Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed Rules 62317

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 has been placed 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, under the authority

delegated to me by the Administrator,

the Federal Aviation Administration

proposes to amend 14 CFR part 39 of the

Federal Aviation Regulations 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.

PART 39—AIRWORTHINESS

DIRECTIVES

§ 39.13 [Amended]

2. FAA amends Section 39.13 by

adding a new airworthiness directive

(AD) to read as follows:

Raytheon Aircraft Company (The Beech

Aircraft Corporation previously was the

holder of Type Certificate 3A15): Docket No.

99–CE–63–AD.

(a) What airplanes are affected by this AD?

Models Beech 35–C33A, E33A, E33C, F33A,

F33C, S35, V35, V35A, V35B, 36, and A36

airplanes, all serial numbers, that:

(1) are certificated in any category;

(2) incorporate a Teledyne Continental

engine equipped with a turbonormalizing

system; and

(3) have Tornado Alley Turbo, Inc.

Supplemental Type Certificate (STC)

SA5223NM and STC SE5222NM

incorporated.

Note 1: Cessna 185 series airplanes could

have the subject clamp installed through the

incorporation of Tornado Alley Turbo, Inc.

STC SE00214DE and STC SE002215DE. The

FAA has determined that the cracks at the

weld spots in these V-band clamps are

occurring because of the specific

configuration of the Raytheon airplanes. We

have received no reports of service problems

with the affected V-band clamps installed on

Cessna 185 series airplanes.

(b) Who must comply with this AD?

Anyone who wishes to operate any of the

airplanes referenced in paragraph (a) of this

AD that are on the U.S. Register must comply

with this AD.

(c) What problem does this AD address?

The actions required by this AD are intended

to prevent the exhaust stack from detaching

from the turbocharger due to failure of the Vband exhaust clamp. This could result in the

release of high temperature gases inside the

engine compartment with a consequent fire

in the engine compartment.

(d) What must I do to address this

problem? To address this problem, you must

accomplish the following actions:

Actions Compliance times Procedures

Repetitively replace the V-band exhaust clamp,

Aeroquip part number 00624–4404C375–M..

Upon accumulating 400 hours time-in-service (TIS)

after incorporating Tornado Alley Turbo, Inc. STC

SA5223NM and STC SE5222NM on the airplane

or within the next 25 hours TIS after the effective

date of this AD, whichever occurs later, and thereafter at intervals not to exceed 400 hours TIS..

Use the procedures in the

Turbo-FliteTM 520/550 System Maintenance and Troubleshooting manual.

(e) Can I comply with this AD in any other

way? You may use an alternative method of

compliance or adjust the compliance time if:

(1) Your alternative method of compliance

provides an equivalent level of safety; and

(2) The Manager, Rotorcraft Directorate,

Special Certification Office, approves your

alternative. Submit your request through an

FAA Principal Maintenance Inspector, who

may add comments and then send it to the

Manager, Rotorcraft Directorate, Special

Certification Office, 2601 Meacham

Boulevard, Fort Worth, Texas 76193–0190.

Note 2: This AD applies to each airplane

identified in paragraph (a) of this AD,

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 (e)

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 you have not

eliminated the unsafe condition, specific

actions you propose to address it.

(f) Where can I get information about any

already-approved alternative methods of

compliance? You can contact Mr. Peter

Hakala, Aerospace Engineer, FAA, Rotorcraft

Directorate, Special Certification Office, 2601

Meacham Boulevard, Fort Worth, Texas

76193–0190;, telephone: (817) 222–5145;

facsimile: (817) 222–5785.

(g) What if I need to fly the airplane to

another location to comply with this AD? The

FAA can issue a special flight permit under

sections 21.197 and 21.199 of the Federal

Aviation Regulations (14 CFR 21.197 and

21.199) to operate your airplane to a location

where you can accomplish the requirements

of this AD.

(1) In order for this permit to be granted,

the airplane must pass the push/pull test

specified in Tornado Alley Turbo, Inc.,

Mandatory Service Bulletin Number TAT 98–

1, dated November 21, 1998.

(2) Anyone who holds at least a private

pilot certificate, as authorized by section 43.7

of the Federal Aviation Regulations (14 CFR

43.7), may accomplish the push/pull test

referenced in paragraph (g)(1) of this. You

must make an entry into the aircraft records

that shows compliance with this portion of

the AD, in accordance with section 43.9 of

the Federal Aviation Regulations (14 CFR

43.9).

(h) How do I get copies of the documents

referenced in this AD? You may obtain copies

of the documents referenced in this AD from

Tornado Alley Turbo, Inc., 300 Airport Road,

Ada, Oklahoma 74820; or may examine this

document at FAA, Central Region, Office of

the Regional Counsel, 901 Locust, Room 506,

Kansas City, Missouri 64106.

Issued in Kansas City, Missouri, on

October 11, 2000.

Marvin R. Nuss,

Acting Manager, Small Airplane Directorate,

Aircraft Certification Service.

