Federal Register, Volume 64 Issue 13 (Thursday, January 21, 1999)

[Federal Register Volume 64, Number 13 (Thursday, January 21, 1999)]
[Proposed Rules]
[Pages 3255-3257]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-1362]

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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

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. 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

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. 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.

[[Page 3256]]

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.
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. 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 Burden^{1
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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.

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:

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 grams^{1 absorbency
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6 and under............................ Junior absorbency.
6 to 9................................. Regular absorbency.
9 to 12................................ Super absorbency.

[[Page 3257]]

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}}