Potential Tobacco Product Violations Reporting Form

ICR 202006-0910-006

OMB: 0910-0716

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2020-06-11
IC Document Collections
ICR Details
0910-0716 202006-0910-006
Active 201706-0910-019
HHS/FDA CTP
Potential Tobacco Product Violations Reporting Form
Extension without change of a currently approved collection   No
Regular
Approved without change 08/14/2020
Retrieve Notice of Action (NOA) 06/17/2020
  Inventory as of this Action Requested Previously Approved
08/31/2023 36 Months From Approved 08/31/2020
5,370 0 1,500
1,343 0 375
24 0 7

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

  84 FR 55161 10/15/2019
85 FR 36597 06/17/2020
Yes

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

  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 5,370 1,500 0 0 3,870 0
Annual Time Burden (Hours) 1,343 375 0 0 968 0
Annual Cost Burden (Dollars) 24 7 0 0 17 0
Yes
Miscellaneous Actions
No
We have adjusted our burden estimate based on the updated number of reports received to approximately 5,370 forms annually, which more accurately reflects the projected number of submissions based on current trends. Using these new figures, our estimated burden for the information collection signifies an overall increase to reflect 2,685 respondents per year and 1,343 hours. This estimate is based on the actual rate of reporting violations through Form FDA 3779 over the past 5 years, from FDA’s toll-free telephone number, online, email and mailed complaints.

$102,030
No
    Yes
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 [email protected]

  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.
06/17/2020


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