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
0671_Supporting Statement_2019.docx Supporting Statement A	2019-10-24

IC Document Collections

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

ICR Details

OMB Control No: 0910-0671	ICR Reference No: 201909-0910-006
Status: Active	Previous ICR Reference No: 201607-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
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: 11/29/2019
	Date Received in OIRA: 10/30/2019
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	11/30/2022	36 Months From Approved	12/31/2019
Responses	14	0	100
Time Burden (Hours)	540	0	6,000
Cost Burden (Dollars)	168	0	1,200

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Abstract: Section 3 of the Comprehensive Smokeless Tobacco Health Education Act of 1986 (the Smokeless Tobacco Act), as amended by section 204 of the Family Smoking Prevention and Tobacco Control Act (the Tobacco Control Act), requires, among other things, that all smokeless tobacco product packages and advertisements bear one of four required warning statements. 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.

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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:
	84 FR 27638	06/13/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 57444	10/25/2019
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	14	100	0	0	-86	0
Annual Time Burden (Hours)	540	6,000	0	0	-5,460	0
Annual Cost Burden (Dollars)	168	1,200	0	0	-1,032	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: We have adjusted our burden estimate, which has resulted in a decrease of 5,460 hours and 86 respondents to the currently approved burden. We received a total number of 44 original smokeless warning plans, and a total of 17 supplements. After receiving the initial influx of original warnings plans, FDA does not expect to receive as many original warning plans annually. We expect that a few supplements will continue to be received as new products are marketed or as warning plans are revised. We anticipate a total number of 10 supplements submitted annually and 4 Original smokeless warning plans.

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Annual Cost to Federal Government: $58,000

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 10/30/2019

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