Document ID: FDA-2017-N-0084-0009
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)
Posted Date: 2023-06-12T04:00Z

[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]

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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 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\
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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]
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