[Federal Register Volume 73, Number 134 (Friday, July 11, 2008)]
[Notices]
[Pages 39969-39970]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-15765]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0137] (formerly Docket No. 2000D-1383)


Guidance for Industry and Food and Drug Administration Staff; 
Surveillance and Detention Without Physical Examination of Condoms; 
Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Surveillance and Detention 
Without Physical Examination of Condoms.'' This guidance document 
provides information to FDA staff and industry about FDA's strategy for 
addressing further imports of condoms from manufacturers/shippers whose 
condoms have failed to meet FDA's minimum acceptable quality criteria. 
The guidance and the strategy are intended to help assure that condoms 
imported to the United States do not have defects that could compromise 
their effectiveness and present a health hazard to consumers who rely 
on condoms for protection from sexually transmitted diseases as well as 
for contraception.

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 ``Surveillance and Detention Without Physical 
Examination of Condoms'' 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 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:  J. Michael Kuchinski, 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

    Consumers use condoms as a barrier to reduce the risk of catching 
or spreading sexually transmitted diseases and to reduce the risk of 
unintended pregnancy. Defective condoms present a potentially 
significant hazard to health for these users.
    FDA's Center for Devices and Radiological Health (CDRH) is aware 
that some foreign manufacturers and shippers of condoms repeatedly 
attempt to import condoms that fail water leak testing, indicating a 
level of defects that does not satisfy the acceptable quality criteria 
described in Compliance Policy Guide 7124.21. To address the issue of 
firms that repeatedly offer nonconforming condoms for import to the 
United States, FDA has devised a risk-based tiered process for placing 
condoms from identified manufacturers/shippers on an import alert, for 
releasing individual shipments, and for removing condoms from 
identified manufacturers/shippers from the import alert and consequent 
potential detention without physical examination. The process involves 
three levels of import surveillance and detention that may be applied 
over a 24-month import surveillance cycle.
    This final guidance document supersedes the draft guidance entitled 
``Surveillance and Detention Without Physical Examination of Condoms,'' 
which was announced in the Federal Register on August 14, 2000 (65 FR 
49585). The comment period closed on November 13, 2000.
    We received a small number of comments, and FDA has made some 
changes to the final guidance document based on these comments. One 
comment indicated that the risk of detention is greater for high-volume 
manufacturers because they have many shipments and many FDA analyses in 
a 24-month period and, therefore, a greater cumulative risk of Type 1 
statistical sampling error resulting in some shipments failing analyses 
even though the shipments are acceptable. After analyzing the import 
data, FDA agrees that, in theory, such sampling errors are possible, 
although FDA believes that such errors are unlikely to affect most 
condom manufacturers because they appear to be producing condoms at a 
defect rate well below the acceptance criteria of the FDA test. 
Nevertheless, the revised document recognizes the opportunity for

[[Page 39970]]

manufacturers to present evidence to FDA in support of a 
reconsideration of their listing on the import alert if they believe 
for any reason that this listing is inappropriate, including as a 
result of statistical sampling errors or because previous defective 
shipments were found during a previously concluded import surveillance 
cycle.
    Another change in the final guidance is that the 24-month 
surveillance period will start when a firm is placed on Level 1 rather 
than when a firm is removed from Level 1, as proposed in the draft 
guidance. This change is being implemented to simplify the process and 
provide a ``level playing field'' for low-volume firms that export 
shipments of condoms to the United States less frequently than high-
volume firms and therefore generally take a longer time to obtain a 
number of consecutive passing entries sufficient for removal from the 
import alert.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on ``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 requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Surveillance and Detention Without 
Physical Examination of Condoms,'' you may either send an e-mail 
request to [email protected] 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 1139 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 refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520). 
The collections of information in 21 CFR part 820 have been approved 
under OMB control number 0910-0073.
    The information collection recommendations included in this 
document as part of the strategy for addressing further shipments of 
condoms from manufacturers/shippers who repeatedly export defective 
condoms to the United States do not require OMB clearance under the 
PRA. These collections of information are excepted from the 
requirements of the PRA under 5 CFR 1320.4(a)(2) and (c). The guidance 
recommends information to be collected and submitted to FDA ``during 
the conduct of an administrative action, investigation, or audit 
involving the agency against specific individuals'' (5 CFR 
1320.4(a)(2)) and ``after a case file or equivalent is opened with 
respect to a particular party'' (5 CFR 1320.4(c)) in order for that 
specific party to rebut the appearance of adulteration and consequently 
obtain release of a specific shipment of condoms or removal of specific 
condoms from listing on Import Alert.

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 Division of Dockets 
Management 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: July 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15765 Filed 7-10-08; 8:45 am]
BILLING CODE 4160-01-S