[Federal Register: June 14, 2004 (Volume 69, Number 113)]
[Notices]
[Page 33034-33035]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14jn04-88]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0017]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Event Pilot
Program for Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 July
14, 2004.
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. To ensure that comments on the information
collection are received, OMB recommends that comments be faxed to the
Office of Information and Regulatory Affairs, OMB, Attn: Fumie Yokota,
Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Peggy Robbins, Office of Management
Programs (HFA-250), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857,301-827-1223.
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 Pilot Program for Medical Devices--(OMB Control Number
0910-0471--Extension)
FDA is requesting approval from OMB for clearance to continue to
conduct a pilot project to evaluate aspects of a national reporting
system mandated by the Food and Drug Modernization Act (FDAMA) of 1997.
Under section 519(b) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 360i(b)), FDA is authorized to require manufacturers to
report medical device related deaths, serious injuries, and
malfunctions; user facilities (hospitals, nursing homes, ambulatory
surgical facilities and outpatient diagnostic and treatment facilities)
to report device-related deaths directly to FDA and to manufacturers,
and to report serious injuries to the
[[Page 33035]]
manufacturer. Section 213 of FDAMA amended section 519(b) of the act.
This amendment legislated the replacement of a 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.
FDA is the regulatory agency responsible for the safety and
effectiveness of medical products including medical devices and
radiological products. Important questions about medical devices, such
as those concerning user experience, durability, and rare effects may
not be answered until after the device has been marketed. To protect
the public health, FDA must be able to rapidly collect information
pertaining to adverse events associated with medical devices after they
have been marketed. This system is called the Medical Product
Surveillance Network (MedSun). 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.
Before writing a regulation to implement the large-scale national
MedSun reporting system, FDA has been conducting a pilot project to
ensure all aspects of the new system address the needs of both the
reporting facilities and FDA. This pilot project began with a small
sample (approximately 25) and was planned to increase to a larger
sample of approximately 250 facilities over a period of approximately 3
years. Data collection began in February 2002 and has been increasing
since that time. FDA has achieved its recruitment goals each year,
reaching 180 sites at the end of fiscal year (FY) 2003. FDA will reach
a total of 240 for FY 2004 and will reach the final goal of 250 by FY
2005. The program has proven to be very popular with sites as FDA has
gained a national reputation, with hospitals waiting in line to join.
However, FDA's current resources will not permit FDA to expand
beyond 250 sites at this time.
The pilot originally had the following three parts to the data
collection: (1) Collecting demographic profile information about the
participation facilities, (2) implementing an electronic version of the
portions of the MedWatch form (FDA Form No. 3500A, OMB control number
0910-0291) used to report adverse events occurring with medical
devices, and (3) adding additional voluntary questions to the data
collection. To date, these three features remain unchanged. However,
there has been an addition to the data collection that was approved by
OMB in the spring of 2004. Therefore, the fourth part of the collection
system is the Medical Device Engineering Network (M-DEN)--a place on
the MedSun software for the reporters to share information with each
other.
In the Federal Register of January 27, 2004 (69 FR 3922), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
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Annual Frequency per Total Annual
Data Type No. of Respondents Response Responses Hours per Response Total Hours
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MedSun\2\ 250 8 2,000 .75 1,500
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M-DEN\3\ 83 10 830 .50 415
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Total .................... .................... .................... .................... 1,915
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\1\ There are no capital costs or operating and maintenance costs associated with this collection.
\2\ MedSun means Medical Product Surveillance Network.
\3\ M-DEN means Medical Device Engineering Network.
Currently, FDA has 180 sites participating in MedSun pilot program,
but expects to have 250 sites over the next 2 years. The frequency of
response reflects what FDA has actually been receiving as the average
number of submissions in the MedSun Program. While six is the actual
average for submissions, FDA hopes to increase this number to eight
once their educational materials reach potential respondents. The time
estimated to respond is based on feedback FDA has received from current
MedSun reporters.
At this time, FDA estimates that one-third of the total number of
respondents will access M-DEN aspect of the MedSun software, or
approximately 83 persons per year. Each respondent is expected to post
5 problems and respond to 5 problems posted by other MedSun
participants for a total of 10 responses per year. It is expected that
each visit to the bulletin will not take longer than 30 minutes.
Dated: June 4, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-13211 Filed 6-10-04; 8:45 am]
BILLING CODE 4160-01-S