Guidance for Industry on Tobacco Retailer Training Programs

ICR 201805-0910-002

OMB: 0910-0745

Federal Form Document

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ICR Details
0910-0745 201805-0910-002
Historical Active 201607-0910-004
Guidance for Industry on Tobacco Retailer Training Programs
No material or nonsubstantive change to a currently approved collection   No
Approved without change 05/10/2018
Retrieve Notice of Action (NOA) 05/03/2018
  Inventory as of this Action Requested Previously Approved
12/31/2019 12/31/2019 12/31/2019
273,900 0 273,900
2,950,660 0 2,950,660
0 0 0

On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act) (Public Law 111-31) into law. The Tobacco Control Act grants FDA important authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. The Tobacco Control Act provides for lower civil money penalties for violations of sale and distribution, including youth access, and advertising and promotions restrictions issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, for retailers who have implemented a training program that complies with standards developed by FDA for such programs. FDA intends to promulgate regulations establishing standards for approved retailer training programs. Until FDA promulgates these regulations, the agency intends to use the lower maximum civil money penalties schedule for all retailers who violate the restriction of the sale and distribution of cigarettes and smokeless tobacco products, whether or not they have implemented a training program. However, FDA may consider further reducing the civil money penalty for retailers who have implemented a training program. In the interim, the guidance document associated with this collection of information is intended to assist tobacco retailers in implementing training programs for employees.

PL: Pub.L. 111 - 31 103 Name of Law: Civil Monetary Penalties

Not associated with rulemaking
Other Documents for OIRA Review

  81 FR 9862 02/26/2016
81 FR 50522 08/01/2016

IC Title Form No. Form Name
Tobacco Retailer Training Program

  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 273,900 273,900 0 0 0 0
Annual Time Burden (Hours) 2,950,660 2,950,660 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
This is a revision to the approved information collection. Pursuant to the publishing of the deeming rule, FDA has added vape shop retailers (3,300) who are expected to participate in this program. The estimated total number of respondents has increased by 3,300 to 273,900. After further review of the recordkeeping burden, FDA believes the “review and update” IC was already covered by the “training program” IC. Therefore we have removed this IC which resulted in a decrease of 135,300. As a result of these changes the total estimated annual burden has decreased by 92,080 hours (3,042,740 - 2,950,660) for a new total of 2,950,660.

Amber Sanford 301 796-8867 [email protected]


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.

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