HUMAN FACTORS REGARDING THE USE OF GLUCOSE MONITORING EQUIPMENT

ICR 198906-0910-029

OMB: 0910-0247

Federal Form Document

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ICR Details
0910-0247 198906-0910-029
Historical Active 198904-0910-011
HHS/FDA
HUMAN FACTORS REGARDING THE USE OF GLUCOSE MONITORING EQUIPMENT
No material or nonsubstantive change to a currently approved collection   No
Emergency 06/27/1989
Approved with change 06/27/1989
Retrieve Notice of Action (NOA) 06/27/1989
  Inventory as of this Action Requested Previously Approved
07/31/1989 07/31/1989 07/31/1989
2,406 0 2,406
707 0 707
0 0 0

FDA NEEDS INFORMATION REGARDING DIABETIC AND EDUCATIONAL USER OPERATION OF PORTABLE, ELECTRONIC BLOOD GLUCOSE METERS. MEDICAL DEVICE REPORTING SYSTEM SUGGESTS PROBLEMS IN OPERATION OF EQUIPMENT ATTRIBUTABLE TO INADEQUACIES IN DESIGN, INSUFFICIENT TRAINING, OR USER INABILITY. THI STUDY IS CRITICAL TO ASSESSING PROBLEM AREAS AND MAKING RECOMMENDATION FOR IMPROVED PROCEDURES AND NEW EQUIPMENT DESIGN.

None
None


No

1
IC Title Form No. Form Name
HUMAN FACTORS REGARDING THE USE OF GLUCOSE MONITORING EQUIPMENT

  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 2,406 2,406 0 0 0 0
Annual Time Burden (Hours) 707 707 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
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.
06/27/1989


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