Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
| Published date | 24 February 2021 |
| Citation | 86 FR 11298 |
| Record Number | 2021-03748 |
| Section | Notices |
| Court | Food And Drug Administration |
Federal Register, Volume 86 Issue 35 (Wednesday, February 24, 2021)
[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,
[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.
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
