Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices, 11298-11300 [2021-03748]
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11298
Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
responses per
respondent
Number of
respondents
Total
burden
(in hr)
Form name
Residents, first responders, business
owners, employees, customers.
Eligibility Screener ............................
Epi CASE Survey .............................
General Survey ................................
Household Survey ............................
Hospital Survey ................................
Medical Chart Abstraction Form ......
900
1,000
800
120
40
25
1
1
1
1
1
10
2/60
15/60
25/60
10/60
25/60
30/60
30
250
333
20
17
125
...........................................................
........................
........................
........................
775
Residents ..........................................
Hospital staff .....................................
Staff from state, local, or tribal health
agencies.
Total ...........................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2021–03703 Filed 2–23–21; 8:45 am]
BILLING CODE 4163–18–P
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
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.
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
SUMMARY:
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Average
burden per
response
(in hr)
Type of respondent
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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
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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://
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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
www.govinfo.gov/content/pkg/FR-201509-18/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
Number of
respondents
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Type of respondent
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total hours
Establishments listing less than 10 SUDs ...........................
Establishments listing 10 or more SUDs .............................
161
14
2
45
322
630
0.1
0.1
32
63
Total ..............................................................................
........................
........................
........................
........................
95
1 There
2 Totals
are no capital costs or operating and maintenance costs associated with this collection of information.
may not sum due to rounding.
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Federal Register / Vol. 86, No. 35 / Wednesday, February 24, 2021 / Notices
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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–7012]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Use of Public
Human Genetic Variant Databases To
Support Clinical Validity for Genetic
and Genomic-Based In Vitro
Diagnostics
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA 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 March 26,
2021.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be submitted to https://
www.reginfo.gov/public/do/PRAMain.
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 0910–0850. Also include
the FDA docket number found in
brackets in the heading of this
document.
SUMMARY:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
khammond on DSKJM1Z7X2PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
SUPPLEMENTARY INFORMATION:
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has submitted the following proposed
collection of information to OMB for
review and clearance.
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Use of Public
Human Genetic Variant Databases To
Support Clinical Validity for Genetic
and Genomic-Based In Vitro
Diagnostics
OMB Control Number 0910–0850—
Extension
Section 2011 of the 21st Century
Cures Act of 2016 (Pub. L. 114–255)
encourages the FDA to develop new
approaches for addressing regulatory
science issues as part of the Precision
Medicine Initiative (PMI).
In the Federal Register of April 13,
2018 (83 FR 16110), FDA announced the
availability of a guidance for industry
entitled ‘‘Use of Public Human Genetic
Variant Databases to Support Clinical
Validity for Genetic and Genomic-Based
In Vitro Diagnostics; Guidance for
Stakeholders and Food and Drug
Administration Staff.’’ 1 The guidance
describes one part of FDA’s PMI effort
to create a flexible and adaptive
regulatory approach to the oversight of
next generation sequencing (NGS)-based
tests. The goal of this effort is to help
ensure patients receive accurate and
meaningful test results, while promoting
innovation in test development. The
guidance describes how publicly
accessible databases of human genetic
variants can serve as sources of valid
scientific evidence to support the
clinical validity of genotype-phenotype
relationships in FDA’s regulatory review
of both NGS-based tests and genetic and
genomic tests based on other
technologies. Publicly accessible genetic
databases may be useful to support the
clinical validity of NGS tests as well as
single gene or panel tests that use other
technology.
The guidance describes FDA’s
considerations in determining whether a
genetic variant database is a source of
valid scientific evidence that could
support the clinical validity of an NGSbased test. The guidance further
outlines the process by which
administrators 2 of genetic variant
databases could voluntarily apply to
FDA for recognition, and how FDA
1 Available at: https://www.fda.gov/regulatoryinformation/search-fda-guidance-documents/usepublic-human-genetic-variant-databases-supportclinical-validity-genetic-and-genomic-based-vitro.
2 FDA acknowledges that many databases may not
use the term ‘‘administrator’’ or may have a
committee of individuals that oversee the database.
Therefore, for the purpose of this guidance, a
genetic variant database administrator is the entity
or entities that oversee database operations.
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would review such applications and
periodically reevaluate recognized
databases. The guidance also
recommends that, at the time of
recognition, the database administrator
make information regarding policies,
procedures, and conflicts of interest
publicly available and accessible on the
genetic variant database’s website.
Respondents are administrators of
genetic databases. Our estimate of five
respondents per year is based on the
current number of databases that may
meet FDA recommendations for
recognition and seek such recognition.
Based on our experience and the
nature of the information, we estimate
that it will take an average of 80 hours
to complete and submit an application
for recognition. We estimate that
maintenance of recognition activities
will take approximately one-fourth of
that time (20 hours) annually. We
estimate that it will take approximately
1 hour to post the information on the
website.
In the Federal Register of September
23, 2020 (85 FR 59801), we published a
60-day notice requesting public
comment on the proposed collection of
information. FDA received two
comments. One comment was not
relevant to the topic or information
collection. A summary of the other
comment and our response are as
follows:
(Comment) One comment expressed
concerns and suggestions regarding the
collection, storage, and security of
personally identifiable information (PII)
and protected health information (PHI).
(Response) The guidance document
‘‘Use of Public Human Genetic Variant
Databases to Support Clinical Validity
for Genetic and Genomic-Based In Vitro
Diagnostics’’ describes, among other
things, FDA’s considerations in
determining whether a publicly
accessible genetic variant database is a
source of valid scientific evidence that
could support the clinical validity of
genetic and genomic-based tests in a
premarket submission and outlines the
process by which administrators of
publicly accessible genetic variant
databases could voluntarily apply to
FDA for recognition, and how FDA
would assess such applications and
periodically reevaluate recognized
databases. FDA recommends that
genetic database administrators should
identify the applicable laws and
regulations to assure that any
requirements are addressed and
transparently documented. Genetic
variant database administrators should
also put in place adequate security
measures to ensure the protection and
privacy of PII and PHI and provide
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Number of
Type of respondent Number of disclosures Total annual Average burden Total hours
respondents per respondent disclosures per disclosure
----------------------------------------------------------------------------------------------------------------
Establishments listing less than 161 2 322 0.1 32
10 SUDs........................
Establishments listing 10 or 14 45 630 0.1 63
more SUDs......................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 95
----------------------------------------------------------------------------------------------------------------
\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
