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

Forms and Documents

Document Name	Status
Form 0920-0210 Ingredient Report Form and Instruction	Modified
Final OSH Response to RAI tsl 040519.docx Supplementary Document	2019-04-08
0920 0210 Research Determination Form Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 10B CDC Response to Comment 2 Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 9b CDC Response to Comment 1 Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 8 FRN 1994 Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 7 Statutory Provisions on Confidentiality Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 6 Certificate of Compliance Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 5b OSH WebPage on Tobacco Ing Reporting Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 5a OSH WebPage on CSTHEA Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 4b Rqst for Addl Info from Mans Pkgs Imps of Tobacco Products Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 3 Initial Federal Notice 1985 Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 2 60 day FRN Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 1b FCLAA Final.pdf Supplementary Document	2019-02-07
0920 0210 Att 1a Smoking Education Act FINAL.pdf Supplementary Document	2019-02-07
0920 0210 SSB Final tsl011619.doc Supporting Statement B	2019-02-07
0920 0210 SSA Final tsl 011619.doc Supporting Statement A	2019-02-07

IC Document Collections

IC ID	Document Title	Status
183310	Ingredient Report Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0210	ICR Reference No: 201902-0920-002
Status: Active	Previous ICR Reference No: 201401-0920-009
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0210
Title: List of Ingredients Added to Tobacco in the Manufacture of Cigarette Products
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: 04/10/2019
	Date Received in OIRA: 02/07/2019
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	04/30/2022	36 Months From Approved
Responses	55	0	0
Time Burden (Hours)	358	0	0
Cost Burden (Dollars)	20,496	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. A decrease in burden is due to fewer respondents for this approval period.

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Authorizing Statute(s): PL: Pub.L. 98 - 474 1341 Name of Law: Comprehensive Smoking Education Act
   US Code: 15 USC 1331 Name of Law: Federal Cigarette Labeling and Advertising 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:
	83 FR 42299	08/21/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 2525	02/07/2019
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
Ingredient Report	0920-0210	Recommended Cigarette 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	55	0	0	55	0	0
Annual Time Burden (Hours)	358	0	0	358	0	0
Annual Cost Burden (Dollars)	20,496	0	0	20,496	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: Decrease in burden is due to a decrease in the number of respondents from 77 to 55.

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Annual Cost to Federal Government: $79,750

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

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     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: 02/07/2019

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