SUPPLEMENTARY INFORMATION

SUPPLEMENTARY INFORMATION: If the

inquiry relates to magnetic media filing

and magnetic media specifications for

Form W–2, Form 499R–2/W–2PR, Form

W–2VI, Form W–2GU, and Form W–

2AS, persons residing in the following

locations should contact the

corresponding Social Security

Administration office (not a toll-free

call):

Alabama (404) 562–1314 (Atlanta),

Alaska (206) 615–2125 (Seattle),

American Samoa (415) 744–4559 (San

Francisco),

Arizona (415) 744–4559 (San Francisco),

Arkansas (501) 324–5466 (Little Rock),

California (415) 744–4559 (San

Francisco),

Colorado (303) 844–2364 (Denver),

Connecticut (617) 565–2895 (Boston),

Delaware (215) 597–4632

(Philadelphia),

District of Columbia (215) 597–4632

(Philadelphia),

Florida (404) 562–1314 (Atlanta),

Georgia (404) 562–1314 (Atlanta),

Guam (415) 744–4559 (San Francisco),

Hawaii (415) 744–4559 (San Francisco),

Idaho (206) 615–2125 (Seattle),

Illinois (312) 575–4244 (Chicago),

Indiana (312) 575–4244 (Chicago),

Iowa (816) 936–5649 (Kansas City),

Kansas (816) 936–5649 (Kansas City),

Kentucky (404) 562–1314 (Atlanta),

Louisiana (504) 389–0426 (Baton

Rouge),

Maine (617) 565–2895 (Boston),

Maryland (215) 597–4632

(Philadelphia),

Massachusetts (617) 565–2895 (Boston),

Michigan (312) 575–4244 (Chicago),

Minnesota (312) 575–4244 (Chicago),

Mississippi (404) 562–1314 (Atlanta),

Missouri (816) 936–5649 (Kansas City),

Montana (303) 844–2364 (Denver),

Nebraska (816) 936–5649 (Kansas City),

Nevada (415) 744–4559 (San Francisco),

New Hampshire (617) 565–2895

(Boston),

New Jersey (212) 264–5643 (New York),

New Mexico (505) 262–6048

(Albuquerque),

New York (212) 264–5643 (New York),

North Carolina (404) 562–1314

(Atlanta),

North Dakota (303) 844–2364 (Denver),

Ohio (312) 575–4244 (Chicago),

Oklahoma (405) 951–3007 (Oklahoma

City),

Oregon (206) 615–2125 (Seattle),

Pennsylvania (215) 597–4632

(Philadelphia),

Puerto Rico (787) 766–5574 (San Juan),

Rhode Island (617) 565–2895 (Boston),

South Carolina (404) 562–1314

(Atlanta),

South Dakota (303) 844–2364 (Denver),

Tennessee (404) 562–1314 (Atlanta),

Texas-Central/South (210) 229–6433

(San Antonio),

Texas-Dallas County (214) 767–6777

(Dallas),

Texas-North (817) 978–3123 (Forth

Worth),

Texas-Southeast (713) 718–3015

(Houston),

Texas-West (505) 262–6048

(Albuquerque),

Utah (303) 844–2364 (Denver),

Vermont (617) 565–2895 (Boston),

Virgin Islands (787) 766–5574 (San

Juan),

Virginia (215) 597–4632 (Philadelphia),

Washington (206) 615–2125 (Seattle),

West Virginia (215) 597–4632

(Philadelphia),

Wisconsin (312) 575–4244 (Chicago),

and

Wyoming (303) 844–2364 (Denver).

If the inquiry relates to either the

waiver procedure for all forms described