[FR Doc. 00–26712 Filed 10–17–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 00N–1520]

Medical Devices; Labeling for

Menstrual Tampons; Ranges of

Absorbency, Change From ‘‘Junior’’ to

‘‘Light’’

AGENCY: Food and Drug Administration,

HHS.

ACTION: Proposed rule.

SUMMARY: The Food and Drug

Administration (FDA) is proposing to

amend its menstrual tampon labeling

regulation to change the current term for

tampons that absorb 6 grams (g) and

under of fluid. A tampon with 6 g or

less absorbency is currently required to

62318 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed Rules

be labeled as ‘‘junior’’. FDA is proposing

to change the term to ‘‘light’’. The term

‘‘junior’’ implies that it is only for

younger, teenage women, while in fact,

women of any age with light menstrual

flow may find this tampon useful. FDA

wishes to encourage women to use the

lowest absorbency tampon appropriate

for their flow to help minimize the risk

of toxic shock syndrome (TSS). At

present, FDA requires standardized

terms to be used for the labeling of a

menstrual tampon to indicate its

particular absorbency. This enables

consumers to compare the absorbency of

one brand and style of tampons with the

absorbency of other brands and styles.

FDA is issuing this proposed rule under

the Federal Food, Drug, and Cosmetic

Act (the act).

DATES: Submit written comments on the

proposed rule by January 16, 2001. See

section II of this document for the

proposed effective date of a final rule

based on this document.

ADDRESSES: Submit written comments

on the proposed rule to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Colin M. Pollard, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1180.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of October 26,

1989 (54 FR 43766), FDA published a

final rule which, among other things,

amended its menstrual tampon labeling

regulation to standardize the existing

absorbency terms (junior, regular, super,

and super plus) corresponding to the

following four absorbency ranges: Less

than 6, 6 to 9, 9 to 12, and 12 to 15 g

of fluid. Recently, the agency proposed

a term for 15 to 18 g absorbency

tampons (‘‘ultra’’). FDA is finalizing that

rule elsewhere in this issue of the

Federal Register. When commenting on

that proposed rule, several tampon

manufacturers suggested changing the

term for the 6 g and under tampon from

‘‘junior’’ to ‘‘light’’, because ‘‘junior’’

implies for teenagers only. These

manufacturers argued that, in reality,

the least absorbent tampon should be

used by all women, commensurate with

the amount of their menstrual flow. The

age or size of a women should not be a

deciding factor. The agency agrees that

this term change would help woman

decide which tampon they should use.

FDA is aware of literature suggesting

that the lowest absorbency of tampon

that is effective should be chosen, to

minimize the risk of TSS. FDA believes

that using the term ‘‘light’’ for low

absorbency tampons (rather than

‘‘junior’’) will help women make the

appropriate selection.

Tampons are currently classified into

class II (special controls) (see 21 CFR

884.5460 and 884.5470). Any person

who is required to register under section

510 of the act (21 U.S.C. 360) and part

807 of the regulations (21 CFR part 807)

and who intends to begin the

introduction or delivery for introduction

into interstate commerce of a tampon for

commercial distribution is required to

submit a premarket notification to FDA

at least 90 days before making such

introduction or delivery in accordance

with section 510(k) of the act (21 U.S.C.

360(k)) and subpart E of part 807. Under

§ 807.87(e), a premarket notification for

a device is to contain, among other

things, labeling for the device.

II. Effective Date

FDA proposes that any final rule that

may issue based on this proposal

become effective 90 days after the date

of publication of the final rule in the

Federal Register.

III. Environmental Impact

The agency has determined under 21

CFR 25.30(h) and (k) 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), as amended by

subtitle D of the Small Business

Regulatory Fairness Act of 1996 (Public

Law 104–121), and the Unfunded

Mandates Reform Act of 1995 (Public

Law 104–4). 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. Any small entity that decided

to enter the market with this product

would incur no additional costs because

of this rule. That small entity would

already be required to identify the

absorbency ranges of its tampons. The

agency, therefore, certifies that the

proposed rule will not have a significant

economic impact on a substantial

number of small entities.

Section 202(a) of the Unfunded

Mandates Reform Act of 1995 requires

that agencies prepare a written

statement of anticipated costs and

benefits before proposing any rule that

may result in an expenditure by State,

local, and tribal governments, in the

aggregate, or by the private sector, of

$100 million in any one year (adjusted

annually for inflation). The Unfunded

Mandates Reform Act does not require

FDA to prepare a statement of costs and

benefits for the proposed rule, because

the proposed rule is not expected to

result in any 1-year expenditure that

would exceed $100 million adjusted for

inflation.

V. Request for Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments regarding this

proposal by January 16, 2001. 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.

VI. Paperwork Reduction Act of 1995

This proposed rule does not contain

information collection provisions that

are subject to review by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995

(44 U.S.C. 3501–3520). This proposed

rule requires public disclosure, on

labeling, of information supplied by

FDA to tampon manufacturers. Such

information is not included in the

definition of ‘‘collection of information’’

under the Paperwork Reduction Act

regulation (5 CFR 1320.3(c)(3)).

