View Information Collection Request (ICR) Package
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Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
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:
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
IC Title
Form No.
Form Name
Tobacco Retailer Training Program - Annual Recordkeeping
Tobacco Retailer Training Program - One-time Recordkeeping
ICR Summary 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
Agency Contact:
Rachel Showalter 202 693-2146 Showalter.Rachel@dol.gov
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
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