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

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Rules and Regulations 62283

believes that the term ‘‘Ultra’’ fits more

clearly within the current scheme of

tampon absorbency terminology than

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

term ‘‘ultra’’ better conveys to the

consumer absorbency abilities that are

beyond ‘‘Super’’ and ‘‘Super Plus’’ and

is less confusing to consumers than the

terms ‘‘extra’’ or ‘‘extra plus’’.

Manufacturers must now define this

absorbency in their labeling along with

the other absorbency categories to help

consumers understand the meaning of

this new term. As before, labeling will

continue to be required to inform

consumers that they should use the

lowest absorbency suitable for their

needs, as well as alternating use of

tampons with use of menstrual pads.

FDA does not permit manufacturers to

promote tampons for a wear time longer

than 8 hours.

2. Five comments suggested changes

in tampon labeling related to the

wording of the consumer information on

TSS. At present, under § 801.430(d)(2),

the tampon labeling regulation requires

that TSS incidence be reported in the

package insert as 1 to 17 cases of TSS

per 100,000 menstruating women and

girls per year. These five comments

requested that this labeling be revised to

reflect more recent data that indicate the

rate of TSS has declined. There were

also various comments on FDA’s draft

guidance document on preparing 510(k)

premarket notifications on menstrual

tampons, dated May 25, 1995 (Ref. 1).

These comments were beyond the

scope of the proposed rule. FDA

recognizes that TSS incidence in the

United States has dropped since this

labeling regulation was issued in 1989.

See response to comment number 6.

FDA will consider these suggestions for

revisions to the labeling regulation to

update the TSS incidence information.

Regarding the second set of comments,

FDA is currently working to improve

the 1995 510(k) guidance document,

and the suggested changes will be

considered during that process. FDA

intends to issue a draft updated

guidance document within a few

months.

3. Five comments suggested changing

the absorbency term ‘‘junior’’, used for

tampons with the lowest absorbency

(less than 6 g), to ‘‘light’’. They

suggested that the term ‘‘junior’’ implied

such tampons were only for young

teenagers.

This comment also was beyond the

scope of this rulemaking. However, FDA

agrees that the term ‘‘light’’ is more

appropriate than ‘‘junior’’ for tampons

with absorbency less than 6 g. A

proposed rule to change the term

‘‘junior’’ to ‘‘light’’ appears elsewhere in

this issue of the Federal Register.

4. One comment asked why FDA did

not propose a new term for tampon

absorbency in the 15 to 18 g range when

the other terms were issued in the

regulation in 1989.

The intent of the 1989 regulation was

to standardize terms currently in use so

that consumers had clear information to

make the best choices regardless of

which brand they purchased. Although

the absorbencies varied across brands,

most manufacturers had no more than

four different absorbencies of tampons

on the market. Most companies chose to

modify their products to match the

standardized absorbency categories and

keep the established terms. Immediately

prior to issuance of the labeling

regulation in 1989, only one marketed

tampon was in the 15 to 18 g range. The

manufacturer of this tampon chose to

reduce its absorbency to 12 to 15 g and

continue to use the term ‘‘super plus’’.

In the preamble to the final regulation

standardizing absorbency terms, FDA

stated that anyone who wished to

market a tampon that absorbs more than

15 g of fluid would be required to

submit a 510(k). The agency would then

determine whether the labeling

submitted for the device was

appropriate and whether the tampon

required premarket approval under

section 515 of the act (21 U.S.C. 360e).

FDA did receive and clear a 510(k) for

such a product earlier this year.

5. One comment asked how FDA

would institute monitoring procedures

for tracking the potential risk of increase

in TSS cases.

FDA requires laboratory testing for all

tampon products, as appropriate,

depending on changes to materials or

design. The agency already has in place

Mandatory Device Reporting (MDR)

requirements for manufacturers to

identify and monitor reports of serious

events related to device use, including

menstrual TSS. In 510(k) premarket

notifications, manufacturers of tampons

with 15 to 18 g absorbency will provide

FDA with their specific plans for

monitoring trends in TSS complaints

with use of their own tampon brands.

The manufacturer of the product already

cleared has such a plan in place. In the

postmarket setting and as part of its

regular MDR Program and User Facility

Reporting Program, FDA will actively

review any reports received on adverse

events, as well as the Centers for Disease

Control and Prevention (CDC) reports on

menstrual-TSS.

CDC has tracked TSS reports in the

United States for 20 years, and produces

periodic morbidity/mortality reports.

CDC recently has published a TSS

surveillance update, reviewing reports

from 1979 to 1996 (Ref. 2). These reports

show a marked drop in TSS cases in the

early 1980’s with a relatively flat,

extremely low number of TSS reports

since approximately 1986. For instance,

in 1996, there were five definite and

four probable menstrual-related TSS

cases reported to CDC.

