[Federal Register: July 11, 2008 (Volume 73, Number 134)]
[Notices]
[Page 39970-39972]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr11jy08-53]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2008-D-0186] (formerly Docket No. 2000D-1384)
Guidance for Industry and Food and Drug Administration Staff;
Surveillance and Detention Without Physical Examination of Surgeons'
and/or Patient Examination Gloves; 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 the guidance entitled ``Surveillance and Detention
Without Physical Examination of Surgeons' and/or Patient Examination
Gloves.'' This guidance document provides information to FDA staff and
industry about FDA's strategy for addressing further imports of
surgeons' and patient examination gloves (medical gloves) from
manufacturers/shippers whose medical gloves have failed to meet FDA's
minimum acceptable quality criteria. The guidance and the strategy are
intended to help assure that medical gloves imported to the United
States meet FDA's minimum acceptable quality criteria and do not have
defects that could compromise their effectiveness and pose a health
hazard to healthcare professionals and patients who rely on medical
gloves for protection from blood- and fluid-borne pathogens.
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 Surgeons' and/or Patient Examination Gloves'' 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
[[Page 39971]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Identify comments with the docket number
found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Diane Goldsberry, Center for Devices
and Radiological Health (HFZ-333), Food and Drug Administration, 2094
Gaither Rd., Rockville, MD 20850, 240-276-0115.
SUPPLEMENTARY INFORMATION:
I. Background
Healthcare providers, professionals, and others use surgeons' and/
or patient examination gloves (medical gloves) as a barrier against the
transmission of blood- and fluid-borne pathogens. Defects in medical
gloves, such as holes, can compromise the effectiveness of the glove
barrier integrity and pose a potentially significant hazard to the
health of users as well as patients.
FDA's Center for Devices and Radiological Health (CDRH) is aware
from its import records that some foreign manufacturers and shippers
repeatedly attempt to import into the United States medical gloves that
fail water leak testing and therefore do not meet the acceptable
quality criteria defined in 21 CFR 800.20. To address this situation,
FDA has devised a risk-based tiered process for placing medical gloves
from identified manufacturers/shippers on an import alert, for
releasing individual shipments, and for removing medical gloves from
the 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 Surgeons'
and/or Patient Examination Gloves,'' which was announced in the Federal
Register of July 26, 2000 (65 FR 45991). The comment period closed on
October 24, 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 medical glove manufacturers because they appear
to be producing medical gloves at a defect rate well below the
acceptance criteria of the FDA test. Nevertheless, the revised document
recognizes the opportunity for 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 was proposed in the
original 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 gloves 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 Surgeons' and/or Patient Examination Gloves.''
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 Surgeons' and/or Patient Examination Gloves,''
you may either send an e-mail request to dsmica@fda.hhs.gov 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 1141 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. A search capability for all CDRH guidance documents is available
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html. Guidance documents are also
available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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
medical gloves from manufacturers/shippers who repeatedly export
defective medical gloves 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 particular shipment of its medical gloves or
removal of its medical gloves from listing on import alert.
[[Page 39972]]
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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov.
Dated: July 1, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15766 Filed 7-10-08; 8:45 am]
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