Document ID: FDA-2010-N-0316-0001
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals: Adverse Event Pilot Program for Medical Products
Posted Date: 2010-07-09T04:00Z

[Federal Register: July 9, 2010 (Volume 75, Number 131)]
[Notices]               
[Page 39535-39537]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09jy10-44]                         

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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, 
Daniel.Gittleson@fda.hhs.gov.

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]
BILLING CODE 4160-01-S