[Federal Register: March 29, 2002 (Volume 67, Number 61)]
[Notices]
[Page 15213-15214]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29mr02-83]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 This draft guidance is being issued for public comment only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