National Panel of Tobacco Consumer Studies

Forms and Documents

Document Name	Status
0815_Supporting_Statement_PART_B_2019_CLEAN_REVISED_022520.docx Supporting Statement B	2020-02-27
0815_Supporting_Statement_PART_A_2019_CLEAN_REVISED_022520.docx Supporting Statement A	2020-02-27

IC Document Collections

IC ID	Document Title	Status
216701	Panel Replenishment Baseline and Enrollment Survey Other-Respondent Materials - English	Modified
216700	Panel Replenishment Household Screening Respondent Other-Questionnaires - English	Modified
216699	Study B and Study C Other-Respondent Materials - English	Modified
216698	Household Screening Respondent Other-Questionnaires - English	Removed

ICR Details

OMB Control No: 0910-0815	ICR Reference No: 201903-0910-010
Status: Historical Active	Previous ICR Reference No: 201802-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: National Panel of Tobacco Consumer Studies
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/28/2020
	Date Received in OIRA: 05/21/2019
Terms of Clearance: Approval is given consistent with the understanding that when communicating or publishing research outcomes associated with this clearance, CTP will present: a) the unweighted distribution of sociodemographic and geographic characteristics of the sample that responded to a given survey, and b) study results based on both weighted and unweighted data. 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 three year clearance covers only survey replenishment and studies as currently described. Additional observational studies conducted under this control number will be submitted to OMB as revisions under the PRA.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2023	36 Months From Approved	02/29/2020
Responses	15,602	0	27,935
Time Burden (Hours)	3,340	0	4,435
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) proposes to established a high-quality, national panel of about 4,000 tobacco users. The panel will includes 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:
	83 FR 53485	10/23/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 22862	05/20/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Panel Replenishment Household Screening Respondent
Household Screening Respondent
Panel Replenishment Baseline and Enrollment Survey
Study B and Study C

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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	15,602	27,935	0	0	-12,333	0
Annual Time Burden (Hours)	3,340	4,435	0	0	-1,095	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: FDA is requesting an extension on the currently approved information collection request for remaining planned studies, panel maintenance and replenishment activities and non-substantive changes to update the estimated burden for an additional year of panel replenishment. The average annual burden hours will increase by 1,699 hours, from 4,435 to 6,134 hours.

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Annual Cost to Federal Government: $3,265,966

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? 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: 05/21/2019

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