Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations

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Published

August 24, 2022

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 medical device labeling regulations.

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<title>Federal Register, Volume 87 Issue 163 (Wednesday, August 24, 2022)</title>
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[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51989-51993]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-18275]

[[Page 51989]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1048]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations

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 medical device labeling regulations.

DATES: Either electronic or written comments on the collection of
information must be submitted by October 24, 2022.

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 October 24, 2022. 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-2014-N-1048 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Labeling
Regulations.'' 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#49191b081a3d282f2f092f2d286721213a672e263f"><span class="__cf_email__" data-cfemail="6f3f3d2e3c1b0e09092f090b0e4107071c41080019">[email&#160;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,

[[Page 51990]]

when appropriate, and other forms of information technology.

Medical Device Labeling Regulations

OMB Control Number 0910-0485--Revision

This information collection supports implementation of medical
device labeling requirements governed by section 502 of the Federal
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 352), codified in
Agency regulations, and discussed in associated Agency guidance. In
accordance with the Unique Device Identification (UDI) system (see part
801, subpart B (21 CFR part 801, subpart B)), medical device labelers,
unless excepted, are required to design and use medical device labels
and device packages to bear a UDI, present dates on labels in a
particular format, and submit data concerning each version or model of
a device to the Global Unique Device Identification Database (GUDID) no
later than the date the label of the device must bear a UDI. Once a
device becomes subject to UDI requirements, respondents will be
required to update the information reported whenever the information
changes.
FDA has identified the following requirements as having burdens
that must be accounted for under the PRA; the burdens associated with
these requirements are summarized in the table that follows.
21 CFR 801.18 requires that whenever a labeler of a medical device
includes an expiration date, a date of manufacture, or any other date
intended to be brought to the attention of the user of the device, the
labeler must present the date on the label in a format that meets the
requirements of this section.
Section 801.20 requires every medical device label and package to
bear a UDI.
Under Sec. 801.35, any labeler of a device that is not required to
bear a UDI on its label may include a UDI on the label of that device
and utilize the GUDID.
Under Sec. 801.45, any device that has to be labeled with a UDI
also has to bear a permanent marking providing the UDI on the device
itself if the device is intended for more than one use and intended to
be reprocessed before each use.
Section 801.50 requires stand-alone software to comply with
specific labeling requirements that identify the software.
Section 801.55 authorizes additional, case-by-case, labeling
exceptions and alternatives to standard UDI labeling requirements.
If a labeler relabels or modifies a label of a device that is
required to bear a UDI, under 21 CFR 830.60 it has to keep a record
showing the relationship of the original device identifier to the new
device identifier.
21 CFR 830.110 requires an applicant seeking initial FDA
accreditation as a UDI-issuing agency to furnish FDA an application
containing certain information, materials, and supporting
documentation.
Under 21 CFR 830.120, an FDA-accredited issuing agency is required
to disclose information concerning its system for the assignment of
UDIs; maintain a list of labelers that use its system for the
assignment of UDIs and provide FDA a copy of such list; and upon
request, provide FDA with information concerning a labeler that is
employing the issuing agency's system for assignment of UDIs.
21 CFR 830.310 and 830.320 require the labeler to provide certain
information to the GUDID concerning the labeler and each version or
model of a device required to be labeled with a UDI, unless the labeler
obtains a waive.
21 CFR 830.360 requires each labeler to retain records showing all
UDIs used to identify devices that must be labeled with a UDI and the
particular version or model associated with each device identifier,
until 3 years after it ceases to market a version or model of a device.
Respondents who are required to submit data to the Agency under
certain other approved information collections are required to include
UDI data elements for the device that is the subject of such
information collection. Addition of the UDI data elements is included
in this burden estimate for the conforming amendments in the following
21 CFR parts: part 803--Medical Device Reporting (OMB control number
0910-0437), part 806--Medical Devices; Reports of Corrections and
Removals (OMB control number 0910-0359), part 814--Premarket Approval
of Medical Devices (OMB control number 0910-0231), part 820--Quality
System Regulation (OMB control number 0910-0073), part 821--Medical
Device Tracking Requirements (OMB control number 0910-0442), and part
822--Postmarket Surveillance (OMB control number 0910-0449).
Medical device labeling requirements, among other things, provide
for the label or labeling content of a medical device so that it is not
misbranded and subject to regulatory action. Certain provisions under
section 502 of the FD&C Act require that manufacturers, importers, and
distributors of medical devices disclose information about themselves
or the devices on the labels or labeling for the devices. Section 502
of the FD&C Act provides, in part, that a device shall be misbranded
if, among other things, its label or labeling fails to bear certain
required information concerning the device, is false or misleading in
any particular way, or fails to contain adequate directions for use.
Medical device labeling regulations in parts 800, 801, 809, and
associated regulations in parts 660 and 1040 (21 CFR parts 660, 800,
801, 809, and 1040), prescribe the disclosure of specific information
by manufacturers, importers, and distributors of medical devices about
themselves and/or the devices, on the label or labeling for the
devices, to health professionals and consumers.
In conjunction with provisions in part 800, part 801, subpart A
sets forth general labeling provisions applicable to all medical
devices, including content and format requirements pertaining to
intended uses, adequate directions for use, misleading statements, and
the prominence of required labeling. Information collection associated
with labeling requirements for Over-the-Counter (OTC) Devices are found
in part 801, subpart C, and cover principal display panel; statement of
identity; declaration of net quantity of contents; and certain warning
statement elements. Information collection associated with exemptions
from adequate directions for use and other exemptions are found in part
801, subparts D and E, respectively. Information collection associated
with special labeling requirements applicable to specific devices are
found in part 801, subpart H. We also include information collection
associated with labeling for in vitro diagnostic products for human
use, as set forth in part 809, subpart B. In addition to the labeling
requirements in part 801 and the certification and identification
requirements of 21 CFR 1010.2 and 1010.3, sunlamp products and
ultraviolet lamps are subject to specific labeling requirements as set
forth in part 1040.
The information collection also includes provisions associated with
stand-alone symbols (not accompanied by explanatory text adjacent to
the symbol), when accompanied by a symbols glossary, as set forth in
part 660, additional standards for diagnostic substances for laboratory
standards for biological products, subparts A, C, D, E, and F. The
requirements are also found in the general medical device labeling
regulations part 801, subpart A, and part 809, subpart B.
The information collection also helps to implement section 502(b)
of the FD&C Act which requires that, for packaged devices, labeling
must bear the name and place of business of the manufacturer, packer,
or distributor;