List of Subjects in 21 CFR Part 801

Labeling, Medical devices, Reporting

and recordkeeping requirements.

Therefore, under the Federal Food,

Drug, and Cosmetic Act and under the

authority delegated to the Commissioner

of Food and Drugs, it is proposed that

21 CFR part 801 be amended as follows:

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Proposed Rules 62319

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.

2. Section 801.430 is amended by

revising the table in paragraph (e)(1) to

read as follows:

§ 801.430 User labeling for menstrual

tampons.

* * * * *

(e) * * *

(1) * * *

Ranges of absorbency in grams1 Corresponding term of absorbency

6 and under Light absorbency.

6 to 9 Regular absorbency.

9 to 12 Super absorbency.

12 to 15 Super plus absorbency.

15 to 18 Ultra absorbency.

Above 18 No term.

1These ranges are defined, respectively, as follows: Less than or equal to 6 grams (g); greater than 6 g up to and including 9 g; greater than 9

g up to and including 12 g; greater than 12 g up to and including 15 g; greater than 15 g up to and including 18 g; and greater than 18 g.

* * * * *

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–26249 Filed 10–17–00; 8:45 am]

BILLING CODE 4160–01–F

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Parts 52 and 81

[MO 114–1114; FRL–6885–7]

Approval and Promulgation of

Implementation Plans; State of

Missouri; Designation of Areas for Air

Quality Planning Purposes; Dent

Township

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA proposes to approve a

State Implementation Plan (SIP)

revision submitted by the state of

Missouri and Missouri’s request to

redesignate the lead nonattainment area

in western Iron County, Missouri, to

attainment of the National Ambient Air

Quality Standards (NAAQS). EPA

proposes to approve the maintenance

plan for this area including a consent

order which was submitted with the

redesignation request, and also proposes

to approve the revision to Missouri’s

Restriction of Emissions of Lead From

Specific Lead Smelter-Refinery

Installations rule which ensures the

permanent and enforceable emission

reductions by clarifying the emissions

limits for the Doe Run Resource

Recycling Facility, and removes the text

which could have allowed this facility

to resume operation as a primary

smelter.

In the final rules section of today’s

Federal Register, EPA is approving the

state’s SIP revision and redesignation

request as a direct final rule without

prior proposal because the Agency

views this as a noncontroversial action

and anticipates no relevant adverse

comments to this action. A detailed

rationale for the approval is set forth in

the direct final rule. If no relevant

adverse comments are received in

response to this action, no further

activity is contemplated in relation to

this action. If EPA receives relevant

adverse comments, the direct final rule

will be withdrawn and all public

comments received will be addressed in

a subsequent final rule based on this

proposed action. EPA will not institute

a second comment period on this action.

Any parties interested in commenting

on this action should do so at this time.

DATES: Comments on this proposed

action must be received in writing by

November 17, 2000.

ADDRESSES: Comments may be mailed to

Kim Johnson, Environmental Protection

Agency, Air Planning and Development

Branch, 901 North 5th Street, Kansas

City, Kansas 66101.

FOR FURTHER INFORMATION CONTACT: Kim

Johnson at (913) 551–7975.

SUPPLEMENTARY INFORMATION: See the

information provided in the direct final

rule which is located in the rules

section of today’s Federal Register.

Dated: September 27, 2000.

Dennis Grams,

Regional Administrator, Region 7.

[FR Doc. 00–26502 Filed 10–17–00; 8:45 am]

BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION

AGENCY

40 CFR Part 721

OPPTS–50639; FRL–6745–5

RIN 2070–AD43

Perfluorooctyl Sulfonates; Proposed

Significant New Use Rule

AGENCY: Environmental Protection

Agency (EPA).

ACTION: Proposed rule.

SUMMARY: EPA is proposing a significant

new use rule (SNUR) under section

5(a)(2) of the Toxic Substances Control

Act (TSCA) for the following chemical

substances: Perfluorooctanesulfonic

acid (PFOSA) and certain of its salts

(PFOSS), perfluorooctanesulfonyl

fluoride (PFOSF), certain higher and

lower homologues of PFOSA and

PFOSF, and certain other chemical

substances, including polymers, that

contain PFOSA and its homologues as

substructures. All of these chemical

substances are referred to collectively in

this proposed rule as perfluorooctyl

sulfonates, or PFOS. This proposed rule

would require manufacturers and

importers to notify EPA at least 90 days

before commencing the manufacture or

import of these chemical substances for

the significant new uses described in

this document. EPA believes that this

action is necessary because the chemical

substances included in this proposed

rule may be hazardous to human health

and the environment. The required

notice would provide EPA with the

opportunity to evaluate an intended

new use and associated activities and, if

necessary, to prohibit or limit that

activity before it occurs.

DATES: Comments, identified by the

docket number OPPTS–50639, are due

November 17, 2000.