Notice2023-12483
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 12, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 88 Issue 112 (Monday, June 12, 2023)</title>
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[Federal Register Volume 88, Number 112 (Monday, June 12, 2023)]
[Notices]
[Pages 38062-38063]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-12483]
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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.
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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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#144446554760757272547270753a7c7c673a737b62"><span class="__cf_email__" data-cfemail="613133203215000707210705004f0909124f060e17">[email protected]</span></a>.
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\
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Number of
Activity Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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Adverse event reporting....................... 300 18 5,400 0.5 (30 minutes)........................ 2,700
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\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]
BILLING CODE 4164-01-P
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