Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Manufactured, Imported, or Packaged in the U.S.

Forms and Documents

Document Name	Status
Smokeless Tobacco Nicotine and Ingredient Report Form	Modified
0920-0338 SS Part B_01 16 2014.doc Supporting Statement B	2014-01-27
Attachment 12b Response to Public Comment 2.docx Supplementary Document	2014-01-27
Attachment 12a Public Comment 2 to FRN 10.31.13.pdf Supplementary Document	2014-01-27
Attachment 11a Public Comment #1.pdf Supplementary Document	2014-01-27
Attachment 10 Summary of Tobacco Ingredient Collections.pdf Supplementary Document	2014-01-27
Attachment 9 Federal Register Notice (1994).pdf Supplementary Document	2014-01-27
Attachment 8b Civil Penatilies for Disclosure of Confidential Information 18USC1905.pdf Supplementary Document	2014-01-27
Attachment 8a Guidelines to Control Protect Documents.pdf Supplementary Document	2014-01-27
Attachment 7 Certificate of Compliance_SLT.doc Supplementary Document	2014-01-27
Attachment 3 Initial Federal Notice.pdf Supplementary Document	2014-01-27
Attachment 11b CDC Response to Public Comment #1.docx Supplementary Document	2014-01-27
Attachment 2a 60-day FRN 10 31 2013.pdf Supplementary Document	2014-01-27
Attachment 1 CSTHEA 4401-4404.pdf Supplementary Document	2014-01-27
Attachment 5 FRN Revisions to the Laboratory Protocol to Measure.pdf Supplementary Document	2014-01-27
Attachment 6b OSH Tobacco Ingredient Reporting Web Page.pdf Supplementary Document	2014-01-27
Attachment 6a OSH Tobacco Ingredient Reporting Web Page.pdf Supplementary Document	2014-01-27
Attachment 4c_Request for Add Information.doc Supplementary Document	2014-01-27
Attachment 4b Reminder Notification Postcard.pdf Supplementary Document	2014-01-27
0920-0338 SS Part A_01 16 2014.doc Supporting Statement A	2014-01-27

IC Document Collections

IC ID	Document Title	Status
37761	Smokeless Tobacco Nicotine and Ingredient Report Form	Modified

ICR Details

OMB Control No: 0920-0338	ICR Reference No: 201402-0920-001
Status: Historical Active	Previous ICR Reference No: 201212-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No: 21357
Title: Annual Submission of the Ingredients Added to, and the Quantity of Nicotine Contained in, Smokeless Manufactured, Imported, or Packaged in the U.S.
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: 12/17/2015
	Date Received in OIRA: 02/03/2014
Terms of Clearance: The data to be collected by the Center for Disease Control (OMB Control No.’s: 0920-0210 and 0920-0338) and FDA’s Center for Tobacco Products (OMB Control No. 0910-0650) overlap in terms of the similar tobacco product ingredient collections being conducted. However, at this time, the CTP data cannot currently be used by CDC due to both logistical reasons and restrictions on the use of information collected. OMB encourages the agencies to consider future efforts to eliminate duplication and reduce burden on respondents

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2018	36 Months From Approved	12/31/2015
Responses	13	0	13
Time Burden (Hours)	22,269	0	22,269
Cost Burden (Dollars)	0	0	0

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Abstract: This is a legislatively mandated information collection. The Comprehensive Smokeless Tobacco Health Education Act of 1986 (15 U.S.C. 4401 et seq. or Pub.L. 99-252) requires each person who manufactures, packages, or imports smokeless tobacco products to provide the Secretary of HHS with an annual list of ingredients added to tobacco in the manufacture of smokeless tobacco products, as well as a specification of quantity of nicotine contained in each product. Responsibility for collecting the information has been delegated to CDC's Office on Smoking and Health.

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Authorizing Statute(s): PL: Pub.L. 99 - 252 4403 Name of Law: Comprehensive Smokeless Tobacco Health Education Act of 1986
  

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 65323	10/31/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 4723	01/29/2014
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Smokeless Tobacco Nicotine and Ingredient Report	none, none	Nicotine Reporting Format ,   Ingredient Reporting Format

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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	13	13	0	0	0	0
Annual Time Burden (Hours)	22,269	22,269	0	0	0	0
Annual Cost Burden (Dollars)	0	0	0	0	0	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:

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Annual Cost to Federal Government: $140,000

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? Yes

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: 02/03/2014

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