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:
201805-0910-002
Status:
Historical Active
Previous ICR Reference No:
201607-0910-004
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Guidance for Industry on Tobacco Retailer Training Programs
Type of Information Collection:
No material or nonsubstantive change to a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
05/10/2018
Retrieve Notice of Action (NOA)
Date Received in OIRA:
05/03/2018
Terms of Clearance:
Inventory as of this Action
Requested
Previously Approved
Expiration Date
12/31/2019
12/31/2019
12/31/2019
Responses
273,900
0
273,900
Time Burden (Hours)
2,950,660
0
2,950,660
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
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
Other Documents for OIRA Review
Federal Register Notices & Comments
60-day Notice:
Federal Register Citation:
Citation Date:
81 FR 9862
02/26/2016
30-day Notice:
Federal Register Citation:
Citation Date:
81 FR 50522
08/01/2016
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
Tobacco Retailer Training Program
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
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
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:
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.
Annual Cost to Federal Government:
$1,734,700
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.
No
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?
Uncollected
Agency Contact:
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.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:
05/03/2018
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