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

ICR 201604-0910-001

OMB: 0910-0582

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2016-04-13
Supporting Statement A
2016-04-04
ICR Details
0910-0582 201604-0910-001
Historical Active 201302-0910-004
HHS/FDA CDRH
Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable
Extension without change of a currently approved collection   No
Regular
Approved without change 08/01/2016
Retrieve Notice of Action (NOA) 04/15/2016
  Inventory as of this Action Requested Previously Approved
08/31/2019 36 Months From Approved 07/31/2016
700 0 700
2,800 0 2,800
0 0 0

The FDA has developed 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 under 21 CFR 812.2 (c) (3), 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.

US Code: 21 USC 360j Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

Not associated with rulemaking

  80 FR 64422 10/23/2015
81 FR 21558 04/12/2016
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 700 700 0 0 0 0
Annual Time Burden (Hours) 2,800 2,800 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$0
No
No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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.
04/15/2016


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