Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations, 51989-51993 [2022-18275]
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Federal Register / Vol. 87, No. 163 / Wednesday, August 24, 2022 / Notices
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’’).
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.
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.
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SUMMARY:
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
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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
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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-201509-18/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, PRAStaff@
fda.hhs.gov.
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,
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when appropriate, and other forms of
information technology.
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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 § 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 § 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
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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 FDAaccredited 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
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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-theCounter (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;
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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
51991
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/regulatoryinformation/search-fda-guidancedocuments.
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
respondents
21 CFR citation
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
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
Symbols glossary—660.2; antibody to 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 ..........................................
3,000
1
3,000
1 ................................
3,000
2 6,199
51
3 316,149
0.0167 (1 minute) ......
5,280
Total ..................................................................
........................
........................
........................
....................................
8,280
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 standalone 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 (§ 660.2), using antibody
to Hepatitis B surface antigen (§ 660.28),
blood grouping reagent (§ 660.35),
reagent red blood cells (§ 660.45),
Hepatitis B surface antigen (§ 660.45);
and anti-human globulin (§ 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
Number of
recordkeepers
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21 CFR citation
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
Total hours
Part 801 subpart A: General Labeling Provisions; subpart E: Other Exemptions; subpart H: Special Requirements for Specific Devices
Processing, labeling, or repacking agreement;
801.150.
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887
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6,652,500
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0.5 (30 minutes) ........
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TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2—Continued
Number of
recordkeepers
21 CFR citation
Impact resistant lenses; invoices, shipping documents, and records of sale or distribution;
801.410(e) and (f).
Hearing aid records; 801.421 ..................................
Menstrual tampons, sampling plan for measuring
absorbency; 801.430(f).
Latex condoms; justification for the application of
testing data to the variation of the tested product; 801.435(g).
UDI; part 801, subpart B ..........................................
Total ..................................................................
Number of
records per
recordkeeper
Total annual
records
Average burden per
recordkeeping
0.0008 (0.048 minutes).
Total hours
1,591
47,050
74,856,550
59,885
10,000
33
160
11
1,600,000
363
0.25 (15 minutes) ......
80 ..............................
400,000
29,040
51
3.65
186
1 ................................
186
3 5,987
51
4 305,337
0.9833 (59 minutes) ..
300,238
........................
........................
83,414,936
....................................
4,115,599
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
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.
2 Numbers
3 Maximum
As set forth in § 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 § 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 §§ 801.421(d), 801.430(f),
and 801.435(g), respectively.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2
Number of
respondents
21 CFR citation
Number of
disclosures
per respondent
Total annual
disclosures
Average burden per
disclosure
Total hours
Part 800 and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
Contact
lens
cleaning
solution
labeling;
800.10(a)(3) and 800.12(c).
Liquid
ophthalmic
preparation
labeling;
800.10(b)(2).
Manufacturer, packer, or distributor information;
801.1.
Adequate directions for use; 801.5 ..........................
Statement of identity; 801.61 ...................................
Declaration of net quantity of contents; 801.62 .......
Prescription device labeling; 801.109 ......................
Retail exemption for prescription devices; 801.110
Processing, labeling, or repacking; non-sterile devices; 801.150(e).
47
8
376
1 ................................
376
25
8
200
1 ................................
200
19,407
7
135,849
1 ................................
135,849
8,526
8,526
8,526
9,681
30,000
453
6
6
6
6
667
34
51,156
51,156
51,156
58,086
20,010,000
15,402
22.35 .........................
1 ................................
1 ................................
17.77 .........................
0.25 ...........................
4 ................................
1,143,337
51,156
51,156
1,032,188
5,002,500
61,608
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Part 801, subpart H: Special Requirements for Specific Devices
Labeling of articles intended for lay use in the repairing and/or refitting of dentures; 801.405(b)(1).
Dentures; information regarding temporary and
emergency use; 801.405(c).
Hearing aids professional and patient labeling;
801.420.
Hearing aids, availability of User Instructional Brochure; 801.421.
User labeling for menstrual tampons; 801.430 .......
User labeling for latex condoms; 801.437 ...............
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35
1
35
4 ................................
140
35
1
35
4 ................................
140
136
12
1,632
80 ..............................
130,560
10,000
5
50,000
0.17 ...........................
8,500
16
52
8
6
128
312
2 ................................
100 ............................
256
31,200
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51993
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 2—Continued
Number of
respondents
21 CFR citation
Number of
disclosures
per respondent
Total annual
disclosures
Average burden per
disclosure
Total hours
Part 809 (in vitro diagnostic products for human use) and part 1040 (light-emitting products)
Format and content of labeling for IVDs; 809.10 ....
Advertising and promotional materials for ASRs;
809.30(d).
Labeling of sunlamp products—1040.20(d) .............
1,700
300
6
25
10,200
7,500
80 ..............................
1 ................................
816,000
7,500
30
1
30
10 ..............................
300
322
630
0.1 (6 minutes) ..........
0.1 (6 minutes) ..........
32
63
FD&C Action Section 502(u)
Establishments listing <10 SUDs ............................
Establishments listing >10 SUDs ............................
161
14
2
45
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 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.
3,000
1
3,000
4 ................................
12,000
UDI ...........................................................................
3 5,987
51
4 305,337
0.8833 (53 minutes) ..
269,704
Total ..................................................................
........................
........................
20,752,542
....................................
8,754,765
Part 801, subpart B
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
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.
2 Numbers
3 Maximum
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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
VerDate Sep<11>2014
19:09 Aug 23, 2022
Jkt 256001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–4951]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Humanitarian Use Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
FOR FURTHER INFORMATION CONTACT:
Notice.
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 September
23, 2022.
ADDRESSES: To ensure that comments on
the information collection are received,
SUMMARY:
PO 00000
Frm 00034
Fmt 4703
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
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 0910–0332. Also include
the FDA docket number found in
brackets in the heading of this
document.
Sfmt 4703
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, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\24AUN1.SGM
24AUN1
]]>Agencies
[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR citation Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 801 subpart A: General Labeling Provisions; subpart E: Other Exemptions; subpart H: Special Requirements for Specific Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. 83,414,936 .......................................... 4,115,599
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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).
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 801, subpart H: Special Requirements for Specific Devices
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
