Potential Tobacco Product Violations Reporting Form

Forms and Documents

Document Name	Status
Form FDA Form 3779 Potential Tobacco Product Violations Reporting Form	Modified
0910-0716 violation form Non substantive change request 83c.docx Justification for No Material/Nonsubstantive Change	2013-10-18
PTVR Call Center General Instructions.doc Supplementary Document	2013-10-18
Screen shot of Tobacco Potential Violation Form Web Form.pdf Supplementary Document	2012-02-29
CDC Report Violation 2_29_2012.pdf Supplementary Document	2012-02-29

IC Document Collections

IC ID	Document Title	Status
201526	Potential Tobacco Product Violations Reporting Form	Modified

ICR Details

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

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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

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Authorizing Statute(s): PL: Pub.L. 111 - 111 31 Name of Law: null
  

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

Did the Agency receive public comments on this ICR? Yes

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

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

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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	1,000	1,000	0	0	0	0
Annual Time Burden (Hours)	250	250	0	0	0	0
Annual Cost Burden (Dollars)	5	5	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: $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

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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: 10/22/2013

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