Emergency Shortages Data Collection System (formerly Emergency Medical Device Shortage Program Survey)

ICR 200603-0910-007

OMB: 0910-0491

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0491 200603-0910-007
Historical Active 200303-0910-005
HHS/FDA
Emergency Shortages Data Collection System (formerly Emergency Medical Device Shortage Program Survey)
Extension without change of a currently approved collection   No
Regular
Approved without change 05/12/2006
Retrieve Notice of Action (NOA) 03/22/2006
  Inventory as of this Action Requested Previously Approved
05/31/2009 05/31/2009 05/31/2006
195 0 250
98 0 125
0 0 0

FDA will maintain a medical device database which allows FDA to identify locations and manufacturers of hard to locate medical devices in the event of future terrorist incidents. This survey will primarily be conducted through email correspondence every 4 months.

None
None


No

1
IC Title Form No. Form Name
Emergency Shortages Data Collection System (formerly Emergency Medical Device Shortage Program Survey)

  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 195 250 0 0 -55 0
Annual Time Burden (Hours) 98 125 0 0 -27 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
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.
03/22/2006


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