Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations, 56274-56276 [2021-22043]
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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Notices
Act of 1995 (44 U.S.C. 3501–3521) is not
required for this guidance. The
previously approved collections of
regulations have been approved by OMB
as listed in the following table:
21 CFR part
Topic
807, subpart E ......................................................
800, 801, and 809 ................................................
Premarket Notification ................................................................................
Medical Device Labeling Regulations ........................................................
Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
collection of information to OMB for
review and clearance.
Medical Device Labeling Regulations
[FR Doc. 2021–22042 Filed 10–7–21; 8:45 am]
OMB Control No. 0910–0485—Revision
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–1048]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Device
Labeling Regulations
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 November
8, 2021.
ADDRESSES: To ensure that comments on
the information collection are received,
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 0910–0485. Also include
the FDA docket number found in
brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
SUMMARY:
jspears on DSK121TN23PROD with NOTICES1
information are subject to review by
OMB under the PRA. The collections of
information in the following FDA
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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. 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 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.
Provisions found in part 801, subpart B
pertaining to labeling requirements for
Unique Device Identification are
currently approved under OMB control
number 0910–0720 and not covered in
this information collection request.
Information collection associated with
labeling requirements for Over-theCounter (OTC) Devices are found in part
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Sfmt 4703
OMB control No.
0910–0120
0910–0485
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;
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)
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
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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Notices
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 (MDUFSA),
FDA issued the guidance document,
‘‘Compliance with Section 301 of the
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.
In the Federal Register of July 13,
2021 (86 FR 36752), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
We estimate the burden of this
collection of information as follows:
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/media/71187/download.
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR citation
Number of
responses per
respondent
Average
burden
per response
Total annual
responses
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
1 There
3,000
1
3,000
1
3,000
are no capital costs or operating and maintenance costs associated with this collection of information.
Our figures are based on data from the
FDA Unified Registration and Listing
System and the OASIS 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
(§ 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 antihuman 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.
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
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
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 ......................
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).
7,500
1,591
887
47,050
6,652,500
74,856,550
0.5 (30 minutes) ............
0.0008 (0.048 minutes)
3,326,250
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
Total ...............................................................................................
........................
........................
83,109,599
........................................
3,815,361
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
jspears on DSK121TN23PROD with NOTICES1
2 Numbers
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
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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
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Sfmt 4703
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
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Federal Register / Vol. 86, No. 193 / Friday, October 8, 2021 / Notices
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 .......................................................
47
25
19,407
8,526
8
8
7
6
376
200
135,849
51,156
Statement of identity; 801.61 ................................................................
Declaration of net quantity of contents; 801.62 ....................................
Prescription device labeling; 801.109 ...................................................
8,526
8,526
9,681
6
6
6
51,156
51,156
58,086
Retail exemption for prescription devices; 801.110 ..............................
Processing, labeling, or repacking; non-sterile devices; 801.150(e) ....
30,000
453
667
34
20,010,000
15,402
1 .....................................
1 .....................................
1 .....................................
22.35 (22 hours and 21
minutes).
1 .....................................
1 .....................................
17.77 (17 hours and
46.2 minutes).
0.25 (15 minutes) ..........
4 .....................................
376
200
135,849
1,143,337
51,156
51,156
1,032,188
5,002,500
61,608
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 ............................................
35
1
35
4 .....................................
140
35
1
35
4 .....................................
140
136
10,000
16
52
12
5
8
6
1,632
50,000
128
312
80 ...................................
0.17 (10 minutes) ..........
2 .....................................
100 .................................
130,560
8,500
256
31,200
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
30
6
25
1
10,200
7,500
30
80 ...................................
1 .....................................
10 ...................................
816,000
7,500
300
2
45
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
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
Total ...............................................................................................
........................
........................
20,447,205
........................................
8,485,061
1 There
jspears on DSK121TN23PROD with NOTICES1
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Numbers have been rounded.
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.
