PROTECTION OF HUMAN SUBJECTS -- CERTIFICATION AND RECORDKEEPING REQUIREMENTS

ICR 198608-0925-003

OMB: 0925-0137

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0925-0137 198608-0925-003
Historical Active 198302-0925-001
HHS/NIH
PROTECTION OF HUMAN SUBJECTS -- CERTIFICATION AND RECORDKEEPING REQUIREMENTS
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 11/03/1986
Retrieve Notice of Action (NOA) 08/08/1986
NO ANNUAL REPORTING REQUIREMENTS ARE APPROVED FOR USE UNDER THIS OMB NUMBER.
  Inventory as of this Action Requested Previously Approved
12/31/1987 12/31/1987
250 0 0
15,022 0 0
0 0 0

THE PUBLIC HEALTH SERVICE ACT MANDATES THAT INSTITUTIONS RECEIVING SUPPORT FOR RESEARCH INVOLVIN HUMAN SUBJECTS REPORT TO THE SECRETARY, IRB REVIEW OF THAT RESEARCH IN ACCORDANCE WITH 45 CFR 46. RECORDS ARE MINUTES OF THE REVIEW.

None
None


No

1
IC Title Form No. Form Name
PROTECTION OF HUMAN SUBJECTS -- CERTIFICATION AND RECORDKEEPING REQUIREMENTS HHS-596

  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 250 0 0 0 250 0
Annual Time Burden (Hours) 15,022 0 0 0 15,022 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.
08/08/1986


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