Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting, 22671-22674 [2021-08962]
Download as PDF
<![CDATA[
Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices
respondents who submitted a duplicate
payment or overpayment for a user fee
cover sheet or invoice. Respondents
may also include firms that withdrew an
application or submission. Transfer
request forms target respondents who
submitted payment for a user fee cover
sheet or invoice and need that payment
to be re-applied to another cover sheet
or invoice (transfer of funds).
The electronic user fee payment
request forms streamline the refund and
transfer processes, facilitate processing,
and improve the tracking of refund or
transfer requests. The burden for this
collection of information is the same for
all customers (small and large
organizations). The information being
requested or required has been held to
the absolute minimum required for the
22671
intended use of the data. Respondents
are able to request a user fee payment
refund or transfer online at https://
www.fda.gov/forindustry/userfees/
default.htm. This electronic submission
is intended to reduce the burden for
customers to submit a user fee payment
refund and transfer request.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Total annual
responses
Average burden
per response
User Fee Payment Refund Request-Form FDA 3913 ..
User Fee Payment Transfer Request-Form FDA 3914
474
194
1
1
474
194
Total .......................................................................
........................
........................
........................
1 There
Dated: April 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08947 Filed 4–28–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6730]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Device
Reporting
AGENCY:
Notice.
VerDate Sep<11>2014
18:32 Apr 28, 2021
Jkt 253001
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 the information
collection associated with requirements
for medical device reporting for user
facilities, manufacturers, importers, and
distributors of medical devices.
DATES: Submit either electronic or
written comments on the collection of
information by June 28, 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 June 28, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 28, 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.
SUMMARY:
Electronic Submissions
Food and Drug Administration,
HHS.
ACTION:
Total hours
0.40 (24 minutes)
0.25 (15 minutes)
190
49
..............................
239
are no capital costs or operating and maintenance costs associated with this collection of information.
The current burden estimate shows a
decrease of approximately 642 hours for
this information collection over that
reported previously. The change reflects
increased experience by the respondents
to correctly submit fee payments, and
increased sophistication in use of the
forms to request payments made in
error. The use of the forms for the user
fee programs (e.g., Prescription Drug
User Fees, Generic Drug User Fees,
Animal Drug User Fees, Animal Generic
Drug User Fees, Biosimilar Drug User
Fees) are optional.
In addition, new information
technology applications have more
accurately calculated the number of
registrants of drug facilities/food
facilities/medical device facilities/
medicated feed facilities, and we have
therefore revised the number of
respondents to the information
collection.
jbell on DSKJLSW7X2PROD with NOTICES
Number of
responses per
respondent
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
PO 00000
Frm 00047
Fmt 4703
Sfmt 4703
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–
2017–N–6730 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Medical
Device Reporting.’’ Received comments,
E:\FR\FM\29APN1.SGM
29APN1
jbell on DSKJLSW7X2PROD with NOTICES
22672
Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices
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-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:
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, 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.
VerDate Sep<11>2014
18:32 Apr 28, 2021
Jkt 253001
‘‘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 Reporting—21 CFR Part
803
OMB Control Number 0910–0437—
Extension
This information collection supports
FDA regulations and FDA’s Medical
Device Reporting program. Section
519(a), (b), and (c) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21
U.S.C. 360i(a), (b), and (c)) requires user
facilities, manufacturers, importers, and
distributors of medical devices to report
adverse events involving medical
devices to FDA. These provisions are
codified in part 803 (21 CFR part 803),
Medical Device Reporting. As amended
most recently by the FDA
Reauthorization Act of 2017 (FDARA)
(Pub. L. 115–52), medical device
manufacturers and importers must
submit medical device reports (MDRs)
using FDA’s electronic submission
system. User facilities, however, may
elect to submit reports using paperbased Form FDA 3500A—MedWatch—
Mandatory Reporting (approved under
OMB control number 0910–0291). The
regulations also establish recordkeeping
requirements and provide for certain
PO 00000
Frm 00048
Fmt 4703
Sfmt 4703
exemptions, variances, or alternative
forms of reporting. Exemptions and/or
variances from individual reporting
must be requested in writing and must
receive Agency approval. Additionally,
the regulations permit user facilities to
submit paper-based annual reports, for
which we have developed Form FDA
3419 entitled ‘‘Medical Device
Reporting Annual User Facility Report.’’
