4024 Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Proposed Rules

applications for this device must be

issued no later than January 28, 1997.

As long as the August 24, 1995, final

rule remains in effect, devices not

subject to approved premarket approval

applications on that date would be

adulterated under section 501(f)(1) of

the act (21 U.S.C. 351(f)(1)). It is not

possible for the agency to propose

revocation of the August 24, 1995, final

rule, offer a lengthy opportunity for

comment on the proposed revocation,

and issue a final revocation by January

28, 1997. Therefore, the agency has

concluded that it is impracticable to

offer a comment period of longer than

15 days on the proposed revocation of

the August 24, 1995, final rule. Even

with a shortened comment period, the

agency will not be able to issue a final

revocation prior to that date.

Accordingly, the agency intends to

exercise its enforcement discretion not

to take regulatory action against the

device during the short time it expects

it will take to complete this rulemaking.

Second, a longer comment period

would be contrary to the public interest.

For the reasons discussed above, the

agency has concluded that it is more

appropriate to invoke the procedures in

section 515(i) of the act for this device.

It is possible that, as a result of those

procedures, the device may be

reclassified and not subject to premarket

approval at all. A lengthy comment

period would prevent the revocation

from becoming effective in time to

ensure continuity of regulation.

Moreover, removal of the device from

the market prior to full consideration of

the information that would be obtained

under section 515(i) of the act would

cause great disruption to both users and

manufacturers of the device and would

have financial consequences. Therefore,

the agency has concluded that it is in

the public interest to shorten the

comment period on this proposed

revocation to 15 days.

Finally, the issues presented by the

proposed revocation are, essentially, the

same issues presented by the proposed

rule to require premarket approval

applications for this device. The agency

received no comments expressing

urgency that the device be subjected to

premarket approval requirements.

Further, the original classification panel

recommended that the CES be

considered a low priority for requiring

premarket approval (43 FR 55640:

November 28, 1978). FDA believes,

therefore, that the shorter comment

period will not deprive interested

persons of the opportunity to express

their views on the proposed revocation.

For the reasons discussed above, a

comment period of longer than 15 days

would be impracticable and contrary to

the public interest. Therefore, FDA

concludes that there is good cause for

shortening the comment period on the

proposed revocation of the August 24,

1995, final rule to 15 days.

III. Environmental Impact

The agency has determined under 21

CFR 25.24(a)(8) 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.

IV. Analysis of Impacts

FDA has examined the impacts of the

proposed rule under Executive Order

12866, and the Regulatory Flexibility

Act (5 U.S.C. 601–612). 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 proposed rule is

consistent with the regulatory

philosophy and principles identified in

the Executive Order. In addition, the

proposed rule is not a significant

regulatory action as defined by the

Executive Order and so is not subject to

review under the Executive Order.

The Regulatory Flexibility Act

requires agencies to analyze regulatory

options that would minimize any

significant impact of a rule on small

entities. Because this proposed rule, if

finalized, will allow FDA to review

information about these devices and

determine the least burdensome degree

of control needed to provide reasonable

assurance of the safety and effectiveness

of the CES device, the agency certifies

that the proposed rule will not have a

significant economic impact on a

substantial number of small entities.

Therefore, under the Regulatory

Flexibility Act, no further analysis is

required.

V. Request for Comments

Interested persons may, on or before

February 12, 1997 submit to the Dockets

Management Branch (address above)

written comments regarding this

proposal. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. Received

comments may be seen in the office

above between 9 a.m. and 4 p.m.,

Monday through Friday.

List of Subjects in 21 CFR Part 882

Medical devices.

Therefore under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 882 be amended as follows:

PART 882—NEUROLOGICAL DEVICES

1. The authority citation for part 882

continues to read as follows:

Authority: Secs. 501, 510, 513, 515, 520,

701 of the Federal Food, Drug and Cosmetic

Act (21 U.S.C. 351, 360, 360c, 360e, 360j,

371).

