[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Pages 71620-71621]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28600]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
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.
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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.
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: 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
laboratories.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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No. of
Activity No. of responses per Total annual Average burden Total hours
respondents respondent responses per response
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MedSun facilities participating in the electronic reporting of 250 15 3,750 0.75 2,813
adverse events program (Form FDA 3670)............................
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\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]
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