Emergency Shortages Data Collection System

ICR 201506-0910-018

OMB: 0910-0491

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement B
2015-06-16
Supporting Statement A
2015-06-16
ICR Details
0910-0491 201506-0910-018
Historical Inactive 201206-0910-005
HHS/FDA CDRH
Emergency Shortages Data Collection System
Extension without change of a currently approved collection   No
Regular
Withdrawn and continue 08/13/2015
Retrieve Notice of Action (NOA) 07/01/2015
  Inventory as of this Action Requested Previously Approved
08/31/2015 36 Months From Approved 08/31/2015
375 0 375
188 0 188
0 0 0

FDA maintains a medical device database which allows FDA to identify locations and manufacturers of hard to locate medical devices in the context of a Federally-declared disaster/emergency, an official emergency preparedness exercise, or a potential public health risk posed by non-disaster-related device shortage. Because of the dynamic nature of the medical device industry, particularly with respect to specific product lines, manufacturing capabilities and raw material/subcomponent sourcing, it is necessary to update the data in the Emergency Shortages Data Collection System at regular intervals, but efforts are made to limit the frequency of outreach to a specific manufacturer to no more than every 4 months. The Emergency Shortages Data Collection System will only include those medical devices for which there will likely be high demand during a specific emergency/disaster, or for which there are sufficiently small numbers of manufacturers such that disruption of manufacture, or loss of one or more of these manufacturers would create a shortage.

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

Not associated with rulemaking

  80 FR 14138 03/18/2015
80 FR 36824 06/26/2015
No

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

No
No

$79,273
Yes Part B of Supporting Statement
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 [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.
07/01/2015


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