Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network), 3417-3419 [2023-00926]
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Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices
3417
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
56.109(d); written statement about minimal risk research when documentation of informed consent
is waived.
56.109(e); written notification to approve or disapprove research.
56.109(g); IRB written statement about public disclosures to sponsor of emergency research
under § 50.24.
Total ..................................................................
1 There
Dated: January 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00974 Filed 1–18–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2017–N–0084]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Adverse Event
Program for Medical Devices (Medical
Product Safety Network)
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Average burden
per disclosure
Total hours
2,520
2
5,040
0.5 (30 minutes) ....
2,520
2,520
40
100,800
0.5 (30 minutes) ....
50,400
8
2
16
1 ............................
16
........................
............................
........................
...............................
103,336
VerDate Sep<11>2014
17:49 Jan 18, 2023
Jkt 259001
solicits comments on information
collections associated with the Adverse
Event Program for Medical Devices
(Medical Program Safety Network
(MedSun)).
Either electronic or written
comments on the collection of
information must be submitted by
March 20, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 20, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
DATES:
Electronic Submissions
Food and Drug Administration
ACTION:
Total annual
disclosures
are no capital costs or operating and maintenance costs associated with this collection of information.
We characterize activities associated
with §§ 50.25 and 56.109(d) and (e) as
disclosure burden. We estimate that
eight IRBs per year will receive a
request to review emergency research
under § 50.24, thus requiring written
notification under § 56.109(g) from the
IRB to the sponsor. We estimate that it
will take an IRB approximately 1 hour
to prepare each written statement, for a
total of 2 hours per study. The total
annual third-party disclosure burden for
IRBs to fulfill this requirement is
estimated at 16 hours.
AGENCY:
Number of
disclosures per
respondent
Number of
respondents
21 CFR section
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
PO 00000
Frm 00042
Fmt 4703
Sfmt 4703
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–0084 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Adverse
Event Program for Medical Devices
(Medical Product Safety Network).’’
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
E:\FR\FM\19JAN1.SGM
19JAN1
3418
Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices
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.
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
SUPPLEMENTARY INFORMATION:
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.
Adverse Event Program for Medical
Devices (Medical Product Safety
Network (MedSun))
OMB Control Number 0910–0471—
Extension
Section 519 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
360i) authorizes FDA to require: (1)
manufacturers to report medical devicerelated deaths, serious injuries, and
malfunctions and (2) user facilities to
report device-related deaths directly to
manufacturers and FDA and serious
injuries to the manufacturer. Section
213 of the Food and Drug
Administration Modernization Act of
1997 (Pub. L. 105–115) amended section
519(b) of the FD&C Act relating to
mandatory reporting by user facilities of
deaths, serious injuries, and serious
illnesses associated with the use of
medical devices. This amendment
legislated the replacement of universal
user facility reporting by a system that
is limited to a ‘‘. . . subset of user
facilities that constitutes a
representative profile of user reports’’
for device-related deaths and serious
injuries. This amendment is reflected in
section 519(b)(5)(A) of the FD&C Act (21
U.S.C. 360i(b)(5)(A)). This legislation
provides FDA with the opportunity to
design and implement a national
surveillance network, composed of welltrained clinical facilities, to provide
high-quality data on medical devices in
clinical use. This system is called
MedSun. FDA is seeking OMB clearance
to continue to use electronic data
collection to obtain information related
to medical devices and tissue products
from the user facilities participating in
MedSun, to obtain a demographic
profile of the facilities, and for
additional questions, which will permit
FDA to better understand the cause of
reported adverse events. Participation in
the program is voluntary and includes
approximately 300 facilities. In addition
to collecting data on the electronic
adverse event report form, MedSun
collects additional information from
participating sites about reported
problems emerging from the MedSun
hospitals. This data collection is also
voluntary and is collected on the same
website as the report information. The
burden estimate is based on the number
of facilities participating in MedSun
(300). FDA estimates an average of 18
reports per site annually. This estimate
is based on MedSun working to promote
reporting in general from the sites, as
well as promoting reporting from
specific parts of the hospitals, such as
the pediatric intensive care units, the
electrophysiology laboratories, and the
hospital laboratories.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
khammond on DSKJM1Z7X2PROD with NOTICES
Adverse event reporting ...............................................
