[Federal Register: June 13, 2007 (Volume 72, Number 113)]
[Notices]
[Page 32670-32672]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13jn07-93]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007N-0218]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Adverse Event Pilot Program for Medical Products
(Formally Medical Device Adverse Event Reporting Program)
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 continuing 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 Device Safety Network
(MedSun). Additionally, the electronic form will include hospital
profile information and several other questions
[[Page 32671]]
related to the use of medical products. A portion of the MedSun
software, called Device-Safety Exchange (DS-X) (formerly called M-Den),
is a moderated site where MedSun members may share information with
each other.
DATES: Submit written comments on the collection of information by
August 13, 2007.
ADDRESSES: Submit electronic comments on the collection of information
to: http://www.fda.gov/dockets/ecomments. Submit written comments on
the collection of information to the Dockets Management Branch (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: Denver Presley, Jr., Office of the
Chief Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-1472.
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 continuing
collection of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on: (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 (21 U.S.C. 360i(b)) 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 a few additional questions which will permit
FDA to better understand the cause of the reported adverse event.
During the pilot program, participants will be asked to complete an
annual outcome measures form to aid FDA in evaluating the effectiveness
of the program. Participation in this pilot is voluntary and currently
includes 400 facilities and over 100 beds. 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.
The paper form takes approximately 1 hour to complete and the
electronic version takes approximately 45 minutes, or less, to
complete. Much of the data which must be filled in by hand on the paper
system is automatically filled in by the electronic version.
In addition to collecting data on the electronic adverse event
report form, MedSun also collects data electronically in DS-X. This
data collection is also voluntary, and is an FDA moderated site. MedSun
sites may send in ``success stories'' describing quality improvement
initiatives they have implemented to improve patient safety with
medical products and also may send in medical product related questions
to which other sites may respond. The maximum time it takes to enter a
story or write or respond to a question is 30 minutes.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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No. of Annual Frequency Total Annual Hours per
Section of the Act Respondents per Response Responses Response Total Hours
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519(b) Facilities participating in the electronic 400 15 6,000 .75 4,500
reporting of adverse events program
519 (b) Facilities participating in DS-X (not used by 200 5 1,000 .50 500
all sites)
Total 5,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 32672]]
The burden estimate for the electronic reporting of adverse events
is based on the number of facilities currently participating in MedSun
(400) and the number of sites (50) expected to be added to the program
over the next 3 years. The current average number of reports per site
is 7 reports annually. For purposes of this renewed data collection, we
are estimating an average of 15 reports per site annually. This
increase is expected since MedSun is 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.
Therefore, this yields a total annual responses of 6,000 (400
facilities x 15 data entries = 6,000.) The participating MedSun
reporters tell FDA that it typically takes 20 to 45 minutes to fill out
the online form. Using the high end of that timeframe, the overall
annual burden hours will be 4,500 hours (6,000 report entries x 0.75
hours = 4,500 hours).
Determining burden for the DS-X portion of MedSun: Not all sites
use this part of the software. To determine the total annual responses
for DS-X: 200 participants multiplied by the number of times each will
access DS-X yields annual responses of 1,000 reports.
It typically takes an average of 30 minutes to enter data into DS-
X, given that there are various types of data entries which are
possible, some of which are lengthier than others. The number of burden
hours for DS-X is determined by multiplying the expected 1,000 times
the site will be accessed by the average amount of time it takes to
make a DS-X data entry (30 minutes). This equals a burden of 500 hours
(1,000 x 0.50 = 500).
The total burden hours for MedSun and DS-X data entry equals 8,000
hours (7,500 for MedSun and 500 for DS-X).
Dated: June 7, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-11400 Filed 6-12-07; 8:45 am]
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