FDA Rapid Response Surveys

ICR 200509-0910-009

OMB: 0910-0500

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
37674
Migrated
ICR Details
0910-0500 200509-0910-009
Historical Active 200405-0910-002
HHS/FDA
FDA Rapid Response Surveys
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 09/28/2005
Retrieve Notice of Action (NOA) 09/28/2005
  Inventory as of this Action Requested Previously Approved
02/28/2006 02/28/2006 02/28/2006
6,000 0 6,000
3,000 0 3,000
0 0 0

This program will obtain data on safety information to support quick-turnaround decision-making about potential safety problems or risk management solutions. This information will be collected from health professionals, hospitals, and other user facilities (e.g., nursing homes, ambulatory surgical facilities and outpatient diagnostic and treatment facilities, etc.), consumers, sponsors and manufacturers of biologics, drugs and medical products, distributors, and importers when FDA must quickly determine whether or not a problem with a medical products impacts the public health.

None
None


No

1
IC Title Form No. Form Name
FDA Rapid Response Surveys

  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) 3,000 3,000 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
Yes Part B of Supporting Statement
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.
09/28/2005


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