[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36330-36332]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12929]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0514]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Administrative Procedures for Clinical Laboratory 
Improvement Amendments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on information collection 
associated with implementation of the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA).

DATES: Submit either electronic or written comments on the collection 
of information by August 15, 2022.

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 August 15, 2022. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of August 15, 2022. 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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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-2013-N-0514 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Administrative Procedures for 
Clinical Laboratory Improvement Amendments Categorization.'' 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, 240-402-7500.
    <bullet> 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

[[Page 36331]]

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.govinfo.gov/content/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, 240-402-7500.

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, 
<a href="/cdn-cgi/l/email-protection#efbfbdaebc9b8e8989af898b8ec187879cc1888099"><span class="__cf_email__" data-cfemail="015153405275606767416765602f6969722f666e77">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.

Administrative Procedures for Clinical Laboratory Improvement 
Amendments of 1988

OMB Control Number 0910-0607--Revision

    This information collection helps support implementation of 
statutory provisions applicable to laboratories that conduct testing on 
human specimen under CLIA. These requirements are codified in 42 U.S.C. 
263a and implementing regulations are found in 42 CFR 493. Regulations 
in 42 CFR 493.17 set forth certain notice requirements and establish 
test categorization criteria with regard to laboratory tests and are 
implemented by FDA's Center for Devices and Radiological Health. The 
guidance document entitled ``Administrative Procedures for CLIA 
Categorization'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/administrative-procedures-clia-categorization) describes procedures FDA uses to assign the 
complexity category to a device. Typically, FDA assigns complexity 
categorizations to devices at the time of clearance or approval of the 
device. In some cases, however, a manufacturer may request CLIA 
categorization even if FDA is not simultaneously reviewing a 510(k) or 
premarket approval application. One example is when a manufacturer 
requests that FDA assign CLIA categorization to a previously cleared 
device that has changed names since the original CLIA categorization. 
Another example is when a device is exempt from premarket review. In 
such cases, the guidance recommends that manufacturers provide FDA with 
a copy of the package insert for the device and a cover letter 
indicating why the manufacturer is requesting a categorization (e.g., 
name change, exempt from 510(k) review). The guidance recommends that 
in the correspondence to FDA the manufacturer should identify the 
product code and classification as well as reference to the original 
510(k) when this is available.
    We are revising the information collection to include provisions 
associated with certificates of waiver. On February 26, 2020, FDA 
revised the 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'' (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-clinical-laboratory-improvement-amendments-1988-clia-waiver-applications). 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.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                                                               Total
                                                             Number of       Number of     Total annual       Average                      operating and
             Information collection activity                respondents    responses per     responses      burden per      Total hours     maintenance
                                                                            respondent                       response                          costs
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Request for CLIA categorization (see 42 CFR 493.17).....              80               5             400               1             400          $2,000
CLIA Waiver Application Submissions.....................              13               1              13           1,200          15,600         350,000
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[[Page 36332]]

 
    Total...............................................  ..............  ..............  ..............  ..............  ..............         352,000
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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
                  Information collection activity                       Number of       records per      Total annual         per          Total hours
                                                                      recordkeepers     recordkeeper       records       recordkeeping
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CLIA Waiver Recordkeeping as discussed in FDA Guidance.............              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.

    We have revised the information collection to include coverage 
previously accounted for under OMB control number 0910-0598 and 
discussed in revised Agency guidance. We otherwise retain our estimates 
of the burden we attribute to the individual elements included in the 
information collection.

    Dated: June 9, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12929 Filed 6-15-22; 8:45 am]
BILLING CODE 4164-01-P


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