28116 Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Proposed Rules

and refinements have been made to

these inspection procedures and tools

based on past in-service experience and

reports from operators of the PW JT8D

series engines.

One commenter concurs with the

proposed AD as written.

Since these changes expand the scope

of the originally proposed rule, the FAA

has determined that it is necessary to

reopen the comment period to provide

additional opportunity for public

comment.

The FAA estimates that 6,815 engines

installed on aircraft of U.S. registry

would be affected by this proposed AD

and that it would take approximately

4.5 work hours per engine to

accomplish the proposed actions. Since

publication of the NPRM, the FAA has

revised its average labor rate estimate

from $55 per work hour to $60 per work

hour to better reflect current costs.

Based on these figures, the total cost

impact of the proposed AD on U.S.

operators is estimated to be $1,840,050.

The regulations proposed herein

would not have substantial direct effects

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,

in accordance with Executive Order

12612, it is determined that this

proposal would not have sufficient

federalism implications to warrant the

preparation of a Federalism Assessment.

For the reasons discussed above, I

certify that this proposed regulation (1)

is not a ‘‘significant regulatory action’’

under Executive Order 12866; (2) is not

a ‘‘significant rule’’ under the DOT

Regulatory Policies and Procedures (44

FR 11034, February 26, 1979); and (3) if

promulgated, will not have a significant

economic impact, positive or negative,

on a substantial number of small entities

under the criteria of the Regulatory

Flexibility Act. A copy of the draft

regulatory evaluation prepared for this

action is contained in the Rules Docket.

A copy of it may be obtained by

contacting 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.

The Proposed Amendment

Accordingly, pursuant to the

authority delegated to me by the

Administrator, the Federal Aviation

Administration proposes to amend 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 USC 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

removing amendment 39–6360 (54 FR

46045, November 1, 1989) and

amendment 39–9204 (60 FR 20019,

April 24, 1995) and by adding a new

airworthiness directive to read as

follows:

Pratt & Whitney: Docket No. 93–ANE–79.

Supersedes AD 87–11–07 R1,

Amendment 39–6360, AD 87–11–07,

Amendment 39–5619, and AD 95–08–15,

Amendment 39–9204.

Applicability: Pratt & Whitney (PW)

Models JT8D–1, –1A, –1B, –7, –7A, –9, –9A,

–11, –15, –15A, –17, –17A, –17R, and –17AR

turbofan engines, with combustion chamber

outer case (CCOC) part numbers (P/Ns)

490547, 542155, 616315, 728829, 728829–

001, 730413, 730413–001, 730414, 730414–

001, 767197, 767279, 767279–001 installed.

These engines are installed on but not

limited to Boeing 737 and 727 series, and

McDonnell Douglas DC–9 series aircraft.

Note: This airworthiness directive (AD)

applies to each engine identified in the

preceding applicability provision, regardless

of whether it has been modified, altered, or

repaired in the area subject to the

requirements of this AD. For engines that

have been modified, altered, or repaired so

that the performance of the requirements of

this AD is affected, the owner/operator must

use the authority provided in paragraph (c)

to request approval from the Federal Aviation

Administration (FAA). This approval may

address either no action, if the current

configuration eliminates the unsafe

condition, or different actions necessary to

address the unsafe condition described in

this AD. Such a request should include an

assessment of the effect of the changed

configuration on the unsafe condition

addressed by this AD. In no case does the

presence of any modification, alteration, or

repair remove any engine from the

applicability of this AD.

Compliance: Required as indicated, unless

accomplished previously.

To prevent CCOC flange cracks that could

result in uncontained engine failure, inflight

engine shutdown, engine cowl release, and

airframe damage, accomplish the following:

(a) Inspect, disposition, and report CCOC

distress, in accordance with the intervals and

procedures described in Paragraphs 2.A and

2.C of PW Alert Service Bulletin (ASB) No.

A6202, Revision 1, dated January 4, 1996.

Reporting requirements have been approved

by the Office of Management and Budget and

assigned OMB control number 2120–0056.

(1) For the purposes of this AD, the

accomplishment effective date to be used for

determination of inspection intervals, as

required by Section 2.A of PW ASB A6202,

Revision 1, dated January 4, 1996, is defined

as the effective date of this AD.

