[Federal Register Volume 71, Number 186 (Tuesday, September 26, 2006)]
[Notices]
[Pages 56153-56154]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15693]


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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of Management and Budget Review; Comment Request; Draft Guidance for 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Draft Guidance for Industry and Food and Drug Administration Staff: 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