This section of the FEDERAL REGISTER

contains notices to the public of the proposed

issuance of rules and regulations. The

purpose of these notices is to give interested

persons an opportunity to participate in the

rule making prior to the adoption of the final

rules.

Proposed Rules Federal Register

46221

Vol. 62, No. 169

Tuesday, September 2, 1997

OFFICE OF PERSONNEL

MANAGEMENT

5 CFR Part 532

RIN 3206–AI01

Prevailing Rate Systems; Survey Order

Month Change for Jefferson, New

York, Nonappropriated Fund Wage

Area

AGENCY: Office of Personnel

Management.

ACTION: Proposed rule.

SUMMARY: The Office of Personnel

Management is issuing a proposed rule

to change the survey order month

beginning with the next full-scale

survey for the Jefferson, NY,

nonappropriated fund (NAF) Federal

Wage System wage area from March to

April. This change is expected to

improve the survey data yield and to

allow the Department of Defense to

better balance its survey workload.

DATES: Comments must be received by

October 2, 1997. The survey order

month change from March to April for

the Jefferson NAF wage area would

begin with the fiscal year 1998 full-scale

survey.

ADDRESSES: Send or deliver comments

to Donald J. Winstead, Assistant

Director for Compensation Policy,

Human Resources Systems Service,

Office of Personnel Management, Room

7H31, 1900 E Street NW., Washington,

DC 20415, or FAX: (202) 606–4264.

FOR FURTHER INFORMATION CONTACT:

Angela Graham Humes, (202) 606-2848.

SUPPLEMENTARY INFORMATION: The

Department of Defense, the lead agency

for the Jefferson NAF wage area,

requested that beginning with the 1998

full-scale survey, the survey order

month be changed from March to April.

The 1996 full-scale survey was the

initial survey in the Jefferson wage area

and satisfied minimum survey adequacy

requirements. This proposed change in

survey order month would avoid the

inclement March weather in the

Jefferson NAF wage area and thereby is

expected to improve wage survey

participation and data yield. In

addition, the new survey month would

allow the Department of Defense to

better balance its survey workload by

moving the Jefferson survey from a

heavy workload month to a light

workload month. The April survey

order month would delay the Jefferson

wage schedule effective date by only 1

month.

The Federal Prevailing Rate Advisory

Committee reviewed this

recommendation and by consensus

recommended approval.

Regulatory Flexibility Act

I certify that these regulations would

not have a significant economic impact

on a substantial number of small entities

because they would affect only Federal

agencies and employees.

List of Subjects in 5 CFR Part 532

Administrative practice and

procedure, Freedom of information,

Government employees, Reporting and

recordkeeping requirements, Wages.

Office of Personnel Management.

James B. King,

Director.

Accordingly, OPM proposes to amend

5 CFR Part 532 as follows:

PART 532—PREVAILING SYSTEMS

1. The authority citation for part 532

continues to read as follows:

Authority. 5 U.S.C. 5343, 5346; § 532.707

also issued under 5 U.S.C. 552.

Appendix B to Subpart B of 532—

[Amended]

2. Appendix B to subpart B is

amended for Jefferson, New York, by

revising the beginning month of survey

listing from March to April.

[FR Doc. 97–23221 Filed 8–29–97; 8:45 am]

BILLING CODE 6325–01–M

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 97–NM–95–AD]

RIN 2120–AA64

Airworthiness Directives; Boeing

Model 777–200 Series Airplanes

Equipped With Air Cruisers Evacuation

Slide/Rafts

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Notice of proposed rulemaking

(NPRM).

SUMMARY: This document proposes the

adoption of a new airworthiness

directive (AD) that is applicable to

certain Boeing Model 777–200 series

airplanes. This proposal would require

modifying the sliding surface of the

door 1 left and door 1 right evacuation

slide/rafts. This proposal is prompted

by a report of injuries to evacuees using

the slide/raft to exit the airplane; the

evacuees were unable to achieve

adequate initial sliding speed and

adequate momentum to carry them

expeditiously down the slide/raft. The

actions specified by the proposed AD

are intended to prevent evacuee

overload of the slide/rafts, and

consequent impeded evacuation and

injury to the evacuees.

DATES: Comments must be received by

October 14, 1997.

ADDRESSES: Submit comments in

triplicate to the Federal Aviation

Administration (FAA), Transport

Airplane Directorate, ANM–103,

Attention: Rules Docket No. 97–NM–

95–AD, 1601 Lind Avenue SW, Renton,

Washington 98055–4056. Comments

may be inspected at this location

between 9:00 a.m. and 3:00 p.m.,

Monday through Friday, except Federal

holidays.

The service information referenced in

the proposed rule may be obtained from

Boeing Commercial Airplane Group,

P.O. Box 3707, Seattle, Washington

98124–2207. This information may be

examined at the FAA, Transport

Airplane Directorate, 1601 Lind Avenue

SW, Renton, Washington.