(b) Inspect, disposition, and report CCOC

distress in accordance with the intervals and

procedures described in Paragraphs 2.A. (Part

I), 2.B. (Part II), and 2.D of PW ASB No.

A6228, dated November 7, 1995. Reporting

requirements have been approved by the

Office of Management and Budget and

assigned OMB control number 2120–0056.

(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, Engine

Certification Office. The request should be

forwarded through an appropriate FAA

Principal Maintenance Inspector, who may

add comments and then send it to the

Manager, Engine Certification Office.

Note: Information concerning the existence

of approved alternative methods of

compliance with this airworthiness directive,

if any, may be obtained from the Engine

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 aircraft to

a location where the requirements of this AD

can be accomplished.

Issued in Burlington, Massachusetts, on

May 22, 1996.

Robert E. Guyotte,

Acting Manager, Engine and Propeller

Directorate, Aircraft Certification Service.

[FR Doc. 96–13889 Filed 6–3–96; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 2, 3, 5, 10, 12, 20, 56,

and 58

[Docket No. 96N–0163]

RIN 0910–AA69

Reinvention of Administrative

Procedures Regulations

AGENCY: Food and Drug Administration,

HHS.

ACTION: Advance notice of proposed

rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is considering

ways to further streamline its

administrative procedures regulations as

a result of a page-by-page review of the

agency’s regulations. This regulatory

review is part of the administration’s

‘‘Reinventing Government’’ initiative

that seeks to streamline Government

and to ease the burden on regulated

industry and consumers. FDA is seeking

public comment on ways to streamline

its administrative procedures

regulations.

DATES: Written comments by September

3, 1996.
Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Proposed Rules 28117

ADDRESSES: Submit written comments

to the Dockets Management Branch

(HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Regarding information concerning the

regulations: Philip L. Chao, Policy

Development and Coordination

Staff (HF–23), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

3380.

Regarding general information on

FDA’s ‘‘reinventing initiative’’: Lisa

M. Helmanis, Regulations Policy

Management Staff (HF–26), Food

and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–443–3480.

SUPPLEMENTARY INFORMATION: On March

4, 1995, President Clinton announced

plans for reforming the Federal

regulatory system as part of his

‘‘Reinventing Government’’ initiative. In

his March 4, 1995, directive, the

President ordered all Federal agencies to

conduct a page-by-page review of their

regulations and to ‘‘eliminate or revise

those that are outdated or otherwise in

need of reform.’’ This notice represents

FDA’s continuing effort to implement

the President’s plan. In previous issues

of the Federal Register, FDA proposed

revoking or revising other regulations;

the agency expects to issue additional

reinvention proposals in the future.

In this notice, FDA is seeking

comments on ways listed in the table

below in which its administrative

regulations could be updated or revised

in order to streamline the agency’s

administrative practices and

procedures.

The following table contains a

section-by-section analysis of the

regulations that FDA is considering

‘‘reinventing.’’ These regulations are

listed numerically as they appear in the

Code of Federal Regulations (CFR).

Section-by-Section Analysis of Regulations Under Consideration

21 CFR Cite Description or Title of Regulation Explanation of Reinvention

§ 1.3 ............................ Defines label and labeling ............................ Should the definitions be amended? There are only two definitions (label

and labeling) involved, but they could be updated to be more consistent with current statutory language.

§ 1.21 .......................... Describes what constitutes a failure to reveal a material fact.This section provides general information on failures to reveal material

facts. Should this section be revised, expanded, or removed?

§ 1.23 .......................... Describes procedures for requesting a variance or exemption from required label

statements.

This provision could be rewritten to remove extraneous material and to

provide better instructions on procedures for a variance or exemption.

§ 1.24 .......................... Lists granted label exemptions for foods,

animal drugs, and cosmetics.

Because much of the text is devoted to foods, the provision could be relocated to that part of the CFR devoted to foods. Similar moves could

be made for the paragraphs on animal drugs and cosmetics. Would it

be more useful to move these provisions to the corresponding subject

areas?

§ 1.90 .......................... Notice of sampling ........................................ This section explains the procedures for notification of sampling of imports. Should this section be consolidated with § 1.91?

