Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network), 38062-38063 [2023-12483]
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38062
Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Notices
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.
Allegations of Regulatory Misconduct
Voluntarily Submitted to the Center for
Devices and Radiological Health
OMB Control Number 0910–0769—
Extension
This information collection supports
the voluntary submission of allegations
of regulatory misconduct to CDRH. An
allegation of regulatory misconduct is a
claim that a medical device
manufacturer or individuals marketing
medical devices or electronic products
regulated by CDRH may be doing so in
a manner that violates the law.
Reporting these allegations can help
make FDA aware of regulatory concerns
it may not learn of otherwise. This
information can help FDA identify the
potential risks to patients and determine
whether further investigation is
warranted, as well as any steps needed
to address or correct a potential
violation. Anyone may file a complaint
reporting an allegation of regulatory
misconduct. FDA encourages people
submitting allegations to include
supporting information and contact
information in case additional
information is needed for FDA to
understand the allegation and act on the
report; however, you can choose to
submit a report anonymously. FDA will
not share your identity or contact
information with anyone outside FDA
unless required to do so by law,
regulation, or court order.
Allegations of regulatory misconduct
may include failure to register and list
a medical device, marketing uncleared
or unapproved products, failure to
follow quality system requirements, or
misleading promotion.
You can submit an allegation through
the Allegations of Regulatory
Misconduct Form (https://www.fda.gov/
medical-devices/reporting-allegationsregulatory-misconduct/allegationsregulatory-misconduct-form), by email,
or by regular mail.
Allegations of regulatory misconduct
related to medical devices and
electronic products are reviewed by
CDRH. CDRH prioritizes the review of
allegations based on the level of
potential risks, within the context of an
overall benefit-risk profile, to patients.
There are different processes based on
the type of allegation and the
completeness of the information
submitted. The general steps CDRH
takes after receiving an allegation of
regulatory misconduct and some
examples of the kind of allegations FDA
has received are provided on our
website (https://www.fda.gov/medicaldevices/medical-device-safety/
reporting-allegations-regulatorymisconduct).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
2,500
1
Electronic submission of voluntary allegations to CDRH ....
1 There
2,500
Average burden
per response
Total hours
0.25 (15 minutes)
625
are no capital costs or operating and maintenance costs associated with this collection of information.
We recently consolidated the intake of
allegations across CDRH Offices. This
has improved our estimate and we have
adjusted the number of responses
accordingly. The number of responses is
based on the voluntary allegations
received by CDRH in 2022. The adjusted
estimated burden for the information
collection reflects an increase of 900
responses and a corresponding increase
of 225 hours.
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12488 Filed 6–9–23; 8:45 am]
VerDate Sep<11>2014
17:39 Jun 09, 2023
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–0084]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Adverse Event
Program for Medical Devices (Medical
Product Safety Network)
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 July 12,
2023.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
SUMMARY:
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Total annual
responses
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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 0910–0471. Also include
the FDA docket number found in
brackets in the heading of this
document.
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
E:\FR\FM\12JNN1.SGM
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Federal Register / Vol. 88, No. 112 / Monday, June 12, 2023 / Notices
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
38063
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.
In the Federal Register of January 19,
2023 (88 FR 3417), FDA published a 60day notice requesting public comment
on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Adverse event reporting ................................................
1 There
Dated: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–12483 Filed 6–9–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–1889]
ddrumheller on DSK120RN23PROD with NOTICES1
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Premarket
Notification of Devices
Food and Drug Administration,
HHS.
ACTION:
300
Total annual
responses
18
Average burden
per response
5,400
Total hours
0.5 (30 minutes) ...
2,700
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
AGENCY:
Number of
responses per
respondent
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
SUMMARY:
VerDate Sep<11>2014
17:39 Jun 09, 2023
Jkt 259001
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(PRA).
DATES: Submit written comments
(including recommendations) on the
collection of information by July 12,
2023.
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 0910–0120. Also include
the FDA docket number found in
brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
collection of information to OMB for
review and clearance.
Premarket Notification of Devices
OMB Control Number 0910–0120—
Revision
This information collection helps
support implementation of statutory
provisions that govern premarket
clearance of devices. Section 510(k) of
the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360(k)) and
implementing regulations in part 807,
subpart E (21 CFR part 807, subpart E),
establish premarket notification
procedures. Persons who intend to
market a medical device, for which a
premarket approval application (PMA)
is not required, must submit a
premarket notification to FDA, unless
the device is exempt from 510(k)
requirements and does not exceed the
limitations of exemptions of the device
classification regulations, at least 90
days before proposing to begin the
introduction, or delivery for
introduction into interstate commerce,
for commercial distribution of a device
intended for human use. Based on the
information provided in the
notification, FDA must determine
whether the new device is substantially
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]]>Agencies
[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38062-38063]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-12483]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-0084]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 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 July 12, 2023.
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 0910-0471. Also include the FDA docket
number found in brackets in the heading of this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
[[Page 38063]]
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.
In the Federal Register of January 19, 2023 (88 FR 3417), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
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.
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: June 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12483 Filed 6-9-23; 8:45 am]
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