Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents

ICR 201909-0910-002

OMB: 0910-0312

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2019-10-11
IC Document Collections
IC ID
Document
Title
Status
192944
Modified
ICR Details
0910-0312 201909-0910-002
Active 201605-0910-015
HHS/FDA CTP
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
Extension without change of a currently approved collection   No
Regular
Approved without change 12/30/2019
Retrieve Notice of Action (NOA) 11/04/2019
  Inventory as of this Action Requested Previously Approved
12/31/2022 36 Months From Approved 12/31/2019
25 0 300
25 0 300
0 0 0

This is a request for OMB renewal for FDA's regulations for cigarettes and smokeless tobacco containing nicotine. The codified regulations at 21 CFR Part 1140 are authorized by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). This collection includes reporting information requirements for § 1140.30, which directs persons to notify FDA if they intend to use a form of advertising that is not addressed in the regulations. As the public is being advised through the FDA guidance entitled "Enforcement Policy Concerning Certain Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco"

PL: Pub.L. 111 - 31 102 Name of Law: Tobacco Control Act
  
None

Not associated with rulemaking

  84 FR 22496 05/17/2019
84 FR 58721 11/01/2019
Yes

1
IC Title Form No. Form Name
Scope of permissible forms of labeling and advertising

  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 25 300 0 0 -275 0
Annual Time Burden (Hours) 25 300 0 0 -275 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
We have adjusted our burden estimate to approximately 25 notifications annually, which more accurately reflects the current number of submissions under this regulation. This is a decrease to the currently approved burden. The decrease in notifications is not unexpected given that the regulation applies to cigarettes and smokeless tobacco and many of the alternative media notifications have been made in previous years.

$116,000
No
    Yes
    No
No
No
No
Uncollected
Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

  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.
11/04/2019


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