[Federal Register Volume 70, Number 218 (Monday, November 14, 2005)]
[Notices]
[Pages 69156-69160]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-22610]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D-0555]


Draft Guidance for Industry and Food and Drug Administration 
Staff; Class II Special Controls Guidance Document: Labeling for Male 
Condoms Made of Natural Rubber Latex; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance

[[Page 69157]]

entitled ``Class II Special Controls Guidance Document: Labeling for 
Male Condoms Made of Natural Rubber Latex.'' This draft guidance 
document describes a means by which natural rubber latex (latex) 
condoms with and without spermicidal lubricant containing nonoxynol-9 
(N-9) may comply with the requirement of special controls for class II 
devices. Elsewhere in this issue of the Federal Register, FDA is 
publishing a proposed rule to amend the classification regulations for 
condoms with and without spermicidal lubricant to designate this draft 
guidance as the special control for latex condoms with and without 
spermicidal lubricant. This draft guidance is neither final nor is it 
in effect at this time.

DATES: Submit written or electronic comments on this draft guidance by 
February 13, 2006. Submit written or electronic comments on the 
information collection by January 13, 2006.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the draft guidance document entitled ``Class II Special 
Controls Guidance Document: Labeling for Male Condoms Made of Natural 
Rubber Latex'' to the Division of Small Manufacturers, International, 
and Consumer Assistance (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850. Send one self-addressed adhesive label to assist that office in 
processing your request or fax your request to 301-443-8818. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the draft guidance document.
    Submit written comments concerning this draft guidance to the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. Identify comments 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT:  John Farnham, Center for Devices and 
Radiological Health (HFZ-332), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 240-276-0115.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft special controls guidance document, announced in this 
document, describes a means by which latex condoms with and without 
spermicidal lubricant may comply with the requirement of special 
controls for class II devices. Following is a brief overview of the 
regulatory history of these devices and an overview of the draft 
special controls guidance document. The preamble to the proposed rule, 
which is published elsewhere in this Federal Register, provides more 
detail on the regulatory history of these devices and FDA's examination 
of condom labeling.