The agency also notes that tampons

with an absorbency as high as 18 g are

currently marketed in other countries

with very low TSS rates (Ref. 3). It

appears that a number of factors may

play a role in the etiology and risk of

menstrual-related TSS, including

tampon materials, continuous tampon

use versus alternating use between

tampons and menstrual pads, the

presence of oxygen in the vaginal

environment, and awareness of TSS

symptoms and seeking early treatment.

Standardized absorbency terms are

intended to minimize the risk of

menstrual-TSS with tampon use. This

rule is consistent with purpose of the

1989 regulation, which is to ensure that

standardized labeling gives women the

information they need to make

appropriate choices among all brands.

FDA does not believe that this final rule

will increase the risk of TSS for women

who use tampons in accordance with

the labeling.

6. One comment asked about the steps

that might be taken to improve

consumer decisionmaking about

choosing the appropriate tampon

absorbency.

FDA agrees that women should have

a good understanding about tampon

absorbency in order to make the best

possible choice when purchasing

tampons. In the United States, there are

several public awareness initiatives in

place. For nearly 20 years, FDA, CDC,

and tampon manufacturers have all

played a part in this process. Education

programs at the local level have been

contributing partners, as well. FDA

believes that the current low TSS rates

in the United States are a reflection of

these highly effective public awareness

initiatives. FDA expects that these

programs, coupled with good tampon

labeling, will ensure continued good

choice patterns among tampon users in

the United States.

IV. Environmental Impact

The agency has determined under 21

CFR 25.30 (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.

62284 Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Rules and Regulations

V. Analysis of Impacts

FDA has examined the impacts of the

final 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 (Pub. L. 104–121),

and the Unfunded Mandates Reform Act

of 1995 (Pub. L. 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 final rule is consistent

with the regulatory philosophy and

principles identified in 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. There currently are no small

entities marketing a tampon of this

absorbency. Any small entity that

decided to enter the market with this

product would incur no additional costs

because of this rule because the small

entity would already be required to

identify the absorbency ranges of its

tampons.

The agency therefore certifies that the

final 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 final rule, because the

final rule is not expected to result in any

1-year expenditure that would exceed

$100 million adjusted for inflation.

VI. Federalism

FDA has analyzed this final rule in

accordance with the principles set forth

in Executive Order 13132. FDA has

determined that the rule does not

contain policies that have substantial

direct effect 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. Accordingly, the

agency has concluded that the rule does

not contain policies that have

federalism implications as defined in

the order and, consequently, a

federalism summary impact statement is

not required.

VII. Paperwork Reduction Act of 1995

This final 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

(the PRA) (44 U.S.C. 3501–3520).

Although the agency submitted the

proposed labeling for public comment

as an information collection in the

proposed rule, FDA now concludes that

the labeling requirement is not subject

to review by OMB because it does not

constitute a ‘‘collection of information’’

under the PRA. Rather, the proposed

labeling is a ‘‘public disclosure of

information originally supplied by the

Federal Government to the recipient for

the purpose of disclosure to the public’’

(5 CFR 1320.3(c)(2)).

VIII. References

The following references have been

placed on display in the Docket

Management Branch (address above)

and may be seen by interested persons

between 9 a.m. and 4 p.m., Monday

through Friday.

1. Guidance for the Content of Premarket

Notifications for Menstrual Tampons (draft,

May 25, 1995).

2. Hajjeh, R. A., A. Reingold, A. Weil, K.

Shutt, A. Schuchat, and B. Perkins, ‘‘Toxic

Shock Syndrome in the United States:

Surveillance Update, 1979–1996,’’ Emerging

Infectious Diseases; vol. 5, no. 6, pp. 807–

810, November/December 1999.

3. TSS rates in Canada, U.K., Germany—

where 15 to 18 g tampons are already

available, Medical Affairs and Regulatory

Affairs at Personal Products Co. at Skillman,

NJ.

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 Drug, 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.

2. Section 801.430 is amended in

paragraph (e)(1) by revising the table 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 Junior 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.

1 These 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.

Federal Register / Vol. 65, No. 202 / Wednesday, October 18, 2000 / Rules and Regulations 62285

* * * * *

Dated: October 2, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–26248 Filed 10–17–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

21 CFR Part 862

[Docket No. 00P–1280]

Medical Devices; Exemption From

Premarket Notification; Class II

Devices; Triiodothyronine Test System

AGENCY: Food and Drug Administration,

HHS.

ACTION: Final rule.

SUMMARY: The Food and Drug

Administration (FDA) is publishing an

order granting a petition requesting

exemption from the premarket

notification requirements for the

triiodothyronine test system with

certain limitations. This rule will

exempt from premarket notification the

triiodothyronine test system intended

for measuring the hormone

triiodothyronine in serum and plasma.

FDA is publishing this order in

accordance with procedures established

by the Food and Drug Administration

Modernization Action of 1997

(FDAMA).

DATES: This rule is effective October 18,

2000.

FOR FURTHER INFORMATION CONTACT:

Heather S. Rosecrans, Center for

Devices, and Radiological Health (HFZ–

404), Food and Drug Administration,

9200 Corporate Blvd., Rockville, MD

20850, 301–594–1190.

