Assessing Physiological, Neural and Self-Reported Response to Tobacco Education Messages

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
SSB Assessing Physiological Neural FINAL.docx	Supporting Statement B	Uploaded 2023-05-05	Repair queued
SSA Assessing Physiological Neural FINAL.docx	Supporting Statement A	Uploaded 2023-05-05	Repair queued
CTP Assessing Physiological Neural and Self-Reported Response to Tobacco Education Messages_SAOP approved 02152023.pdf	Supplementary Document	Uploaded 2023-04-14	Repair queued
CERSI Flyer for OMB, revised 030623.pdf	Supplementary Document	Uploaded 2023-04-14	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
259672	Screener; Parental Permission Process; Consent; Main Study	Other-Screener	New

ICR Details

OMB Control No: 0910-0919	ICR Reference No: 202304-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Assessing Physiological, Neural and Self-Reported Response to Tobacco Education Messages
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: 07/31/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 05/05/2023
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2026	36 Months From Approved
Responses	375	0	0
Time Burden (Hours)	193	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The FDA’s Center for Tobacco Products via Johns Hopkins Center for Excellence in Regulatory Science and Innovation is proposing to conduct an in-person study with a sample size of 100 youth and young adults aged 13-24. Participants will complete one study visit (about 90 minutes) in which self-reported, physiological, and neural response to FDA tobacco education and prevention messages will be assessed. To identify effective message strategies, research on the self-reported, physiological, and neural response to these education messages is needed. The results of this survey will be used to inform specific recommendations around FDA’s public education programs’ impact and effectiveness in reducing tobacco-related death and disease.

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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:
	87 FR 71335	11/22/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 24994	04/25/2023
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Screener; Parental Permission Process; Consent; Main Study

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ICR Summary of Burden

table that charts list 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	375	0	0	0	375	0
Annual Time Burden (Hours)	193	0	0	0	193	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: No

Burden Reduction Due to:

Short Statement: This is a new data collection.

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Annual Cost to Federal Government: $178,313

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.     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.     Yes

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: 05/05/2023

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