A. Overview of Regulatory History

    Condoms are devices that were on the market prior to the enactment 
of the Medical Device Amendments of 1976 and were intended for 
contraceptive and prophylactic (preventing transmission of sexually 
transmitted diseases (STDs)) uses. Condoms are classified at Sec.  
884.5300 (21 CFR 884.5300).
    Condoms with spermicidal lubricant containing N-9 were introduced 
to the market after the enactment of the Medical Device Amendments. As 
discussed in more detail in the preamble to the proposed rule published 
elsewhere in this Federal Register, since 1982, condoms with 
spermicidal lubricant containing N-9 have been required to bear a 
contraceptive effectiveness statement to be classified under Sec.  
884.5310. This contraceptive effectiveness statement was part of the 
reclassification order for condoms with spermicidal lubricant on 
October 29, 1982 (47 FR 49021).
    Both condoms and condoms with spermicidal lubricant containing N-9 
are classified in class II. Both were originally classified before the 
enactment of provisions of the Safe Medical Devices Act of 1990 that 
broadened the definition of class II devices and now permit FDA to 
establish special controls beyond performance standards to help provide 
reasonable assurance of the safety and effectiveness of such devices. 
The notice of proposed rulemaking published elsewhere in this issue of 
the Federal Register proposes to establish this draft guidance document 
as such a special control. Both condoms and condoms with spermicidal 
lubricant have also been the subject of specific labeling requirements 
and recommendations, as discussed next.
    In 1987, shortly after the U.S. Surgeon General recommended using a 
condom for protection against Human Immunodeficiency Virus (HIV) and 
Acquired Immune Deficiency Syndrome (AIDS), FDA issued a letter to 
condom manufacturers with recommendations on condom labeling. This 
letter was part of a far-reaching public health campaign to inform the 
American public about AIDS, which was identified in 1981 and associated 
with HIV and sexual transmission vectors in 1983. The purpose of FDA's 
1987 letter was to improve existing condom labeling to better inform 
condom users about protecting themselves against the spread of HIV/AIDS 
and other STDs. In 1989, FDA issued a letter further explaining its 
policy on condom labeling and the necessity of including in the 
labeling a statement of the condom's intended use(s).
    In 1997, FDA published final labeling regulations applicable to 
latex condoms that address expiration dating and latex sensitivity 
(Sec. Sec.  801.435 and 801.437 (21 CFR 801.435 and 801.437)). FDA 
established expiration dating requirements in response to information 
that showed that the effectiveness of latex condoms as a barrier to 
sexually transmitted diseases, including HIV, is dependent upon the 
integrity of the latex material. The expiration dating regulation of 
September 26, 1997, addresses the risk of condom deterioration due to 
product aging and helps ensure that consumers have information 
regarding the safe use of latex condoms (62 FR 50497 at 50501). The 
latex sensitivity labeling requirements of September 30, 1997, were 
added in response to numerous reports of severe allergic reactions and 
deaths related to a wide range of medical devices containing natural 
rubber (62 FR 51021 at 51029).
    In July 1998, to encourage conformance with condom performance 
standards, FDA issued a guidance document entitled ``Latex Condoms for 
Men: Information for 510(k) Premarket Notifications: Use of Consensus 
Standards for Abbreviated Submissions,'' which outlined FDA's 
``abbreviated review'' approach toward 510(k)s for condoms. To qualify 
for an abbreviated review, the condom manufacturer must declare 
conformance to standards recognized by FDA in accordance with section 
514(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360d). 
This guidance also carried forward previously issued guidance on 
suggested labeling for the primary retail package and the package 
insert, as well as the foil wrapper for individual condoms. In 
particular, FDA guidance suggested that labeling on the primary package 
address contraception, and also include the following statement 
regarding STDs: ``If used properly, latex condoms will help to reduce 
the risk of transmission of HIV infection (AIDS) and many other 
sexually transmitted diseases.''
    This same statement was also recommended for the individual foil 
wrapper of the condom.
    FDA also carried forward a labeling recommendation for the package 
insert

[[Page 69158]]

to include the following expanded version of the previous statement:
    If used properly, latex condoms will help to reduce the risk of 
transmission of HIV infection (AIDS) and many other sexually 
transmitted diseases, including chlamydia infections, genital herpes, 
genital warts, gonorrhea, hepatitis B, and syphilis.
    In December 2000, Congress enacted Public Law 106-554, which among 
other provisions, directed FDA to ``reexamine existing condom labels'' 
and ``determine whether the labels are medically accurate regarding the 
overall effectiveness or lack of effectiveness of condoms in preventing 
sexually transmitted diseases, including [human papillomavirus 
(HPV)].'' In re-examining condom labeling as directed by Public Law 
106-554, and in the development of the draft special controls guidance 
document, FDA considered the following points:
     Physical properties of condoms;
     Condom slippage and breakage during actual use,
     Plausibility for STD risk reduction attributable to 
condoms,
     Evaluations of condom effectiveness against STDs by other 
Federal agencies,
     Clinical data regarding condom protection against STDs,
     Information on N-9 and contraception.
    The information FDA considered during the course of its re-
examination of the medical accuracy of condom labeling and its analysis 
support the conclusion that condoms reduce the overall risk of STD 
transmission, although the degree of risk reduction for different types 
of STDs varies with their routes of transmission. The preamble to the 
proposed rule designating this draft guidance as a special control for 
male condoms made of natural rubber latex, published elsewhere in this 
Federal Register, discusses in detail FDA's review and resulting 
conclusions, which form the basis for the recommendations made in the 
draft guidance document.

