Required Warnings for Cigarette Packages and Advertisements

ICR 201908-0910-005

OMB: 0910-0877

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-08-16
IC Document Collections
ICR Details
0910-0877 201908-0910-005
Historical Inactive
HHS/FDA CTP
Required Warnings for Cigarette Packages and Advertisements
New collection (Request for a new OMB Control Number)   No
Regular
Comment filed on proposed rule 09/16/2019
Retrieve Notice of Action (NOA) 08/16/2019
OMB is withholding approval at this time. Prior to publication of the final rule, the agency should provide a summary of any comments related to the information collection and their response, including any changes made to the ICR as a result of comments. In addition, the agency must enter the correct burden estimates.
  Inventory as of this Action Requested Previously Approved
36 Months From Approved
0 0 0
0 0 0
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 387c Name of Law: Federal Food, Drug, and Cosmetic Act
   US Code: 21 USC 387i 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
   US Code: 21 USC 387e(g) Name of Law: Federal Food, Drug, and Cosmetic Act
  
None

0910-AI39 Proposed rulemaking 84 FR 42754 08/16/2019

No

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

No
No
This is a new data collection.

No
    No
    No
No
Yes
Yes
Uncollected
Amber Sanford 301 796-8867 [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.
08/16/2019


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