Emergency Medical Device Shortage Program

ICR 200203-0910-004

OMB: 0910-0491

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
6193
Migrated
ICR Details
0910-0491 200203-0910-004
Historical Active
HHS/FDA
Emergency Medical Device Shortage Program
New collection (Request for a new OMB Control Number)   No
Emergency 04/26/2002
Approved without change 04/29/2002
Retrieve Notice of Action (NOA) 03/29/2002
Approved for six months. Upon resubmission, FDA shall provide OMB with a list of devices covered by this collection (this list may be coded for security purposes and discussed with OMB) to allow for a more thorough assessment of the practical utility and the burden of this collection. If the burden of this collection increases over the next six months, FDA shall submit a revised icr sooner than the six month expiration.
  Inventory as of this Action Requested Previously Approved
10/31/2002 10/31/2002
7,000 0 0
700 0 0
0 0 0

The purpose of the telephone survey is to assist CDRH in implementing an emergency device shortage program so that the Agency can respond quickly to medical device shortages that might arise in the aftermath of a bioterroist attach. CDRH is compiling a ist of medical devices that would be needed to treat patients in the event of an attack using biological or chemical weapon. CDRH plans to collect manufacturing and inventory information concerning the devices on this list, starting with those devices that are considered critical to patient care. This information will......

None
None


No

1
IC Title Form No. Form Name
Emergency Medical Device Shortage Program

  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 7,000 0 0 7,000 0 0
Annual Time Burden (Hours) 700 0 0 700 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
03/29/2002


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