B. Overview of Guidance

    The recommendations in the draft guidance reflect the FDA's re-
examination of the medical accuracy of condom labeling, as required by 
Public Law 106-554. The draft guidance document describes a means by 
which latex condoms with and without spermicidal lubricant may comply 
with the requirement of special controls for class II devices. The 
draft guidance document identifies the issues requiring special 
controls associated with these devices and recommends addressing these 
issues through labeling.
    The labeling recommendations in the draft guidance are intended to 
provide information to users of latex condoms with and without 
spermicidal lubricant. The draft special controls guidance recommends 
labeling to inform users about the extent of protection provided by 
condoms against unintended pregnancy and against various types of STDs, 
as well as information about possible risks associated with exposure to 
N-9 contained in the spermicidal lubricant of some condoms. The 
labeling recommendations provide important information for condom users 
to assist them in determining whether latex condoms are appropriate for 
their needs and, if so, to determine whether a condom with or without 
N-9 lubricant is most suitable. FDA believes that this draft guidance 
is an appropriate special control to help provide reasonable assurance 
of the safety and effectiveness of latex condoms and latex condoms with 
spermicidal lubricant containing N-9.
    At this time, FDA is not proposing to designate a special control 
for any condoms made of natural membrane (skin) or synthetic materials. 
Discussions with the condom industry indicate that condoms made from 
natural rubber latex represent nearly 98 percent of the U.S. retail 
market for condoms. The agency understands that all condoms distributed 
by public health and other organizations are also made from natural 
rubber latex, based on its discussions with manufacturers. The agency 
believes, therefore, that the recommendations in the draft special 
controls guidance document address the vast majority of condoms 
distributed in the United States. However, at a future date, FDA also 
intends to address condoms made from other materials that are not 
specifically addressed by this draft guidance. Until FDA provides 
further specific guidance for these products, manufacturers of 
synthetic condoms may consult Part C of FDA's guidance document 
entitled ``Testing Guidance for Male Condoms Made from New Material 
(June 25, 1995),'' which is available at http://www.fda.gov/cdrh/ode/oderp455.html, and manufacturers of natural membrane condoms may 
consult the guidance document entitled ``Guidance for Industry-Uniform 
Contraceptive Labeling (July 23, 1998),'' which is available at http://www.fda.gov/cdrh/ode/contrlab.html.
    FDA believes, however, that most of the recommendations contained 
in the draft special controls guidance document for latex condoms 
regarding labeling to address N-9 are also applicable to nonlatex 
condoms containing N-9, and encourages manufacturers to follow those 
aspects, as noted in the draft guidance itself.
    The labeling recommendations in the special controls guidance 
document, when final, will supersede statements in a number of 
documents, including:
     FDA letter to ``All U.S. Condom Manufacturers, Importers 
and Repackagers'' (April 7, 1987);
     FDA letter to ``Manufacturers, Importers, and Repackagers 
of Condoms for Contraception or Sexually-Transmitted Disease 
Prevention'' (February 13, 1989), which is available at http://www.fda.gov/cdrh/comp/053.pdf.
     Contraceptive effectiveness statement required by the 1982 
reclassification order for latex condoms with the spermicide, 
nonoxynol-9, as outlined in an October 29, 1982, Federal Register 
document (47 FR 49201).
    If the draft guidance is finalized, FDA intends to withdraw or 
amend other documents to ensure consistency with the labeling 
recommendations in the special controls guidance document. Following 
the finalization of this guidance and the implementation of any final 
classification rule designating this document as a special control for 
latex condoms and latex condoms with spermicidal lubricant, labeling 
for those devices will need to address the issues covered in the final 
special controls guidance document, unless the device manufacturer in 
some other way provides equivalent assurances of safety and 
effectiveness.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, if 
finalized, will represent the agency's current thinking on labeling for 
male condoms made of natural rubber latex. It does not create or confer 
any rights for or on any person and does not operate to bind FDA or the 
public. An alternative approach may be used if such approach satisfies 
the requirements of the applicable statute and regulations.

III. Electronic Access

    To receive the draft ``Class II Special Controls Guidance Document: 
Labeling for Male Condoms Made of Natural Rubber Latex'' by fax 
machine, call the CDRH Facts-On-Demand system at 800-899-0381 or 301-
827-0111 from a touch-tone telephone. Press 1 to enter the system. At 
the second voice prompt, press 1 to order a document. Enter the 
document number (1548) followed by the pound sign (). Follow 
the remaining voice prompts to complete your request.

