HUMAN FACTORS REGARDING THE USE OF GLUCOSE MONITORING EQUIPMENT

ICR 198805-0910-006

OMB: 0910-0247

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0247 198805-0910-006
Historical Active
HHS/FDA
HUMAN FACTORS REGARDING THE USE OF GLUCOSE MONITORING EQUIPMENT
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 08/25/1988
Retrieve Notice of Action (NOA) 05/31/1988
This study is being approved with the understanding that FDA intends to use this information to ensure the safe and effective use of glucose monitors and not as a basis for intervening in the practice of medicine.
  Inventory as of this Action Requested Previously Approved
07/31/1989 07/31/1989
2,406 0 0
707 0 0
0 0 0

FDA NEEDS INFORMATION REGARDING DIABETIC AND EDUCATIONAL USER OPERATION OF PORTABLE, ELECTONIC 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 0 0 2,406 0 0
Annual Time Burden (Hours) 707 0 0 707 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.
05/31/1988


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