Document ID: FDA-2010-N-0316-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Adverse Event Pilot Program for Medical Products
Posted Date: 2010-12-07T05:00Z

[Federal Register Volume 75, Number 234 (Tuesday, December 7, 2010)]
[Notices]
[Pages 76010-76011]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-30583]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0316]

Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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 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 January 
6, 2011.

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: 202-395-7285, or e-mailed to oira_submission@omb.eop.gov. 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: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
Daniel.Gittleson@fda.hhs.gov.

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--(OMB Control Number 
0910-0471)--Extension

    Under section 519 of the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act) (21 U.S.C. 360i), 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 FD&C 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 FD&C 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 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 is proposing to collect additional information from 
participating sites about reported problems emerging from the MedSun 
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.
    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.
    In the Federal Register of July 9, 2010 (75 FR 39535), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

[[Page 76011]]

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                      Annual
              Item                   Nunber of     frequency per   Total annual      Hours per      Total hours
                                    respondents      response        responses       response
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MedSun facilities participating              400              15           6,000            0.75           4,500
 in the electronic reporting of
 adverse events program.........
MedSun facilities' electronic                400              10           4,000             0.5           2,000
 responses to Public Health
 Questions (PHQs)...............
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    Total hours.................  ..............  ..............  ..............  ..............           6,500
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: December 1, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-30583 Filed 12-6-10; 8:45 am]
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