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View ICR - Agency Submission
COMMENT
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OMB Control No:
0910-0671
ICR Reference No:
202503-0910-005
Status:
Received in OIRA
Previous ICR Reference No:
202410-0910-010
Agency/Subagency:
HHS/FDA
Agency Tracking No:
CTP
Title:
Warning Plans for Smokeless Tobacco Products
Type of Information Collection:
Extension without change of a currently approved collection
Common Form ICR:
No
Type of Review Request:
Regular
Date Submitted to OIRA:
01/28/2026
Requested
Previously Approved
Expiration Date
36 Months From Approved
01/31/2026
Responses
3
5
Time Burden (Hours)
120
180
Cost Burden (Dollars)
0
0
Abstract:
Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (the Smokeless Tobacco Act), requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements. This information collection--the submission to FDA of warning plans for smokeless tobacco products--is statutorily mandated. Section (b)(3)(A) of 15 U.S.C. 4402 requires that the warnings be displayed on packaging and advertising for each brand of smokeless tobacco “in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer” to, and approved by, FDA. The warning plans will be reviewed by FDA to determine whether the companies' plans for the equal distribution and display of warning statements on packaging and the quarterly rotation of warning statements in advertising for each brand requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements.
Authorizing Statute(s):
PL:
Pub.L. 113 - 31 3
Name of Law: Tobacco Control Act
US Code:
15 USC 4402
Name of Law: Comprehensive Smokeless Tobacco Health Education Act of 1986
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:
90 FR 29559
07/03/2025
30-day Notice:
Federal Register Citation:
Citation Date:
91 FR 2135
01/16/2026
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Submission of original rotational plans for health warning statements for smokeless tobacco products
ICR Summary of Burden
Total Request
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
3
5
0
0
-2
0
Annual Time Burden (Hours)
120
180
0
0
-60
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:
FDA estimates a total of 2 respondents will submit a supplement to an approved smokeless tobacco warning plan, a decrease from the previously approved 4 respondents, based on 2022–2024 trends for smokeless tobacco warning plans. FDA is not adjusting the assumption that it will take approximately 30 hours to complete and submit a supplement to an approved smokeless tobacco warning plan. FDA adjustments result in reducing the total annual burden hours associated with the supplement to an approved smokeless tobacco warning plan from 120 hours to 60 hours. The FDA has adjusted its burden estimate, which has resulted in a decrease of 60 hours and 2 respondents compared to the currently approved burden.
Annual Cost to Federal Government:
$132,638
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:
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:
01/28/2026
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