Emergency Health Surveys

ICR 200010-0910-006

OMB: 0910-0457

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
6148
Migrated
ICR Details
0910-0457 200010-0910-006
Historical Active
HHS/FDA
Emergency Health Surveys
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 02/05/2001
Retrieve Notice of Action (NOA) 10/31/2000
OMB approves FDA's use of Emergency Health Surveys for 1 year to enable FDA to quickly obtain targeted information on potential medical device problems. The information gathered will be based on purposeful samples and therefore can not be used for estimates of incidents. Instead, the information gathered should be used to trigger a more complete analysis of the problem, and a determination of the extent of a public health problem. As a condition of clearance, FDA will (1) submit a copy of the complete survey along with a justification describing the need for the survey, (2) provide a complete description of the statistical methods to be employed, including the respondent universe and sample selection method, the information collection procedures, and the expected response rate, (3) an estimate of the burden. OMB will review the survey and the accompanying justification in 10 working days or less. At the time of the next submission, FDA and OMB shall evaluate the process used under this generic clearance and determine how well it has worked and whether any changes are necessary.
  Inventory as of this Action Requested Previously Approved
03/31/2002 03/31/2002
2,000 0 0
4,000 0 0
0 0 0

This program will provide data when FDA must quickly determine whether or not a post-market problem with a medical device impacts the public health. The data collectrd will provide FDA with information to: alow a more complete analysis of the problem; determine the existence and extent of a public health problem; and then, if necessary, to disseminate the information to the health care community. All of these processes must be accomplished in a timeframe that limits further incidents causing injury to the public. While the form for data collection will be standardized, the targeted respondent........

None
None


No

1
IC Title Form No. Form Name
Emergency Health 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 2,000 0 0 2,000 0 0
Annual Time Burden (Hours) 4,000 0 0 4,000 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
10/31/2000


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