National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products

Forms and Documents

Document Name	Status
natl consumer sruveys ss PART B 6-29-11.doc Supporting Statement B	2011-06-29
natl cons survey invitation follow up e-rewards.pdf Supplementary Document	2011-06-22
natl cons survey invitation e-rewards.pdf Supplementary Document	2011-06-22
natl cons survey follow up letter.doc Supplementary Document	2011-06-22
natl cons survey letter.doc Supplementary Document	2011-06-22
National Consumer Survey ss 12-14-2011.doc Supporting Statement A	2011-12-14

IC Document Collections

IC ID	Document Title	Status
198385	Internet Panel Survey Other-Web Survey	New
198384	Telephone Survey Other-Phone Survey	New
198383	Screener Other-Screener (web) Survey	New
198382	Pretests Other-Pretest (web) Survey	New

ICR Details

OMB Control No: 0910-0698	ICR Reference No: 201107-0910-001
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: National Consumer Surveys on Understanding the Risks and Benefits of FDA-Regulated Medical Products
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: 12/20/2011
	Date Received in OIRA: 07/05/2011
Terms of Clearance: This collection is approved under the understanding that FDA’s presentation of results will describe the data as exploratory and descriptive. Due to the purposeful nature of the statistical sample, the results cannot be generalized to the U.S. population.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2014	36 Months From Approved
Responses	9,730	0	0
Time Burden (Hours)	1,428	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The information collected will be used by FDA in the development of more effective risk communication strategies and messages. FDA recognizes that these surveys should only be used for internal purposes (e.g., to better understand consumer perceptions). The data will not be used for the purposes of making policy or regulatory decisions. The surveys will provide FDA insight as to how well the public understands and incorporates risk/benefit information into their belief structures, and how well the public understands the context within which FDA makes decisions on medical product recalls and warnings.

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Authorizing Statute(s): US Code: 21 USC 393 Name of Law: FD&C 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:
	75 FR 61490	10/05/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 38186	06/29/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Pretests
Screener
Telephone Survey
Internet Panel 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	9,730	0	0	9,730	0	0
Annual Time Burden (Hours)	1,428	0	0	1,428	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 collection of information.

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Annual Cost to Federal Government: $380,731

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: 07/05/2011

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