Medical Devices; Exception from General Requirements for Informed Consent

Forms and Documents

Document Name	Status
Supporting statement informed consent Final rule 2011.doc Supporting Statement A	2011-06-13

IC Document Collections

IC ID	Document Title	Status
6309	Medical Devices; Exception from General Requirements for Informed Consent	Modified

ICR Details

OMB Control No: 0910-0586	ICR Reference No: 201106-0910-006
Status: Historical Active	Previous ICR Reference No: 201005-0910-014
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Exception from General Requirements for Informed Consent
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/05/2011
	Date Received in OIRA: 06/24/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2014	08/31/2013	08/31/2013
Responses	1,350	0	900
Time Burden (Hours)	1,463	0	1,350
Cost Burden (Dollars)	200	0	100

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Abstract: The information collections are associated with FDA's informed consent regulation, which provides an exception to the general requirement to obtain informed consent from the subject of an investigation involving an unapproved or not cleared in vitro diagnostic device intended to identify a chemical, biological, radiological, or nuclear agent. This regulation was issued under the statutory authority provided in section 520(g)(3)(D) of the Federal Food Drug and Cosmetic Act, which outlines the criteria under which an exemption from informed consent may be permissible.

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Authorizing Statute(s): Statute at Large: 21 Stat. 360 Name of Statute: null
  

Citations for New Statutory Requirements: US Code: 21 USC 360j Name of Law: Section 520

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AC25	Final or interim final rulemaking	76 FR 36989	06/24/2011

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Medical Devices; Exception from General Requirements for Informed Consent

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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	1,350	900	0	450	0	0
Annual Time Burden (Hours)	1,463	1,350	0	113	0	0
Annual Cost Burden (Dollars)	200	100	0	100	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: FDA is making one change to the interim final rule, in response to comments that the rule did not protect against misuse of this limited exception from informed consent requirements. In response to those concerns, FDA is adding one new requirement (amending the regulation) that investigators also send the documentation required in paragraph (e)(1) or (e)(2) to FDA, not just to the reviewing IRB. FDA has created this exception to help ensure that individuals who may have been exposed to a chemical, biological, radiological, or nuclear agent are able to benefit from the timely use of the most appropriate diagnostic devices, including those that are investigational. The final rule will add 150 respondents, 450 total annual responses, and 113 burden hours.

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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: 06/24/2011

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