3584 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Rules and Regulations

amended in light of the comments

received. Factual information that

supports the commenter’s ideas and

suggestions is extremely helpful in

evaluating the effectiveness of the AD

action and determining whether

additional rulemaking action would be

needed.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the rule that might suggest a need to

modify the rule. All comments

submitted will be available, both before

and after the closing date for comments,

in the Rules Docket for examination by

interested persons. A report that

summarizes each FAA-public contact

concerned with the substance of this AD

will be filed in the Rules Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this rule must

submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket No. 99–SW–72–AD.’’ The

postcard will be date stamped and

returned to the commenter.

The regulations adopted herein will

not have a substantial direct effect on

the States, on the relationship between

the national Government and the States,

or on the distribution of power and

responsibilities among the various

levels of government. Therefore, it is

determined that this final rule does not

have federalism implications under

Executive Order 13132.

The FAA has determined that this

regulation is an emergency regulation

that must be issued immediately to

correct an unsafe condition in aircraft,

and that it is not a ‘‘significant

regulatory action’’ under Executive

Order 12866. It has been determined

further that this action involves an

emergency regulation under DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979). If it is

determined that this emergency

regulation otherwise would be

significant under DOT Regulatory

Policies and Procedures, a final

regulatory evaluation will be prepared

and placed in the Rules Docket. A copy

of it, if filed, may be obtained from the

Rules Docket at the location provided

under the caption ADDRESSES.

List of Subjects in 14 CFR Part 39

Air transportation, Aircraft, Aviation

safety, Safety.

Adoption of the Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration amends part 39 of the

Federal Aviation Regulations (14 CFR

part 39) as follows:

PART 39—AIRWORTHINESS

DIRECTIVES

1. The authority citation for part 39

continues to read as follows:

Authority: 49 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding a new airworthiness directive to

read as follows:

AD 99–26–04 Kaman Aerospace

Corporation: Amendment 39–11523.

Docket No. 99–SW–72–AD.

Applicability: Model K–1200 helicopters,

with clutch assembly, part number (P/N)

K974002–701, installed, certificated in any

category.

Note 1: This AD applies to each helicopter

identified in the preceding applicability

provision, regardless of whether it has been

otherwise modified, altered, or repaired in

the area subject to the requirements of this

AD. For helicopters that have been modified,

altered, or repaired so that the performance

of the requirements of this AD is affected, the

owner/operator must request approval for an

alternative method of compliance in

accordance with paragraph (c) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or

repair on the unsafe condition addressed by

this AD; and if the unsafe condition has not

been eliminated, the request should include

specific proposed actions to address it.

Compliance: Required before the first flight

of each day.

To prevent failure of the engine adapter

flange, loss of power to the main rotors, and

a subsequent forced landing, accomplish the

following:

(a) Inspect the integrity of the clutch

assembly, in a location where background

noise would not hinder evaluation, by firmly

and uniformly rotating the Kaflex shaft in the

anti-rotating direction (counter-clockwise

looking forward) while maintaining hand

contact. The anti-rotation speed should be

approximately one-fourth to one-half

revolution per second. An unairworthy

clutch will feel rough with a continuous dry

‘‘raspy’’ feel and sound, or it may feel as

though the clutch has heavy detents or

‘‘catches’’ on the interior surface that impede

the free rotary motion.

(b) Remove any unairworthy clutch

assembly, P/N K974002–701, before further

flight and replace with an airworthy clutch

assembly.

Note 2: Kaman K–1200 K–MAX

Maintenance Manual Temporary Revision

(TR) No. 284, dated November 5, 1999, which

revises the procedures for engine area daily

inspections and TR No. 289, dated November

12, 1999, which describes the method of

inspecting the transmission assembly, pertain

to the subject of this AD.

(c) An alternative method of compliance or

adjustment of the compliance time that

provides an acceptable level of safety may be

used if approved by the Manager, Boston

Aircraft Certification Office, FAA. Operators

shall submit their requests through an FAA

Principal Maintenance Inspector, who may

concur or comment and then send it to the

Manager, Boston Aircraft Certification Office.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Boston Aircraft

Certification Office.

