Medical Devices; Labeling for Menstrual Tampons; Ranges of Absorbency

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 801

[Docket No. 98N-0970]

Medical Devices; Labeling for Menstrual Tampons; Ranges of

Absorbency

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

its menstrual tampon labeling regulation to provide an absorbency term

for tampons that absorb 15 to 18 grams (g) of fluid. The purpose of

this proposed rule is to enable 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: Written comments on the proposed rule should be submitted by

April 21, 1999. See section II of this document for the proposed

effective date of a final rule based on this document. Written comments

on the information collection requirements should be submitted by

February 22, 1999.

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. All comments should be identified

with the docket number found in brackets in the heading of this

document. Submit written comments regarding the information collection

requirements to the Office of Information and Regulatory Affairs, OMB,

New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC

20503, Attn: Desk Officer for FDA.

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

he Office of Information and Regulatory Affairs, OMB,

New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC

20503, Attn: Desk Officer for FDA.

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. The final rule did not include corresponding terms of absorbency

for 15 to 18 g nor the range above 18 g of fluid. Tampon manufacturers

have asserted that many women with heavy menstrual flow need higher

absorbency tampons to manage their heavy menstrual flow (see 54 FR

43766 at 43769).

FDA has consulted with the Center for Disease Control on this

proposed rule. Tampons with absorbency up to 18 g have been marketed in

other countries with very low Toxic Shock Syndrome (TSS) rates. FDA

believes that the proposed rule will not materially increase the risk

of TSS for women using tampons in accordance with the labeling.

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 (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

Sec

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

Sec. 807.87(e), a premarket notification for a device is to contain,

among other things, labeling for the device. Because there is no

uniform labeling term for tampons that absorb 15 to 18 g of fluid, the

agency is now proposing that tampons that absorb 15 to 18 g of fluid be

labeled as`` ultra absorbency''. The agency is specifically seeking

comment on the term ``ultra'' for this absorbency range, and it invites

suggestions of any alternative terms. At this time, FDA is not

proposing a term describing tampons with absorbency above 18 g of

fluid, and does not anticipate that tampons in the above 18 g

absorbency range will be considered for premarket clearance based on

this proposed rule.

II. Effective Date

FDA proposes that any final rule that may issue based on this

proposal become effective 30 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

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 (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 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. Because manufacturers already are required to

identify the absorbency ranges of their tampons, establishing a

standardized term for tampons that absorb 15 to 18 g of fluid will

impose no significant economic impact on any small entities. The agency

therefore certifies that this proposed rule will not have a significant

economic impact on a substantial number of small entities

small entities. Because manufacturers already are required to

identify the absorbency ranges of their tampons, establishing a

standardized term for tampons that absorb 15 to 18 g of fluid will

impose no significant economic impact on any small entities. The agency

therefore certifies that this proposed rule will not have a significant

economic impact on a substantial number of small entities. The rule

also does not trigger the requirement for a written statement under

section 202(a) of the Unfunded Mandates Reform Act because it does not

impose a mandate that results in an expenditure of $100 million or more

by State, local, or tribal governments in the aggregate, or by the

private sector, in any 1 year.

V. Request for Comments

Interested persons may, on or before April 21, 1999, submit to the

Dockets Management Branch (address above) written comments regarding

this proposal. 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 contains 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). The title, description, and respondent description of the

information collection are shown below with an estimate of the annual

reporting burden. Included in the estimate is the time for reviewing

instructions, gathering and maintaining the data needed, and completing

and reviewing each collection of information.

At this time, FDA is seeking clearance only for the information

collections that would be imposed by this proposed rule. FDA intends to

seek clearance for other information collections in Sec. 801.430 (21

CFR 801.430) in the immediate future

estimate is the time for reviewing

instructions, gathering and maintaining the data needed, and completing

and reviewing each collection of information.

At this time, FDA is seeking clearance only for the information

collections that would be imposed by this proposed rule. FDA intends to

seek clearance for other information collections in Sec. 801.430 (21

CFR 801.430) in the immediate future.

