[Federal Register Volume 85, Number 94 (Thursday, May 14, 2020)]
[Notices]
[Pages 28954-28955]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-10353]


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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) 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 June 15, 2020.

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.

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. 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 the Medical Product Safety Network (MedSun).
    FDA is seeking OMB clearance to continue to use electronic data 
collection to obtain the information on Form FDA 3500A (approved under 
OMB control number 0910-0291) 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 September 20, 2019 (84 FR 49526), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment was received offering general 
support for the collection but offered no suggested changes to the 
burden estimate.
    We estimate 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  0.50 (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


[[Page 28955]]

    Our estimated burden for the information collection reflects an 
overall decrease of 113 hours despite a corresponding increase of 1,650 
responses. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years but a decrease in the 
amount of time spent entering data due to IT efficiencies that have 
been built into the MedSun reporting system to reduce data entry by 
user facilities.

    Dated: May 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-10353 Filed 5-13-20; 8:45 am]
BILLING CODE 4164-01-P