[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