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

Forms and Documents

Document Name	Status
UCM210766.pdf Supplementary Document	2013-07-12
0910-0312 tobacco regs SS.doc Supporting Statement A	2013-07-11

IC Document Collections

IC ID	Document Title	Status
5882	Format and Content Requirements for labeling and advertising - 3rd party	Modified
192945	Format and content requirements for labeling and advertising	Modified
192944	Scope of permissible forms of labeling and advertising	Modified

ICR Details

OMB Control No: 0910-0312	ICR Reference No: 201304-0910-003
Status: Historical Active	Previous ICR Reference No: 201005-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: 18658
Title: Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 07/16/2013
	Date Received in OIRA: 04/10/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	07/31/2016	36 Months From Approved	07/31/2013
Responses	302	0	25,032
Time Burden (Hours)	302	0	125,007
Cost Burden (Dollars)	0	0	3,000,000

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Abstract: 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.

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Authorizing Statute(s): PL: Pub.L. 111 - 31 102 Name of Law: Tobacco Control Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 59622	09/28/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 20923	04/08/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Scope of permissible forms of labeling and advertising
Format and content requirements for labeling and advertising
Format and Content Requirements for labeling and advertising - 3rd party

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ICR Summary of Burden

	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

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: 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.)

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Annual Cost to Federal Government: $116,000

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 04/09/2013

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