SUPPLEMENTARY INFORMATION:

I. Statutory Background

Under section 513 of the Federal

Food, and Drug, and Cosmetic Act (the

act) (21 U.S.C. 360c), FDA must classify

devices into one of three regulatory

classes: Class I, class II, or class III. The

FDA classification of a device is

determined by the amount of regulation

necessary to provide a reasonable

assurance of safety and effectiveness.

Under the Medical Device Amendments

of 1976 (the 1976 amendments (Public

Law 94–295)), as amended by the Safe

Medical Devices Act of 1990 (the SMDA

(Public Law 101–629)), devices are to be

classified into class I (general controls)

if there is information showing that the

general controls of the act are sufficient

to ensure safety and effectiveness; into

class II (special controls), if general

controls, by themselves, are insufficient

to provide reasonable assurance of

safety and effectiveness, but there is

sufficient information to establish

special controls to provide such

assurance; and into class III (premarket

approval), if there is insufficient

information to support classifying a

device into class I or class II and the

device is a life-sustaining or lifesupporting device or is for a use that is

of substantial importance in preventing

impairment of human health, or

presents a potential unreasonable risk of

illness or injury.

Most generic types of devices that

were on the market before the date of

the 1976 amendments (May 28, 1976)

(generally referred to as preamendments

devices) have been classified by FDA

under the procedures set forth in section

513(c) and (d) of the act through the

issuance of classification regulations

into one of these three regulatory

classes. Devices introduced into

interstate commerce for the first time on

or after May 28, 1976, (generally

referred to as postamendments devices)

are classified through the premarket

notification process under section

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

Section 510(k) of the act and the

implementing regulations, 21 CFR part

807, require persons who intend to

market a new device to submit a

premarket notification report (510(k))

containing information that allows FDA

to determine whether the new device is

substantially equivalent within the

meaning of section 513(i) of the act to

a legally marketed device that does not

require premarket approval.

On November 21, 1997, the President

signed into law FDAMA (Public Law

105–115). Section 206 of FDAMA, in

part, added a new section 510(m) to the

act. Section 510(m)(1) of the act requires

FDA, within 60 days after enactment of

FDAMA, to publish in the Federal

Register a list of each type of class II

device that does not require a report

under section 510(k) of the act to

provide reasonable assurance of safety

and effectiveness. Section 510(m) of the

act further provides that a 510(k) will no

longer be required for these devices

upon the date of publication of the list

in the Federal Register. FDA published

that list in the Federal Register of

January 21, 1998 (63 FR 3142).

Section 510(m)(2) of the act provides

that 1 day after date of publication of

the list under section 510(m)(1), FDA

may exempt a device on its own

initiative or upon petition of an

interested person, if FDA determines

that a 510(k) is not necessary to provide

reasonable assurance of the safety and

effectiveness of the device. This section

requires FDA to publish in the Federal

Register a notice of intent to exempt a

device, or of the petition, and to provide

a 30-day comment period. Within 120

days of publication of this document,

FDA must publish in the Federal

Register its final determination

regarding the exemption of the device

that was the subject of the notice. If FDA

fails to respond to a petition under this

section within 180 days of receiving it,

the petition shall be deemed granted.

II. Criteria for Exemption

There are a number of factors FDA

may consider to determine whether a

510(k) is necessary to provide

reasonable assurance of the safety and

effectiveness of a class II device. These

factors are discussed in the guidance the

agency issued on February 19, 1998,

entitled ‘‘Procedures for Class II Device

Exemptions from Premarket

Notification, Guidance for Industry and

CDRH Staff.’’ That guidance can be

obtained through the Internet on the

CDRH home page at http://

www.fda.gov/cdrh or by facsimile

through CDRH Facts-on-Demand at 1–

800–899–0381 or 301–827–0111.

Specify ‘‘159’’ when prompted for the

document shelf number.

III. Petition

On April 26, 2000, FDA received a

petition requesting an exemption from

premarket notification for the

triiodothyronine test system. The

triiodothyronine test system is currently

classified under 21 CFR 862.1710. In the

Federal Register of July 11, 2000 (65 FR

42706), FDA published a notice

announcing that this petition had been

received and provided an opportunity

for interested persons to submit

comments on the petition by August 10,

2000. FDA received no comments. FDA

has reviewed the petition and has

determined that the triiodothyronine

test system intended for measuring the

hormone triiodothyronine in serum and

plasma does meet the criteria for

exemption from the notification

requirements. This is the only type of

triiodothyronine test system of which

FDA presently has any knowledge. The

exemption is limited to triiodothyronine

test systems of the type described and

is also subject to the general limitations

on exemptions from premarket

notification for clinical chemistry and

clinical toxicology devices as described

in 21 CFR 870.9. For example, the

exemption will not apply to devices of

this type that present new indications,

novel designs, or alternative materials.

The exemption also will not apply if the