Document ID: FDA-2004-D-0375-0019
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2008-12-23T05:00Z

[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