Adverse Event Pilot Program for Medical Devices

ICR 200406-0910-004

OMB: 0910-0471

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
IC ID
Document
Title
Status
6169
Migrated
ICR Details
0910-0471 200406-0910-004
Historical Active 200403-0910-005
HHS/FDA
Adverse Event Pilot Program for Medical Devices
Extension without change of a currently approved collection   No
Regular
Approved with change 09/03/2004
Retrieve Notice of Action (NOA) 06/24/2004
This collection is approved as amended by FDA's revisions of 9/2/04 on the following conditions: If FDA determines that modifications to the collection are necessary during the course of the pilot (e.g., expansion of the number of respondents, questions asked), FDA shall request OMB approval of the changes through a memorandum explaining the need for such changes prior to initiating a revised collection. Once approved, OMB will amend the file accordingly. FDA should also send OMB an update on the progress of the pilot prior to the development of the regulation.
  Inventory as of this Action Requested Previously Approved
09/30/2007 09/30/2007 09/30/2004
3,960 0 2,045
2,680 0 1,334
0 0 0

This pilot includes: continuing to implement an electronic version of the portions of the 3500A form used by user facilities to report adverse events occurring with medical devices (which includes past approved additional voluntary questions); and continuing to implement a sharing of device problems between the reporting sites with the opportunity to provide solutions. Participation in this pilot is voluntary. During the first three years of the program 180 facilities were enrolled. It is anticipated that the number of voluntary participants will increase to approximately..

None
None


No

1
IC Title Form No. Form Name
Adverse Event Pilot Program for Medical Devices

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 3,960 2,045 0 1,915 0 0
Annual Time Burden (Hours) 2,680 1,334 0 1,346 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
No

$0
Yes Part B of Supporting Statement
No
Uncollected
Uncollected
Uncollected
Uncollected

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
06/24/2004


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