[Federal Register: September 7, 2005 (Volume 70, Number 172)]
[Notices]
[Page 53231-53233]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07se05-71]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0044]
Draft Guidance for Industry and Food and Drug Administration
Staff: Recommendations for Clinical Laboratory Improvement Amendments
of 1988 Waiver Applications; 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availability of the draft guidance entitled ``Recommendations for
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver
Applications.'' FDA is issuing this draft guidance to recommend an
approach for determining whether a laboratory test may be performed by
laboratories with a certificate of waiver under CLIA. This draft
guidance replaces the previous draft guidance entitled ``Guidance for
Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for
Waiver,'' March 1, 2001.
DATES: Submit written or electronic comments on this draft guidance by
December 6, 2005. Submit written comments on the information collection
provisions by November 7, 2005.
ADDRESSES: Submit written requests for single copies on a 3.5''
diskette of the draft guidance document entitled ``Recommendations for
Clinical Laboratory Improvement Amendments of 1988 (CLIA) for Waiver
Applications'' 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 301-443-8818. See the
SUPPLEMENTARY INFORMATION section for information on electronic access
to the guidance.
Submit written comments concerning this draft guidance and the
information collection provisions 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.fda.gov/dockets/ecomments.
Identify comments with the docket number found in
brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Carol Benson, Center for Devices and
Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 240-276-0443, ext. 144.
SUPPLEMENTARY INFORMATION:
I. Background
CLIA requires that clinical laboratories obtain a certificate from
the Secretary of Health and Human Services (the Secretary) before
accepting materials derived from the human body for laboratory tests
(42 U.S.C. 263(b)).
Laboratories that perform only tests that are ``simple'' and that
have an ``insignificant risk of an erroneous result'' may obtain a
certificate of waiver (42 U.S.C. 263a(c)(2)). The Secretary has
delegated to FDA the authority to determine under CLIA whether
particular tests (waived tests) are ``simple'' and have ``an
insignificant risk of an erroneous result'' (April 27, 2004, 69 FR
22849). This draft guidance document describes recommendations for
device manufacturers submitting to FDA an application for determination
that a cleared or approved device meets this CLIA standard (CLIA waiver
application).
FDA previously issued a draft guidance entitled ``Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver''
on March 1, 2001. This new draft guidance replaces the previous draft
guidance.
The changes compared to the previous draft guidance include the
following: (1) Greater emphasis on scientifically-based flex studies
and validation studies, linked to the hazard analysis for each device;
(2) recognition that reference methods may not be
[[Page 53232]]
available for every device type (although devices should be traceable
to methods of known accuracy when true reference methods are
available); (3) additional emphasis on use of quality control
procedures; (4) greater emphasis on intended users during studies
testing the device; and (5) updated study recommendations with emphasis
on use of patient specimens, in an intended use environment, over time.
FDA bases the recommendations in this draft guidance on its
interpretation of CLIA, FDA's experience with CLIA complexity
determinations, and the agency's interactions with stakeholders. One of
the interactions with stakeholders was at an open public workshop on
August 14 and 15, 2000. In addition, a proposal presented by (Advanced
Medical Technology Association) AdvaMed at the September 2003 Clinical
Laboratory Improvement Advisory Committee (CLIAC) meeting, and
recommendations proposed by CLIAC during the February 2004 meeting were
considered in the development of this guidance.
II. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance when
finalized will represent the agency's current thinking on
recommendations for CLIA Waiver Applications. 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
To receive ``Clinical Laboratory Improvement Amendments of 1988
(CLIA) Waiver Applications,'' you may either send a fax request to 301-
443-8818 to receive a hard copy of the document, or send an e-mail
request to gwa@cdrh.fda.gov to receive a hard copy or an electronic
copy. Please use the document number (1171) to identify the guidance
you are requesting.
