Tobacco Retailer Training Programs

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
0745_SupportingStatement_2022 11-14-22.docx	Supporting Statement A	Uploaded 2022-11-15	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
256760	Tobacco Retailer Training Program - One-time Recordkeeping	Other-Guidance	New
206305	Tobacco Retailer Training Program - Annual Recordkeeping	Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0745	ICR Reference No: 202203-0910-008
Status: Active	Previous ICR Reference No: 201909-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Retailer Training Programs
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 with change	Conclusion Date: 02/09/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 11/22/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2026	36 Months From Approved	02/28/2023
Responses	1,036,100	0	273,900
Time Burden (Hours)	2,183,780	0	2,939,860
Cost Burden (Dollars)	0	0	0

---

Abstract: FDA intends to issue regulations establishing standards for approved tobacco retailer training programs. In the interim, FDA published a guidance document which is intended to assist tobacco retailers to voluntarily implement effective training programs for employees. Until FDA promulgates 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. FDA may consider further reducing the civil money penalty for retailers who have implemented a training program. Retailers who have received a Complaint for Civil Money Penalties or No-Tobacco Sale Order and who wish to submit evidence that they have a training program in place, for purposes of settlement negotiations only, may do so when filing an Answer to the Complaint.

---

Authorizing Statute(s): US Code: 21 USC 387f(d) Name of Law: Federal Food, Drug and Cosmetic Act
   PL: Pub.L. 111 - 31 103 Name of Law: Civil Monetary Penalties
  

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:
	87 FR 26766	05/05/2022
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 67043	11/07/2022
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Tobacco Retailer Training Program - Annual Recordkeeping
Tobacco Retailer Training Program - One-time Recordkeeping

---

ICR Summary of Burden

table that charts list of burden

	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	1,036,100	273,900	0	0	762,200	0
Annual Time Burden (Hours)	2,183,780	2,939,860	0	0	-756,080	0
Annual Cost Burden (Dollars)	0	0	0	0	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 and the number of respondents, which has resulted in a decrease of 756,080 burden hours. This adjustment is based on available data estimating the number of retail establishments that sell tobacco products in the United States. Additionally, the burden chart was updated to reflect a change from an estimation over the course of 3 years to annualized burden and we reassigned the one-time reporting burden to one-time recordkeeping to more accurately capture the nature of the activity.

---

Annual Cost to Federal Government: $0

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

---

Common Form ICR:  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:

(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: 11/22/2022

---