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 052212.doc Supporting Statement B	2012-06-29
Att 12 Resp to 60d FRN Publ Comts.pdf Supplementary Document	2012-06-29
Att 11 60d FRN Publ Comts.pdf Supplementary Document	2012-06-29
Att 10 FCLAA-FDA-CDC OMB (latest version 051011).pdf Supplementary Document	2012-06-29
Att 9 1994 FRN.pdf Supplementary Document	2012-06-29
Att 7 Cert of Compl_SLT.doc Supplementary Document	2012-06-29
Att 2 Published 60d FRN.pdf Supplementary Document	2012-06-29
Att 8a Guidelines to Ctrl Prot Docs.pdf Supplementary Document	2012-06-29
Att 1 CSTHEA 4401-4404.pdf Supplementary Document	2012-06-29
Att 3 1985 FRN.pdf Supplementary Document	2012-06-29
Att 6b Web Page_OSH Comp Smokeless Tob Hlth Edu Act.pdf Supplementary Document	2012-06-29
Att 6a Web Page_OSH Tob Ingred Rep.pdf Supplementary Document	2012-06-29
Att 4c Reminder Notification.doc Supplementary Document	2012-06-29
Att 4b Reminder Notification.pdf Supplementary Document	2012-06-29
0338 SS Part A 052212.doc Supporting Statement A	2012-06-29

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: 201207-0920-005
Status: Historical Inactive	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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Improperly submitted and continue	Conclusion Date: 08/30/2012
	Date Received in OIRA: 07/16/2012
Terms of Clearance: Per the previous terms of clearance, "CDC will work with FDA’s Center for Tobacco Products to identify duplication of tobacco product ingredient collections. No later than one year from the date of this approval, CDC will submit a brief report to OMB identifying redundancies in the data collections along with strategies for eliminating duplication and reducing burden on respondents." The last element of these terms (strategies for eliminating duplication and reducing burden on respondents) has not been provided. Therefore, the collection is being returned as improperly submitted.

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2012	36 Months From Approved	10/01/2012
Responses	11	0	11
Time Burden (Hours)	18,843	0	18,843
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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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: There is no change in how the information is being collected. However, there is an increase number of respondents, which increases the burden hour. There is no change in the annual response burden fo each company, due to the fact that some respondents report only one product, or brand, and other respondents could report as many as 20, which burden and cost for an individual respondent may differ from the overal average.

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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: 07/16/2012

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