Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Rules and Regulations 62281

(ii) Before installing any replacement spar

tube that has previously been installed on

any helicopter, inspect it IAW the

Accomplishment Instructions, paragraphs

2.B.1.1 and 2.B.2. of the SB.

(2) 1400 or more hours TIS or 30 or more

calendar months:

(i) Within 200 hours TIS or 2 calendar

months, whichever occurs first, and

thereafter at intervals NTE 3000 hours TIS or

72 calendar months, whichever occurs first,

inspect the spar tube IAW the

Accomplishment Instructions, paragraphs

2.B.1.1 and 2.B.2. of the SB.

(A) If the spar tube passes the hardness

inspection of paragraph 2.B.1.1 of the SB and

the scratch, corrosion, and crack inspection

of paragraph 2.B.2 of the SB, replace the

bushing with a new bushing before further

flight.

(B) If the spar tube fails either the hardness

inspection of paragraph 2.B.1.1 of the SB or

the scratch, corrosion, or crack inspection of

paragraph 2.B.2 of the SB, replace the spar

tube with an airworthy spar tube before

further flight.

(ii) Before installing any replacement spar

tube that has previously been installed on

any helicopter, inspect it IAW the

Accomplishment Instructions, paragraphs

2.B.1.1 and 2.B.2. of the SB.

(b) For all spar tubes:

(1) With less than 7500 hours TIS or 144

calendar months since original installation:

(i) Prior to accumulating 7500 hours TIS or

144 calendar months, remove the spar tube

and inspect IAW the Accomplishment

Instructions, paragraphs 2.B.1.1 and 2.B.2. of

the SB.

(ii) After accomplishing the requirements

of paragraph (b)(1)(i) of this AD, install an

airworthy spar tube before further flight.

Before installing any replacement spar tube

that has been previously installed in any

helicopter, inspect it IAW the

Accomplishment Instructions, paragraphs

2.B.1.1 and 2.B.2. of the SB.

(2) With 7500 or more hours TIS or 144 or

more calendar months since original

installation:

(i) Within 500 hours TIS or 12 calendar

months, whichever occurs first, remove the

spar tube and inspect IAW the

Accomplishment Instructions, paragraphs

2.B.1.1 and 2.B.2. of the SB.

(ii) After accomplishing the requirements

of paragraph (b)(2)(i) of this AD, install an

airworthy spar tube before further flight.

Before installing any replacement spar tube

that has been previously installed in any

helicopter, inspect it IAW the

Accomplishment Instructions, paragraph

2.B.1.1 and 2.B.2. of the SB.

(3) After accomplishing the requirements

of either paragraph (b)(1) or (b)(2) of this AD,

as applicable, thereafter, at intervals NTE

7500 hours TIS or 144 calendar months,

whichever occurs first, remove the spar tube

and inspect IAW the Accomplishment

Instructions, paragraphs 2.B.1.1 and 2.B.2. of

the SB.

(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, Regulations

Group, Rotorcraft Directorate, FAA.

Operators shall submit their requests through

a FAA Principal Maintenance Inspector, who

may concur or comment and then send it to

the Manager, Regulations Group.

Note 2: Information concerning the

existence of approved alternative methods of

compliance with this AD, if any, may be

obtained from the Regulations Group.

(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) The inspections shall be done in

accordance with the Accomplishment

Instructions, paragraphs 2.B.1.1 and 2.B.2., in

Eurocopter France Service Bulletin No.

01.00.57, Revision 1, dated November 24,

1999. This incorporation by reference was

approved by the Director of the Federal

Register in accordance with 5 U.S.C. 552(a)

and 1 CFR part 51. Copies may be obtained

from American Eurocopter Corporation, 2701

Forum Drive, Grand Prairie, Texas 75053–

4005, telephone (972) 641–3460, fax (972)

641–3527. Copies may be inspected at the

FAA, Office of the Regional Counsel,

Southwest Region, 2601 Meacham Blvd.,

Room 663, Fort Worth, Texas; or at the Office

of the Federal Register, 800 North Capitol

Street, NW., suite 700, Washington, DC.

(f) This amendment becomes effective on

November 22, 2000.

Note 3: The subject of this AD is addressed

in Direction Generale De L’Aviation Civile

(France) AD 1999–039–073(A)R1, dated

December 29, 1999.

Issued in Fort Worth, Texas, on September

29, 2000.

Henry A. Armstrong,

Manager, Rotorcraft Directorate, Aircraft

Certification Service.

