Document ID: FDA-2013-N-0514-0010
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments
Posted Date: 2022-10-07T04:00Z

[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61029-61030]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-21843]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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: Submit written comments (including recommendations) on the 
collection of information by November 7, 2022.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0607. Also include the FDA docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
[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.

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 specimens under the Clinical Laboratory Improvement Amendments of 
1988 (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.
    In the Federal Register of June 16, 2022 (87 FR 36330), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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 burden                   operating and
             Information collection activity                respondents    responses per     responses     per response     Total hours     maintenance
                                                                            respondent                                                         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
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............        $352,000
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\1\ There are no capital costs associated with this collection of information.

[[Page 61030]]

                                                   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: September 30, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-21843 Filed 10-6-22; 8:45 am]
BILLING CODE 4164-01-P