Document ID: FDA-2011-N-0672-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
Posted Date: 2021-02-24T05:00Z

[Federal Register Volume 86, Number 35 (Wednesday, February 24, 2021)]
[Notices]
[Pages 11298-11300]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-03748]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0672]

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Prominent and Conspicuous Mark of Manufacturers on 
Single-Use Devices

AGENCY: Food and Drug Administration, 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, 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 reprocessed, single-use device labeling.

DATES: Submit either electronic or written comments on the collection 
of information by April 26, 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 April 26, 2021. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of April 26, 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-2011-N-0672 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Prominent and Conspicuous Mark of 
Manufacturers on Single-Use Devices.'' 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://

[[Page 11299]]

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: JonnaLynn Capezzuto, Office of 
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-3794, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used; (3) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (4) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques, when 
appropriate, and other forms of information technology.

Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices

OMB Control Number 0910-0577--Extension

    Section 502 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) 
(21 U.S.C. 352), among other things, establishes requirements that the 
label or labeling of a medical device must meet so that it is not 
misbranded and subject to regulatory action. 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 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) (Pub. L. 109-43) amends 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.
    As directed by MDUFSA, FDA issued the guidance 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'' (https://www.fda.gov/media/71187/download) 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. However, the guidance does not 
contain additional information collections.
    The requirements of section 502(u) of the FD&C Act impose a minimal 
burden on industry. This section of the FD&C Act only requires the 
manufacturer, packer, or distributor of a device to include their name 
and address on the labeling of a device. This information is readily 
available to the establishment and easily supplied. From FDA's Unified 
Registration and Listing System database, FDA estimates that there are 
175 establishments that distribute approximately 946 reprocessed SUDs. 
The majority of establishments (161) distribute an average of 2 SUDs 
per establishment. The remaining 14 establishments distribute an 
average of 45 SUDs per establishment. Each response is anticipated to 
take 0.1 hours (6 minutes).
    FDA estimates the burden of this collection of information as 
follows:

                           Table 1--Estimated Annual Third-Party Disclosure Burden 1 2
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                                                     Number of
       Type of respondent            Number of      disclosures    Total annual   Average burden    Total hours
                                    respondents   per respondent    disclosures   per disclosure
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Establishments listing less than             161               2             322             0.1              32
 10 SUDs........................
Establishments listing 10 or                  14              45             630             0.1              63
 more SUDs......................
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    Total.......................  ..............  ..............  ..............  ..............              95
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Totals may not sum due to rounding.

[[Page 11300]]

    Our estimated burden for the information collection reflects an 
increase of 52 hours. We attribute this adjustment to an increase in 
the number of establishments and reprocessed SUDs.

    Dated: February 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-03748 Filed 2-23-21; 8:45 am]
BILLING CODE 4164-01-P