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
Form no number List of Ingredients Added in the Manufacture of Smokeless Tobacco Products Form and Instruction	Modified
Attachment 9. FRN 11-08-94.doc Supplementary Document	2007-12-12
Attachment 7. FRN 12-03-85.doc Supplementary Document	2007-12-12
Attachment 6. Confidentiality Guidelines PL 98-474.doc Supplementary Document	2007-12-12
Attachment 5. 60-day FRN 7.24.07.pdf Supplementary Document	2007-12-12
Attachment 2. Civil Penalties for Disclosure.doc Supplementary Document	2007-12-12
Attachment 1. Legislative Authority.doc Supplementary Document	2007-12-12
Attachment 8. Request for Add Info.doc Supplementary Document	2007-12-12
Attachment 4b. OSH Web Page on Act.pdf Supplementary Document	2007-12-12
Attachment 3. Reminder Postcard.doc Supplementary Document	2007-12-12
0920-0338 SS 12.06.07.doc Supporting Statement A	2007-12-19

IC Document Collections

IC ID	Document Title	Status
37761	List of Ingredients Added in the Manufacture of Smokeless Tobacco Products Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0338	ICR Reference No: 200801-0920-001
Status: Historical Active	Previous ICR Reference No: 200503-0920-005
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 with change of a previously approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/02/2008
	Date Received in OIRA: 01/03/2008
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2011	36 Months From Approved
Responses	11	0	0
Time Burden (Hours)	18,843	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: The Comprehensive Smokeless Tobacco Health Education Act of 1986 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 the quantity of nicotine contained in each product. CDC has been delegated the authority for implementing this regulation. HHS uses the information in research on the health effects of ingredients added to tobacco in the manufacture of smokeless tobacco products and to prepare reports to Congress.

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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:
	72 FR 40296	07/24/2007
30-day Notice:	Federal Register Citation:	Citation Date:
	72 FR 71414	12/17/2007
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
List of Ingredients Added in the Manufacture of Smokeless Tobacco Products	no number	Tobacco Ingredient Reporting Web Page

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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	11	0	0	11	0	0
Annual Time Burden (Hours)	18,843	0	0	18,843	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 a reinstatement of a Congressionally-mandated information collection that has been previously approved by OMB. The previous approval expired August 31, 2007.

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Annual Cost to Federal Government: $140,000

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]? Uncollected

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? Uncollected

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? Uncollected

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: 01/03/2008

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