Notice2022-12929
Agency Information Collection Activities; Proposed Collection; Comment Request; Administrative Procedures for Clinical Laboratory Improvement Amendments
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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
June 16, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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).
Full Text
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<title>Federal Register, Volume 87 Issue 116 (Thursday, June 16, 2022)</title>
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[Federal Register Volume 87, Number 116 (Thursday, June 16, 2022)]
[Notices]
[Pages 36330-36332]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <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 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: <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-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 <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
[[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: <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#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 <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.
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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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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