PERFORMANCE STANDARDS DEVELOPMENT

ICR 198806-0910-002

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
109567
Migrated
ICR Details
0910-0072 198806-0910-002
Historical Active 198506-0910-002
HHS/FDA
PERFORMANCE STANDARDS DEVELOPMENT
Revision of a currently approved collection   No
Regular
Approved without change 08/18/1988
Retrieve Notice of Action (NOA) 06/23/1988
  Inventory as of this Action Requested Previously Approved
08/31/1991 08/31/1991 08/31/1988
9 0 40
440 0 1,920
0 0 0

THE FDA IS AUTHORIZED UNDER SECTION 5 OF THE FD&C ACT TO DEVELOP AND/OR ESTABLISH PERFORMANCE STANDARDS FOR MEDICAL DEVICES. THE RECEIPT AND EVALUATION OF THIS INFORMATION PERMI FDS TO ENSURE THAT THE PROPOSED STANDARD PROVIDES REASONABLE ASSURANCE OF THE SAFETY AND EFFECTIVENESS OF THE DEVICE.

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 9 40 0 -31 0 0
Annual Time Burden (Hours) 440 1,920 0 -1,480 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes

$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.
06/23/1988


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