Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0891 Gen IC Summary 2026-091126.docx	Supplementary Document	Uploaded 2026-09-11	Available
0891_OMB Gen IC MemoTemplate_2026.docx	Supplementary Document	Uploaded 2026-08-28	Available
PRA - 0891 - SSB_2026.docx	Supporting Statement B	Uploaded 2026-08-28	Available
PRA - 0891 - SSA_2026.docx	Supporting Statement A	Uploaded 2026-09-21	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form

ICR Details

OMB Control No: 0910-0891	ICR Reference No: 202608-0910-012
Status: Received in OIRA	Previous ICR Reference No: 202302-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: HFP
Title: Generic Clearance for Qualitative Data to Support Social and Behavioral Research for Food, Dietary Supplements, Cosmetics, and Animal Food and Feed
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 09/24/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	09/30/2026
Responses	10,664	20,464
Time Burden (Hours)	3,870	7,394
Cost Burden (Dollars)	0	0

---

Abstract: This is a request is for approval of a Generic Information Collection that utilizes qualitative methods (i.e., individual in-depth interviews (IDIs), focus groups, small group discussions, and observations) for studies about food and cosmetic products, dietary supplements, and animal food and feed. This information will be used to inform the regulatory science knowledge base, as well as to explore areas of interest and assist in the development of quantitative study proposals, complementing other important research efforts in the agency. This information may also be used to help develop communications and educational messages related to public health.

---

Authorizing Statute(s): None

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:
	91 FR 20693	04/17/2026
30-day Notice:	Federal Register Citation:	Citation Date:
	91 FR 57895	09/11/2026
Did the Agency receive public comments on this ICR? No

---

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

---

ICR Summary of Burden

table that charts list 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	10,664	20,464	0	-9,800	0	0
Annual Time Burden (Hours)	3,870	7,394	0	-3,524	0	0
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: Based on a review of the information collection since our last request for OMB approval, we have adjusted our burden estimate based on actual usage of this collection of information and have decreased the number of responses and hours. We have reduced our estimate for the number of responses from 19,600 to 9,800 responses (a decrease of 9,800 responses) and reduced the number of hours from 7,048 to 3,524 hours (a decrease of 3,524 hours) based on our experience conducting these collections of information over the past three years.

---

Annual Cost to Federal Government: $1,060,917

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: 09/24/2026

---