View Information Collection Request (ICR) Package

OMB Control No: 0910-0716	ICR Reference No: 202006-0910-006
Status: Historical Active	Previous ICR Reference No: 201706-0910-019
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/14/2020
	Date Received in OIRA: 06/17/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2023	36 Months From Approved	08/31/2020
Responses	5,370	0	1,500
Time Burden (Hours)	1,343	0	375
Cost Burden (Dollars)	24	0	7

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.

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

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 55161	10/15/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 36597	06/17/2020
Did the Agency receive public comments on this ICR? Yes

Number of Information Collection (IC) in this ICR: 1

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

ICR Summary of Burden

	Total Approved	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	5,370	1,500	3,870
Annual Time Burden (Hours)	1,343	375	968
Annual Cost Burden (Dollars)	24	7	17

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: 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.

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

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

View ICR - OIRA Conclusion