[Federal Register Volume 75, Number 131 (Friday, July 9, 2010)]
[Notices]
[Pages 39535-39537]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-16807]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-N-0316]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Event Pilot 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 continuation of a pilot
project to evaluate the electronic collection of the 3500A Form for
adverse events related to the use of medical products to obtain data
from user facilities participating in the Medical Product Safety
Network (MedSun). Additionally, the electronic form will include
hospital profile information and several other questions related to the
use of medical products. It will no longer contain the page called
Device-Safety Exchange (DS-X) (formerly called M-Den), which was a
moderated site where MedSun members shared information with each other.
This will be replaced by a page where questions about possible emerging
[[Page 39536]]
signals will be asked of the MedSun sites.
DATES: Submit either electronic or written comments on the collection
of information by September 7, 2010.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[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 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 Pilot Program for Medical Products--21 U.S.C. 360(i) (OMB
Control Number 0910-0471)--Extension
Under section 519 of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360(i)), FDA is authorized to require: Manufacturers to
report medical device related deaths, serious injuries, and
malfunctions; and user facilities to report device-related deaths
directly to manufacturers and FDA, and to report serious injuries to
the manufacturer. Section 213 of the FDA Modernization Act of 1997
(FDAMA), amended section 519(b) of the act relating to mandatory
reporting by user facilities of deaths and 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 act. The current universal reporting system
remains in place during the pilot stages of the new program, and until
FDA implements the new national system by regulation. 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 MedSun.
FDA is continuing to conduct a pilot of the MedSun system before
the agency issues a regulation to change from universal mandatory
reporting for medical device user facilities to reporting by a
representative sample of facilities. This data collection has been
ongoing since February 20, 2002, and this notice is for continuation of
this data collection.
FDA is seeking OMB clearance to continue to use electronic data
collection to obtain the information on the 3500A Form related to
medical devices and tissue products from the user facilities
participating in MedSun, to obtain a demographic profile of the
facilities, and to pilot additional questions which will permit FDA to
better understand the cause of reported adverse events. During the
pilot program, participants will be asked to complete an annual outcome
measures form, as a Customer/Partner Service Survey (approved under OMB
control number 0910-0360) to aid FDA in evaluating the effectiveness of
the program. Participation in this pilot is voluntary and currently
includes 400 facilities. The use of an interactive electronic data
collection system is easier and more efficient for the participating
user facilities to use than the alternative paper system.
In addition to collecting data on the electronic adverse event
report form, MedSun also is proposing to collect additional information
from participating sites about reported problems emerging from the
MedSun Network hospitals. This data collection is also voluntary, and
will be collected on the same Web site as the report information. This
will replace the Device-Safety Exchange (DS-X). The burden to respond
to these questions will take the same time as that used for DS-X, 30
minutes.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency Total Annual Hours per
Activity No. of Respondents per Response Responses Response Total
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Facilities participating in the electronic 400 15 6,000 .75 4,500
reporting of adverse events programs
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Facilities responding to emerging signal questions 300 10 3,000 .50 1,500
(not used by all sites)
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Total .................. .................... .................. .................. 6,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 39537]]
The total burden hours for MedSun and emerging signal questions
equals 6,000 hours (4,500 for MedSun and 1,500 for emerging signals).
The burden estimate for the electronic reporting of adverse events
is based on the number of facilities currently participating in MedSun
(400). 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,
electrophysiology laboratories, and the hospital laboratories.
The burden estimate for the emerging signal portion of MedSun is
based on the assumption that not all sites will use this part of the
software each time questions are asked, because not all sites will use
the device in question.
Dated: July 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-16807 Filed 7-8-10; 8:45 am]
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