[Federal Register Volume 67, Number 61 (Friday, March 29, 2002)]
[Notices]
[Pages 15213-15214]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7582]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0103]


Draft Revised Compliance Policy Guide; Male Condom Defects; 
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 a draft revised compliance policy guide (CPG) entitled 
``Male Condom Defects (CPG 7124.21).'' This draft CPG provides guidance 
concerning FDA's water leak testing and air burst testing of male 
condoms. This draft guidance is being issued for public comment only 
and will not be implemented until a final CPG is announced in the 
Federal Register.

DATES: Submit written or electronic comments on the draft by June 27, 
2002.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft CPG, current CPG, and Laboratory Information Bulletin 
(LIB) No. 4176 to the Division of Small Manufacturers, International 
and Consumer Assistance (DSMICA), Center for Devices and Radiological 
Health (CDRH) (HFZ-220), Food and Drug Administration, 1350 Piccard 
Dr., Rockville, MD 20850 (301-443-6597 or outside MD 1-800-638-2041). 
Send two self-addressed adhesive labels to assist that office in 
processing your request, or fax your request to 301-443-8818. Submit 
written comments on the draft CPG to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to these documents.

FOR FURTHER INFORMATION CONTACT: John J. Farnham, Center for Devices 
and Radiological Health, Food and Drug Administration, 2098 Gaither 
Rd., Rockville, MD 20850, 301-594-4618, ext. 117.

SUPPLEMENTARY INFORMATION:

I. Background

    The draft CPG entitled ``Male Condom Defects (CGP 7124.21)'' is 
revising CPG 7124.21 that is currently entitled ``Condoms; Defects--
Criteria for Direct Reference Seizure.'' The title of this CPG was 
changed in the draft document; however, the CPG number remains the 
same.
    The purpose of this draft CPG is to provide guidance to FDA 
personnel concerning FDA's water leak testing of both latex and 
synthetic male condoms as well as air burst testing of latex male 
condoms.
    In accordance with section 514(c) of the Federal Food, Drug, and 
Cosmetic Act (the act) (21 U.S.C. 360d(c)), as amended by the FDA 
Modernization Act of 1997, the agency now recognizes some voluntary 
industrial standards for purposes of meeting the act's requirements. 
For latex male condoms, FDA has recognized, in part, two standards: (1) 
American Society for Testing and Materials' Standard Specification for 
Rubber Contraceptives (Male Condoms)-ASTM D3492-97 and (2) 
International Organization for Standardization's Rubber Condoms 
Standard-ISO 4074-1.
    Several important changes were included in this draft revised CPG 
to conform to these two standards. For water leak testing, the 
acceptable quality level was lowered from 0.4 to 0.25 in conformance 
with the two referenced standards. Regulatory guidance and sampling 
plans were included for FDA's air burst testing for the first time. FDA 
is concerned about the ability of latex condoms to resist breakage and 
has implemented air burst testing as a measure of elasticity and 
strength. A ``lot'' definition for FDA sampling and more specific 
guidance on sampling and analyses were also added to the revised draft 
CPG.

II. Significance of Guidance

    This draft guidance document represents the agency's current 
thinking on male condom defect regulatory guidance and test and 
sampling methods. 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. In accordance with FDA's good 
guidance practices (21 CFR 10.115), this draft CPG is considered level 
1 guidance. This draft guidance document is being issued for public 
comment only and is not in effect at this time. Only after a notice of 
availability is published in the Federal Register for the final CPG 
will the agency implement the revised policy.

III. Electronic Access

    Copies of the draft CPG and current CPG may be downloaded to a 
personal computer with access to the Internet. The Office of Regulatory 
Affairs' home page includes these documents and may be accessed at 
http://www.fda.gov/ora. The referenced documents will be available on 
the Compliance References page.
    Facsimiles of the draft CPG, current CPG, and LIB 4176 are 
available from DSMICA. To receive the referenced documents on your FAX 
machine, call the CDRH Facts-On-Demand (FOD) system at 1-800-899-0381 
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 numbers 39 (current CPG), 1399 (draft CPG) and 1400 (LIB 
4176) followed by the pound sign (#). Follow the remaining voice 
prompts to complete the request.

IV. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments on this draft CPG by June 27, 
2002. Two copies of any comments are to be submitted, 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. The 
agency will review all comments, but in issuing a final CPG, need not 
specifically address each comment. If appropriate, the agency will make 
changes to the CPG in response to comments. Copies of the draft CPG,

[[Page 15214]]

current CPG, LIB 4176, and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 21, 2002.
Dennis E. Baker,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 02-7582 Filed 3-28-02; 8:45 am]
BILLING CODE 4160-01-S