[FR Doc. 00–26235 Filed 10–17–00; 8:45 am]

BILLING CODE 4910–13–P

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. 99–NM–228–AD; Amendment

39–11756; AD 2000–11–08]

RIN 2120–AA64

Airworthiness Directives; Boeing

Model 747 and 767 Series Airplanes

Powered by General Electric Model

CF6–80C2 Series Engines; Correction

AGENCY: Federal Aviation

Administration, DOT.

ACTION: Final rule; correction.

SUMMARY: This document corrects a

typographical error that appeared in

airworthiness directive (AD) 2000–11–

08, amendment 39–11756, that was

published in the Federal Register on

June 1, 2000 (65 FR 34935). The

typographical error resulted in a

reference to an incorrect fuel

specification. That AD is applicable to

certain Boeing Model 747 and 767 series

airplanes. That AD supersedes an earlier

airworthiness directive to require

revising the FAA-approved Airplane

Flight Manual (AFM) to prohibit the use

of certain fuels; and either replacing an

existing placard with a new placard, or

replacing all dribble flow fuel nozzles

(DFFN) with standard fuel nozzles,

which terminates the requirements for

the new placard and AFM revision. That

AD also includes identical requirements

applicable to airplanes on which

standard fuel nozzles are not installed.

DATES: Effective July 6, 2000.

FOR FURTHER INFORMATION CONTACT: Ed

Hormel, Aerospace Engineer,

Propulsion Branch, ANM–140S, FAA,

Seattle Aircraft Certification Office,

1601 Lind Avenue, SW., Renton,

Washington 98055–4056; telephone

(425) 227–2681; fax (425) 227–1181.

SUPPLEMENTARY INFORMATION:

Airworthiness Directive (AD) 2000–11–

08, amendment 39–11756, applicable to

certain Boeing Model 747 and 767 series

airplanes, was published in the Federal

Register on June 1, 2000 (65 FR 34935).

That AD supersedes AD 98–08–23,

amendment 39–10472 (63 FR 18817,

April 16, 1998) to require revising the

FAA-approved Airplane Flight Manual

(AFM) to prohibit the use of certain

fuels; and either replacing an existing

placard with a new placard, or replacing

all dribble flow fuel nozzles (DFFN)

with standard fuel nozzles, which

terminates the requirements for the new

placard and AFM revision. That AD also

includes identical requirements

applicable to airplanes on which

standard fuel nozzles are not installed.

As published, AD 2000–11–08

contains an erroneous fuel specification

in paragraphs (a)(1)(i) and (c)(1) of that

AD. Those paragraphs incorrectly

reference MIL–T–83113, which is a

specification that does not exist. The

correct reference is MIL–T–83133.

Since no other part of the regulatory

information has been changed, the final

rule is not being republished.

Accordingly, in FR Doc. 00–13447

published June 1, 2000 (65 FR 34935),

make the following corrections:

The effective date of this AD remains

July 6, 2000.

§ 39.13 [Corrected]

1. On page 34937, in the second

column, paragraph (a)(1)(i) of AD 2000–

11–08 is corrected to read as follows:

AD 2000–11–08

* * * * *

(a) * * *

62282 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Rules and Regulations

(1) * * *

(i) Revise paragraph 1 of the Engine

Fuel System section to read as follows:

‘‘The fuel designation is General Electric

(GE) Specification D50TF2, as revised.

Fuel conforming to commercial jet fuel

specification ASTM–D–1655, Jet A, and

Jet A–1 are authorized for unlimited use

in this engine. Fuels conforming to

MIL–T–5624 grade JP–5 and MIL–T–

83133 grade JP–8 are acceptable

alternatives. The engine will operate

satisfactorily with any of the foregoing

fuels or any mixture thereof.’’ And,

* * * * *

2. On page 34937, in the third

column, paragraph (c)(1) of AD 2000–

11–08 is corrected to read as follows:

* * * * *

(c) * * *

(1) Revise paragraph 1 of the Engine

Fuel System section to read as follows:

‘‘The fuel designation is General Electric

(GE) Specification D50TF2, as revised.

Fuel conforming to commercial jet fuel

specification ASTM–D–1655, Jet A, and

Jet A–1 are authorized for unlimited use

in this engine. Fuels conforming to

MIL–T–5624 grade JP–5 and MIL–T–

83133 grade JP–8 are acceptable

alternatives. The engine will operate

satisfactorily with any of the foregoing

fuels or any mixture thereof.’’ And,

* * * * *

Issued in Renton, Washington, on October

5, 2000.