FOR FURTHER INFORMATION CONTACT: Jim

Cashdollar, Aerospace Engineer,

Airframe Branch, ANM–120S, FAA,

Seattle Aircraft Certification Office,
46222 Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Proposed Rules

1601 Lind Avenue SW, Renton,

Washington; telephone (425) 227–2785;

fax (425) 227–1181.

SUPPLEMENTARY INFORMATION:

Comments Invited

Interested persons are invited to

participate in the making of the

proposed rule by submitting such

written data, views, or arguments as

they may desire. Communications shall

identify the Rules Docket number and

be submitted in triplicate to the address

specified above. All communications

received on or before the closing date

for comments, specified above, will be

considered before taking action on the

proposed rule. The proposals contained

in this notice may be changed in light

of the comments received.

Comments are specifically invited on

the overall regulatory, economic,

environmental, and energy aspects of

the proposed 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

summarizing each FAA-public contact

concerned with the substance of this

proposal will be filed in the Rules

Docket.

Commenters wishing the FAA to

acknowledge receipt of their comments

submitted in response to this notice

must submit a self-addressed, stamped

postcard on which the following

statement is made: ‘‘Comments to

Docket Number 97–NM–95–AD.’’ The

postcard will be date stamped and

returned to the commenter.

Availability of NPRMs

Any person may obtain a copy of this

NPRM by submitting a request to the

FAA, Transport Airplane Directorate,

ANM–103, Attention: Rules Docket No.

97–NM–95–AD, 1601 Lind Avenue SW,

Renton, Washington 98055–4056.

Discussion

The FAA has received a report

indicating that, during a full-scale

evacuation demonstration on a Boeing

Model 777 series airplane equipped

with Air Cruisers evacuation slide/rafts,

evacuees were injured because they

were unable to achieve adequate initial

sliding speed and adequate momentum

to carry them expeditiously to the toe

end of the door 1 evacuation slide/raft.

Investigation revealed a shallow sliding

angle of the slide/raft, which resulted in

delayed descent of the evacuees down

the slide/raft; this, in turn, resulted in

evacuee overload of the slide/raft. This

condition, if not corrected, could result

in impeded evacuation and injury to the

evacuees.

Explanation of Relevant Service

Information

The FAA has reviewed and approved

Boeing Alert Service Bulletin 777–

25A0035, dated December 2, 1996,

which describes procedures for

modifying the sliding surface of the

door 1 left and door 1 right evacuation

slide/rafts. (The alert service bulletin

references Air Cruisers Company

Service Bulletin S.B. 777–107–25–02,

dated October 29, 1996, as an additional

source of service information for

accomplishment of the modification.)

The modification involves the

application of dry lubricant McLube

1720L to a specified area of the sliding

area of the sliding lane of each

evacuation slide/raft, and the

subsequent reidentification of the slide/

rafts. Accomplishment of the

modification will improve the initial

evacuee sliding speed to provide

adequate momentum to carry evacuees

through to the toe ends of the slides.

Explanation of Requirements of

Proposed Rule

Since an unsafe condition has been

identified that is likely to exist or

develop on other products of this same

type design, the proposed AD would

require modifying the sliding surface of

the door 1 left and door 1 right

evacuation slide/rafts. The actions

would be required to be accomplished

in accordance with the alert service

bulletin described previously.

Cost Impact

There are approximately 43 Boeing

Model 777–200 series airplanes of the

affected design in the worldwide fleet.

The FAA estimates that 16 airplanes of

U.S. registry would be affected by this

proposed AD, that it would take

approximately 4 work hours per

airplane to accomplish the proposed

actions, and that the average labor rate

is $60 per work hour. Required parts

would be provided by the manufacturer

at no cost to the operators. Based on

these figures, the cost impact of the

proposed AD on U.S. operators is

estimated to be $3,840, or $240 per

airplane.

The cost impact figure discussed

above is based on assumptions that no

operator has yet accomplished any of

the proposed requirements of this AD

action, and that no operator would

accomplish those actions in the future if

this AD were not adopted.

Regulatory Impact

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 U.S.C. 106(g), 40113, 44701.

§ 39.13 [Amended]

2. Section 39.13 is amended by

adding the following new airworthiness

directive:

Boeing: Docket 97–NM–95–AD.

Applicability: Model 777–200 series

airplanes, line positions 2 through 48,

excluding line positions 10, 41, 43, and 47;

equipped with Air Cruisers evacuation slide/

rafts, as identified in Air Cruisers Service

Bulletin S.B. 777–107–25–02; certificated in

any category.

Note 1: This AD applies to each airplane

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

airplanes 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 (b) of this AD.

The request should include an assessment of

the effect of the modification, alteration, or
Federal Register / Vol. 62, No. 169 / Tuesday, September 2, 1997 / Proposed Rules 46223

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 as indicated, unless

accomplished previously.

To prevent evacuee overload of the slide/

raft, and consequent impeded evacuation and

injury to the evacuees, accomplish the

following:

(a) Within 180 days after the effective date

of this AD, modify the sliding surfaces of the

door 1 left and door 1 right evacuation slide/

rafts, in accordance with Boeing Alert

Service Bulletin 777–25A0035, dated

December 2, 1996.