[[Page 51991]]

and an accurate statement of the quantity of the contents. Section
502(f) of the FD&C Act requires also that the labeling for a device
must contain adequate directions for use unless FDA grants an
exemption. Section 502(u) of the FD&C Act requires reprocessed single-
use devices (SUDs) to bear prominently and conspicuously the name of
the manufacturer, a generally recognized abbreviation of such name, or
a unique and generally recognized symbol identifying the manufacturer.
Under this provision, if the original SUD or an attachment to it
prominently and conspicuously bears the name of the manufacturer, then
the reprocessor of the SUD is required to identify itself by name,
abbreviation, or symbol in a prominent and conspicuous manner on the
device or attachment to the device. If the original SUD does not
prominently and conspicuously bear the name of the manufacturer, the
manufacturer who reprocesses the SUD for reuse may identify itself
using a detachable label that is intended to be affixed to the patient
record. As required by the Medical Device User Fee Stabilization Act of
2005, FDA issued the guidance document, ``Compliance with Section 301
of the Medical Device User Fee and Modernization Act of 2002, as
amended--Prominent and Conspicuous Mark of Manufacturers on Single-Use
Devices'' (May 2006), to assist respondents with these requirements.
The guidance document was issued consistent with our Good Guidance
Practice regulations in 21 CFR 10.115, which provide for public comment
at any time. We maintain a searchable guidance database on our website,
and this guidance is available at <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
The guidance document is intended to identify circumstances in
which the name or symbol of the original SUD manufacturer is not
prominent and conspicuous, as used in section 502(u) of the FD&C Act.
FDA estimates the burden of this collection of information as
follows:

Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR citation Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling; Part 809, subpart B: Labeling
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Symbols glossary--660.2; antibody to 3,000 1 3,000 1......................................... 3,000
Hepatitis B surface antigen requirements,
660.28; blood grouping labeling, 660.35;
reagent red blood cell labeling, 660.45,
hepatitis B surface antigen labeling,
660.55; anti-human globulin labeling,
801.15; medical devices labeling and use of
symbols; 809.10, labeling for in vitro
diagnostic products.
UDI; part 801, subpart B.................... \2\ 6,199 51 \3\ 316,149 0.0167 (1 minute)......................... 5,280
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Total................................... .............. .............. .............. .......................................... 8,280
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
fewer respondents.
\3\ Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
involve fewer total annual responses.

Our figures are based on data from the FDA Unified Registration and
Listing System and the Operational and Administration System for Import
Support shipment information. FDA regulations allow for the use of
stand-alone graphical representations of information, or symbols, in
the labeling for the medical devices and diagnostic substances for
laboratory standards, if the symbol has been established in a Standards
Development Organization developed standard, provided that such symbol
is explained in a symbols glossary that is included in the labeling for
the medical device and otherwise complies with section 502
(misbranding) of the FD&C Act. These labeling requirements are set
forth in part 660, subparts A, C, D, E, and F, in the additional
standards for diagnostic substances for laboratory standards for
biological products, including: general requirements (Sec. 660.2),
using antibody to Hepatitis B surface antigen (Sec. 660.28), blood
grouping reagent (Sec. 660.35), reagent red blood cells (Sec.
660.45), Hepatitis B surface antigen (Sec. 660.45); and anti-human
globulin (Sec. 660.55). The requirements are also found in the general
medical device labeling regulations (part 801, subpart A) and in the in
vitro diagnostic product labeling regulations (part 809, subpart B).

Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
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Number of
21 CFR citation Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Part 801 subpart A: General Labeling Provisions; subpart E: Other Exemptions; subpart H: Special Requirements for Specific Devices
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Processing, labeling, or repacking 7,500 887 6,652,500 0.5 (30 minutes).......................... 3,326,250
agreement; 801.150.

[[Page 51992]]

Impact resistant lenses; invoices, shipping 1,591 47,050 74,856,550 0.0008 (0.048 minutes).................... 59,885
documents, and records of sale or
distribution; 801.410(e) and (f).
Hearing aid records; 801.421................ 10,000 160 1,600,000 0.25 (15 minutes)......................... 400,000
Menstrual tampons, sampling plan for 33 11 363 80........................................ 29,040
measuring absorbency; 801.430(f).
Latex condoms; justification for the 51 3.65 186 1......................................... 186
application of testing data to the
variation of the tested product; 801.435(g).
UDI; part 801, subpart B.................... \3\ 5,987 51 \4\ 305,337 0.9833 (59 minutes)....................... 300,238
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Total................................... .............. .............. 83,414,936 .......................................... 4,115,599
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
\3\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
fewer respondents.
\4\ Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
involve fewer total annual responses.

As set forth in Sec. 801.150(a)(2), device manufacturers are
required to retain a copy of the agreement containing the
specifications for the processing, labeling, or repacking of the device
for 2 years after the final shipment or delivery of the device. Section
801.150(a)(2) requires that copies of this agreement be made available
for inspection at any reasonable hour upon request by any officer or
employee of the Department of Health and Human Services (HHS). In Sec.
801.410(e) copies of invoices, shipping documents, and records of sale
or distribution of all impact resistant lenses, including finished
eyeglasses and sunglasses, are required to be maintained for 3 years by
the retailer and made available upon request by any officer or employee
of FDA or by any other officer or employee acting on behalf of the
Secretary of HHS. Section 801.410(f) requires that the results of
impact tests and description of the test method and apparatus be
retained for a period of 3 years.
Specific recordkeeping requirements applicable to hearing aid
dispensers, manufacturers of menstrual tampons, and manufacturers of
latex condoms are set forth in Sec. Sec. 801.421(d), 801.430(f), and
801.435(g), respectively.

