Potential Tobacco Product Violations Reporting Form

Forms and Documents

Document Name	Status
Form FDA 3779 Potential Tobacco Product Violations Reporting Form and Instruction	Modified
0716 Supporting Statement 2023.docx Supporting Statement A	2023-07-21

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: 202301-0910-001
Status: Received in OIRA	Previous ICR Reference No: 202006-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Potential Tobacco Product Violations Reporting Form
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 07/24/2023

	Requested	Previously Approved
Expiration Date	36 Months From Approved	08/31/2023
Responses	6,000	5,370
Time Burden (Hours)	1,500	1,343
Cost Burden (Dollars)	0	24

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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:
	88 FR 7091	02/02/2023
30-day Notice:	Federal Register Citation:	Citation Date:
	88 FR 47145	07/21/2023
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 3779	Potential Tobacco Product Violations Report

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ICR Summary of Burden

	Total Request	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	6,000	5,370	0	0	630	0
Annual Time Burden (Hours)	1,500	1,343	0	0	157	0
Annual Cost Burden (Dollars)	0	24	0	-24	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: We have adjusted our burden estimate, which has resulted in an increase to the currently approved burden. The total estimated burden for this information collection is 1,500 burden hours, and 6,000 annual responses. Our estimated burden for the information collection reflects an overall increase of 157 hours and a corresponding increase of 630 responses. We attribute this adjustment to an increase in the number of submissions we received over the last few years.

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Annual Cost to Federal Government: $102,030

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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? No

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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: 07/24/2023

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