Note 2: The Boeing alert service bulletin

references Air Cruisers Company Service

Bulletin S.B. 777–107–25–02, dated October

29, 1996, as an additional source of service

information.

(b) 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, Seattle

Aircraft Certification Office (ACO), FAA,

Transport Airplane Directorate. Operators

shall submit their requests through an

appropriate FAA Principal Maintenance

Inspector, who may add comments and then

send it to the Manager, Seattle ACO.

Note 3: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Seattle ACO.

(c) 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 airplane to

a location where the requirements of this AD

can be accomplished.

Issued in Renton, Washington, on August

26, 1997.

John J. Hickey,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 97–23173 Filed 8–29–97; 8:45 am]

BILLING CODE 4910–13–U

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 334

[Docket No. 78N–036L]

RIN 0910–AA01

Laxative Drug Products for Over-theCounter Human Use; Proposed

Amendment to the Tentative Final

Monograph

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Food and Drug

Administration (FDA) is reopening the

administrative record and proposing to

amend the tentative final monograph for

over-the-counter (OTC) laxative drug

products to reclassify the stimulant

laxative ingredients danthron and

phenolphthalein from Category I

(generally recognized as safe and

effective and not misbranded) to

Category II (not generally recognized as

safe and effective or misbranded) and

adding these ingredients to a list of

nonmonograph active ingredients. FDA

is issuing this proposed rulemaking

after considering data and information

on the safety of danthron and

phenolphthalein. This proposal is part

of the ongoing review of OTC drug

products conducted by FDA.

DATES: Submit written comments by

October 2, 1997. Written comments on

the agency’s economic impact

determination by October 2, 1997. FDA

is proposing that any final rule based on

this proposal be effective on the date of

its publication in the Federal Register.

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:

Cheryl A. Turner, Center for Drug

Evaluation and Research (HFD–560),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–2222.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of March 21,

1975 (40 FR 12902), FDA published,

under § 330.10(a)(6) (21 CFR

330.10(a)(6)), an advance notice of

proposed rulemaking to establish a

monograph for OTC laxative,

antidiarrheal, emetic, and antiemetic

drug products, together with the

recommendations of the Advisory

Review Panel on OTC Laxative,

Antidiarrheal, Emetic, and Antiemetic

Drug Products (the Panel), which was

the advisory review panel responsible

for evaluating data on the active

ingredients in these classes. In the

advance notice of proposed rulemaking,

the Panel recommended Category I

status for the OTC stimulant laxative

ingredients aloe, bisacodyl, cascara

sagrada preparations, danthron,

phenolphthalein, and senna

preparations (40 FR 12902 at 12908 to

12910). The agency concurred with the

Panel’s Category I classification of these

ingredients in the tentative final

monograph published in the Federal

Register of January 15, 1985 (50 FR 2124

at 2152 to 2156).

II. Danthron

Following publication of the laxative

tentative final monograph in 1985, FDA

became aware of studies concerning the

potential carcinogenic risk of danthron.

In January 1987, a leading U.S.

pharmaceutical manufacturer informed

FDA that it would voluntarily cease

manufacture and distribution of

products containing danthron. The

company’s decision was partly in

response to published studies in Britain

and Japan that strongly suggested that

chronic administration of high doses of

danthron to rats and mice resulted in

development of intestinal and liver

tumors and that danthron is, therefore,

a potential carcinogen in humans (Refs.

1 and 2). Danthron, in common with

other anthraquinone compounds, has

also been shown to exhibit a positive

mutagenic effect in some in vitro

models (Refs. 3 and 4). FDA

subsequently initiated a recall that

extended to the retail/dispensing level

of all danthron-containing drug

products, by sending a recall letter to all

registered drug firms and distributors

(Ref. 5). FDA stated that ‘‘danthron

toxicity in humans has not been

specifically demonstrated, but because

of potential risk, FDA has requested an

immediate halt to all manufacturing,

relabeling, repackaging, and further

distribution of human drug products

containing danthron as an ingredient’’

(Ref. 6). The agency notes that, although

danthron was removed from OTC

laxative drug products in 1987, it was

not specifically included in part 310 (21

CFR part 310) as a new drug. Therefore,

in this rulemaking, the agency is

proposing to amend § 310.545 to

include danthron as a nonmonograph

ingredient.

III. New Information on

Phenolphthalein

Recently, FDA became aware of data

indicating that phenolphthalein is a

potential carcinogen in humans. Under

the direction of the National Institute of

Environmental Health Science (NIEHS)

through the National Toxicology

Program (NTP), phenolphthalein was

studied for its carcinogenic potential in

rats and mice. The National Cancer

Institute (NCI) nominated

phenolphthalein for study because of its

widespread chronic use in OTC laxative

drug products and the lack of adequate

testing for carcinogenicity in

experimental animals. The preliminary

findings were reported in a 1995 NTP

draft technical report (NTP TR 465, NIH

publication No. 95–3390), which

indicated that phenolphthalein

demonstrated evidence of carcinogenic