[Federal Register Volume 84, Number 58 (Tuesday, March 26, 2019)]
[Notices]
[Pages 11307-11309]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-05759]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 or Agency) is announcing 
an opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(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 (CLIA) waiver 
applications.

DATES: Submit either electronic or written comments on the collection 
of information by May 28, 2019.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before May 28, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 28, 2019. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are postmarked or the delivery service 
acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2008-D-0031 for ``CLIA Waiver Applications.'' Received comments, 
those filed in a timely manner (see ADDRESSES), will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

[[Page 11308]]


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: 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.

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 
``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 
``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.
    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.

    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).

[[Page 11309]]

    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: March 20, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-05759 Filed 3-25-19; 8:45 am]
 BILLING CODE 4164-01-P