Notice2022-21843
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 87 Issue 194 (Friday, October 7, 2022)</title>
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[Federal Register Volume 87, Number 194 (Friday, October 7, 2022)]
[Notices]
[Pages 61029-61030]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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: 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,
<a href="/cdn-cgi/l/email-protection#e5b5b7a4b691848383a5838184cb8d8d96cb828a93"><span class="__cf_email__" data-cfemail="fdadafbcae899c9b9bbd9b999cd395958ed39a928b">[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
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 <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.
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 <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>). 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
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Total............................................... .............. .............. .............. .............. .............. $352,000
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\1\ There are no capital costs associated with this collection of information.
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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
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