§ 1.91 .......................... Payment for samples ................................... This section provides that FDA will pay for import samples of nonviolative

goods.

§ 2.125 ........................ Establishes procedures to permit the use of

chlorofluorocarbons (CFC’s) in self-pressurized containers.

Should this provision be modified to reflect current requirements under

the Clean Air Act and to correspond with the Environmental Protection

Agency regulations on CFC use and warning labels?

§ 3.6 ............................ States who the product jurisdiction officer is This section should be amended to reflect the current information.

Part 5 .......................... Delegations of authority ............................... Some of the delegations of authority refer to offices or titles that no

longer exist or have changed due to reorganizations. This part should

be revised to reflect the most current information. Does it remain useful

to codify these delegations of authority?

Part 10 subparts A

and B.

Administrative practices and procedures ..... These regulations govern the practices and procedures for petitions,

hearings, and other administrative proceedings and activities conducted by FDA. Some sections should be revised to provide more

flexibility or efficiency. For example, could FDA’s citizen petitions process be made more efficient?

Part 12 ........................ Formal evidentiary public hearing ................ Should FDA’s regulations governing formal hearings be simplified or

clarified?

Part 20 ........................ Public information ......................................... This part governs FDA’s communication with the public. Does this part

continue to reflect the best way for FDA to handle public information?

Are there better, more efficient approaches that should be embodied in

FDA’s regulations?

§ 56.104 ...................... Describes exemptions from institutional

review boards requirements.

The first two exempt classes are probably inapplicable today because

they refer to clinical research begun before July 27, 1981. Should this

section be amended by removing paragraphs (a) and (b)?

Part 58 ........................ Good laboratory practice regulations ........... This part describes fundamental principles for laboratories to observe

and are intended to ensure the quality and integrity of safety data. Updating to reflect current technology (such as greater use of computers)

may be needed.

Interested persons may, on or before,

September 3, 1996, submit to the

Dockets Management Branch (address

above) written comments regarding this

advance notice of proposed rulemaking

(ANPRM). 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.
28118 Federal Register / Vol. 61, No. 108 / Tuesday, June 4, 1996 / Proposed Rules

This ANPRM is issued under section

301 et seq. of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 301 et seq.)

and under the authority of the

Commissioner of Food and Drugs.

Dated: May 28, 1996.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 96–13980 Filed 6–3–96; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF THE TREASURY

Internal Revenue Service

26 CFR Part 1

[INTL–0054–95]

RIN 1545–AT96

Proposed Amendments to the

Regulations on the Determination of

Interest Expense Deduction of Foreign

Corporations and Branch Profits Tax;

Correction

AGENCY: Internal Revenue Service (IRS),

Treasury.

ACTION: Correction to notice of proposed

rulemaking.

SUMMARY: This document contains a

correction to the notice of proposed

rulemaking [INTL–0054–95] which was

published in the Federal Register for

Friday, March 8, 1996 (61 FR 9377). The

notice of proposed rulemaking relate to

the determination of the interest

expense deduction of foreign

corporations, and the branch profits tax.

FOR FURTHER INFORMATION CONTACT:

Ahmad Pirasteh or Richard Hoge (202)

622–3870 (not a toll-free number).

SUPPLEMENTARY INFORMATION:

Background

The notice of proposed rulemaking

that is subject to these corrections are

under sections 882 and 884 of the

Internal Revenue Code.

Need for Correction

As published, the proposed

rulemaking contains errors that are in

need of clarification.

Correction of Publication

Accordingly, the publication of the

proposed rulemaking which is the

subject of FR Doc. 96–5264 is corrected

as follows:

1. On page 9378, in the preamble

under column 2, following the

paragraph heading ‘‘B. Hedging

transactions’’, line 6, the language ‘‘case

may be, the amount of their U.S.’’ is

corrected to read ‘‘case may be, the

amount of its U.S.’’.

§ 1.882–5 [Corrected]

2. On page 9379, column 3, § 1.882–

5(d)(6), Example 4. (i), line 18, the

language ‘‘liabilities of 90x U.S. dollars

and 1000 x’’ is corrected to read

‘‘liabilities of 90x U.S. dollars and

1000x’’.

