Required Warnings for Cigarette Packages and Advertisements

ICR 202102-0910-002

OMB: 0910-0877

Federal Form Document

Forms and Documents
Document
Name
Status
Justification for No Material/Nonsubstantive Change
2021-02-11
Supplementary Document
2021-02-11
Supporting Statement A
2020-03-17
IC Document Collections
ICR Details
0910-0877 202102-0910-002
Active 202005-0910-009
HHS/FDA CTP
Required Warnings for Cigarette Packages and Advertisements
No material or nonsubstantive change to a currently approved collection   No
Regular
Approved without change 02/17/2021
Retrieve Notice of Action (NOA) 02/17/2021
  Inventory as of this Action Requested Previously Approved
04/30/2023 04/30/2023 04/30/2023
178 0 178
11,367 0 11,367
0 0 0

This ICR collects information from manufacturers, distributors, and certain retailers of cigarettes who will be required to submit plans to FDA relating to the random and equal display and distribution of required warning statements on cigarette packaging and quarterly rotation of required warning statements in alternating sequence in cigarette product advertising ("plan" or "plans"). A record of the FDA-approved plan must also be established and maintained.

US Code: 21 USC 387i Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 387c Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 387e(g) Name of Law: Federal Food, Drug, and Cosmetic Act
   PL: Pub.L. 111 - 31 123 Name of Law: Tobacco Control Act
   US Code: 21 USC 371 Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 374 Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

0910-AI39 Final or interim final rulemaking 85 FR 15638 03/18/2020

No

3
IC Title Form No. Form Name
Recordkeeping Burden
Supplements
Initial plans

  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 178 178 0 0 0 0
Annual Time Burden (Hours) 11,367 11,367 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This is a new data collection.

$1,740,000
No
    No
    No
No
No
No
No
Jonna Capezzuto 301 796-3794 [email protected]

  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:
 
 
 
 
 
 
 
    (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.
02/17/2021


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