FDA invites comments on: (1) Whether the proposed collection of

information is necessary for the proper performance of FDA's functions,

including whether the information will have practical utility; (2) the

accuracy of FDA's estimate of the burden of the proposed collection of

information, including the validity of the methodology and assumptions

used; (3) ways to enhance the quality, utility, and clarity of the

information to be collected; and (4) ways to minimize the burden of the

collection of information on respondents, including through the use of

automated collection techniques, when appropriate, and other forms of

information technology.

Title: Medical Devices; Labeling for Menstrual Tampons; Ranges of

Absorbency of 15 to 18 grams.

Description: These information collection requirements in this

proposed rule apply to tampon manufacturers. This proposed rule would

establish a standardized term of absorbency, ``ultra,'' for 15 to 18 g

of fluid. Standardized terms already have been established for lower

ranges of absorbency. Manufacturers of ``ultra'' absorbency tampons

would be required to label the product in accordance with Sec. 801.430.

The labeling would have to be supported by design and performance

specifications, as well as certain test results, including dimensions,

pledget weight, absorbency by Syngyna method, adequate string

attachment, and microbiological testing

ished for lower

ranges of absorbency. Manufacturers of ``ultra'' absorbency tampons

would be required to label the product in accordance with Sec. 801.430.

The labeling would have to be supported by design and performance

specifications, as well as certain test results, including dimensions,

pledget weight, absorbency by Syngyna method, adequate string

attachment, and microbiological testing. The purpose of the proposed

rule is to enable consumers to compare the absorbency of one brand and

style of tampons with the absorbency of other brands and styles and

choose the least absorbent tampon needed to control menstrual flow and,

thus, reduce their risk of TSS.

Description of Respondents: Businesses or other for profit

organizations.

FDA estimates the burden for this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden1

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No. of Total

21 CFR Section No. of Responses per Total Annual Hours per Total Annual Operating

Respondents Respondent Responses Response Hours Costs

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801.430(e)(1) 2 1 2 40 80 3,200

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\1\ There are no capital or maintenance costs associated with this collection of information.

ndents Respondent Responses Response Hours Costs

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801.430(e)(1) 2 1 2 40 80 3,200

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\1\ There are no capital or maintenance costs associated with this collection of information.

These estimates are based on agency communications with industry

and FDA's knowledge and experience with tampon labeling. FDA expects

that only two manufacturers would revise the labels of their products

to incorporate the ``ultra'' absorbency range of 15 to 18 g. FDA

estimates that the operating costs for changes in labeling would

require a one-time cost of $1,600 per manufacturer.

FDA tentatively concludes that the labeling requirements found in

Sec. 801.430(c) and (d) are not subject to review by OMB because they

do not constitute a ``collection of information'' under the PRA (44

U.S.C. 3501 et seq.). Rather, the warning statements are ``public

disclosure[s] 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)).

In compliance with the PRA (44 U.S.C 3507(d)), the agency has

submitted the collection of information provisions of the proposed rule

to OMB for review. Interested persons wishing to submit comments

regarding the information collection requirements should do so by

February 22, 1999, and should direct them to the Office of Information

and Regulatory Affairs, OMB, address above.

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

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 801 be amended as follows:

PART 801--LABELING

1. The authority citation for 21 CFR part 801 continues to read as

follows:

ve.

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

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 801 be 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:

Sec. 801.430 User labeling for menstrual tampons.

* * * * *

(e) * * *

(1) * * *

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Corresponding term of

Ranges of absorbency in grams1 absorbency

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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.

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\1\These ranges are defined, respectively, as follows: Less than or

equal to 6 grams; greater than 6 grams up to and including 9 grams;

greater than 9 grams up to and including 12 grams; greater than 12

grams up to an including 15 grams; greater than 15 grams up to and

including 18 grams; and greater than 18 grams.

* * * * *

Dated: January 13, 1999.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 99-1362 Filed 1-20-99; 8:45 am]

BILLING CODE 4160-01-F