Lirio Liu Nelson,

Acting Manager, Transport Airplane

Directorate, Aircraft Certification Service.

[FR Doc. 00–26237 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. 98N–0970]

Medical Devices; Labeling for

Menstrual Tampon for the ‘‘Ultra’’

Absorbency

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is issuing a final

rule that amends its menstrual tampon

labeling regulation to add the term

‘‘ultra’’ absorbency for tampons that

absorb 15 to 18 grams (g) of fluid with

the syngyna test. At present, FDA

requires standardized terms to be used

for the labeling of a menstrual tampon

to indicate its particular absorbency.

This rule enables consumers to compare

the absorbency of one brand and style

of tampon with the absorbency of other

brands and styles. FDA is issuing this

final rule under the Federal Food, Drug,

and Cosmetic Act (the act) to ensure that

labeling of menstrual tampons is not

misleading. Elsewhere in this issue of

the Federal Register, FDA is proposing

to change the standardized menstrual

tampon term ‘‘junior’’ to ‘‘light’’.

DATES: This rule is effective January 16,

2001.

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’’) to

correspond with the following four

absorbency ranges: Less than 6 g; 6 to

9 g; 9 to 12 g; and 12 to 15 g of fluid,

as measured by the syngyna test. The

1989 final rule did not include terms for

tampons with absorbency in the 15 to 18

g range. Tampon manufacturers have

asserted that many women need

tampons with this higher level of

absorbency to manage their heavy

menstrual flow. See 54 FR 43766 to

43769.

Tampons are currently classified into

class II (special controls) at 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 (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 and subpart E of part

807. Under § 807.87(e), a 510(k)

premarket notification for a menstrual

tampon must contain, among other

thing, the proposed labeling for the

tampon. Section 801.430 (21 CFR

801.430) spells out the specific labeling

required for tampons with 15 g or less

of absorbency, including standardized

terms for absorbency as determined by

testing with the specified syngyna

methodology. Because the regulation

currently provides no uniform labeling

term for tampons that absorb 15 to 18

g of fluid with the syngyna test, the

agency is requiring that such tampons

be labeled as ‘‘ultra’’ absorbency. FDA

has recently cleared a menstrual

tampons product in this absorbency

range, and they are available to women

in the United States. FDA believes that

designating a standard term for this

absorbency range will improve

consumer understanding of tampons

across brands and allow for better

adherence to advice in the tampon

labeling about toxic shock syndrome

(TSS).

II. The Proposed Rule

In the Federal Register of January 21,

1999 (64 FR 3255 through 3257), FDA

published a proposed rule to add the

term ‘‘ultra’’ to describe tampons with a

15 to 18 g absorbency as measured by

the syngyna test. The 90-day comment

period closed on April 21, 1999.

The agency received nine comments

from individuals, tampon

manufacturers, one trade association,

and one from a member of the U.S.

Congress. Besides comments specific to

use of the term ‘‘ultra’’, other comments

addressed FDA’s 1995 draft guidance

document on the preparation of 510(k)

premarket notifications for menstrual

tampons (Ref. 1). Several comments

recommended changing the currently

used term for tampon absorbency less

than 6 g, from ‘‘junior’’ to ‘‘light’’. A

summary of the written comments and

FDA’s response to the comments is

provided in section III of this document.

III. Response to Comments

1. Two comments from manufacturers

supported the term ‘‘ultra’’. They noted

that the term ‘‘ultra’’ is defined in

Webster’s Dictionary (and others) as

‘‘going beyond what is usual or

ordinary’’ and ‘‘going beyond others’’.

These comments also noted that

menstrual tampons with this absorbency

are called ‘‘Ultra Plus’’ in Canada.

Comments from two other

manufacturers did not favor the term

‘‘ultra’’ for this tampon absorbency.

They argued that ‘‘ultra’’ implies the

product is more compact in size, more

concentrated, more environmentally

sound, or possibly superior. The

comments noted that ‘‘ultra’’ is a

proprietary term carrying one or more of

these meanings for a variety of other

household products, such as

dishwashing detergents and sanitary

napkins. These manufacturers proposed

the terms ‘‘extra’’ or ‘‘extra plus’’.

FDA concludes that the term ‘‘Ultra’’

is suitable to identify the absorbency of

tampons in the range of 15 to 18 g. FDA