[Federal Register Volume 79, Number 71 (Monday, April 14, 2014)]
[Notices]
[Pages 20887-20888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-08212]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1439]


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) 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 May 14, 
2014.

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 [email protected]. 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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)--(OMB Control Number 0910-0471)--Extension

    Among other things, 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 currently 
includes 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 currently 
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 November 29, 2013 (78 FR 71620), 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:

[[Page 20888]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Number of
                            Activity                                Number of     responses per   Total annual     Average burden  per      Total hours
                                                                   respondents     respondent       responses            response
--------------------------------------------------------------------------------------------------------------------------------------------------------
MedSun facilities participating in the electronic reporting of              250              15           3,750        0.75 (45 minutes)           2,813
 adverse events program (Form FDA 3670)........................
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.


    Dated: April 7, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-08212 Filed 4-11-14; 8:45 am]
BILLING CODE 4160-01-P