Table 3--Estimated Annual Third-Party Disclosure Burden \1\ \2\
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Number of
21 CFR citation Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 800 and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
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Contact lens cleaning solution labeling; 47 8 376 1......................................... 376
800.10(a)(3) and 800.12(c).
Liquid ophthalmic preparation labeling; 25 8 200 1......................................... 200
800.10(b)(2).
Manufacturer, packer, or distributor 19,407 7 135,849 1......................................... 135,849
information; 801.1.
Adequate directions for use; 801.5.......... 8,526 6 51,156 22.35..................................... 1,143,337
Statement of identity; 801.61............... 8,526 6 51,156 1......................................... 51,156
Declaration of net quantity of contents; 8,526 6 51,156 1......................................... 51,156
801.62.
Prescription device labeling; 801.109....... 9,681 6 58,086 17.77..................................... 1,032,188
Retail exemption for prescription devices; 30,000 667 20,010,000 0.25...................................... 5,002,500
801.110.
Processing, labeling, or repacking; non- 453 34 15,402 4......................................... 61,608
sterile devices; 801.150(e).
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Part 801, subpart H: Special Requirements for Specific Devices
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Labeling of articles intended for lay use in 35 1 35 4......................................... 140
the repairing and/or refitting of dentures;
801.405(b)(1).
Dentures; information regarding temporary 35 1 35 4......................................... 140
and emergency use; 801.405(c).
Hearing aids professional and patient 136 12 1,632 80........................................ 130,560
labeling; 801.420.
Hearing aids, availability of User 10,000 5 50,000 0.17...................................... 8,500
Instructional Brochure; 801.421.
User labeling for menstrual tampons; 801.430 16 8 128 2......................................... 256
User labeling for latex condoms; 801.437.... 52 6 312 100....................................... 31,200
--------------------------------------------------------------------------------------------------------------------------------------------------------

[[Page 51993]]

Part 809 (in vitro diagnostic products for human use) and part 1040 (light-emitting products)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and content of labeling for IVDs; 1,700 6 10,200 80........................................ 816,000
809.10.
Advertising and promotional materials for 300 25 7,500 1......................................... 7,500
ASRs; 809.30(d).
Labeling of sunlamp products--1040.20(d).... 30 1 30 10........................................ 300
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FD&C Action Section 502(u)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishments listing <10 SUDs............. 161 2 322 0.1 (6 minutes)........................... 32
Establishments listing >10 SUDs............. 14 45 630 0.1 (6 minutes)........................... 63
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling Provisions; Part 809, subpart B: Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Symbols glossary--660.2; antibody to 3,000 1 3,000 4......................................... 12,000
Hepatitis B surface antigen requirements,
660.28; blood grouping labeling, 660.35;
reagent red blood cell labeling, 660.45,
hepatitis B surface antigen labeling,
660.55; anti-human globulin labeling,
801.15; medical devices labeling and use of
symbols; 809.10, labeling for in vitro
diagnostic products.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 801, subpart B
--------------------------------------------------------------------------------------------------------------------------------------------------------
UDI......................................... \3\ 5,987 51 \4\ 305,337 0.8833 (53 minutes)....................... 269,704
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. 20,752,542 .......................................... 8,754,765
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Numbers have been rounded.
\3\ Maximum No. of Respondents for any regulatory requirement within each category. Individual regulatory requirements within the category may involve
fewer respondents.
\4\ Maximum Total Annual Responses for any regulatory requirement within each category. Individual regulatory requirements within the category may
involve fewer total annual responses.

Because many labeling provisions correspond to specific
recordkeeping requirements, we have accounted for burden attendant to
the provisions enumerated in table 3 as third-party disclosures. These
figures reflect what we believe to be the average burden incurred by
respondents to applicable information collection activities.
We are revising this information collection to include OMB control
number 0910-0720. Our estimated burden for the information collection
reflects an overall increase of 579,633 hours and a corresponding
increase of 926,823 responses/records. We attribute this adjustment to
the revision of this information collection to include OMB control
number 0910-0720.

Dated: August 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18275 Filed 8-23-22; 8:45 am]
BILLING CODE 4164-01-P

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