(d) Special flight permits may be issued in

accordance with sections 21.197 and 21.199

of the Federal Aviation Regulations (14 CFR

21.197 and 21.199) to operate the helicopter

to a location where the requirements of this

AD can be accomplished.

(e) This amendment becomes effective on

February 8, 2000, to all persons except those

persons to whom it was made immediately

effective by Emergency Priority Letter AD

99–26–04, issued December 8, 1999, which

contained the requirements of this

amendment.

Issued in Fort Worth, Texas, on January 13,

2000.

Eric Bries,

Acting Manager, Rotorcraft Directorate,

Aircraft Certification Service.

[FR Doc. 00–1642 Filed 1–21–00; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 99N–4955]

Amendment of Various Device

Regulations to Reflect Current

American Society for Testing and

Material Citations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Direct final rule.

SUMMARY: The Food and Drug

Administration (FDA) is amending

certain references in various medical

device regulations. The amendments

update the references in those

regulations to various standards of the

American Society for Testing and

Materials (ASTM) to reflect the current

standards designations. Elsewhere in

this issue of the Federal Register, FDA

is publishing a companion proposed

rule, under FDA’s usual procedures for

notice-and-comment, to provide a

procedural framework to finalize the

rule in the event that the agency

receives any significant adverse

comment and withdraws the direct final

rule.

DATES: The rule is effective June 7, 2000.

Submit written comments on or before

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Rules and Regulations 3585

April 10, 2000. If FDA receives no

significant adverse comments within the

specified comment period, the agency

intends to publish in the Federal

Register a document confirming the

effective date of the direct final rule

within 30 days after the comment

period on this direct final rule ends. If

the agency receives any adverse

comments, FDA intends to withdraw

this final rule by publication in the

Federal Register of a document within

30 days after the comment period ends.

The Director of the Office of the Federal

Register approves the incorporation by

reference in accordance with 5 U.S.C.

552(a) and 1 CFR part 51 of certain

publications in § 801.410(d)(2) (21 CFR

801.410(d)(2)) and § 801.430(f)(2) (21

CFR 801.430(f)(2), effective June 7,

2000.

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Philip L. Chao, Office of Policy,

Planning, and Legislation (HF–23), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–827–

3380.

SUPPLEMENTARY INFORMATION:

I. Background

The ASTM notified FDA that ASTM

had been working on a project to help

Federal agencies update and maintain

the ASTM standards that are referenced

in the Code of Federal Regulations

(CFR’s). Use of consensus standards

such as those developed by ASTM is

consistent with the purposes of the

National Technology Transfer and

Advancement Act of 1995, signed into

law on March 7, 1996 (Public Law 104–

113). As part of the ASTM project,

ASTM informed FDA that many ASTM

standards cited in FDA’s food additive

and device regulations were out-of-date

and provided a list of standards with

their current year designations. ASTM

listed 58 different regulations which, in

its opinion, needed to be updated.

FDA examined the ASTM’s

documentation and, upon closer

examination, found that 56 of the 58

different FDA regulations identified by

ASTM cited obsolete ASTM standards

or that, in some cases, cited ASTM

standards that had been withdrawn.

Most regulations involved direct and

indirect food additives, although two of

the affected regulations involved

medical devices. Consequently, through

this rulemaking, FDA is revising the

device regulations identified by ASTM

that contain obsolete or withdrawn

ASTM standards to reflect the current

ASTM standards designations. FDA will

update the citations for the food

additive regulations in a separate

rulemaking.

This direct final rule amends

§§ 801.410(d)(2) and 801.430(f)(2) by

incorporating by reference into the

regulation the updated standard as

follows:

• Section 801.410 Use of impactresistant lenses in eyeglasses and

sunglasses—The agency is amending

paragraph (d)(2) by removing ‘‘ASTM

Method D 1415–68 ‘Test for

International Hardness of Vulcanized

Rubber,’ ’’ and by adding in its place

‘‘ASTM Method D 1415–88, Standard

Test Method for Rubber Property—

International Hardness,’’ and also by

removing ‘‘ASTM Method D 412–68

‘Tension Test of Vulcanized Rubber,’ ’’

and by adding in its place ‘‘ASTM

Method D 412–97, Standard Test

Methods for Vulcanized Rubber and

Thermoplastic Rubbers and

Thermoplastic Elastomers—Tension,’’.

