FDA Rapid Response Surveys

ICR 200405-0910-002

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
6211
Migrated
ICR Details
0910-0500 200405-0910-002
Historical Active 200210-0910-007
HHS/FDA
FDA Rapid Response Surveys
Extension without change of a currently approved collection   No
Regular
Approved with change 09/01/2004
Retrieve Notice of Action (NOA) 05/10/2004
This generic clearance for FDA focus groups is approved for 18 months consistent with the FDA clarifications on 9/1/04 and under the following conditions: 1) FDA shall submit memos for individual surveys (e.g., statement of need for rapid response, intended use of information, description of respondents, information collection procedures, expected response rate, justification for incentive, estimated burden, survey instrument) 2) OMB will respond with clearance or questions within 10 working days 3) OMB and FDA will jointly evaluate the generic clearance upon resubmission in 18 months. Upon resubmission, FDA will provide a summary of each collection approved under the generic clearance (e.g., actual response rate, representativeness of data, use of information).
  Inventory as of this Action Requested Previously Approved
02/28/2006 02/28/2006 08/31/2004
6,000 0 30
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 30 0 5,970 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.
05/10/2004


© 2024 OMB.report | Privacy Policy