Medical Devices; Exception from General Requirements for Informed Consent

Forms and Documents

Document Name	Status
0910-0586 final SS.doc Supporting Statement A	2010-08-16

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: 201005-0910-014
Status: Historical Active	Previous ICR Reference No: 200702-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Devices; Exception from General Requirements for Informed Consent
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: 08/29/2010
	Date Received in OIRA: 05/27/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2013	36 Months From Approved	08/31/2010
Responses	900	0	900
Time Burden (Hours)	1,350	0	1,350
Cost Burden (Dollars)	100	0	0

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Abstract: FDA is requiring this information disclosure in order to assure that exceptions to the informed consent requirement occur only in cases in which the investigator may not obtain informed consent in sufficient time to protect the health of the subject.

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

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AC25	Final or interim final rulemaking	71 FR 32827	06/07/2006

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 7278	02/18/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	75 FR 24960	05/06/2010
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
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	900	900	0	0	0	0
Annual Time Burden (Hours)	1,350	1,350	0	0	0	0
Annual Cost Burden (Dollars)	100	0	0	0	100	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]? Uncollected

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: 05/27/2010

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