Notice2025-20774
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
Primary source
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Published
November 24, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 90 Issue 224 (Monday, November 24, 2025)</title>
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[Federal Register Volume 90, Number 224 (Monday, November 24, 2025)]
[Notices]
[Pages 52960-52961]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-20774]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1109]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Administrative
Procedures for Clinical Laboratory Improvement Amendments of 1988
Categorization
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: Submit written comments (including recommendations) on the
collection of information by December 24, 2025.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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: Amber Barrett, Office of Operations,
[[Page 52961]]
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#8adad8cbd9feebececcaeceeeba4e2e2f9a4ede5fc"><span class="__cf_email__" data-cfemail="93c3c1d2c0e7f2f5f5d3f5f7f2bdfbfbe0bdf4fce5">[email protected]</span></a>.
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 Categorization
OMB Control Number 0910-0607--Extension
This information collection helps support implementation of
statutory provisions applicable to laboratories that conduct testing on
human specimens 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 for laboratory tests and are
implemented by FDA's Center for Devices and Radiological Health. The
guidance document entitled ``Administrative Procedures for CLIA
Categorization'' (October 2017) (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/administrative-procedures-clia-categorization">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/administrative-procedures-clia-categorization</a>) 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.
In addition, this information collection includes provisions
associated with certificates of waiver. 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'' (February
2020) (available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-clinical-laboratory-improvement-amendments-1988-clia-waiver-applications">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/recommendations-clinical-laboratory-improvement-amendments-1988-clia-waiver-applications</a>) 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 July 3, 2025 (90 FR 29568), 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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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......................... 86 5 430 1 430 $2,150
CLIA Waiver Application Submissions..................... 20 1 20 1,200 24,000 540,000
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Total............................................... .............. .............. .............. .............. 24,430 542,150
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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............. 20 1 20 2,800 56,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
FDA estimates an increase of 30 responses for requests for CLIA
categorization and 7 responses for waiver application submission based
on recent FDA receipt data to more accurately reflect recent receipts
of requests for CLIA categorization and CLIA waiver application
submissions. Our total burden for this collection will be 80,430 hours
(24,430 reporting + 56,000 recordkeeping). Our estimated burden for the
information collection reflects an overall increase of 28,030 hours and
a corresponding increase of $190,150 total operating and maintenance
costs.
Lowell M. Zeta,
Acting, Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-20774 Filed 11-21-25; 8:45 am]
BILLING CODE 4164-01-P
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