Notice2021-14768
Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Labeling Regulations
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Published
July 13, 2021
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with medical device labeling regulations.
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<title>Federal Register, Volume 86 Issue 131 (Tuesday, July 13, 2021)</title>
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[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36752-36756]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2021-14768]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-1048]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Labeling Regulations
AGENCY: Food and Drug Administration, Health and Human Services (HHS).
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information,
[[Page 36753]]
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 information collection
associated with medical device labeling regulations.
DATES: Submit either electronic or written comments on the collection
of information by September 13, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before September 13, 2021. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of September 13, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-1048 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Labeling
Regulations.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#dd8d8f9c8ea9bcbbbb9dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="66363427351207000026000207480e0e1548010910">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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
[[Page 36754]]
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 part 1040 (21 CFR parts 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 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. Finally, 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.
We have revised the information collection to include reference to
Agency guidance. The guidance documents were developed and issued
consistent with our Good Guidance Practice regulations in 21 CFR
10.115, which provide for public comment at any time.
Section 502(b) of the FD&C Act requires that, for packaged devices,
the label 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 that the labeling
for a device must contain adequate directions for use. FDA may,
however, grant an exemption if the Agency determines that the adequate
directions for use labeling requirements are not necessary for the
particular case as it relates to protection of the public health.
Section 301 of the Medical Device User Fee and Modernization Act of
2002 (Pub. L. 107-250) amended section 502 of the FD&C Act to add
paragraph (u) to section 502 to require devices (both new and
reprocessed) 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.
Section 2(c) of the Medical Device User Fee Stabilization Act of
2005 (MDUFSA) amended section 502(u) of the FD&C Act by limiting the
provision to reprocessed single-use devices (SUDs) and the
manufacturers who reprocess them. Under the amended 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. MDUFSA required that FDA issue
guidance identifying the circumstances in which the name, abbreviation,
or symbol of the manufacturer of an original device is not ``prominent
and conspicuous'' under section 502(u) of the FD&C Act. Accordingly, we
issued the guidance document entitled ``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), 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. We believe the
information disclosures discussed in the guidance impose no burden
beyond that which we attribute already to complying with disclosure
provisions found in the applicable regulations; however, we include the
guidance document for respondents' instructional use and reference.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
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Symbols glossary................................................... 3,000 1 3,000 1 3,000
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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 allows the use
of stand-alone graphical representations of information, or symbols, in
the labeling for the medical devices, 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.
[[Page 36755]]
Table 2--Estimated Annual Recordkeeping Burden 1 2
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Number of Average burden
Activity Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
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Processing, labeling, or 7,500 887 6,652,500 0.5 (30 minutes) 3,326,250
repacking agreement; 801.150.
Impact resistant lenses; 1,591 47,050 74,856,550 0.0008 (0.048 59,885
invoices, shipping documents, minutes).
and records of sale or
distribution; 801.410(e) and
(f).
Hearing aid records; 801.421.. 10,000 160 1,600,000 0.25 (15 400,000
minutes).
Menstrual tampons, sampling 33 11 363 80.............. 29,040
plan for measuring
absorbency; 801.430(f).
Latex condoms; justification 51 3.65 186 1............... 186
for the 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) (21 CFR 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) (21 CFR 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 21 CFR 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
Activity Number of disclosures Total annual Average burden per Total hours
respondents per respondent disclosures disclosure
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Parts 800; and Part 801, subparts A, C, D, and E: General Labeling; OTC Devices; Exemptions
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Contact lens cleaning 47 8 376 1................. 376
solution labeling;
800.10(a)(3) and 800.12(c).
Liquid ophthalmic 25 8 200 1................. 200
preparation labeling;
800.10(b)(2).
Manufacturer, packer, or 19,407 7 135,849 1................. 135,849
distributor information;
801.1.
Adequate directions for use; 8,526 6 51,156 22.35............. 1,143,337
801.5.
Statement of identity; 8,526 6 51,156 1................. 51,156
801.61.
Declaration of net quantity 8,526 6 51,156 1................. 51,156
of contents; 801.62.
Prescription device 9,681 6 58,086 17.77............. 1,032,188
labeling; 801.109.
Retail exemption for 30,000 667 20,010,000 0.25.............. 5,002,500
prescription devices;
801.110.
Processing, labeling, or 453 34 15,402 4................. 61,608
repacking; non-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 35 1 35 4................. 140
intended for lay use in the
repairing and/or refitting
of dentures; 801.405(b)(1).
Dentures; information 35 1 35 4................. 140
regarding temporary and
emergency use; 801.405(c).
Hearing aids professional 136 12 1,632 80................ 130,560
and patient labeling;
801.420.
Hearing aids, availability 10,000 5 50,000 0.17.............. 8,500
of User Instructional
Brochure; 801.421.
User labeling for menstrual 16 8 128 2................. 256
tampons; 801.430.
User labeling for latex 52 6 312 100............... 31,200
condoms; 801.437.
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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 1,700 6 10,200 80................ 816,000
labeling for IVDs; 809.10.
Advertising and promotional 300 25 7,500 1................. 7,500
materials for ASRs;
809.30(d).
Labeling of sunlamp 30 1 30 10................ 300
products--1040.20(d).
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[[Page 36756]]
FD&C Action Section 502(u)
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Establishments listing <10 161 2 322 0.1 (6 minutes)... 32
SUDs.
Establishments listing >10 14 45 630 0.1 (6 minutes)... 63
SUDs.
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Total................... .............. .............. 952 .................. 95
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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 currently approved under OMB control numbers
0910-0577 and 0910-0740 pertaining to recommendations found in Agency
guidance and discussed in this notice. This results in an increase to
the information collection by 30,482 burden hours annually. At the same
time, we have reduced our estimate of the total responses by 53,143,810
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. We invite comment on
our estimates and these assumptions.
Dated: July 2, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-14768 Filed 7-12-21; 8:45 am]
BILLING CODE 4164-01-P
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