Persons interested in obtaining a copy of the draft guidance may
also do so by 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 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 on the Division of
Dockets Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. Paperwork Reduction Act of 1995
Under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C.
3501-3520), Federal agencies must obtain approval from the Office of
Management and Budget (OMB) for each collection of information they
conduct or sponsor. ``Collection of information'' is defined in 44
U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or
requirements that members of the public submit reports, keep records,
or provide information to a third party. Section 3506(c)(2)(A) of the
PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a
60-day notice in the Federal Register concerning each proposed
collection of information before submitting the collection to OMB for
approval. To comply with this requirement, FDA is publishing notice of
the proposed collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on the following topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Title: Recommendations for CLIA Waiver Applications
Description: Congress passed the CLIA (Public Law 100-578) in 1988
to establish quality standards for all laboratory testing. The purpose
was to ensure the accuracy, reliability, and timeliness of patient test
results regardless of where the test took place. CLIA requires that
clinical laboratories obtain a certificate from the Secretary of Health
and Human Services before accepting materials derived from the human
body for laboratory tests (42 U.S.C. 263a(b)). Laboratories that
perform only tests that are ``simple'' and that have an ``insignificant
risk of an erroneous result'' may obtain a certificate of waiver (42
U.S.C. 263a(c)(2)). The Secretary has delegated to FDA the authority to
determine whether particular tests (waived tests) are ``simple'' and
have ``an insignificant risk of an erroneous result'' under CLIA (69 FR
22849). This guidance document describes recommendations for device
manufacturers submitting to FDA an application for determination that a
cleared or approved device meets this CLIA standard (CLIA waiver
application).
The guidance recommends that CLIA waiver applications include a
description of the features of the device that make it ``simple''; a
report describing a hazard analysis that identifies potential sources
of error, including a summary of the design and results of flex studies
and conclusions drawn from the flex studies; a description of fail-safe
and failure alert mechanisms and a description of the studies
validating these mechanisms; a description of clinical tests that
demonstrate the accuracy of the test in the hands of intended
operators; and statistical analyses of clinical study results. The
guidance also makes recommendations concerning labeling of waived
tests. The burden associated with most of these labeling
recommendations is approved under OMB control number 0910-0485. Only
new information collections not already approved are included in the
estimate below. The recommendation for quick reference instructions is
a new information collection which FDA is submitting to OMB for review.
Quick reference instructions are a short version of the instructions
that are written in simple language and that can be posted. The
guidance also notes that waived tests remain subject to applicable
reporting and recordkeeping requirements under 21 CFR part 803. The
burden associated with this provision is approved under OMB control
number 0910-0437.
Respondents to this collection of information are manufacturers of
in vitro diagnostic devices.
FDA estimates the burden of this collection as follows.
[[Page 53233]]
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Operating and Maintenance
No. of Respondents Response Total Annual Responses Hours per response Total Hours Costs
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40 1 40 780 31,200 $5,500
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency per Operating and Maintenance
No. of Recordkeepers Recordkeeping Total Annual Records Hours per Record Total Hours Costs
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40 1 40 2,800 112,000 $60,700
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on previous years' experience with CLIA waiver applications,
FDA expects 40 manufacturers to apply for one CLIA waiver per year. The
annual reporting burden to respondents is estimated to be 31,200 hours,
and recordkeeping burdens for respondents is estimated to be 112,000
hours. FDA based the reporting and recordkeeping burden on an agency
analysis of premarket submissions with clinical trials similar to the
waived laboratory tests.
The total operating and maintenance cost associated with the
implementation of this draft guidance is estimated to be $66,200. The
cost consists of specimen collection for the clinical study (estimated
at $23,500); laboratory supplies, reference testing and study oversight
(estimated $26,700); shipping and office supplies (estimated $6,000);
and educational materials, including quick reference instructions
($10,000).
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.
Dated: August 31, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-17732 Filed 9-1-05; 4:00 pm]
BILLING CODE 4160-01-S