[Federal Register: November 14, 2005 (Volume 70, Number 218)]
[Notices]
[Page 69156-69160]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no05-58]
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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Draft Guidance for Industry and Food and Drug Administration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availability of the draft guidance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 This draft guidance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condoms with and without spermicidal lubricant to designate this draft
guidance as the special control for latex condoms with and without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 This draft guidance is neither final nor is it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DATES: Submit written or electronic comments on this draft guidance by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diskette of the draft guidance document entitled ``Class II Special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to the draft guidance document.
Submit written comments concerning this draft guidance to the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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/.
guidance.html. Guidance documents are also available on the Division of
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
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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