[Federal Register Volume 72, Number 172 (Thursday, September 6, 2007)]
[Notices]
[Pages 51231-51232]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-17562]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2007N-0218]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 October 
9, 2007.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
FAX: 202-395-6974, or e-mailed to [email protected]. All comments 
should be identified with the OMB control number 0910-0471. Also 
include the FDA 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, 301-827-1427.

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 Products--21 U.S.C. 360(i) (OMB 
Control Number 0910-0471)--Extension

    Under section 519 of the 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. 360 i(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 the Medical Product 
Safety Network (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 the Device-
Safety Exchange (DS-X).

[[Page 51232]]

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.
    In the Federal Register of June 13, 2007 (72 FR 32670), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. In response to that notice, 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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                         No. of        Annual Frequency     Total Annual        Hours per
  Section of Act      Respondents        per Response        Responses           Response         Total Hours
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519(b) Facilities                400                 15              6,000                .75              4,500
 participating in
 the electronic
 reporting of
 adverse event
 programs.
----------------------------------------------------------------------------------------------------------------
Section 519 (b)                  200                  5              1,000                .50                500
 Facilities
 participating in
 DS-X ( not used
 by all sites)
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Total              .................  .................  .................  .................              5,000
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    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 seven reports annually. For purposes of the renewal for this data 
collection, we are estimating an average of 15 reports per site 
annually. This increase is expected because 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. Thus, the total annual responses is calculated to be 
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 on-line form. Using the high end of that time frame, the 
total burden estimate for facilities participating in the electronic 
reporting of adverse event programs, is estimated to be 4,500 hours 
(6,000 report entries x .75 hours = 4,500 hours).
    Determination of burden estimate for the DS-X portion of MedSun: 
All sites do not use this part of the software. To determine the total 
annual responses for DS-X, 200 participants are multiplied by the 
number of times each will access DS-X. Thus the total annual responses 
are calculated to be 1,000 reports (200 x 5 = 1,000). It typically 
takes an average of 30 minutes to enter data into the 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 entry 
(30 minutes). Thus the total burden estimate for DS-X is calculated to 
be 500 hours (1,000 x 0.5 = 500). Therefore, the combined total burden 
estimate for MedSun and DS-X is calculated to be 5,000 hours (4,500 + 
500 = 5,000).

    Dated: August 29, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-17562 Filed 9-5-07; 8:45 am]
BILLING CODE 4160-01-S