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 0920-0338 Smokeless Tobacco Product Manufacturers, Packagers, and Importers Form and Instruction	Modified
Form 0920-0338 Smokeless Tobacco Product Manufacturers, Packagers, and Importers Form and Instruction	New
0338 PN.pdf Supplementary Document	2022-04-19
0338 Att 8b Civil Penalties for Disclosure of Confidential Info.pdf Supplementary Document	2022-04-19
0338 Att 8a Gdelines to Control Protect Docs that Contain Privileged Info.pdf Supplementary Document	2022-04-19
0338 Att 7 Compliance Cert Manufacs Pkgers & Imps of Smokeless Tobacco Products.pdf Supplementary Document	2022-04-19
0338 Att 6b OSH Tobacco Ing and Nicotine Rptng Instructs Webpage.pdf Supplementary Document	2022-04-19
0338 Att 6a OSH Comp Smokeless Tobacco Health Ed Act Webpage.pdf Supplementary Document	2022-04-19
0338 Att 5 FRN Revs to Lab Protocol.pdf Supplementary Document	2022-04-19
0338 Att 4d Human Subjects Non-research Determination.pdf Supplementary Document	2022-04-19
0338 Att 4c Req for Addl Info from Manufacs, Pkgers & Imps of Tobacco Products.pdf Supplementary Document	2022-04-19
0338 Att 3 Smokeless Tobacco Sub Req.pdf Supplementary Document	2022-04-19
0338 Att 1 Comp Smokeless Tobacco Health Ed Act.pdf Supplementary Document	2022-04-19
0920 0338 Research Determination Form Final.pdf Supplementary Document	2019-01-15
0920 0338 Privacy Narrative Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 10b CDC Response to Comment 2 Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 9b CDC Response to Comment 1 Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 8 Disclosure of Confidential Info Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 7 Certificate of Compliance Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 6b CSLTHEA Web Page Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 6a OSH Tobacco Ing Rep Instructions Web Page Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 5 FRN Revisions to the Lab Protocol 2009 Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 4c Request for Additional Information Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 3b FRN 1994.pdf Supplementary Document	2019-01-15
0920 0338 Att 3a Initial FRN 1994 Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 2 60d FRN Final.pdf Supplementary Document	2019-01-15
0920 0338 Att 1 Smokeless Tobacco Health Education Act Final.pdf Supplementary Document	2019-01-15
0338 SSB.docx Supporting Statement B	2022-04-18
0338 SSA.docx Supporting Statement A	2022-04-18

IC Document Collections

IC ID	Document Title	Status
37761	Smokeless Tobacco Product Manufacturers, Packagers, and Importers Form and Instruction	Modified
252931	Smokeless Tobacco Product Manufacturers, Packagers, and Importers Form and Instruction	New

ICR Details

OMB Control No: 0920-0338	ICR Reference No: 202204-0920-001
Status: Received in OIRA	Previous ICR Reference No: 201901-0920-001
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: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 04/19/2022

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2022
Responses	22	11
Time Burden (Hours)	18,843	18,843
Cost Burden (Dollars)	0	0

---

Abstract: This Information Collection Request (ICR) supports the Extension of a Congressionally 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:
	86 FR 53305	09/27/2021
30-day Notice:	Federal Register Citation:	Citation Date:
	87 FR 22889	04/18/2022
Did the Agency receive public comments on this ICR? No

---

Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Smokeless Tobacco Product Manufacturers, Packagers, and Importers	0920-0338	SLT Nicotine Report
Smokeless Tobacco Product Manufacturers, Packagers, and Importers	0920-0338	SLT Ingredient Report

---

ICR Summary of Burden

	Total Request	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	22	11	0	11	0	0
Annual Time Burden (Hours)	18,843	18,843	0	0	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: Yes

Burden Reduction Due to: Miscellaneous Actions

Short Statement: This Information Collection Request (ICR) supports the Extension of a Congressionally mandated information collection with an estimated 18,843 burden hours.

---

Annual Cost to Federal Government: $66,250

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? No

---

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: 04/19/2022

---