[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Pages 46693-46694]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-16886]



Food and Drug Administration

[Docket No. FDA-2008-D-0031]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Clinical Laboratory 
Improvement Amendments Act of 1988 Waiver Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


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 August 
17, 2016.

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: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 0910-0598. 
Also include the FDA docket number found in brackets in the heading of 
this document.

Food and Drug Administration, Three White Flint North, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, [email protected].

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.

CLIA Waiver Applications--OMB Control Number 0910-0598--Extension

    Congress passed the 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

[[Page 46694]]

``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.
    In the Federal Register of April 1, 2016 (81 FR 18858), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                        Number of                                                        Total operating
                     Activity                          Number of      responses per     Total annual    Average burden    Total hours    and maintenance
                                                      respondents       respondent       responses       per response                         costs
CLIA waiver application...........................              40                1               40            1,200           48,000         $350,000
\1\ There are no capital costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
                                                                                         Number of                       Average burden
                              Activity                                  Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
CLIA waiver records................................................              40                1               40            2,800          112,000
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The total number of reporting and recordkeeping hours is 160,000 
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 1,200 hours per waiver application for a total of 48,000 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 $350,000. This cost is largely attributed 
to clinical study costs incurred, which include site selection and 
qualification, protocol review, and study execution (initiation, 
monitoring, closeout, and clinical site/subject compensation--including 
specimen collection for study as well as shipping and supplies).

    Dated: July 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16886 Filed 7-15-16; 8:45 am]