Notice2021-22043
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Labeling Regulations
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Published
October 8, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 86 Issue 193 (Friday, October 8, 2021)</title>
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[Federal Register Volume 86, Number 193 (Friday, October 8, 2021)]
[Notices]
[Pages 56274-56276]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-22043]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#306062716344515656705654511e5858431e575f46"><span class="__cf_email__" data-cfemail="83d3d1c2d0f7e2e5e5c3e5e7e2adebebf0ade4ecf5">[email protected]</span></a>.
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 <a href="https://www.fda.gov/media/71187/download">https://www.fda.gov/media/71187/download</a>. The guidance document is intended to identify
circumstances in which the name or symbol of the original SUD
manufacturer is not prominent and conspicuous, as used in section
502(u) of the FD&C Act.
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\
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Number of
21 CFR citation Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling; Part 809, subpart B: Labeling
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Symbols glossary--660.2; antibody to 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...............................................
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\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
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Number of
21 CFR citation Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
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Part 801 subpart A: General Labeling Provisions; subpart E: Other Exemptions; subpart H: Special Requirements for Specific Devices
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Processing, labeling, or repacking 7,500 887 6,652,500 0.5 (30 minutes).......................... 3,326,250
agreement; 801.150.
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
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Number of
21 CFR citation Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures
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Part 800; and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
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Contact lens cleaning solution labeling; 47 8 376 1......................................... 376
800.10(a)(3) and 800.12(c).
Liquid ophthalmic preparation labeling; 25 8 200 1......................................... 200
800.10(b)(2).
Manufacturer, packer, or distributor 19,407 7 135,849 1......................................... 135,849
information; 801.1.
Adequate directions for use; 801.5.......... 8,526 6 51,156 22.35 (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
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Labeling of articles intended for lay use in 35 1 35 4......................................... 140
the repairing and/or refitting of dentures;
801.405(b)(1).
Dentures; information regarding temporary 35 1 35 4......................................... 140
and emergency use; 801.405(c).
Hearing aids professional and patient 136 12 1,632 80........................................ 130,560
labeling; 801.420.
Hearing aids, availability of User 10,000 5 50,000 0.17 (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)
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Format and content of labeling for IVDs; 1,700 6 10,200 80........................................ 816,000
809.10.
Advertising and promotional materials for 300 25 7,500 1......................................... 7,500
ASRs; 809.30(d).
Labeling of sunlamp products--1040.20(d).... 30 1 30 10........................................ 300
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FD&C Action Section 502(u)
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Establishments listing <10 SUDs............. 161 2 322 0.1 (6 minutes)........................... 32
Establishments listing >10 SUDs............. 14 45 630 0.1 (6 minutes)........................... 63
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Part 660, subparts A, C, D, E, and F: Antibody to Hepatitis B Surface Antigen; Blood Grouping Reagent; Reagent Red Blood Cells; Hepatitis B Surface
Antigen; Anti-Human Globulin; Part 801 subpart A: General Labeling Provisions; Part 809, subpart B: Labeling
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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
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