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

Forms and Documents

Document Name	Status
Template - CFSAN Quallitative Generic SS and BR.docx Supplementary Document	2020-07-01
Supporting Statement Part B Qualitative Data to Support Social Behavioral and Research 2020.docx Supporting Statement B	2020-07-01
Supporting Statement Part A Qualitative Data to Support Social Behavior and Research 2020.docx Supporting Statement A	2020-07-01

IC Document Collections

IC ID	Document Title	Status
248080	Focus Groups on Bioactives in Infant Formula - Phase 1 (CFSAN) Other-Screener	New

ICR Details

OMB Control No: 0910-0891	ICR Reference No: 202007-0910-001
Status: Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
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: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/13/2020
	Date Received in OIRA: 07/08/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved
Responses	20,464	0	0
Time Burden (Hours)	7,394	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports FDA under section 505 of the FD&C Act, which provides that FDA may take appropriate action to protect the public health when necessary. The act also authorizes FDA to conduct educational and public information programs. In addition to overseeing food and cosmetic products, dietary supplements, and animal food and feed, CFSAN also conducts studies to support communications with the public on these topics. To ensure that regulatory actions and communications activities have the highest potential to be received, understood, and accepted by those for whom they are intended, CFSAN and related FDA offices conduct research and studies relating to the control and prevention of disease as authorized by section 301 of the Public Health Service Act. FDA is requesting approval of this new generic for collecting information using 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

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Authorizing Statute(s): None

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:
	85 FR 7564	02/10/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 40299	07/06/2020
Did the Agency receive public comments on this ICR? Yes

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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	20,464	0	0	20,464	0	0
Annual Time Burden (Hours)	7,394	0	0	7,394	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 collection of information.

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Annual Cost to Federal Government: $1,049,610

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

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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: 07/08/2020

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