[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 51989-51993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
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 https://www.regulations.gov.
     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:
     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.
     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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. 
and 4 p.m., Monday through Friday, 240-402-7500.
     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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov 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, 
[email protected].

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
    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\
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                                                                 Number of
               21 CFR citation                   Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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   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
                                             -----------------------------------------------------------------------------------------------------------
    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
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                                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
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[[Page 51993]]

 
                              Part 809 (in vitro diagnostic products for human use) and part 1040 (light-emitting products)
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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)
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Establishments listing <10 SUDs.............             161               2             322  0.1 (6 minutes)...........................              32
Establishments listing >10 SUDs.............              14              45             630  0.1 (6 minutes)...........................              63
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   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