This information collection also
includes the use of existing formats
such as Form FDA 3500A 1—
MedWatch—Mandatory Reporting to
allow manufacturers to summarize in a
single report multiple events with
shared characteristics for device
associated reportable malfunction
events. For example, the Voluntary
Malfunction Summary Reporting
Program (VMSRP) 2 provides
recommendations for manufacturers of
certain devices to submit a single report
that summarizes multiple device
associated reportable malfunction
events on a quarterly basis. The VMSRP
was established under section
519(a)(1)(B)(ii) of the FD&C Act and
reflects goals for streamlining
malfunction reporting as outlined in the
Medical Device User Fee Amendments
(MDUFA) IV ‘‘Commitment Letter’’ for
2018 through 2022 agreed to by FDA
and industry and submitted to Congress.
The Commitment Letter was finalized
with the passage of FDARA on August
18, 2017, and, as passed, is entitled
‘‘MDUFA Performance Goals And
Procedures, Fiscal Years 2018 Through
2022.’’ 3
The information that is obtained from
this information collection will be used
to evaluate risks associated with
medical devices and enable FDA to take
appropriate measures to protect the
public health. Complete, accurate, and
timely adverse event information is
necessary for the identification of
emerging device problems so the
Agency can protect the public health
under section 519 of the FD&C Act. FDA
makes the releasable information
available to the public for downloading
on its website. Respondents are
manufacturers and importers of medical
devices and device user facilities.4
1 Form FDA 3500A is approved under OMB
control number 0910–0291.
2 In the Federal Register of August 17, 2018 (83
FR 40973), FDA issued a notification permitting
manufacturers to report certain device malfunction
MDRs in summary form on a quarterly basis.
3 Available at: https://www.fda.gov/downloads/
ForIndustry/UserFees/MedicalDeviceUserFee/
UCM535548.pdf.
4 Device user facility means a hospital,
ambulatory surgical facility, nursing home,
outpatient diagnostic facility, or outpatient
treatment facility as defined in § 803.3, which is not
a physician’s office (also defined in § 803.3).
E:\FR\FM\29APN1.SGM
29APN1
Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices
22673
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Total
annual
responses
FDA
form No.
Exemptions/Variances—803.19 ........
User Facility Reporting—803.30 and
803.32.
User Facility Annual Reporting—
803.33.
Importer Reporting, Death and Serious Injury—803.40 and 803.42.
Manufacturer
Reporting—803.50,
803.52 and 803.53.
Voluntary Malfunction Summary Reporting Program.
Supplemental Reports—803.56 ........
....................
....................
85
520
4
10.06
340
5,232
1 ................................
0.35 (21 minutes) .....
340
1,831
3419
159
1
159
1 ................................
159
....................
578
1
578
1 ................................
578
....................
1,240
272.50
337,900
0.10 (6 minutes) .......
33,790
....................
1,240
54.47
67,546
0.10 (6 minutes) .......
6,755
....................
1,050
128.71
135,148
0.10 (6 minutes) .......
13,515
Total ...........................................
....................
........................
........................
........................
...................................
56,968
1 There
Number of
respondents
Number of
responses per
respondent
Activity/21 CFR section
Average burden
per response
Total hours 2
are no capital costs or operating and maintenance costs associated with this collection of information.
has been rounded.
2 Number
The number of respondents to the
information collection is based on
MDRs received by FDA recently. The
annual frequency per response and total
annual responses shown are based on
the number of MDRs reported during
the same period. FDA estimates that
approximately 10 percent of
malfunction reports are submitted.
Approximately 67 percent of the
manufacturer reports received under 21
CFR 803.50, 803.52, and 803.53 are
malfunction reports.
Supplemental Reports—21 CFR
803.56. We estimate that, at most, the
number of supplemental reports is
approximately one third of the total
number of individual reports and
summary reports submitted annually.
Therefore, our estimate of the number of
responses per respondent is 128.71.
Voluntary Malfunction Summary
Reporting Program. The VMSRP
includes the same respondent pool as
individual manufacturer reporting. We
expect that a summary report will take
approximately the same amount of time
to prepare as an individual report.
(Note: device-led combination products
are included in the burden estimate for
the VMSRP.) As discussed in section I
of the proposed VMSRP, FDA’s Pilot
Program for Medical Device Reporting
on Malfunctions showed an 87 percent
reduction in the volume of reporting for
malfunction reports with use of
malfunction summary reporting.
Assuming 90 percent of malfunction
reports are submitted in summary
reports, we estimate that manufacturers
would submit an average of 54.47
summary reports annually under the
program.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
records per
recordkeeper
Number of
recordkeepers
Activity/21 CFR section
Total annual
records
Average
burden per
recordkeeping
Total hours
MDR Procedures—803.17 ........................................
MDR Files—803.18 ..................................................
1,240
1,240
1
1
1,240
1,240
3.3 .............................
1.5 .............................
4,092
1,860
Total ...................................................................
........................