Overall, the information collection
reflects changes and adjustments. For
efficiency of operations, we have
consolidated related information
collection previously approved under
OMB control numbers 0910–0577 and
0910–0740. This results in an increase
to the information collection by 15,095
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burden hours annually (for reporting
and disclosure burden related to the
symbols glossary regulatory
requirements and disclosure burden
related to Section 502(u)). We have
increased our estimate of the total
responses by 21,647,170 annually. The
increase is due to adjustments reflecting
updated data and the inclusion of the
consolidated information collection. At
the same time, we have reduced our
estimate of disclosure responses by
1,597,520 annually. Upon review, we
believe we previously double-counted
burden ascribed to disclosures
provisions having accounted for the
same burden as that associated with
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Fmt 4703
Sfmt 9990
recordkeeping activities. Finally, upon
submission of the ICR, we are correcting
inadvertent calculation errors to the
burden hour increase (by adding 12,000
burden hours to account for disclosure
of the symbols glossary) and decrease in
total responses displayed in our 60-day
notice in the Federal Register of July 13,
2021.
Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–22043 Filed 10–7–21; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Pages 56274-56276]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22043]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1048]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Device
Labeling Regulations
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing that a proposed collection of information has been submitted
to the Office of Management and Budget (OMB) for review and clearance
under the Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by November 8, 2021.
ADDRESSES: To ensure that comments on the information collection are
received, 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 0910-0485. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Medical Device Labeling Regulations
OMB Control No. 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.
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
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. Provisions found in part 801,
subpart B pertaining to labeling requirements for Unique Device
Identification are currently approved under OMB control number 0910-
0720 and not covered in this information collection request.
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; 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) 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
[[Page 56275]]
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 (MDUFSA), 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/media/71187/download. 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.
In the Federal Register of July 13, 2021 (86 FR 36752), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR citation Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 3,000 1 3,000 1 3,000
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...............................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Our figures are based on data from the FDA Unified Registration and
Listing System and the OASIS 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.
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).
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Total................................... .............. .............. 83,109,599 .......................................... 3,815,361
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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.
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
[[Page 56276]]
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 (22 hours and 21 minutes)........... 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 (17 hours and 46.2 minutes)......... 1,032,188
Retail exemption for prescription devices; 30,000 667 20,010,000 0.25 (15 minutes)......................... 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
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 (10 minutes)......................... 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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Part 809 (in vitro diagnostic products for human use) and Part 1040 (light-emitting products)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Format and content of labeling for IVDs; 1,700 6 10,200 80........................................ 816,000
809.10.
Advertising and promotional materials for 300 25 7,500 1......................................... 7,500
ASRs; 809.30(d).
Labeling of sunlamp products--1040.20(d).... 30 1 30 10........................................ 300
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FD&C Action Section 502(u)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Establishments listing <10 SUDs............. 161 2 322 0.1 (6 minutes)........................... 32
Establishments listing >10 SUDs............. 14 45 630 0.1 (6 minutes)........................... 63
--------------------------------------------------------------------------------------------------------------------------------------------------------
Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling Provisions; Part 809, subpart B: Labeling
--------------------------------------------------------------------------------------------------------------------------------------------------------
Symbols glossary--660.2; antibody to 3,000 1 3,000 4......................................... 12,000
Hepatitis B surface antigen requirements,
660.28; blood grouping labeling, 660.35;
reagent red blood cell labeling, 660.45,
hepatitis B surface antigen labeling,
660.55; anti-human globulin labeling,
801.15; medical devices labeling and use of
symbols; 809.10, labeling for in vitro
diagnostic products.
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Total................................... .............. .............. 20,447,205 .......................................... 8,485,061
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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.
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.
Overall, the information collection reflects changes and
adjustments. For efficiency of operations, we have consolidated related
information collection previously approved under OMB control numbers
0910-0577 and 0910-0740. This results in an increase to the information
collection by 15,095 burden hours annually (for reporting and
disclosure burden related to the symbols glossary regulatory
requirements and disclosure burden related to Section 502(u)). We have
increased our estimate of the total responses by 21,647,170 annually.
The increase is due to adjustments reflecting updated data and the
inclusion of the consolidated information collection. At the same time,
we have reduced our estimate of disclosure responses by 1,597,520
annually. Upon review, we believe we previously double-counted burden
ascribed to disclosures provisions having accounted for the same burden
as that associated with recordkeeping activities. Finally, upon
submission of the ICR, we are correcting inadvertent calculation errors
to the burden hour increase (by adding 12,000 burden hours to account
for disclosure of the symbols glossary) and decrease in total responses
displayed in our 60-day notice in the Federal Register of July 13,
2021.
Dated: October 4, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22043 Filed 10-7-21; 8:45 am]
BILLING CODE 4164-01-P
