[Federal Register: September 26, 2006 (Volume 71, Number 186)]
[Notices]
[Page 56153-56154]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26se06-81]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0044]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Draft Guidance for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 that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by October
26, 2006.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Draft Guidance for Industry and Food and Drug Administration Staff:
Recommendations for Clinical Laboratory Improvement Amendments (CLIA)
of 1988 Waiver Applications; Availability
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 (the Secretary) before accepting materials derived from
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, April 27, 2004). This
guidance document describes recommendations for device manufacturers
submitting to FDA an application for determination that a cleared or
approved device meets CLIA standards (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 mechanism and a description of the studies validating
these mechanisms; a description of clinical tests that demonstrate
accuracy of the test in the hands of intended operators; and
statistical analysis of clinical study results. The guidance also make
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 in this document. Recommendations for quick reference
instructions are written in simple language 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
[[Page 56154]]
with this provision is approved under OMB control number 0910-0437.
Respondents to this collection of information are manufacturers of
in vitro diagnostic devices.
In the Federal Register of September 7, 2005 (70 FR 53231), FDA
solicited comments on the collection of information requirements. No
comments were received in response to this notice.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No of Annual Frequency Total Annual Hours per Total Operating &
Respondents per Response Responses Response Total Hours Maintenance Costs
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40 1 40 780 31,200 $5,500
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\1\There are no capital costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden\1\
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Annual Frequency Total Annual Total Operating &
No. of Recordkeepers per Recordkeeper Records Hours per Record Total Hours Maintenance Costs
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40 1 40 2,800 112,000 $60,700
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\1\There are no capital costs associated with this collection of information.
Based on previous years of 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 the recordkeeping burden for respondents is estimated
to be 112,00 hours. FDA based the reporting and recordkeeping burden on
agency analysis of premarket submissions with clinical trials similar
to the waived laboratory tests.
The total operating and maintenance costs associated with the
implementation of this draft guidance is estimated to be $66,200. The
cost consists of specimen collections for the clinical study (estimated
at $23,500); laboratory supplies, reference testing, and study
oversight (estimated at $26,700); shipping and office supplies
(estimated at $6,000); and educational materials, including quick
reference instructions (estimated at $10,000).
Dated: September 15, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-15693 Filed 9-25-06; 8:45 am]
BILLING CODE 4160-01-S