........................
........................
...................................
5,952
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in table 2
is based on the MDRs reported to FDA’s
internal databases recently. We believe
that the majority of respondents
(manufacturers, user facilities, and
importers) have already established
written procedures and MDR files to
document complaints and information
to meet the MDR requirements as part
of their internal quality control system.
We have therefore adjusted our estimate
downward.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
jbell on DSKJLSW7X2PROD with NOTICES
Activity/21 CFR section
Importer Reporting, Death and Serious Injury—
803.40 and 803.42.
1 There
Number of
disclosures per
respondent
578
25
Total annual
disclosures
14,450
Average burden
per disclosure
0.35 (21 minutes) .....
are no capital costs or operating and maintenance costs associated with this collection of information.
has been rounded.
2 Number
VerDate Sep<11>2014
18:32 Apr 28, 2021
Jkt 253001
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
E:\FR\FM\29APN1.SGM
29APN1
Total hours 2
5,058
22674
Federal Register / Vol. 86, No. 81 / Thursday, April 29, 2021 / Notices
The number of respondents for each
CFR section in table 3 was identified
from the MDRs reported to FDA’s
internal databases during the period
recently.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
changes to our burden estimate.
Dated: April 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–08962 Filed 4–28–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0359]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Human Drug
Compounding, Repackaging, and
Related Activities Regarding Sections
503A and 503B of the Federal Food,
Drug, and Cosmetic Act
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 information
collection associated with Agency
guidance documents pertaining to
pharmacies, outsourcing facilities, and
other entities with regard to human drug
compounding, repackaging, and related
activities.
DATES: Submit either electronic or
written comments on the collection of
information on or before June 28, 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 June 28, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of June 28, 2021. Comments
jbell on DSKJLSW7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:32 Apr 28, 2021
Jkt 253001
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–
2021–N–0359 for ‘‘Human Drug
Compounding, Repackaging, and
Related Activities Regarding Sections
503A and 503B of the Federal Food,
Drug, and Cosmetic Act.’’ 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
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
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-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:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, 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.
E:\FR\FM\29APN1.SGM
29APN1
]]>Agencies
[Federal Register Volume 86, Number 81 (Thursday, April 29, 2021)]
[Notices]
[Pages 22671-22674]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-08962]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6730]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting
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 the information collection associated with
requirements for medical device reporting for user facilities,
manufacturers, importers, and distributors of medical devices.
DATES: Submit either electronic or written comments on the collection
of information by June 28, 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 June 28, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 28, 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-2017-N-6730 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Medical Device Reporting.''
Received comments,
[[Page 22672]]
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 Reporting--21 CFR Part 803
OMB Control Number 0910-0437--Extension
This information collection supports FDA regulations and FDA's
Medical Device Reporting program. Section 519(a), (b), and (c) of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360i(a),
(b), and (c)) requires user facilities, manufacturers, importers, and
distributors of medical devices to report adverse events involving
medical devices to FDA. These provisions are codified in part 803 (21
CFR part 803), Medical Device Reporting. As amended most recently by
the FDA Reauthorization Act of 2017 (FDARA) (Pub. L. 115-52), medical
device manufacturers and importers must submit medical device reports
(MDRs) using FDA's electronic submission system. User facilities,
however, may elect to submit reports using paper-based Form FDA 3500A--
MedWatch--Mandatory Reporting (approved under OMB control number 0910-
0291). The regulations also establish recordkeeping requirements and
provide for certain exemptions, variances, or alternative forms of
reporting. Exemptions and/or variances from individual reporting must
be requested in writing and must receive Agency approval. Additionally,
the regulations permit user facilities to submit paper-based annual
reports, for which we have developed Form FDA 3419 entitled ``Medical
Device Reporting Annual User Facility Report.''
This information collection also includes the use of existing
formats such as Form FDA 3500A \1\--MedWatch--Mandatory Reporting to
allow manufacturers to summarize in a single report multiple events
with shared characteristics for device associated reportable
malfunction events. For example, the Voluntary Malfunction Summary
Reporting Program (VMSRP) \2\ provides recommendations for
manufacturers of certain devices to submit a single report that
summarizes multiple device associated reportable malfunction events on
a quarterly basis. The VMSRP was established under section
519(a)(1)(B)(ii) of the FD&C Act and reflects goals for streamlining
malfunction reporting as outlined in the Medical Device User Fee
Amendments (MDUFA) IV ``Commitment Letter'' for 2018 through 2022
agreed to by FDA and industry and submitted to Congress. The Commitment
Letter was finalized with the passage of FDARA on August 18, 2017, and,
as passed, is entitled ``MDUFA Performance Goals And Procedures, Fiscal
Years 2018 Through 2022.'' \3\
---------------------------------------------------------------------------
\1\ Form FDA 3500A is approved under OMB control number 0910-
0291.
