[Federal Register Volume 84, Number 143 (Thursday, July 25, 2019)]
[Notices]
[Pages 35871-35872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-15787]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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 Waiver Applications

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 August 
26, 2019.

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.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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.

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).
    On January 30, 2008, FDA published a guidance document entitled 
``Recommendations for Clinical Laboratory Improvement Amendments of 
1988 (CLIA) Waiver Applications for Manufacturers of In Vitro 
Diagnostic Devices--Guidance for Industry and FDA Staff'' (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm079632.htm). This guidance 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 March 26, 2019 (84 FR 11307), 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 
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...........................              13                1               13            1,200           15,600         $350,000
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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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                                                     Number of                    Average burden
            Activity                 Number of      records per    Total annual         per         Total hours
                                   recordkeepers   recordkeeper       records      recordkeeping
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CLIA Waiver Records.............              13               1              13           2,800          36,400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.


[[Page 35872]]

    The total number of reporting and recordkeeping hours is 52,000 
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 13 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 15,600 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 36,400 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).
    Our estimated burden for the information collection reflects a 
decrease of 27 responses and 27 records, and a corresponding overall 
decrease of 108,000 hours. We attribute this adjustment to a decrease 
in the average number of submissions we received over the last few 
years.

    Dated: July 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-15787 Filed 7-24-19; 8:45 am]
BILLING CODE 4164-01-P