National Panel of Tobacco Consumer Studies

Forms and Documents

Document Name	Status
OMB_Change_Request_Memo_071817.docx Justification for No Material/Nonsubstantive Change	2017-07-20
OMB_Change_Request_Memo_042117.docx Justification for No Material/Nonsubstantive Change	2017-04-25
OMB_Change_Request_Memo_041917.docx Justification for No Material/Nonsubstantive Change	2017-04-21
OMB_Change_Request_Memo_ Dec 16_FINAL clean.docx Justification for No Material/Nonsubstantive Change	2017-01-03
0910-0815 change request justification memo Aug 2016.docx Justification for No Material/Nonsubstantive Change	2016-08-10
Attachment_6_INCENTIVES.pdf Supplementary Document	2016-06-07
Attachment_5_SUMMARY OF THE SAMPLE DESIGN FOR THE PANEL.pdf Supplementary Document	2016-06-07
0815__Supporting_Statement_PART_B_7-2017.docx Supporting Statement B	2017-07-20
0815__Supporting_Statement_PART_A_7-2017.docx Supporting Statement A	2017-07-20

IC Document Collections

IC ID	Document Title	Status
216701	Panel Replenishment Baseline and Enrollment Survey Other-Respondent Materials - Spanish	Unchanged
216700	Panel Replenishment Screening Respondent Other-Questionnaires - English	Unchanged
216699	Panel Member Enroll, Baseline Survey & Study 1 Other-Respondent Materials - Spanish	Unchanged
216698	Household Screening Respondent Other-Questionnaires - English	Modified

ICR Details

OMB Control No: 0910-0815	ICR Reference No: 201707-0910-013
Status: Historical Active	Previous ICR Reference No: 201704-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: National Panel of Tobacco Consumer Studies
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: 07/25/2017
	Date Received in OIRA: 07/20/2017
Terms of Clearance: Previous terms continue: When communicating or publishing research outcomes associated with this clearance, CTP will clearly describe the sociodemographic and geographic characteristics of the sample that responded to a given survey, explicitly characterizing potential limitations in generalizability. Consistent with obligations under HHS and OMB’s Information Quality Guidelines, CTP will assess the quality of the information generated by collections conducted under this OMB Control Number for each regulatory or policy purpose under consideration. This first 3 year clearance will cover only the following activities of the panel: Respondent screening, enrollment/replenishment survey, the baseline survey, and the 1st observational study. Future observational studies conducted under this control number will be submitted as revision requests to OMB for formal review.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	06/30/2019	06/30/2019
Responses	22,793	0	20,648
Time Burden (Hours)	3,766	0	3,488
Cost Burden (Dollars)	0	0	0

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Abstract: The U. S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP)(FDA) proposes to establish a high-quality, national panel of 4,000 tobacco users. The panel will include individuals who agree to participate in up to 8 experimental or observational studies over a 3-year period to assess consumers’ responses to tobacco marketing, warning statements, product labels, and other communications about tobacco products. CTP proposes the establishment of the panel of consumers because currently existing panels have a number of significant limitations for use in tracking tobacco users.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 201 Name of Law: 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:
	79 FR 62160	10/16/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	80 FR 32963	06/10/2015
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Household Screening Respondent
Panel Replenishment Baseline and Enrollment Survey
Panel Member Enroll, Baseline Survey & Study 1
Panel Replenishment Screening Respondent

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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	22,793	20,648	0	0	2,145	0
Annual Time Burden (Hours)	3,766	3,488	0	0	278	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:

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Annual Cost to Federal Government: $5,572,691

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 07/20/2017

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