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
0338_SS_Part_B_12 20 2012.doc Supporting Statement B	2012-12-21
Attachment 12 Response to Public Comments to Federal Register Notice_Smokeless_0920-0338.pdf Supplementary Document	2012-12-21
Attachment 11 Public Comments of published FRN 03.01.2012_Smokeless Ingredient Nicotine Reporting.pdf Supplementary Document	2012-12-21
Attachement 10 FCLAA-FDA-CDC OMB packages latest version 5-10-11.pdf Supplementary Document	2012-12-21
Attachment 9 Federal Register Notice 1994.pdf Supplementary Document	2012-12-21
Attachment 8a Guidelines to Control Protect Documents.pdf Supplementary Document	2012-12-21
Attachment 7 Certificate of Compliance_SLT.doc Supplementary Document	2012-12-21
Attachment 3 Initial Federal Notice.pdf Supplementary Document	2012-12-21
Attachment 2 Published_60d_FRN.pdf Supplementary Document	2012-12-21
Attachment 1 CSTHEA 4401-4404.pdf Supplementary Document	2012-12-21
Attachment 6b OSH Web Page on Comprehensive Smokeless Tobacco Health Education Act.pdf Supplementary Document	2012-12-21
Attachment 6a OSH tobacco Ingredient Reporting Web Page.pdf Supplementary Document	2012-12-21
Att 4c_Request for Add Info.doc Supplementary Document	2011-01-14
Att 4b_Reminder Notification Postcard.pdf Supplementary Document	2011-01-14
0338_SS_Part_A_12 20 212.doc Supporting Statement A	2012-12-21

IC Document Collections

IC ID	Document Title	Status
37761	List of Ingredients Added in the Manufacture of Smokeless Tobacco Products Other-WORD	Modified

ICR Details

OMB Control No: 0920-0338	ICR Reference No: 201212-0920-007
Status: Historical Active	Previous ICR Reference No: 201102-0920-006
Agency/Subagency: HHS/CDC	Agency Tracking No:
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: Reinstatement without change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 02/04/2013
	Date Received in OIRA: 01/03/2013
Terms of Clearance: Approved without change for 1 year consistent with the understanding that CDC will work with FDA¿s Center for Tobacco Products to identify duplication of tobacco product ingredient collections. Within this year, CDC will work with FDA, OMB, and HHS to eliminate duplication and reduce burden on respondents. As part of this effort, HHS, including CDC and FDA, should determine why the existing collection of information by the Center for Tobacco Products (OMB Control Number 0910-0650, and a pending ICR titled Reporting Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke Under the Federal Food, Drug, and Cosmetic Act) would not eliminate the need for and the practical utility of CDC¿s annual collection of this information. HHS should also consider whether the authority delegated to CDC for this collection should be delegated to the Center for Tobacco Products.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2014	36 Months From Approved
Responses	13	0	0
Time Burden (Hours)	22,269	0	0
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): US Code: 15 USC 4401 Name of Law: Comprehensive Smokeless Tobacco Education 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 12595	03/01/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 40362	07/09/2012
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
List of Ingredients Added in the Manufacture of Smokeless Tobacco Products

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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	0	0	13	0	0
Annual Time Burden (Hours)	22,269	0	0	22,269	0	0
Annual Cost Burden (Dollars)	0	0	0	0	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: No

Burden Reduction Due to:

Short Statement: This is a request for reinstatement without change of a previous approved collection. There are no changes to data collection procedures or the estimated burden per response.

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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: 12/21/2012

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