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

Forms and Documents

Document Name	Status
0312 ss 6-16-2010.doc Supporting Statement A	2010-06-16

IC Document Collections

IC ID	Document Title	Status
5882	Format and content requirements for labeling and advertising	Modified
192945	Format and content requirements for labeling and advertising	New
192944	Scope of permissible forms of labeling and advertising	New

ICR Details

OMB Control No: 0910-0312	ICR Reference No: 201005-0910-009
Status: Historical Active	Previous ICR Reference No: 199608-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
Type of Information Collection: Reinstatement with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 06/25/2010
	Date Received in OIRA: 05/19/2010
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2013	36 Months From Approved
Responses	25,032	0	0
Time Burden (Hours)	125,007	0	0
Cost Burden (Dollars)	3,000,000	0	0

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Abstract: The regulations, which are codified at 21 CFR Part 1140 (previously codified at 21 CFR Part 897), are authorized by section 102 of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) (Public Law 111-31). Section 102 of the Tobacco Control Act requires FDA to publish a final rule regarding cigarettes and smokeless tobacco identical in its provisions to the regulation issued by FDA in 1996 (61 FR 44396, August 28, 1996) with certain specified exceptions including that subpart C (which included ? 897.24) and ? 897.32(c) be removed from the reissued rule (? 102(a)(2)(B)). In accordance with the statutory mandate, the rule includes section 1140.30 (formerly ? 897.30) which directs persons to notify FDA if they intend to use a form of advertising that is not addressed in the rule. Section 1140.32 (formerly ? 897.32) states that the advertising must use black text on a white background, but that this particular requirement does not apply to adult newspapers, magazines, periodicals, or other publications. The rule indicates that competent and reliable survey evidence is required to determine whether a particular publication is an "adult" publication.

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

Citations for New Statutory Requirements: PL: Pub.L. 111 - 31 102 Name of Law: Tobacco Control Act

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AG33	Final or interim final rulemaking	75 FR 13225	03/19/2010

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? Yes

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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

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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	25,032	0	-2,019	0	0	27,051
Annual Time Burden (Hours)	125,007	0	-80,394	0	0	205,401
Annual Cost Burden (Dollars)	3,000,000	0	-17,301,000	0	0	20,301,000

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The estimated burden hours have been reduced from 205,001 hours to 125,007. The reduction reflects the removal of 21 CFR 897.24, which were part of the 1999 information collection request for this rule, from this 2010 information collection request. The Tobacco Control Act struck these provisions from the reissued final rule.

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Annual Cost to Federal Government: $257,785

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]? Uncollected

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: 05/19/2010

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