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

Forms and Documents

Document Name	Status
0865 SSB 1-24-25.docx Supporting Statement B	2025-04-29
0865 SSA 1-24-25.docx Supporting Statement A	2025-04-29
0865 OMB template FINAL.docx Supplementary Document	2025-04-29
0865 Summaries FINAL.docx Supplementary Document	2025-04-29

IC Document Collections

IC ID	Document Title	Status

ICR Details

OMB Control No: 0910-0865	ICR Reference No: 202504-0910-010
Status: Received in OIRA	Previous ICR Reference No: 202201-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Generic Clearance for Quantitative Testing for the Development of FDA Communications (HFP)
Type of Information Collection: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 05/05/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved
Responses	93,744	0
Time Burden (Hours)	10,498	0
Cost Burden (Dollars)	0	0

---

Abstract: This Generic Clearance supports the submission and approval of individual information collections designed to test messages relating to products regulated by the Human Foods Program (HFP), including foods and cosmetic products, dietary supplements, and animal food and feed, as they are being developed. We use the information to help improve the effectiveness of FDA communications and educational programs through surveys and experimental studies.

---

Authorizing Statute(s): US Code: 21 USC 393(d)(2)(D) Name of Law: FFDCA; Objectives of Agency Plan
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 61453	07/31/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 18678	05/01/2025
Did the Agency receive public comments on this ICR? No

---

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

---

ICR Summary of Burden

	Total Request	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: Based on an evaluation of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate. Current estimates are based on both historical numbers of participants from past projects as well as estimates for projects to be conducted in the next 3 years. The number of participants to be included in each new survey will vary, depending on the nature of the compliance efforts and the target audience.

---

Annual Cost to Federal Government: $959,007

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.     Yes

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

---

Common Form ICR:  No

---

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: 05/05/2025

---