PROTECTION OF HUMAN SUBJECTS -- CERTIFICATION AND RECORDKEEPING REQUIREMENTS

ICR 198708-0925-003

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 198708-0925-003
Historical Active 198708-0925-002
HHS/NIH
PROTECTION OF HUMAN SUBJECTS -- CERTIFICATION AND RECORDKEEPING REQUIREMENTS
No material or nonsubstantive change to a currently approved collection   No
Emergency 08/21/1987
Approved with change 08/21/1987
Retrieve Notice of Action (NOA) 08/21/1987
  Inventory as of this Action Requested Previously Approved
12/31/1987 12/31/1987 12/31/1987
250 0 250
12,803 0 15,022
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 250 250 0 0 0 0
Annual Time Burden (Hours) 12,803 15,022 0 0 -2,219 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.
08/21/1987


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