Potential Tobacco Product Violations Reporting Form

Forms and Documents

Document Name	Status
Form FDA Form 3779 Potential Tobacco Product Violations Reporting Form	New
Tobacco_Violation_Form_All_Comments.pdf Supplementary Document	2012-03-08
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
Retailer Study SS A.doc Supporting Statement A	2012-07-20

IC Document Collections

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

ICR Details

OMB Control No: 0910-0716	ICR Reference No: 201203-0910-002
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Potential Tobacco Product Violations Reporting Form
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: 07/30/2012
	Date Received in OIRA: 03/12/2012
Terms of Clearance: In accordance with the terms of 5 CFR 1320, OMB approves this information collection request for a period of two years. OMB understands that telephone call screeners will request exactly the same information that is collected through the equivalent paper form. Before seeking reapproval of this collection, FDA should submit a formal telephone script as a non-substantive change to this collection.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2014	36 Months From Approved
Responses	1,000	0	0
Time Burden (Hours)	250	0	0
Cost Burden (Dollars)	5	0	0

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Abstract: This collection allows individuals to report potential violations of the Tobacco Control Act.

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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
60-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 52333	08/22/2011
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 14018	03/08/2012
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	0	0	1,000	0	0
Annual Time Burden (Hours)	250	0	0	250	0	0
Annual Cost Burden (Dollars)	5	0	0	5	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: This is a new information collection. FDA's estimate of 250 hours to submit the information by phone, Internet form, paper form, by mail, smartphone application, or e-mail is based on the previous rate of reporting for FDA's cigarette flavor ban, reports received from the FDA's toll-free telephone number and e-mail address, and FDA experience. FDA expects the rate of calls and reporting for potential tobacco product violations to remain constant over the next three years.

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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: 03/12/2012

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