Document ID: FDA-2012-N-0937-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Clinical Laboratory Improvement Amendments of 1988 Waiver Applications
Posted Date: 2012-09-14T04:00Z

[Federal Register Volume 77, Number 179 (Friday, September 14, 2012)]
[Notices]
[Pages 56846-56847]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-22660]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0937]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Clinical Laboratory Improvement Amendments of 1988 
Waiver Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on collections of information 
associated with Clinical Laboratory Improvement Amendments of 1988 
waiver applications.

DATES: Submit either electronic or written comments on the collection 
of information by November 13, 2012.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under 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, including 
each proposed extension of an existing 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 these 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.

[[Page 56847]]

Clinical Laboratory Improvement Amendments Waiver Applications--(OMB 
Control Number 0910-0598)--Extension

    Congress passed the Clinical Laboratory Improvement Amendments 
(CLIA) (Pub. L. 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 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(d)(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).
    On January 30, 2008, FDA published a guidance document entitled 
``Guidance for Industry and FDA Staff: Recommendations for Clinical 
Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications 
for Manufacturers of In Vitro Diagnostic Devices'' (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079632.htm). 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 total number of reporting and recordkeeping hours is 143,200 
hours. FDA bases the burden on an Agency analysis of premarket 
submissions with clinical trials similar to the waived laboratory 
tests. Based on previous years' experience with CLIA waiver 
applications, FDA expects 40 manufacturers to submit one CLIA waiver 
application per year. The time required to prepare and submit a waiver 
application, including the time needed to assemble supporting data, 
averages 780 hours per waiver application for a total of 31,200 hours 
for reporting.
    Based on previous years' experience with CLIA waiver applications, 
FDA expects that each manufacturer will spend 2,800 hours creating and 
maintaining the record for a total of 112,000 hours. The total 
operating and maintenance cost associated with the waiver application 
is estimated at $66,200. The cost consists of specimen collection for 
the clinical study (estimated $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 (estimated $10,000).
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                        Number of                                                        Total operating
                     Activity                          Number of      responses per     Total annual    Average burden    Total hours    and maintenance
                                                      respondents       respondent       responses       per response                         costs
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CLIA waiver application...........................              40                1               40              780           31,200          $66,200
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\1\ There are no capital costs associated with this collection of information.

                                                     Table 2--Estimated Annual Recordkeeping Burden
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                                                                                                                                                  Total
                                                                                                                                                operating
                 Activity                       Number of       Number of records     Total annual     Average burden per      Total hours         and
                                              recordkeepers     per recordkeeper         records          recordkeeping                        maintenance
                                                                                                                                                  costs
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CLIA waiver records......................                 40                   1                  40               2,800             112,000
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    Dated: August 30, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-22660 Filed 9-13-12; 8:45 am]
BILLING CODE 4160-01-P