[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Pages 71620-71621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28600]



Food and Drug Administration

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

Agency Information Collection Activities; Proposed Collection; 
Comment Request; Adverse Event Program for Medical Products

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies are required to publish notice in the 
Federal Register concerning each proposed collection of information, 
including each proposed extension of an existing collection of 
information, and to allow 60 days for public comment in response to the 
notice. This notice solicits comments on the collection of information 
regarding the Adverse Event Program for medical devices.

DATES: Submit either electronic or written comments on the collection 
of information by January 28, 2014.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852. All comments should be identified with the docket 
number found in brackets in the heading of this document.

Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
Agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes Agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal Agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information set forth in this document.
    With respect to the following collection of information, FDA 
invites comments on these topics: (1) Whether the proposed collection 
of information is necessary for the proper performance of FDA's 
functions, including whether the information will have practical 
utility; (2) the accuracy of FDA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and

[[Page 71621]]

assumptions used; (3) ways to enhance the quality, utility, and clarity 
of the information to be collected; and (4) ways to minimize the burden 
of the collection of information on respondents, including through the 
use of automated collection techniques, when appropriate, and other 
forms of information technology.

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 
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                           No. of
                              Activity                                    No. of       responses  per   Total  annual   Average  burden    Total hours
                                                                       respondents       respondent       responses      per  response
MedSun facilities participating in the electronic reporting of                  250               15            3,750             0.75            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: November 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28600 Filed 11-27-13; 8:45 am]