Generic Clearance for Quantitative Testing for the Development of FDA Communications (CFSAN)

Forms and Documents

Document Name	Status
Supporting Statement Part B Quantitative Testing for the Dev of FDA Communications 2019.doc Supporting Statement B	2019-02-01
Supporting Statement Part A Quantitative Testing for the Dev of FDA Comm 2019.docx Supporting Statement A	2019-02-07

IC Document Collections

IC ID	Document Title	Status
234476	Self-Administered Surveys/Experimental Studies Other-GenIC Memo	New
234475	Self-Administered Surveys/Experimental Studies Screener Other-GenIC Memo	New
234474	Pre-Testing Study Other-GenIC Memo	New
234473	Pre-Test Study Screener Other-GenIC Memo	New
234472	Cognitive Interviews Other-GenIC Memo	New
234471	Cognitive Interviews Screener Other-GenIC Memo	New

ICR Details

OMB Control No: 0910-0865	ICR Reference No: 201812-0910-007
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Generic Clearance for Quantitative Testing for the Development of FDA Communications (CFSAN)
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: 02/08/2019
	Date Received in OIRA: 02/05/2019
Terms of Clearance: FDA will submit individual collections under this generic clearance to OMB. Individual collections will also undergo review by FDA’s Research Involving Human Subjects Committee (RIHSC), senior leadership in the Center for Food Safety and Applied Nutrition, and Paperwork Reduction Act (PRA) specialists. FDA will prepare a report during the OMB collection renewal summarizing the number of hours used, as well as the nature and results of the activities completed under this clearance.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2022	36 Months From Approved
Responses	93,744	0	0
Time Burden (Hours)	10,498	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR supports the creation of an information collection for the development of a “Generic Clearance for Quantitative Testing for the Development of FDA Communications.” The generic studies covered by this request will be used to quantitatively test FDA communications and educational messages related to FDA-regulated food and cosmetic products, dietary supplements, and animal food and feed as they are being developed and before they are released to the public. Data will be collected using consumer panels or mall intercepts for surveys and experimental studies.

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Authorizing Statute(s): US Code: 21 USC 393 Name of Law: FFDCA
  

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:
	83 FR 44888	09/04/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 67300	12/28/2018
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Cognitive Interviews Screener
Cognitive Interviews
Pre-Test Study Screener
Self-Administered Surveys/Experimental Studies
Pre-Testing Study
Self-Administered Surveys/Experimental Studies Screener

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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	93,744	0	0	93,744	0	0
Annual Time Burden (Hours)	10,498	0	0	10,498	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 request.

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Annual Cost to Federal Government: $939,150

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 02/05/2019

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