[Federal Register Volume 86, Number 131 (Tuesday, July 13, 2021)]
[Notices]
[Pages 36752-36756]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 https://www.regulations.gov 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:
     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, 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 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. 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).
                               ---------------------------------------------------------------------------------
    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.
                             -----------------------------------------------------------------------------------
    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