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

Forms and Documents

Document Name	Status
0582 guidance.pdf Supplementary Document	2016-04-13
0582_Supporting Statement.doc Supporting Statement A	2016-04-04

IC Document Collections

IC ID	Document Title	Status
6305	Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable	Modified

ICR Details

OMB Control No: 0910-0582	ICR Reference No: 201604-0910-001
Status: Historical Active	Previous ICR Reference No: 201302-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDRH
Title: Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/01/2016
	Date Received in OIRA: 04/15/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2019	36 Months From Approved	07/31/2016
Responses	700	0	700
Time Burden (Hours)	2,800	0	2,800
Cost Burden (Dollars)	0	0	0

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Abstract: 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.

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Authorizing Statute(s): US Code: 21 USC 360j Name of Law: Federal Food, Drug, and Cosmetic Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 64422	10/23/2015
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 21558	04/12/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Guidance on Informed Consent for in Vitro Diagnostic Studies Using Leftover Human Specimens that are not Individually Identifiable

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $0

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/15/2016

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