PERFORMANCE STANDARDS DEVELOPMENT

ICR 198506-0910-002

OMB: 0910-0072

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
109566
Migrated
ICR Details
0910-0072 198506-0910-002
Historical Active 198404-0910-003
HHS/FDA
PERFORMANCE STANDARDS DEVELOPMENT
Extension without change of a currently approved collection   No
Regular
Approved without change 08/08/1985
Retrieve Notice of Action (NOA) 06/04/1985
  Inventory as of this Action Requested Previously Approved
08/31/1988 08/31/1988 06/30/1985
40 0 40
1,920 0 1,920
0 0 0

THE FDA IS AUTHORIZED UNDER SECTION 514 OF THE FD&C ACT TO DEVELOP AND/OR ESTABLISH PERFORMANCE STANDARDS FOR MEDICAL DEVICES. THE RECEI AND EVALUATION OF THIS INFORMATION PERMITS FDA TO ENSURE THAT THE PROPOSED STANDARD PROVIDES REASONABLE ASSURANCE OF THE SAFETY EFFECTIVENESS OF THE DEVICE. ONE LABELING REQUIREMENT PREVIOUSLY CLEARED UNDER 0910-0195 IS ALSO INCLUDED.

None
None


No

1
IC Title Form No. Form Name
PERFORMANCE STANDARDS DEVELOPMENT

  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 40 40 0 0 0 0
Annual Time Burden (Hours) 1,920 1,920 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.
06/04/1985


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