Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules 3627

Cloxacillin

Colistimethate

Colistin

Cyclacillin

Cycloserine

Cyclosporine

Dactinomycin

Dalfopristin

Daunorubicin

Demeclocycline

Detorubicin

Dicloxacillin

Dihydrostreptomycin

Dirithromycin

Doxorubicin

Doxycycline

Epirubicin

Erythromycin

Floxacillin

Fosfomycin

Fusidate/fusidic acid

Gentamicin

Gramicidin

Griseofulvin

Hetacillin

Idarubicin

Imipenem

Ivermectin

Kanamycin

Lincomycin

Loracarbef

Meclocycline

Meropenem

Methacycline

Methicillin

Mezlocillin

Minocycline

Mitomycin

Moxalactam

Mupirocin

Mycophenolate/mycophenolic acid

Nafcillin

Natamycin

Neomycin

Netilmicin

Niphimycin

Novobiocin

Nystatin

Oleandomycin

Oxacillin

Oxytetracycline

Paromomycin

Penicillamine

Penicillin G

Penicillin V

Phenethicillin

Piperacillin

Plicamycin

Polymyxin B

Quinupristin

Rifabutin

Rifampin

Rifamycin

Rolitetracycline

Sisomicin

Spectinomycin

Streptomycin

Streptozocin

Sulbactam

Sultamicillin

Tacrolimus

Tazobactam

Teicoplanin

Tetracycline

Ticarcillin

Tobramycin

Troleandomycin

Tyrothricin

Vancomycin

Vidarabine

Viomycin

Dated: October 5, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy.

[FR Doc. 00–1536 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

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

Materials Citations; Companion

Document to Direct Final Rule

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend certain references in various

medical device regulations. The

amendments would update the

references in those regulations to

various standards of the American

Society for Testing and Materials

(ASTM) to reflect the current standards

designations. This proposed rule is a

companion document to the direct final

rule published elsewhere in this issue of

the Federal Register.

DATES: Submit written comments by

April 10, 2000. If FDA receives no

significant adverse comment on these

various medical devices regulations

within the specified comment period,

the agency intends to publish in the

Federal Register a document confirming

the effective date of the final rule within

30 days after the comment period on the

direct final rule ends. The direct final

rule will be effective June 7, 2000. If

FDA receives any significant adverse

comment regarding this rule, FDA will

publish a document withdrawing the

direct final rule within 30 days after the

comment period ends and will proceed

to respond to all of the comments under

this companion proposed rule using

usual notice-and-comment procedures.

The comment period for this companion

proposed rule runs concurrently with

the direct final rule comment period.

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 proposing to

revise the device regulations identified

by ASTM that contain obsolete or

withdrawn ASTM standards to reflect

3628 Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules

the current ASTM standards

designations. FDA will update the

citations for the food additive

regulations in a separate rulemaking.

This rule is proposing to amend

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

CFR 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 proposal would amend

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 proposal

would amend 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 Materials.

II. Additional Information

This proposed rule is a companion to

the direct final rule published in the

final rule section of this issue of the

Federal Register. This companion

proposed rule is substantially identical

to the direct final rule. FDA is

publishing the direct final rule because

the rule contains noncontroversial

changes, and FDA anticipates that it

will receive no significant adverse

comments. A detailed discussion of this

rule is set forth in the preamble of the

direct final rule. If no significant

comment is received in response to the

direct final rule, no further action will

be taken related to this proposed rule.

Instead, FDA will publish in the Federal

Register a confirmation within 30 days

after the comment period ends

confirming that the direct final rule will

go into effect on June 7, 2000.

Additional information about FDA’s

direct final rulemaking procedures is set

forth in a guidance published in the

Federal Register of November 21, 1997

(62 FR 62466).

If FDA receives any significant

adverse comment regarding this rule,

FDA will publish a document

withdrawing the direct final rule within

30 days after the comment period ends

and will proceed to respond to all of the

comments under this companion

proposed rule using usual notice-andcomment procedures. The comment

period for this companion proposed rule

runs concurrently with the direct final

rule’s comment period. Any comments

received under this companion

proposed rule will be considered as

comments regarding the direct final

rule.

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. For

example, a comment recommending a

rule change in addition to the rule will

not be considered a significant adverse

comment unless the comment states

why the rule would be ineffective

without the additional change. 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.

