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

ICR 200905-0910-001

OMB: 0910-0491

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2009-04-16
ICR Details
0910-0491 200905-0910-001
Historical Active 200603-0910-007
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 08/10/2009
Retrieve Notice of Action (NOA) 05/11/2009
  Inventory as of this Action Requested Previously Approved
08/31/2012 36 Months From Approved 08/31/2009
375 0 195
188 0 98
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.

US Code: 21 USC 393(d)(2) Name of Law: Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  73 FR 77718 12/19/2008
74 FR 21688 05/08/2009
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 375 195 0 0 180 0
Annual Time Burden (Hours) 188 98 0 0 90 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$76,562
No
No
Uncollected
Uncollected
No
Uncollected
Denver Presley 3018271462

  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.
05/11/2009


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