Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Document Roadmap September 2020.docx	Supplementary Document	Uploaded 2020-09-22	Available
Change Request Memo Sept 2020.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-09-22	Available
Change Request Memo.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-06-16	Available
Rationale for Item Changes to the ExPECTT 2nd Follow-up Instrument.docx	Supplementary Document	Uploaded 2020-01-09	Available
2. Part B ExPECTT.FU3_clean.docx	Supporting Statement B	Uploaded 2020-09-22	Available
1. Part A ExPECTT.FU3_clean.docx	Supporting Statement A	Uploaded 2020-09-22	Available
Suppl 2_E2b. Rationale for Changes to ExPECTT Instrument.docx	Supplementary Document	Uploaded 2017-11-02	Available
Attachment 9. E2 Privacy and Data Security.docx	Supplementary Document	Uploaded 2017-11-02	Available
Attachment 5. Incentives.doc	Supplementary Document	Uploaded 2016-06-09	Available
Attachment 2a. Rationale for Outcome Evaluation Measures.doc	Supplementary Document	Uploaded 2016-06-09	Available
Attachment 1. FSPTCA.pdf	Supplementary Document	Uploaded 2016-06-09	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
222024	Cohort 2--Youth Aged 11 to 18	Other-Routing for Consent ExPECTT	Modified
222019	Cohort 2--Youth Assent	Other-Youth Assent under 18	Modified
208712	Parent Of Youth Baseline Survey Participants	Other-Email Reminder 3 ExPECTT	Modified
208707	General Population Screener and Consent Process (Youth and Parent)	Other-Parent Permission ExPECTT FU	Modified

ICR Details

OMB Control No: 0910-0753	ICR Reference No: 202009-0910-008
Status: Active	Previous ICR Reference No: 202006-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Evaluation of the Food and Drug Administration's General Market Youth Tobacco Prevention Campaign
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 09/28/2020
	Date Received in OIRA: 09/23/2020
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2023	01/31/2023	01/31/2023
Responses	27,401	0	25,707
Time Burden (Hours)	8,894	0	7,327
Cost Burden (Dollars)	0	0	0

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Abstract: The Food and Drug Administration (FDA) requests Office of Management and Budget (OMB) approval to conduct in-person and Web-based surveys of youth in targeted areas in the United States. These surveys will be fielded for purposes of evaluating FDA's general market youth tobacco prevention campaigns. The primary outcome evaluation will consist of an initial baseline survey before the launch of each of three campaigns and three longitudinal follow-up surveys of those participants in 8-month intervals following the baseline data collection. In addition, a tracking survey to assess awareness of the campaigns and receptivity to campaign messages will occur in 8-month intervals throughout the data collection period. As part of the outcome evaluation study, a baseline survey will also be conducted with the parent or legal guardian of each youth baseline survey participant in order to collect data on household characteristics and media use. Data from this evaluation will be used to gauge campaign awareness and examine the statistical relationships between exposure to the campaigns and changes in outcome variables of interest.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 31 Name of Law: Family Smoking Prevention and Tobacco Control 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:
	84 FR 22499	05/17/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 46021	09/03/2019
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

table that charts list of burden

IC Title	Form No.	Form Name
Cohort 2--Youth Assent
Cohort 2--Youth Aged 11 to 18
Parent Of Youth Baseline Survey Participants
General Population Screener and Consent Process (Youth and Parent)

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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	27,401	25,707	0	1,694	0	0
Annual Time Burden (Hours)	8,894	7,327	0	1,567	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: FDA has added burden for the fourth follow up. This resulted in an increase of 1,694 responses and 1,567 hours. The new estimated burden for this collection is 8,894 hours.

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Annual Cost to Federal Government: $12,641,919

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: 09/23/2020

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