\2\ In the Federal Register of August 17, 2018 (83 FR 40973),
FDA issued a notification permitting manufacturers to report certain
device malfunction MDRs in summary form on a quarterly basis.
\3\ Available at: https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM535548.pdf.
---------------------------------------------------------------------------
The information that is obtained from this information collection
will be used to evaluate risks associated with medical devices and
enable FDA to take appropriate measures to protect the public health.
Complete, accurate, and timely adverse event information is necessary
for the identification of emerging device problems so the Agency can
protect the public health under section 519 of the FD&C Act. FDA makes
the releasable information available to the public for downloading on
its website. Respondents are manufacturers and importers of medical
devices and device user facilities.\4\
---------------------------------------------------------------------------
\4\ Device user facility means a hospital, ambulatory surgical
facility, nursing home, outpatient diagnostic facility, or
outpatient treatment facility as defined in Sec. 803.3, which is
not a physician's office (also defined in Sec. 803.3).
---------------------------------------------------------------------------
[[Page 22673]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section FDA form Number of responses per Total annual Average burden per response Total hours
No. respondents respondent responses \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemptions/Variances--803.19.......... ........... 85 4 340 1.................................. 340
User Facility Reporting--803.30 and ........... 520 10.06 5,232 0.35 (21 minutes).................. 1,831
803.32.
User Facility Annual Reporting--803.33 3419 159 1 159 1.................................. 159
Importer Reporting, Death and Serious ........... 578 1 578 1.................................. 578
Injury--803.40 and 803.42.
Manufacturer Reporting--803.50, 803.52 ........... 1,240 272.50 337,900 0.10 (6 minutes)................... 33,790
and 803.53.
Voluntary Malfunction Summary ........... 1,240 54.47 67,546 0.10 (6 minutes)................... 6,755
Reporting Program.
Supplemental Reports--803.56.......... ........... 1,050 128.71 135,148 0.10 (6 minutes)................... 13,515
-----------------------------------------------------------------------------------------------------------------
Total............................. ........... .............. .............. .............. ................................... 56,968
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number has been rounded.
The number of respondents to the information collection is based on
MDRs received by FDA recently. The annual frequency per response and
total annual responses shown are based on the number of MDRs reported
during the same period. FDA estimates that approximately 10 percent of
malfunction reports are submitted. Approximately 67 percent of the
manufacturer reports received under 21 CFR 803.50, 803.52, and 803.53
are malfunction reports.
Supplemental Reports--21 CFR 803.56. We estimate that, at most, the
number of supplemental reports is approximately one third of the total
number of individual reports and summary reports submitted annually.
Therefore, our estimate of the number of responses per respondent is
128.71.
Voluntary Malfunction Summary Reporting Program. The VMSRP includes
the same respondent pool as individual manufacturer reporting. We
expect that a summary report will take approximately the same amount of
time to prepare as an individual report. (Note: device-led combination
products are included in the burden estimate for the VMSRP.) As
discussed in section I of the proposed VMSRP, FDA's Pilot Program for
Medical Device Reporting on Malfunctions showed an 87 percent reduction
in the volume of reporting for malfunction reports with use of
malfunction summary reporting. Assuming 90 percent of malfunction
reports are submitted in summary reports, we estimate that
manufacturers would submit an average of 54.47 summary reports annually
under the program.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
MDR Procedures--803.17...................... 1,240 1 1,240 3.3....................................... 4,092
MDR Files--803.18........................... 1,240 1 1,240 1.5....................................... 1,860
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 5,952
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The number of respondents in table 2 is based on the MDRs reported
to FDA's internal databases recently. We believe that the majority of
respondents (manufacturers, user facilities, and importers) have
already established written procedures and MDR files to document
complaints and information to meet the MDR requirements as part of
their internal quality control system. We have therefore adjusted our
estimate downward.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity/21 CFR section Number of disclosures per Total annual Average burden per disclosure Total hours
respondents respondent disclosures \2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Importer Reporting, Death and Serious 578 25 14,450 0.35 (21 minutes)........................ 5,058
Injury--803.40 and 803.42.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Number has been rounded.
[[Page 22674]]
The number of respondents for each CFR section in table 3 was
identified from the MDRs reported to FDA's internal databases during
the period recently.
Based on a review of the information collection since our last
request for OMB approval, we have made no changes to our burden
estimate.
Dated: April 21, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-08962 Filed 4-28-21; 8:45 am]
BILLING CODE 4164-01-P