[[Page 69159]]

    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. CDRH maintains an entry on the 
Internet for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with Internet 
access. Updated on a regular basis, the CDRH home page includes device 
safety alerts, Federal Register reprints, information on premarket 
submissions (including lists of approved applications and 
manufacturers' addresses), small manufacturer's assistance, information 
on video conferencing and electronic submissions, Mammography Matters, 
and other device-oriented information. The CDRH web site may be 
accessed at http://www.fda.gov/cdrh. A search capability for all CDRH 
guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Division of 
Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995 (the PRA)

    Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain 
approval from the Office of Management and Budget (OMB) for each 
collection of information they conduct or sponsor. ``Collection of 
information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and 
includes agency requests or requirements that members of the public 
submit reports, keep records, or provide information to a third party. 
Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires 
Federal agencies to provide a 60-day notice in the Federal Register 
concerning each proposed collection of information, before submitting 
the collection to OMB for approval. To comply with this requirement, 
FDA is publishing notice of the proposed collection of information set 
forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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: Labeling for Male Condoms Made of Natural Rubber Latex
    Description: Under the Medical Device Amendments of 1976 (Public 
Law 94-295), class II devices were defined as those devices for which 
there was insufficient information to show that general controls 
themselves would provide a reasonable assurance of safety and 
effectiveness, but for which there was sufficient information to 
establish performance standards to provide such assurance.
    Both condoms and condoms with spermicidal lubricant containing N-9 
are classified in class II. Both were originally classified before the 
enactment of provisions of the Safe Medical Devices Act of 1990 (Public 
Law 101-629) that broadened the definition of class II devices and now 
permit FDA to establish special controls beyond performance standards, 
including guidance documents, to help provide reasonable assurance of 
the safety and effectiveness of such devices.
    In December 2000, Congress enacted Public Law 106-554, which among 
other provisions, directed FDA to ``reexamine existing condom labels'' 
and ``determine whether the labels are medically accurate regarding the 
overall effectiveness or lack of effectiveness in preventing sexually 
transmitted diseases* * *.'' FDA is recommending labeling changes 
intended to provide important information for condom users, including 
the extent of protection provided by condoms against various types of 
STDs.
    Respondents to this collection of information are manufacturers and 
repackagers of male condoms made of natural rubber latex. FDA believes 
that this a one-time burden, because once a label is redesigned, it can 
be used indefinitely.
    FDA estimates the burden of this collection as follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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   No. of      Annual Frequency  per
 Respondents          Response         Total Annual  Responses    Hours  per Response          Total Hours
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35\2\                              34                    1,190                       12                   14,280
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3\3\                               34                      102                       12                    1,224
----------------------------------------------------------------------------------------------------------------
Total                                                                                                     15,504
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Current manufacturers for year one.
\3\ New manufacturers for years two and three.

    The reporting burden hours to respondents in the first year is a 
one-time burden of 14,280 hours. FDA expects three new manufacturers or 
repackagers to enter the market yearly, and collectively have a one-
time burden of 1,224 hours. The number of respondents and prospective 
new manufacturers cited in table 1 of this document are based on FDA's 
database of premarket submissions. The remaining figures were derived 
from a study performed for FDA by Eastern Research Group, Inc., an 
economic consulting firm, to estimate the impact of the 1999 Over-the-
Counter (OTC) Human Drug Labeling Requirements final rule (64 FR 13254, 
March 17, 1999). Because the packaging requirements for condoms are 
similar to those of many OTC drugs, we believe the burden to redesign 
the labeling for OTC drugs is an appropriate proxy for the estimated 
burden to redesign condom labeling.
    The latex allergy caution required by Sec.  801.437 and referenced 
in the draft guidance does not constitute a ``collection of 
information'' under the PRA. Rather, it 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)). The expiration dating requirements established by Sec.  
801.435 and referenced in the draft guidance have been approved by OMB 
under OMB control number 0910-0485.

[[Page 69160]]

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), written or electronic comments regarding this 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: June 21, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-22610 Filed 11-10-05; 8:45 am]
BILLING CODE 4160-01-S