Requirements under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Family Smoking Prevention and Tobacco Control Act

Forms and Documents

Document Name	Status
SS 0910-0671 2013 FINAL.doc Supporting Statement A	2013-06-07

IC Document Collections

IC ID	Document Title	Status
193985	Submission of rotational warning plans for health warning label statements Instruction	Modified

ICR Details

OMB Control No: 0910-0671	ICR Reference No: 201306-0910-004
Status: Historical Active	Previous ICR Reference No: 201007-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: 19749
Title: Requirements under the Comprehensive Smokeless Tobacco Health Education Act of 1986, as amended by the Family Smoking Prevention and Tobacco Control Act
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/16/2013
	Date Received in OIRA: 06/10/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2016	36 Months From Approved	10/31/2013
Responses	100	0	20
Time Burden (Hours)	6,000	0	2,000
Cost Burden (Dollars)	1,200	0	240

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Abstract: This information collection--the submission to FDA of warning plans for smokeless tobacco products--is statutorily mandated. The Smokeless Tobacco Act requires that the warnings be displayed on packaging and advertising for each brand of smokeless tobacco "in accordance with a plan submitted by the tobacco product manufacturer, importer, distributor, or retailer" to, and approved by, FDA. The warning plans will be reviewed by FDA, to determine whether the companies' plans for the equal distribution and display of warning statements on packaging and the quarterly rotation of warning statements in advertising for each brand requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements. The Act does not specify the means for submission of warning plans. There are three ways to submit warning plans: electronic format submitted via the FDA Electronic Submission Gateway; electronic format submitted on physical media (e.g., CD or DVD); or paper format.

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Authorizing Statute(s): PL: Pub.L. 113 - 31 3 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:
	78 FR 16678	03/18/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 34107	06/06/2013
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 1

IC Title	Form No.	Form Name
Submission of rotational warning plans for health warning label statements

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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	100	20	0	0	80	0
Annual Time Burden (Hours)	6,000	2,000	0	0	4,000	0
Annual Cost Burden (Dollars)	1,200	240	0	0	960	0

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: This is a request for an extension with an adjustment in burden due to new estimates. The number of respondents is expected to increase from 20 to 100 and the number of burden hours is expected to increase from 2,000 to 6,000 hours due to FDA's estimates that new smokeless tobacco companies will submit warning plans under this collection of information. The total increase in burden is 4,000 hours, due to an expected increase in industry education and more importers and retailers realizing that they will need to submit warning plans.

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Annual Cost to Federal Government: $58,000

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: 06/10/2013

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