• Section 801.430 User labeling for

menstrual tampons—The agency is

amending paragraph (f)(2) by removing

‘‘(ASTM), D 3492–83, ‘Standard

Specification for Rubber Contraceptives

(Condoms)’’ ’ and by adding in its place

‘‘(ASTM) D 3492–96, Standard

Specification for Rubber Contraceptives

(Male Condoms)’’.

In addition, FDA is updating in

§ 801.410(d)(2) the address for the

American Society for Testing and

Materials.

II. Additional Information

In the Federal Register of November

21, 1997 (62 FR 62466), FDA described

when and how it will employ direct

final rulemaking. FDA believes this rule

is appropriate for direct final

rulemaking because FDA views this rule

as making noncontroversial

amendments to existing regulations, i.e.,

adopting revised ASTM methods for

certain medical device regulations, and

FDA anticipates no significant adverse

comments. Consistent with FDA’s

procedures on direct final rulemaking,

elsewhere in this issue of the Federal

Register, FDA is publishing a

companion proposed rule to amend the

relevant medical device regulations. The

companion proposed rule is

substantially identical to the direct final

rule. The companion proposed rule

provides a procedural framework within

which the rule may be finalized in the

event the direct final rule is withdrawn

because of any significant adverse

comments. The comment period for the

direct final rule runs concurrently with

the comment period of the companion

proposed rule. Any comments received

under the companion proposed rule will

be considered as comments regarding

the direct final rule.

FDA is providing a comment period

on the direct final rule of 75 days after

January 24, 2000. If the agency receives

any significant adverse comments, FDA

intends to withdraw this final rule by

publication in the Federal Register of a

document within 30 days after the

comment period ends. A significant

adverse comment is defined as a

comment that explains why the rule

would be inappropriate, including

challenges to the rule’s underlying

premise or approach, or would be

ineffective or unacceptable without

change. In determining whether a

significant adverse comment is

sufficient to terminate a direct final

rulemaking, FDA will consider whether

the comment raises an issue serious

enough to warrant a substantive

response in a notice-and-comment

process. Comments that are frivolous,

insubstantial, or outside the scope of the

rule will not be considered significant

or adverse under this procedure. In

addition, if a significant adverse

comment applies to an amendment,

paragraph, or section of this rule and

that provision can be severed from the

remainder of the rule, FDA may adopt

as final those provisions of the rule that

are not the subject of a significant

adverse comment.

If FDA withdraws the direct final rule,

all comments received will be

considered under the companion

proposed rule in developing a final rule

under the usual notice-and-comment

procedures under the Administrative

Procedure Act (5 U.S.C. 552 et seq.). If

FDA receives no significant adverse

comments during the specified

comment period, FDA intends to

publish a confirmation notice in the

Federal Register within 30 days after

the comment period ends. FDA intends

to make the direct final rule effective

June 7, 2000.

III. Environmental Impact

The agency has determined, under 21

CFR 25.30(i) 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

final 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

3586 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Rules and Regulations

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). Executive Order

12866 classifies a rule as significant if

it meets any one of a number of

specified conditions, including having

an annual effect on the economy of $100

million or adversely affecting in a

material way a sector of the economy,

competition, or jobs, or if it raises novel

legal or policy issues. The revised

ASTM standard citations that FDA is

adopting in the medical device

regulations reflect minor changes to the

currently listed methods in those

regulations. The updated citations are

the result of periodic reapprovals of

long-standing test methods or standards

and should have no significant adverse

impact on those who use the standard.

Thus, the rule is not a significant

regulatory action as defined in

Executive Order 12866, and so is not

subject to review under the Executive

Order.

Under section 603(a) of the Regulatory

Flexibility Act (RFA), for any proposed

rule for which the agency is required by

section 553 of the Administrative

Procedure Act or any other law to

publish a general notice of proposed

rulemaking, the agency is required to

analyze regulatory options that would

minimize any significant economic

impact of a rule on small entities. The

agency has published, in the companion

proposed rule published elsewhere in

this Federal Register, an initial

regulatory flexibility analysis. Because

the companion proposed rule is a

proposed rule for which a general notice

of proposed rulemaking is required, and

therefore is subject to the RFA, the

agency will consider any comments it

receives on the initial regulatory

flexibility analysis in the companion

proposed rule when deciding whether

to withdraw this direct final rule.

