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

ICR 201605-0910-015

OMB: 0910-0312

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-05-19
ICR Details
0910-0312 201605-0910-015
Historical Active 201304-0910-003
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 12/16/2016
Retrieve Notice of Action (NOA) 06/21/2016
  Inventory as of this Action Requested Previously Approved
12/31/2019 36 Months From Approved 12/31/2016
300 0 302
300 0 302
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

  81 FR 1428 01/12/2016
81 FR 40319 06/21/2016
No

  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 300 302 0 0 -2 0
Annual Time Burden (Hours) 300 302 0 0 -2 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$116,000
No
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.
06/21/2016


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