1 There
Number of
responses per
respondent
300
18
Total annual
responses
Average burden
per response
5,400
0.5 (30 minutes) ....
are no capital costs or operating and maintenance costs associated with this collection of information.
VerDate Sep<11>2014
17:49 Jan 18, 2023
Jkt 259001
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Fmt 4703
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E:\FR\FM\19JAN1.SGM
19JAN1
Total hours
2,700
Federal Register / Vol. 88, No. 12 / Thursday, January 19, 2023 / Notices
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Dated: January 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–00926 Filed 1–18–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–3657]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Accreditation
Scheme for Conformity Assessment
Program
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) 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 the
Accreditation Scheme for Conformity
Assessment (ASCA) Program.
DATES: Either electronic or written
comments on the collection of
information must be submitted by
March 20, 2023.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
March 20, 2023. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
VerDate Sep<11>2014
17:49 Jan 18, 2023
Jkt 259001
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–
2019–N–3657 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Accreditation Scheme for Conformity
Assessment Program.’’ 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
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
3419
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.
‘‘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
E:\FR\FM\19JAN1.SGM
19JAN1
]]>Agencies
[Federal Register Volume 88, Number 12 (Thursday, January 19, 2023)]
[Notices]
[Pages 3417-3419]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-00926]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0084]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Event Program for Medical Devices (Medical
Product Safety Network)
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 collections
associated with the Adverse Event Program for Medical Devices (Medical
Program Safety Network (MedSun)).
DATES: Either electronic or written comments on the collection of
information must be submitted by March 20, 2023.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 20, 2023. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received 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-0084 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Adverse Event Program for Medical
Devices (Medical Product Safety Network).'' 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
[[Page 3418]]
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.
Adverse Event Program for Medical Devices (Medical Product Safety
Network (MedSun))
OMB Control Number 0910-0471--Extension
Section 519 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 360i) authorizes FDA to require: (1) manufacturers to report
medical device-related deaths, serious injuries, and malfunctions and
(2) user facilities to report device-related deaths directly to
manufacturers and FDA and serious injuries to the manufacturer. Section
213 of the Food and Drug Administration Modernization Act of 1997 (Pub.
L. 105-115) amended section 519(b) of the FD&C Act relating to
mandatory reporting by user facilities of deaths, serious injuries, and
serious illnesses associated with the use of medical devices. This
amendment legislated the replacement of universal user facility
reporting by a system that is limited to a ``. . . subset of user
facilities that constitutes a representative profile of user reports''
for device-related deaths and serious injuries. This amendment is
reflected in section 519(b)(5)(A) of the FD&C Act (21 U.S.C.
360i(b)(5)(A)). This legislation provides FDA with the opportunity to
design and implement a national surveillance network, composed of well-
trained clinical facilities, to provide high-quality data on medical
devices in clinical use. This system is called MedSun. FDA is seeking
OMB clearance to continue to use electronic data collection to obtain
information related to medical devices and tissue products from the
user facilities participating in MedSun, to obtain a demographic
profile of the facilities, and for additional questions, which will
permit FDA to better understand the cause of reported adverse events.
Participation in the program is voluntary and includes approximately
300 facilities. In addition to collecting data on the electronic
adverse event report form, MedSun collects additional information from
participating sites about reported problems emerging from the MedSun
hospitals. This data collection is also voluntary and is collected on
the same website as the report information. The burden estimate is
based on the number of facilities participating in MedSun (300). FDA
estimates an average of 18 reports per site annually. This estimate is
based on MedSun working to promote reporting in general from the sites,
as well as promoting reporting from specific parts of the hospitals,
such as the pediatric intensive care units, the electrophysiology
laboratories, and the hospital laboratories.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Adverse event reporting....................... 300 18 5,400 0.5 (30 minutes)........................ 2,700
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 3419]]
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Dated: January 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-00926 Filed 1-18-23; 8:45 am]
BILLING CODE 4164-01-P
