Food and Drug Administration, HHS.
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.
Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.
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 Start Printed Page 78815information 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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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 § 884.5300 (21 CFR 884.5300), and latex condoms with spermicidal lubricant containing nonoxynol-9, classified under § 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 § 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 § 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 § 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 § 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 § 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 email@example.com 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 Start Printed Page 78816approved 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)).
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.Start Signature
Dated: December 16, 2008.
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30586 Filed 12-22-08; 8:45 am]
BILLING CODE 4160-01-S