[Federal Register Volume 65, Number 157 (Monday, August 14, 2000)]
[Notices]
[Pages 49585-49586]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20463]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1383]


Draft Guidance for Industry on Surveillance and Detention Without 
Physical Examination of Condoms; 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availability of a draft guidance for industry entitled ``Guidance for 
Industry, Surveillance and Detention Without Physical Examination of 
Condoms.'' Many foreign manufacturers and shippers of condoms have 
consistently failed to provide condoms of adequate quality for 
distribution in the United States, which presents a potentially serious 
hazard to health for users. The draft guidance is intended to help 
industry understand FDA's policy to monitor continuously recidivist 
firms under our import program. This policy is neither final nor is it 
in effect at this time.

DATES: Submit written comments on the draft guidance by November 13, 
2000.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Guidance for Industry, Surveillance 
and Detention Without Physical Examination of Condoms'' to the Division 
of Small Manufacturers Assistance (HFZ-220), Center for Devices and 
Radiological Health (CDRH), 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 
301-443-8818. See the SUPPLEMENTARY INFORMATION section for information 
on electronic access to the draft guidance.
    Submit written comments concerning this draft guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Comments should be 
identified with the docket number found in the brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT:  John J. Farnham, Center for Devices 
and Radiological Health (HFZ-332), Food and Drug Administration, 2094 
Gaither Rd., Rockville, MD 20850, 301-594-4616.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ''Surveillance and Detention Without Physical Examination of 
Condoms.'' This draft guidance is intended to provide guidance to FDA 
staff and industry about a recidivist policy for firms that repeatedly 
attempt to import condoms that violate quality requirements. FDA's 
experience with sampling, examination, and testing of condoms raises 
concerns about the barrier properties of some condoms exported to the 
United States. Our analyses of condoms exported to the United States 
show a significant variation in the quality of the condoms exported by 
various manufacturers/shippers. We repeatedly place the same 
manufacturers/shippers on import detention due to leaks and defects in 
their condoms. These firms then need to provide us with private 
laboratory analyses for a number of shipments in order to demonstrate 
that the quality of the condoms and the firm's manufacturing operations 
comply with FDA standards. Once the firms provide such evidence, we 
remove them from import alert. However, many of these same 
manufacturers/shippers have repeated violative analyses and return to 
import alert status. This cyclical problem of violations requires 
continuous auditing and monitoring of recidivist firms to prevent the 
entry of defective condoms into the United States.
    In an attempt to ensure that condoms exported to the United States 
are in compliance with FDA standards, we revised Import Alert #85-02, 
``Surveillance (100% Sampling) and Detention Without Physical 
Examination of Condoms,'' referred to as the ``Recidivist Policy.'' 
This initiative was a joint effort between the agency's Center for 
Devices and Radiological Health's Office of Compliance, the Office of 
Regulatory Affairs' Division of Import Operations

[[Page 49586]]

and Policy, and the Office of Chief Counsel.
    The Recidivist Policy defines three increasingly stringent 
compliance levels for firms who have shipped violative condoms to the 
United States. Levels 1 and 2 allow voluntary compliance opportunities, 
while Level 3 provides a mechanism to issue a warning letter for 
apparent violations of the Federal Food, Drug, and Cosmetic Act, 
including noncompliance with the quality systems regulation for good 
manufacturing practices. A finding of Level 3 noncompliance will 
automatically place any future shipments of condoms from the 
manufacturer/shipper on detention, without the need for FDA to perform 
an actual inspection at the foreign manufacturer, due to the continued 
failure of condoms to pass minimum FDA standards upon import.
    The agency has adopted good guidance practices (GGP's), which set 
forth the agency's policies and procedures for the development, 
issuance, and use of guidance documents (62 FR 8961, February 27, 
1997). This draft guidance is issued as a draft Level 1 guidance 
consistent with GGP's.
    This draft guidance represents the agency's current thinking on the 
surveillance and detention without physical examination of condoms. 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 applicable statute, regulations, or 
both.

II. Electronic Access

    In order to receive the draft guidance entitled ``Surveillance and 
Detention Without Physical Examination of Condoms'' via your fax 
machine, call the CDRH Facts-On-Demand (FOD) system at 800-899-0381 or 
301-827-0111 from a touch-tone telephone. At the first voice prompt 
press 1 to access DSMA Facts, at second voice prompt press 2, and then 
enter the document number 1139 followed by the pound sign (#). Then 
follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so using the Internet. 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 access to the Internet. 
Updated on a regular basis, the CDRH home page includes various Level 1 
guidance documents for comment, device safety alerts, Federal Register 
reprints, information on premarket submissions (including lists of 
approved applications and manufacturers' addresses), small 
manufacturers' assistance, information on video conferencing and 
electronic submissions, mammography matters, and other device-oriented 
information. The CDRH home page may be accessed at http://www.fda.gov/cdrh. ``Surveillance and Detention Without Physical Examination of 
Condoms'' will be available at http://www.fda.gov/cdrh/oc/condom1.pdf.

III. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written comments regarding this draft guidance by November 13, 
2000. 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 
draft guidance and received comments may be seen in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 31, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-20463 Filed 8-11-00; 8:45 am]
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