List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products

Forms and Documents

Document Name	Status
0920-0210 SS Part B_12 27 12.doc Supporting Statement B	2012-12-28
Attachment 11 Response to Public Comments_6.13.12.doc Supplementary Document	2012-12-21
Attachment 10 Public Comments on the FRN.pdf Supplementary Document	2012-12-21
Attachment 9 Summary of Tobacco Ingredient Collections.pdf Supplementary Document	2012-12-21
Attachment 7b Statutory Provisions on Confidentiality.pdf Supplementary Document	2012-12-21
Attachment 7a Guidelines to Control Protect Documents that contain Privileged info.pdf Supplementary Document	2012-12-21
Attachment 6 Certificate of Compliance.doc Supplementary Document	2012-12-21
Attachment 5b OSH Web Page on Tobacco Ingredient Reporting.pdf Supplementary Document	2012-12-21
Attachment 5a OSH Web Page CSTHEA.pdf Supplementary Document	2012-12-21
Attachment 3 Initial Federal Notice.pdf Supplementary Document	2012-12-21
Attachment 2 Federal Register Notice.pdf Supplementary Document	2012-12-21
Attachment 1b FCLAA.pdf Supplementary Document	2012-12-21
Attachment 1a Smoking Education Act.pdf Supplementary Document	2012-12-28
Attachment 4c Request for Additional Information.pdf Supplementary Document	2012-12-28
Attachment 4b Reminder Notification.pdf Supplementary Document	2012-12-28
Attachment 8. Request for Add Info.doc Supplementary Document	2007-12-12
0920-0210 SS Part A_12 27 12.doc Supporting Statement A	2012-12-28

IC Document Collections

IC ID	Document Title	Status
183310	Ingredient Report Other-WORD	Modified

ICR Details

OMB Control No: 0920-0210	ICR Reference No: 201301-0920-003
Status: Historical Active	Previous ICR Reference No: 201102-0920-007
Agency/Subagency: HHS/CDC	Agency Tracking No:
Title: List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products
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: 01/04/2013
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	77	0	0
Time Burden (Hours)	501	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This is a legislatively mandated information collection. Since 1986, as required by the Comprehensive Smoking Education Act of 1984 (CSEA, 15 U.S.C. 1336 or P.L. 98-474) CDC's Office on Smoking and Health has collected information from cigarette manufacturers, packagers and importers about the ingredients used in cigarette products. This collection is commonly known as the Ingredient Report.

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Authorizing Statute(s): US Code: 15 USC 1331 Name of Law: Federal Cigarette Labeling and Advertising Act
   PL: Pub.L. 98 - 474 1341 Name of Law: Comprehensive Smoking 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 11126	02/24/2012
30-day Notice:	Federal Register Citation:	Citation Date:
	77 FR 37677	06/22/2012
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
Ingredient Report

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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	77	0	0	77	0	0
Annual Time Burden (Hours)	501	0	0	501	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 reinstatement without changes after discussion with OMB and FDA.

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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? 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: 01/04/2013

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