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OMB Control No: 0910-0815	ICR Reference No: 201505-0910-005
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: NATIONAL PANEL OF TOBACCO CONSUMER STUDIES
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 with change	Conclusion Date: 06/08/2016
	Date Received in OIRA: 06/15/2015
Terms of Clearance: 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	36 Months From Approved
Responses	20,648	0	0
Time Burden (Hours)	3,488	0	0
Cost Burden (Dollars)	0	0	0

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.

Authorizing Statute(s): PL: Pub.L. 111 - 31 201 Name of Law: Tobacco Control Act

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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

ICR Summary of Burden

	Total Approved	Change Due to Agency Discretion
Annual Number of Responses	20,648	20,648
Annual Time Burden (Hours)	3,488	3,488
Annual Cost Burden (Dollars)	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: New collection

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

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

View ICR - OIRA Conclusion