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

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form 0920-0338 Smokeless Tobacco Nicotine and Ingredient Report	Form and Instruction	Modified	Available
0920 0338 Research Determination Form Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Privacy Narrative Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 10b CDC Response to Comment 2 Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 9b CDC Response to Comment 1 Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 8 Disclosure of Confidential Info Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 7 Certificate of Compliance Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 6b CSLTHEA Web Page Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 6a OSH Tobacco Ing Rep Instructions Web Page Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 5 FRN Revisions to the Lab Protocol 2009 Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 4c Request for Additional Information Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 3b FRN 1994.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 3a Initial FRN 1994 Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 2 60d FRN Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 Att 1 Smokeless Tobacco Health Education Act Final.pdf	Supplementary Document	Uploaded 2019-01-15	Available
0920 0338 SSB Final.doc	Supporting Statement B	Uploaded 2019-01-15	Available
0920 0338 SSA Final tsl 011419 clean.doc	Supporting Statement A	Uploaded 2019-01-15	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
37761	Smokeless Tobacco Nicotine and Ingredient Report	Form and Instruction	Modified

ICR Details

OMB Control No: 0920-0338	ICR Reference No: 201901-0920-001
Status: Active	Previous ICR Reference No: 201402-0920-001
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-0338
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: 04/23/2019
	Date Received in OIRA: 02/27/2019
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

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2022	36 Months From Approved
Responses	11	0	0
Time Burden (Hours)	18,843	0	0
Cost Burden (Dollars)	0	0	0

---

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.

---

Authorizing Statute(s): PL: Pub.L. 99 - 252 4403 Name of Law: Comprehensive Smokeless Tobacco Health Education Act of 1986
  

Citations for New Statutory Requirements: None

---

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 163	08/22/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 4468	02/15/2019
Did the Agency receive public comments on this ICR? Yes

---

Number of Information Collection (IC) in this ICR: 1

table that charts list of burden

IC Title	Form No.	Form Name
Smokeless Tobacco Nicotine and Ingredient Report	0920-0338, 0920-0338	Ingredient Reporting Format ,   Nicotine Report Format

---

ICR Summary of Burden

table that charts list 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: Reduction due to fewer reports received in previous year

---

Annual Cost to Federal Government: $79,750

Does this IC contain surveys, censuses, or employ statistical methods? No

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

---

Common Form ICR:  No

---

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: 02/27/2019

---