Medical Device Decision Analysis: A Risk-Tolerance Pilot Study

Forms and Documents

Document Name	Status
Patient Risk Tolerance Survey for Weight-Reduction Devices--Supporting Statement B--8-28-12.doc Supporting Statement B	2012-08-29
Attachment F--Patient Risk Tolerance Survey for Obesity Devices--Pretest Report.pdf Supplementary Document	2012-06-20
Attachment E--IRB Approval.pdf Supplementary Document	2012-06-20
Attachment D--KN Privacy Policy.doc Supplementary Document	2012-06-20
FDA Obesity - Survey Screen Shots Final.pdf Supplementary Document	2012-06-21
Patient Risk Tolerance Survey for Weight-Reduction Devices Supporting Statement Part A.doc Supporting Statement A	2012-06-20

IC Document Collections

IC ID	Document Title	Status
203027	Full Survey Other-Obesity Survey	New
203026	Consent Form Other-Consent Form	New
203025	Survey Invitation Other-Email Invitation	New

ICR Details

OMB Control No: 0910-0722	ICR Reference No: 201207-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Medical Device Decision Analysis: A Risk-Tolerance Pilot Study
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 08/31/2012
	Date Received in OIRA: 07/05/2012
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2014	18 Months From Approved
Responses	2,150	0	0
Time Burden (Hours)	240	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The purpose of this pilot study is to summarize patient preferences and willingness to accept tradeoffs among attributes of medical interventions. The pilot study will help FDA evaluate the feasibility and validity of this approach for providing evidence about patients' preferences and risk tolerance. Specifically, the weight-reduction device case study will elicit trade-off preferences of subjects with self-reported BMI of 30 kg/m2 or above for the most salient features or attributes of weight reduction medical devices. The pilot study information will be used by the FDA to evaluate stated-preference methods as a possible source of evidence about patients' benefit-risk trade-off preferences for devices. FDA's Center for Devices and Radiological Health (CDRH) is evaluating processes to incorporate patient preferences on treatment benefits and risks in its device review process. To obtain such preferences in a systematic and scientifically valid way, CDRH has commissioned this survey to be administered to members of a web panel that is representative of the U.S. population.

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Authorizing Statute(s): None

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:
	77 FR 23484	04/19/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 38299	06/27/2012
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Survey Invitation
Consent Form
Full Survey

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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	2,150	0	0	2,150	0	0
Annual Time Burden (Hours)	240	0	0	240	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

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

Burden Reduction Due to:

Short Statement: This is a new information collection for a one-time survey.

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Annual Cost to Federal Government: $52,408

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

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: 07/05/2012

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