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

ICR 201911-0910-011

OMB: 0910-0865

Federal Form Document

Forms and Documents
Justification for No Material/Nonsubstantive Change
Supporting Statement B
Supporting Statement A
ICR Details
0910-0865 201911-0910-011
Active 201812-0910-007
Generic Clearance for Quantitative Testing for the Development of FDA Communications (CFSAN)
No material or nonsubstantive change to a currently approved collection   No
Approved without change 11/06/2019
Retrieve Notice of Action (NOA) 11/06/2019
Previous terms continue: 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
02/28/2022 02/28/2022 02/28/2022
93,744 0 93,744
10,498 0 10,498
0 0 0

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.

US Code: 21 USC 393 Name of Law: FFDCA

Not associated with rulemaking

  83 FR 44888 09/04/2018
83 FR 67300 12/28/2018

  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 93,744 0 0 0 0
Annual Time Burden (Hours) 10,498 10,498 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0

Yes Part B of Supporting Statement
Ila Mizrachi 301 796-7726 [email protected]


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:
    (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;
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.

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