Potential Tobacco Product Violations Reporting Form

Forms and Documents

Document Name	Status
Form FDA 3779 Potential Tobacco Product Violations Reporting Form and Instruction	Modified
0910-0716 Potential Violation Form change request 83c Final.docx Justification for No Material/Nonsubstantive Change	2016-05-26
0910-0716 Potential Violation Form change request 83c Final.docx Justification for No Material/Nonsubstantive Change	2016-01-29
0716_SS_Potential_Tobacco_Violation_Form-05-7-14.doc Supporting Statement A	2014-05-07

IC Document Collections

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

ICR Details

OMB Control No: 0910-0716	ICR Reference No: 201601-0910-007
Status: Historical Active	Previous ICR Reference No: 201405-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
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 with change	Conclusion Date: 05/26/2016
	Date Received in OIRA: 05/13/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2017	07/31/2017	07/31/2017
Responses	800	0	800
Time Burden (Hours)	200	0	200
Cost Burden (Dollars)	4	0	4

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Abstract: This Information Collection Request (ICR) is for an extension of an existing approved collection. As part of its enforcement strategy, FDA created the Tobacco Call Center (with a toll-free number: 1-877-CTP-1373) to accept information from the public regarding potential violations of the Tobacco Control Act. Callers may report potential violations of the Tobacco Control Act, and FDA may conduct targeted followup investigations based on information received. When reporting a potential violation, callers will be asked to provide as much information about the violation as they can recall. The caller will also be asked to list the potential violator's Web site (if available), describe the potential violation, and provide any additional files or information pertinent to the potential violation. FDA currently provides a form that may be used to solicit this information from the caller (FDA Form 3779, Potential Tobacco Product Violations Reporting) and seeks renewal of Form 3779. This form is posted on FDA's Web site. The public and interested stakeholders will also be able to report information regarding possible violations of the Tobacco Control Act through the following methods: calling the Tobacco Call Center using CTP's toll-free number; using a fillable form found on FDA's Web site; downloading a PDF version of the form to send via email or mail to FDA; requesting a copy of FDA Form 3779 by contacting the Center for Tobacco Products and sending by mail to FDA; and sending a letter to FDA's Center for Tobacco Products. The public and interested stakeholders will also be able to report information regarding possible violations of the Tobacco Control Act in the future using FDA's tobacco violation reporting smartphone application.

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Authorizing Statute(s): PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and 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 9216	02/18/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 26765	05/09/2014
Did the Agency receive public comments on this ICR? No

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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 3779	Potential Tobacco Product Violations Report

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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	800	800	0	0	0	0
Annual Time Burden (Hours)	200	200	0	0	0	0
Annual Cost Burden (Dollars)	4	4	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: $15,200

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: 05/13/2016

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