INFORMED CONSENT: DISCLOSURE REQUIREMENTS

ICR 198402-0925-003

OMB: 0925-0228

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
111495
Migrated
ICR Details
0925-0228 198402-0925-003
Historical Active
HHS/NIH
INFORMED CONSENT: DISCLOSURE REQUIREMENTS
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 04/13/1984
Retrieve Notice of Action (NOA) 02/14/1984
  Inventory as of this Action Requested Previously Approved
04/30/1985 04/30/1985
100,000 0 0
25,000 0 0
0 0 0

THE REGULATIONS GOVERNING USE OF HUMAN SUBJECTS IN RESEARCH (45 CFR 46 REQUIRE THAT SOME BUT NOT ALL SUCH RESEARCH MUST BE PRECEDED BY DISCLOSURE OF INFORMATION TO ENABLE SUBJECTS TO CONSIDER WHETHER OR NOT TO PARTICIPATE, IN SOME INSTANCES CONSENT MUST BE DOCUMENTED.

None
None


No

1
IC Title Form No. Form Name
INFORMED CONSENT: DISCLOSURE REQUIREMENTS

  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 100,000 0 0 0 100,000 0
Annual Time Burden (Hours) 25,000 0 0 0 25,000 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.
02/14/1984


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