V. Paperwork Reduction Act of 1995

This direct final 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.

Interested persons may, on or before

April 10, 2000, submit to the Dockets

Management Branch (address above)

written comments regarding this final

rule. The comment period runs

concurrently with the comment period

for the companion proposed rule. 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. All

comments received will be considered

as comments regarding the proposed

rule and this direct final rule. In the

event that the direct final rule is

withdrawn, all comments received

regarding the companion proposed rule

and the direct final rule will be

considered as comments on the

proposed rule.

List of Subjects in 21 CFR Part 801

Hearing aids, Incorporation by

reference, Medical devices, Professional

and patient labeling.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under

authority delegated to the Commissioner

of Food and Drugs, 21 CFR part 801 is

amended as follows:

PART 801—LABELING

1. The authority citation for 21 CFR

part 801 continues to read as follows:

Authority : 21 U.S.C. 321, 331, 351, 352,

360i, 360j, 371, 374.

§ 801.410 [Amended]

2. Section 801.410 Use of impactresistant lenses in eyeglasses and

sunglasses is amended in paragraph

(d)(2) by removing ‘‘ASTM Method D

1415–68 ‘Test for International

Hardness of Vulcanized Rubber,’ ’’ and

by adding in its place ‘‘ASTM Method

D 1415–88, Standard Test Method for

Rubber Property—International

Hardness,’’; by removing ‘‘ASTM

Method D 412–68 ‘Tension Test of

Vulcanized Rubber,’ ’’ and by adding in

its place ‘‘ASTM Method D 412–97,

Standard Test Methods for Vulcanized

Rubber and Thermoplastic Rubbers and

Thermoplastic Elastomers—Tension,’’;

and by removing ‘‘1916 Race St.,

Philadelphia, PA 19103, or available for

inspection at the Office of the Federal

Register, 800 North Capitol Street, NW.,

suite 700, Washington, DC 20408.)’’ and

by adding in its place ‘‘100 Barr Harbor

Dr., West Conshohocken, Philadelphia,

PA 19428, or available for inspection at

the Center for Devices and Radiological

Health’s Library, 9200 Corporate Blvd.,

Rockville, MD 10850, or at the Office of

the Federal Register, 800 North Capitol

St. NW., suite 700, Washington, DC.’’

§ 801.430 [Amended]

3. Section 801.430 User labeling for

menstrual tampons is amended in

paragraph (f)(2) by removing ‘‘(ASTM),

D 3492–83, ‘Standard Specification for

Rubber Contraceptives (Condoms)’ ’’ and

by adding in its place ‘‘(ASTM) D 3492–

96, ‘Standard Specification for Rubber

Contraceptives (Male Condoms)’ ’’; and

by revising the footnote to read ‘‘Copies

of the standard are available from the

American Society for Testing and

Materials, 100 Barr Harbor Dr., West

Conshohocken, PA 19428, or available

for inspection at the Center for Devices

and Radiological Health’s Library, 9200

Corporate Blvd., Rockville, MD 10850,

or at the Office of the Federal Register,

800 North Capitol St. NW., suite 700,

Washington, DC.’’

Dated: December 29, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–1404 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1 and 602

[TD 8863]

RIN 1545–AX64

Stock Transfer Rules: Supplemental

Rules

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Temporary regulations.

SUMMARY: This document contains

temporary regulations that provide an

election for certain taxpayers engaged in

certain exchanges described in section

367(b). These regulations provide

guidance for taxpayers that make the

specified election in order to determine

the extent to which income must be

included and certain corresponding

adjustments must be made. The text of

the temporary regulations also serves as

the text of the proposed regulations set

forth in the notice of proposed

rulemaking on this subject in the

Proposed Rules section of this issue of

the Federal Register.

DATES: Effective Date. These regulations

are effective as of February 23, 2000.

Applicability Date. These regulations

apply to section 367(b) exchanges that

occur on or after February 23, 2000.

FOR FURTHER INFORMATION CONTACT:

Mark D. Harris, (202) 622–3860 (not a

toll-free number).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

These regulations are being issued

without prior notice and public

procedure pursuant to the