2. Section 882.5800 is amended by

revising paragraph (c) to read as follows:

§ 882.5800 Cranial electrotherapy

stimulator.

* * * * *

(c) Date PMA or notice of completion

of a PDP is required. No effective date

has been established of the requirement

for premarket approval. See § 882.3.

Dated: January 22, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–1929 Filed 1–27–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1 and 301

[REG–209803–95]

RIN 1545–AU08

Magnetic Media Filing Requirements

for Information Returns; Hearing

Cancellation

AGENCY: Internal Revenue Service,

Treasury.

ACTION: Cancellation of notice of public

hearing on proposed regulations.

SUMMARY: This document provides

notice of cancellation of a public

hearing on proposed Income Tax

Regulations relating to the requirements

for filing information returns on

magnetic media or in other machinereadable form under section 6011(e) of

the Internal Revenue Code.

DATES: The public hearing originally

scheduled for Wednesday, February 5,

1997, beginning at 10:00 a.m. is

cancelled.

FOR FURTHER INFORMATION CONTACT:

Mike Slaughter of the Regulations Unit,
Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Proposed Rules 4025

Assistant Chief Counsel (Corporate),

(202) 622–7190, (not a toll-free number).

SUPPLEMENTARY INFORMATION: The

subject of the public hearing is proposed

regulations under section 6011(e) of the

Internal Revenue Code. A notice of

proposed rulemaking and notice of

public hearing appearing in the Federal

Register on Thursday, October 10, 1996

(61 FR 53161), announced that the

public hearing on proposed regulations

under section 6011 of the Internal

Revenue Code would be held on

Wednesday, February 5, 1997,

beginning at 10:00 a.m., in the

Commissioner’s Conference Room,

Room 3313, Internal Revenue Building,

1111 Constitution Avenue, NW.

Washington, D.C.

The public hearing scheduled for

Wednesday, February 5, 1997, is cancelled.

Cynthia E. Grigsby,

Chief, Regulations Unit Assistant Chief

Counsel (Corporate).

[FR Doc. 97–2069 Filed 1–27–97; 8:45 am]

BILLING CODE 4830–01–U

FEDERAL MINE SAFETY AND HEALTH

REVIEW COMMISSION

29 CFR Part 2704

Implementation of Equal Access to

Justice Act in Commission

Proceedings

AGENCY: Federal Mine Safety and Health

Review Commission.

ACTION: Notice of proposed rulemaking;

extension of comment period.

SUMMARY: The Federal Mine Safety and

Health Review Commission previously

published, on December 19, 1996 (61 FR

66961), proposed revisions to its rules

providing for the award of attorneys’

fees and other expenses under the Equal

Access to Justice Act, 5 U.S.C. 504. The

period for comments to the proposed

rules was set to end on January 21,

1997. A request was made that the

comment period be extended and the

Commission has agreed to do so.

DATES: Comments should be received by

February 3, 1997.

ADDRESSES: Comments should be sent to

Richard L. Baker, Executive Director,

Federal Mine Safety and Health Review

Commission, 1730 K Street, NW, 6th

Floor, Washington, DC 20006. For the

convenience of persons who will be

reviewing the comments, it is requested

that commenters provide an original

and three copies of their comments.

FOR FURTHER INFORMATION CONTACT:

Norman M. Gleichman, General

Counsel, Office of the General Counsel,

1730 K Street, NW, 6th Floor,

Washington, DC 20006, telephone: 202–

653–5610 (202–566–2673 for TDD

Relay). These are not toll-free numbers.

Issued this 22nd day of January, 1997 at

Washington, D.C.

Mary Lu Jordan,

Chairman, Federal Mine Safety and Health

Review Commission.

[FR Doc. 97–1945 Filed 1–27–97; 8:45 am]

BILLING CODE 6735–01–P–M

DEPARTMENT OF DEFENSE

Department of the Air Force

32 CFR Part 806b

[Air Force Reg. 12–35]

Air Force Privacy Act Program

AGENCY: Department of the Air Force,

DOD.

