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OMB Control No: 0910-0716	ICR Reference No: 201310-0910-001
Status: Historical Active	Previous ICR Reference No: 201203-0910-002
Agency/Subagency: HHS/FDA	Agency Tracking No: 20692
Title: Potential Tobacco Product Violations Reporting Form
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: 11/22/2013
	Date Received in OIRA: 10/22/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2014	07/31/2014	07/31/2014
Responses	1,000	0	1,000
Time Burden (Hours)	250	0	250
Cost Burden (Dollars)	5	0	5

Abstract: FDA created the Tobacco Call Center with a toll-free number to accept information from the public regarding potential violations of the Tobacco Control Act. Callers report potential violations of the Tobacco Control Act and FDA may conduct targeted follow-up investigation based on information received. When callers report a potential violation, the caller will be asked to provide as much information about the violation as they can recall, including: the date the potential violation happened, product type (e.g., cigarette, smokeless, roll-your-own, etc.), tobacco brand, type of potentially violative promotional materials, potential violation type, who potentially violated, and the name, address, phone number, and e-mail address of the potential violator. The caller will be asked to list the potential violator's website, describe the potential violation, and provide any additional files or information. FDA has developed FDA Form 3779, Potential Tobacco Production Violations Reporting that will be used to solicit this information from the caller. This form is intended to eventually replace FDA Form 3734 Cigarette Flavor Ban Violations Form. This new form will be posted on FDA's website to complete on-line or the public can download it or request a copy of the form by contacting the Center for Tobacco Products. In addition, FDA has developed a smartphone application for use with mobile devices (i.e., iPhones, Android) to allow consumers to report potential violations to the FDA via their smartphone. Other stakeholders may simply choose to send a letter to FDA with their information. The public and interested stakeholders will be able to report information regarding possible violations of the Tobacco Control Act by calling the Tobacco Call Center using CTP's toll-free number; using a fill-able form found on FDA's Web site; using FDA's tobacco violation reporting smartphone application; or sending a letter to FDA's Center for Tobacco Products

Authorizing Statute(s): PL: Pub.L. 111 - 111 31

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
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Potential Tobacco Product Violations Reporting	FDA Form 3779

ICR Summary of Burden

	Total Approved	Previously Approved
Annual Number of Responses	1,000	1,000
Annual Time Burden (Hours)	250	250
Annual Cost Burden (Dollars)	5	5

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:

Annual Cost to Federal Government: $19,000

Does this IC contain surveys, censuses, or employ statistical methods? No

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: JonnaLynn Capezzuto 301 827-4659 jonnalynn.capezzuto@fda.hhs.gov

View ICR - OIRA Conclusion