Generic Clearance for Quick Turnaround Testing of Communication Effectiveness

Forms and Documents

Document	Type	Status	Availability
PRA - 0876 - SSA_clean-102225.docx	Supporting Statement A	Uploaded 2026-02-18	Available
PRA - 0876 - SSA_clean-102225.docx	Supporting Statement A	Uploaded 2026-02-18	Repair queued
PRA - 0876 Individual IC Summaries_2025-clean-102225.docx	Supplementary Document	Uploaded 2025-11-18	Repair queued
PRA - 0876 Individual IC Summaries_2025-clean-102225.docx	Supplementary Document	Uploaded 2025-11-18	Repair queued
PRA - 0876 - SSB_2025.10.21.docx	Supporting Statement B	Uploaded 2025-11-18	Repair queued
PRA - 0876 - SSB_2025.10.21.docx	Supporting Statement B	Uploaded 2025-11-18	Repair queued
0876 OMB Memo Template_2025.docx	Supplementary Document	Uploaded 2025-10-14	Repair queued
0876 OMB Memo Template_2025.docx	Supplementary Document	Uploaded 2025-10-14	Repair queued

IC Document Collections

IC ID	Collection	Type	Status	Form

ICR Details

OMB Control No: 0910-0876	ICR Reference No: 202510-0910-001
Status: Active	Previous ICR Reference No: 202203-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Generic Clearance for Quick Turnaround Testing of Communication Effectiveness
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/14/2026
Retrieve Notice of Action (NOA)	Date Received in OIRA: 02/19/2026
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2029	36 Months From Approved
Responses	12,468	0	0
Time Burden (Hours)	1,833	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request supports FDA programs by creating an information collection for the development of a “Generic Clearance for Quick Turnaround Testing of Communication Effectiveness.” Section 1003(d)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)) authorizes the FDA to conduct food research and educational and public information programs relating to the safety of the nation’s food supply. The generic studies covered by this request will be used to test FDA communications and educational messages related to FDA-regulated food, infant formula, dietary supplements, and animal food and feed when there is a need for a quick OMB clearance turnaround during matters requiring urgent public health communications. Collecting information from consumers and other stakeholders during urgent public health matters will help ensure that FDA’s messaging has reached the target audience and has been understood. Data will be collected using self-report web-based surveys, focus groups, and one-on-one in-depth interviews.

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Authorizing Statute(s): US Code: 21 USC 393(d)(2) 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:
	90 FR 29565	07/03/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 7503	02/18/2026
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 0

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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	12,468	0	0	-27,000	0	39,468
Annual Time Burden (Hours)	1,833	0	0	-3,003	0	4,836
Annual Cost Burden (Dollars)	0	0	0	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: Since our initial request for continued approval, we have reevaluated actual usage of individual clearance requests. We have reduced our estimate for the number of responses for "Self-Administered Surveys-Study Screener" from 30,000 to 7,500 responses (a drop of 1877.5 hours from 2,500 to 622.5 hours). We have also reduced our estimate for "Self-Administered Surveys" from 6,000 to 1,500 responses (a reduction of 1,125 hours from 1,500 to 375 hours). These estimates were made based on our past experience with conducting these collections of information. The total reduction, therefore, has been 27,000 responses and 3,002.5 hours.

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Annual Cost to Federal Government: $900,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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? No

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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: 02/19/2026

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