ACTION: Proposed rule.

SUMMARY: The Department of the Air

Force proposes to amend its Privacy Act

regulations to add an exemption for a

system of records identified as F111 AF

JA B, Courts-Martial and Article 15

Records.

DATES: Comments must be received on

or before March 31, 1997, to be

considered by this agency.

ADDRESSES: Send comments to the Air

Force Access Programs Manager, HQ

USAF/SCMI, 1250 Air Force Pentagon,

Washington, DC 20330–1250.

FOR FURTHER INFORMATION CONTACT: Ms.

Anne Rollins at (703) 697–8674 or DSN

227–8674.

SUPPLEMENTARY INFORMATION: Executive

Order 12866. It has been determined

that this Privacy Act proposed rule for

the Department of Defense does not

constitute ‘significant regulatory action’.

Analysis of the rule indicates that it

does not have an annual effect on the

economy of $100 million or more; does

not create a serious inconsistency or

otherwise interfere with an action taken

or planned by another agency; does not

materially alter the budgetary impact of

entitlements, grants, user fees, or loan

programs or the rights and obligations of

recipients thereof; does not raise novel

legal or policy issues arising out of legal

mandates, the President’s priorities, or

the principles set forth in Executive

Order 12866.

Regulatory Flexibility Act. It has been

determined that this Privacy Act

proposed rule for the Department of

Defense does not have significant

economic impact on a substantial

number of small entities because it is

concerned only with the administration

of Privacy Act systems of records within

the Department of Defense.

Paperwork Reduction Act. It has been

determined that this Privacy Act

proposed rule for the Department of

Defense imposes no information

requirements beyond the Department of

Defense and that the information

collected within the Department of

Defense is necessary and consistent

with 5 U.S.C. 552a, known as the

Privacy Act, and 44 U.S.C. Chapter 35.

List of subjects in 32 CFR part 806b

Privacy.

Accordingly, 32 CFR part 806b is

proposed to be amended as follows:

PART 806b – AIR FORCE PRIVACY

ACT PROGRAM

1. The authority citation for 32 CFR

Part 806b continues to read as follows:

Authority: Pub. L. 93–579, 88 Stat 1896 (5

U.S.C. 552a).

2. Appendix C to Part 806b is

proposed to be amended by adding

paragraph (b)(20) as follows:

Appendix C to Part 806b-General and

specific exemptions.

* * * * *

b. Specific exemptions. * * *

(20) System identifier and name: F111

AF JA B, Courts-Martial and Article 15

Records.

(i) Exemption. Portions of this system

of records may be exempt pursuant to 5

U.S.C. 552a(j)(2) from the following

subsection of 5 U.S.C. 552a(c)(3), (c)(4),

(d), (e)(1), (e)(2), (e)(3), (e)(4)(G), (H) and

(I), (e)(5), (e)(8), (f), and (g).

(ii) Exemption. Portions of this system

of records may be exempt pursuant to 5

U.S.C. 552a(k)(2) from the following

subsection of 5 U.S.C. 552a(c)(3), (d),

(e)(1), (e)(4)(G), (H) and (I), and (f).

(iii) Authority: 5 U.S.C. 552a(j)(2) and

(k)(2).

(iv) Reason: (1)From subsection (c)(3)

because the release of the disclosure

accounting, for disclosures pursuant to

the routine uses published for this

system, would permit the subject of a

criminal investigation or matter under

investigation to obtain valuable

information concerning the nature of

that investigation which will present a

serious impediment to law enforcement.

(2) From subsection (c)(4) because an

exemption is being claimed for

subsection (d), this subsection will not

be applicable.

(3) From subsection (d) because

access to the records contained in this

system would inform the subject of a

criminal investigation of the existence

of that investigation, provide the subject

of the investigation with information

that might enable him to avoid detection

or apprehension, and would present a

serious impediment to law enforcement.