Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable

ICR 200601-0910-001

OMB: 0910-0582

Federal Form Document

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Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0582 200601-0910-001
Historical Active
HHS/FDA
Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable
New collection (Request for a new OMB Control Number)   No
Emergency 01/24/2006
Approved with change 03/13/2006
Retrieve Notice of Action (NOA) 01/06/2006
  Inventory as of this Action Requested Previously Approved
09/30/2006 09/30/2006
600 0 0
2,400 0 0
0 0 0

The FDA is developing a guidance document that will inform sponsors, institutional review boards (IRBs), clinical investigators, and agency staff that the FDA intends to exercise enforcement discretion, under certain circumstances, with respect to its informed consent regulations for in vitro diagnostic device studies that are conducted using leftover specimens. This guidance responds to an immediate need of the research community. Sponsors that follow this guidance should maintain written documentation demonstrating that they meet the circumstances outlined in the guidance.

None
None


No

  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 600 0 0 600 0 0
Annual Time Burden (Hours) 2,400 0 0 2,400 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
01/06/2006


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