[Federal Register: July 9, 2010 (Volume 75, Number 131)]


[Page 39535-39537]

From the Federal Register Online via GPO Access []




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.


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

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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 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.


Information Management, Food and Drug Administration, 1350 Piccard Dr.,

PI50-400B, Rockville, MD 20850, 301-796-5156,

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


FDA estimates the burden of this collection of information as


Table 1.--Estimated Annual Reporting Burden\1\


Annual Frequency Total Annual Hours per

Activity No. of Respondents per Response Responses Response Total


Facilities participating in the electronic 400 15 6,000 .75 4,500

reporting of adverse events programs


Facilities responding to emerging signal questions 300 10 3,000 .50 1,500

(not used by all sites)


Total .................. .................... .................. .................. 6,000


\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

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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]