§ 1.884–1 [Corrected]

3. On page 9380, column 3, § 1.884–

1(d)(2)(xi), Example 8., last line, the

language ‘‘from securities) of the value

of the securities.’’ is corrected to read

‘‘from securities) of the amount of the

securities.’’.

Cynthia E. Grigsby,

Chief, Regulations Unit, Assistant Chief

Counsel (Corporate).

[FR Doc. 96–13722 Filed 6–3–96; 8:45 am]

BILLING CODE 4830–01–U

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 180

[PP 5E04443/P659; FRL–5371–5]

RIN 2070–AB18

1,1-Difluoroethane; Proposed

Exemption from Tolerance

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: This document proposes that

residues of 1,1-difluoroethane (CAS Reg.

No. 75–37–6) be exempted from the

requirement of a tolerance when used as

an inert ingredient (aerosol propellant)

in aerosol pesticide formulations used

for insect control in food- and feedhandling establishments and animals.

This proposed regulation was requested

by The Dupont Company, pursuant to

the Federal Food, Drug, and Cosmetic

Act (FFDCA).

DATES: Comments, identified by the

docket control number [PP 5E04443/

P659], must be received on or before

July 5, 1996.

ADDRESSES: By mail, submit written

comments to: Public Response and

Program Resources Branch, Field

Operations Division (7506C), Office of

Pesticide Programs, Environmental

Protection Agency, 401 M St., SW.,

Washington, DC 20460. In person

deliver comments to: Rm. 1132, Crystal

Mall #2, 1921 Jefferson Davis Highway,

Arlington, VA.

Information submitted as a comment

concerning this document may be

claimed confidential by marking any

part or all of that information as

‘‘Confidential Business Information’’

(CBI). Information so marked will not be

disclosed except in accordance with

procedures set forth in 40 CFR part 2.

A copy of the comment that does not

contain CBI must be submitted for

inclusion in the public record.

Information not marked confidential

will be included in the public docket by

EPA without prior notice. The public

docket is available for public inspection

in Rm. 1132 at the address given above,

from 8 a.m. to 4:30 p.m., Monday

through Friday, excluding legal

holidays.

Comments and data may also be

submitted electronically by sending

electronic mail (e-mail) to: oppdocket@epamail.epa.gov. Electronic

comments must be submitted as an

ASCII file avoiding the use of special

characters and any form of encryption.

Comments and data will also be

accepted on disks in WordPerfect in 5.1

file format or ASCII file format. All

comments and data in electronic form

must be identified by the docket

number, [PP 5E04443/P659]. No CBI

should be submitted through e-mail.

Electronic comments on this proposed

rule may be filed online at many Federal

Depository Libraries. Additional

information on electronic submissions

can be found below in this document.

FOR FURTHER INFORMATION CONTACT: By

mail: Amelia M. Acierto, Registration

Support Branch, Registration Division

(7505W), Office of Pesticide Programs,

Environmental Protection Agency, 401

M St., SW., Washington, DC 20460.

Office location, telephone number, and

e-mail address: 2800 Crystal Drive,

North Tower, Arlington, VA, (703) 308–

8375, e-mail:

acierto.amelia@epamail.epa.gov.

SUPPLEMENTARY INFORMATION: The

Dupont Company, 1007 Market Street,

Wilmington, DE 19898 has submitted

pesticide petition (PP) 5E04443 to EPA

requesting that the Administrator,

pursuant to section 408(e) of the

FFDCA, 21 U.S.C. 346a(e), propose to

amend 40 CFR 180.1001(c) and (e) by

establishing an exemption from the

requirement of a tolerance for the

residues of 1,1-difluoroethane (CAS Reg.

No. 75–37–6) when used as an inert

ingredient (aerosol propellant) in

aerosol pesticide formulations used for

insect control in food- and feedhandling establishments and animals.

Inert ingredients are all ingredients

that are not active ingredients as defined

in 40 CFR 153.125 and include, but are

not limited to, the following types of

ingredients (except when they have a

pesticidal efficacy of their own):

solvents such as alcohols and

hydrocarbons; surfactants such as