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

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). 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 impact on those

who use the standard. Thus, the

proposal is not a significant regulatory

action as defined in Executive Order

12866, 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 economic impact of a rule on

small entities. The proposed rule, if

finalized, would simply update ASTM

citations used in various device

regulations. The updated citations are

the result of periodic re-approvals of

long-standing ASTM test methods or

standards and will have no significant

adverse impact on those who use the

ASTM standards. Under the Regulatory

Flexibility Act, FDA certifies that the

proposed rule will not impose any

additional regulatory burdens on small

entities.

V. Paperwork Reduction Act of 1995

FDA tentatively concludes that this

proposed 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

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 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

Federal Register / Vol. 65, No. 15 / Monday, January 24, 2000 / Proposed Rules 3629

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 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. 00–1405 Filed 1–21–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Parts 1

[REG–116048–99]

RIN 1545–AX63

Stock Transfer Rules: Supplemental

Rules

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Notice of proposed rulemaking

and notice of public hearing.

SUMMARY: This document proposes, by

cross-reference to temporary

regulations, amendments to the final

regulations concerning the Federal tax

treatment of certain exchanges subject to

section 367(b) of the Internal Revenue

Code (Code). The temporary regulations,

published in the Rules and Regulations

section of this issue of the Federal

Register, provide an election for certain

taxpayers engaged in certain exchanges

described in section 367(b). The

temporary 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. This document

also provides notice of a public hearing

on the proposed regulations.

DATES: Written comments must be

received by April 24, 2000. Requests to

speak (with outlines of oral comments)

at the public hearing scheduled for

April 20, 2000, must be submitted by

March 31, 2000.

ADDRESSES: Send submissions to:

CC:DOM:CORP:R (REG–116048–99),

room 5228, Internal Revenue Service,

POB 7604, Ben Franklin Station,

Washington, DC 20044. In the

alternative, submissions may be hand

delivered between the hours of 8 a.m.

and 5 p.m. to: CC:DOM:CORP:R (REG–

116048–99), Courier’s Desk, Internal

Revenue Service, 1111 Constitution

Avenue NW., Washington, DC.

Alternatively, taxpayers may submit

comments electronically via the Internet

by selecting the ‘‘Tax Regs’’ option of

the IRS Home Page, or by submitting

comments directly to the IRS Internet

site at: http://www.irs.ustreas.gov/prod/

tax—regs/regslist.html. The public

hearing will be held in room 2615,

Internal Revenue Building, 1111

Constitution Avenue, NW., Washington,

DC.

FOR FURTHER INFORMATION CONTACT:

Concerning the regulations, Mark D.

Harris, (202) 622–3860 (not a toll-free

number); concerning submissions and

the hearing, Guy Traynor, (202) 622–

7180 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Paperwork Reduction Act

The collection of information

contained in this notice of proposed

rulemaking has been submitted to the

Office of Management and Budget for

review in accordance with the

Paperwork Reduction Act of 1995 (44

U.S.C. 3507(d)). Comments on the

collection of information should be sent

to the Office of Management and

Budget, Attn: Desk Officer for the

Department of the Treasury, Office of

Information and Regulatory Affairs,

Washington, DC 20503, with copies to

the Internal Revenue Service, Attn: IRS

Reports Clearance Officer, OP:FS:FP,

Washington, DC 20224. Comments on

the collection of information should be

received by March 24, 2000. Comments

are specifically requested concerning:

Whether the proposed collection of

information is necessary for the proper

performance of the functions of the

Internal Revenue Service, including

whether the information will have

practical utility;

The accuracy of the estimated burden

associated with the proposed collection

of information (see below);

How the quality, utility, and clarity of

the information to be collected may be

enhanced;

How the burden of complying with

the proposed collection of information

may be minimized, including through

the application of automated collection

techniques or other forms of information

technology; and

Estimates of capital or start-up costs

and costs of operation, maintenance,

and purchase of service to provide

information.

The collection of information in this

proposed regulation is in § 1.367(b)–

3(b)(4). This information is required to

properly make an election to include an

amount in income that is different than

the inclusion currently required under

§ 1.367(b)–3 of the final regulations.

This information will be used to verify

proper compliance with the section

367(b) regulations, including that the

election provided herein was made and

that the required adjustments will be

made by all parties to the section 367(b)

transaction. The collection of

information is mandatory. The likely

respondents are businesses or other forprofit institutions.

Estimated total annual reporting

burden: 85 hours.