Notice2025-12412
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments of 1988 Categorization
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Published
July 3, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 information collection associated with implementation of the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
Full Text
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<title>Federal Register, Volume 90 Issue 126 (Thursday, July 3, 2025)</title>
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[Federal Register Volume 90, Number 126 (Thursday, July 3, 2025)]
[Notices]
[Pages 29568-29570]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-12412]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-1109]
Agency Information Collection Activities; Proposed Collection;
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 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 information collection associated with
implementation of the Clinical Laboratory Improvement Amendments of
1988 (CLIA).
DATES: Either electronic or written comments on the collection of
information must be submitted by September 2, 2025.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 2, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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-2025-N-1109] for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Administrative Procedures for
Clinical Laboratory Improvement Amendments of 1988 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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#bceceefdefc8dddadafcdad8dd92d4d4cf92dbd3ca"><span class="__cf_email__" data-cfemail="dc8c8e9d8fa8bdbaba9cbab8bdf2b4b4aff2bbb3aa">[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
[[Page 29569]]
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 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.
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 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......................... 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.
[[Page 29570]]
Dated: June 26, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-12412 Filed 7-2-25; 8:45 am]
BILLING CODE 4164-01-P
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