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

ICR 201304-0910-003

OMB: 0910-0312

Federal Form Document

Forms and Documents
Supplementary Document
Supporting Statement A
ICR Details
0910-0312 201304-0910-003
Historical Active 201005-0910-009
HHS/FDA 18658
Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
Revision of a currently approved collection   No
Approved without change 07/16/2013
Retrieve Notice of Action (NOA) 04/10/2013
  Inventory as of this Action Requested Previously Approved
07/31/2016 36 Months From Approved 07/31/2013
302 0 25,032
302 0 125,007
0 0 3,000,000

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," the recordkeeping and disclosure requirements under section 1140.32 are not being enforced, and therefore, FDA is including 2 hours of burden as placeholders with this provision.

PL: Pub.L. 111 - 31 102 Name of Law: Tobacco Control Act

Not associated with rulemaking

  77 FR 59622 09/28/2012
78 FR 20923 04/08/2013

  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 302 25,032 0 -24,730 0 0
Annual Time Burden (Hours) 302 125,007 0 -124,705 0 0
Annual Cost Burden (Dollars) 0 3,000,000 0 -3,000,000 0 0
Miscellaneous Actions
Miscellaneous Actions
The estimated burden hours have been reduced from 125,007 hours to 302 hours. The reduction reflects: • FDA's is not enforcing § 1140.32 (for a reduction of 125,004 hours), and • The expected increase of 299 hours due to the expectation that 300 respondents will notify the FDA under § 1140.30 if they intend to use an advertising medium that is not listed in the regulation (Note that FDA has placed two 1-hour place holders for burden in § 1140.32 to reflect FDA enforcement discretion.)

Daniel Gitteson 3017965156 [email protected]


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.

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