Document ID: FDA-2017-N-0084-0002
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: 2017-05-26T04:00Z

[Federal Register Volume 82, Number 101 (Friday, May 26, 2017)]
[Notices]
[Page 24356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-10844]

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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: Fax written comments on the collection of information by June 
26, 2017.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All 
comments should be identified with the OMB control number 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, 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
PRAStaff@fda.hhs.gov.

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

    Under section 519 of the Federal Food, Drug, and Cosmetic Act (the 
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 250 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 Web site 
as the report information.
    The burden estimate is based on the number of facilities 
participating in MedSun (250). FDA estimates an average of 15 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, 2017 (82 FR 6566), 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     Total hours
                                  respondents     respondent       responses      per response
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Adverse event reporting.......             250              15           3,750  .75 (45 minutes)           2,813
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: May 22, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-10844 Filed 5-25-17; 8:45 am]
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