[Federal Register: December 23, 2008 (Volume 73, Number 247)]
[Notices]
[Page 78814-78816]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23de08-98]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2004-D-0375] (formerly Docket No. 2004D-0555)
Guidance for Industry and Food and Drug Administration Staff;
``Class II Special Controls Guidance Document: Labeling for Natural
Rubber Latex Condoms Classified Under 21 CFR 884.5300''; 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 guidance entitled ``Class II Special Controls
Guidance Document: Labeling for Natural Rubber Latex Condoms Classified
Under 21 CFR 884.5300.'' This guidance document describes a means by
which male condoms made of natural rubber latex (latex condoms) may
comply with the requirement of special controls for class II devices.
FDA believes that the labeling recommendations contained in this
guidance, in addition to general controls, will provide reasonable
assurance of the safety and effectiveness of latex condoms without
spermicidal lubricant. In the Federal Register of November 10, 2008 (73
FR 66522), FDA published a final rule that amended the classification
regulation for condoms from class II (performance standards) to class
II (special controls) and designated this guidance document as the
special control for male condoms made of natural rubber latex
classified under that regulation.
DATES: Submit written or electronic comments on this guidance at any
time. General comments on agency guidance documents are welcome at any
time.
ADDRESSES: Submit written requests for single copies of the guidance
document entitled ``Class II Special Controls Guidance Document:
Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR
884.5300'' 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 240-276-3151. See the
SUPPLEMENTARY INFORMATION section for
[[Page 78815]]
information on electronic access to the guidance.
Submit written comments concerning this 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.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Paul Tilton, 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
On December 21, 2000, Congress enacted Public Law 106-554, which
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].''
Under this mandate, FDA conducted a review of scientific information
and of existing latex condom labeling, and concluded that existing
latex condom labeling was medically accurate in presenting the
conclusion that, as an overall matter, condoms are effective in
reducing the risk of sexually transmitted infections (STIs). To help
consumers make appropriate choices for their particular needs, and
therefore to ensure the safe and effective use of latex condoms, FDA
issued a proposed rule to establish a labeling guidance as a special
control to address some additional, more nuanced information about
latex condoms and STIs, as well as to provide information about
contraception, and about appropriate directions and precautions for use
of latex condoms (the 2005 proposed rule) (70 FR 69102, November 14,
2005). The rule proposed to amend existing classification regulations
to designate a labeling guidance document entitled ``Class II Special
Controls Guidance Document: Labeling for Male Condoms Made of Natural
Rubber Latex'' as the special control for condoms made of natural
rubber latex (latex condoms), classified under Sec. 884.5300 (21 CFR
884.5300), and latex condoms with spermicidal lubricant containing
nonoxynol-9, classified under Sec. 884.5310 (21 CFR 884.5310). Also in
the Federal Register of November 14, 2005 (70 FR 69156), FDA announced
the availability of the draft guidance entitled ``Class II Special
Controls Guidance Document: Labeling for Male Condoms Made of Natural
Rubber Latex'' (the 2005 draft guidance). FDA invited interested
persons to comment on the 2005 proposed rule and 2005 draft guidance by
February 13, 2006.
In response to FDA's requests for comments, more than 100
commenters submitted information and comments to the docket for the
2005 proposed rule and the docket for the 2005 draft guidance. Because
of the intertwined nature of the 2005 proposed rule and the 2005 draft
guidance, and because of the significant overlap in comments, FDA
considered all comments in preparing both the final rule and special
controls guidance. The analysis of comments is contained in the final
rule.
In the Federal Register of November 10, 2008 (73 FR 66522), FDA
issued a final rule which amended the classification regulation for
condoms in Sec. 884.5300 and designated the guidance document entitled
``Class II Special Controls Guidance Document: Labeling for Natural
Rubber Latex Condoms Classified Under 21 CFR 884.5300,'' which is the
subject of this notice, as the special control for latex condoms
classified under that regulation. This guidance is based on the draft
guidance proposed as a special control in November 2005 entitled
``Class II Special Controls Guidance Document: Labeling for Male
Condoms Made of Natural Rubber Latex.'' FDA assigned a new title to the
final special control guidance document designated as a special control
by Sec. 884.5300 in order to avoid confusion with the 2005 draft
guidance, which remains available (but not for implementation) as the
proposed special control for latex condoms with spermicidal lubricant
(classified under Sec. 884.5310) in association with the proposal to
amend that classification regulation. FDA is continuing to study the
issues surrounding latex condoms with spermicidal lubricant and has not
yet issued a new final rule regarding those devices.
II. Significance of Special Controls Guidance Document
FDA believes that adherence to the labeling recommendations
described in this guidance document, in addition to the general
controls, will provide reasonable assurance of the safety and
effectiveness of latex condoms classified under Sec. 884.5300. The
final rule establishing this guidance document as a special control
will be effective January 9, 2009. Following the effective date of the
final rule, latex condoms classified under Sec. 884.5300 must comply
with the requirement of special controls; manufacturers must address
the issues requiring special controls as identified in the guidance,
either by following the recommendations in the guidance or by some
other means that provides equivalent assurances of safety and
effectiveness.
III. Electronic Access
Persons interested in obtaining a copy of the guidance may do so by
using the Internet. To receive ``Class II Special Controls Guidance
Document: Labeling for Natural Rubber Latex Condoms Classified Under 21
CFR 884.5300,'' you may either send an e-mail request to
dsmica@fda.hhs.gov to receive an electronic copy of the document or
send a fax request to 240-276-3151 to receive a hard copy. Please use
the document number (1688) to identify the guidance you are requesting.
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 at http://www.regulations.gov.
IV. Paperwork Reduction Act of 1995
This guidance 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 new collections of information in this guidance were approved under
OMB control number 0910-0633.
This guidance also refers to previously approved collections of
information found in FDA regulations. The collections of information in
21 CFR part 807, subpart E, have been approved under OMB control number
0910-0120; the collections of information in 21 CFR part 820 have been
approved under OMB control number 0910-0073; the collections of
information in 21 CFR part 801, including those in 21 CFR 801.435,
referenced in the guidance, have been
[[Page 78816]]
approved under OMB control number 0910-0485. The latex allergy caution
required by 21 CFR 801.437 and referenced in the 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)).
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
paper 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.
Please note that on January 15, 2008, the FDA Web site transitioned
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic comments or
submissions will be accepted by FDA only through FDMS at http://
www.regulations.gov.
Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30586 Filed 12-22-08; 8:45 am]
BILLING CODE 4160-01-S