Potential Tobacco Product Violations Reporting Form

ICR 202301-0910-001

OMB: 0910-0716

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2023-07-21
IC Document Collections
ICR Details
0910-0716 202301-0910-001
Received in OIRA 202006-0910-006
HHS/FDA CTP
Potential Tobacco Product Violations Reporting Form
Extension without change of a currently approved collection   No
Regular 07/24/2023
  Requested Previously Approved
36 Months From Approved 08/31/2023
6,000 5,370
1,500 1,343
0 24

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.

PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  
None

Not associated with rulemaking

  88 FR 7091 02/02/2023
88 FR 47145 07/21/2023
Yes

1
IC Title Form No. Form Name
Potential Tobacco Product Violations Reporting FDA 3779 Potential Tobacco Product Violations Report

  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
No
No
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.

$102,030
No
    Yes
    No
No
No
No
No
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  No

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:
 
 
 
 
 
 
 
    (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;
 
 
 
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.
07/24/2023


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