Adverse Event Pilot Program for Medical Devices

ICR 201110-0910-009

OMB: 0910-0471

Federal Form Document

Forms and Documents
Document
Name
Status
Form
Modified
Justification for No Material/Nonsubstantive Change
2011-10-19
Supplementary Document
2011-03-25
IC Document Collections
IC ID
Document
Title
Status
37668 Modified
ICR Details
0910-0471 201110-0910-009
Historical Active 201012-0910-002
HHS/FDA
Adverse Event Pilot Program for Medical Devices
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 10/31/2011
Retrieve Notice of Action (NOA) 10/25/2011
  Inventory as of this Action Requested Previously Approved
05/31/2014 05/31/2014 05/31/2014
6,000 0 6,000
4,500 0 4,500
0 0 0

This is an electronic reporting system for hospitals to inform FDA of problems with the use of medical devices. This system involves not only reporting but sharing of information between the participants.

US Code: 21 USC 360 Name of Law: null
  
None

Not associated with rulemaking

No

1
IC Title Form No. Form Name
MedSun FDA Form 3670 Medsun Submission

  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 6,000 6,000 0 0 0 0
Annual Time Burden (Hours) 4,500 4,500 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$5,100,000
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 [email protected]

  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.
10/25/2011


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