Tobacco Product Establishment Registration and Submission of Certain Health Information

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form Form FDA 3741 Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution	Form and Instruction	New	Available
Form Form FDA 3741b Tobacco Product List Spreadsheet	Form and Instruction	New	Available
Form Form FDA 3741 Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution	Form and Instruction	New	Available
Form Form FDA 3741 Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution	Form and Instruction	New	Available
Form Form FDA 3741b Tobacco Product List Spreadsheet	Form and Instruction	New	Available
Form Form FDA 3741 Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution	Form and Instruction	New	Available
Form Form FDA 3741 Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution	Form and Instruction	New	Available
Form Form FDA 3741b Tobacco Product List Spreadsheet	Form and Instruction	New	Available
Form Form FDA 3741 Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution	Form and Instruction	New	Available
Form FDA 3741b Tobacco Product List Spreadsheet	Form and Instruction	Modified	Available
Form eSubmitter; FDA Fo Tobacco Ingredients Importer	Form and Instruction	Unchanged	Available
Form eSubmitter; FDA Fo Tobacco Ingredients Manufacturer	Form and Instruction	Unchanged	Available
Form FDA 3742 Tobacco Product Ingredients Importer form	Form and Instruction	Unchanged	Available
Form FDA 3741 (New) Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution	Form and Instruction	Modified	Available
Form FDA 3741a (Current Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments	Form and Instruction	Modified	Available
Form FDA 3742 Listing of Ingredients in Tobacco Products	Form and Instruction	Unchanged	Available
Form FDA 3741a (Current) Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments	Form and Instruction	Modified	Available
Form FDA 3741 Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution	Form and Instruction	Modified	Available
Updated Wireframes for v.3.0 OMB submission.pdf	Supplementary Document	Uploaded 2026-06-29	Available
Form 3741 v2.0 to v.3.0 Net Change (4.28.26 for OMB).pdf	Supplementary Document	Uploaded 2026-06-29	Available
0910-0650-RL Proposed Rule_Supporting Statement A.docx	Supporting Statement A	Uploaded 2026-06-29	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
281086	(Proposed Rule) Recurring - Domestic and Foreign Maintaining historical file		New
281085	(Proposed Rule) First Time - Domestic and Foreign Maintaining historical file		New
281084	(Proposed Rule) Recurring - Foreign Waiver from electronic submission requirement		New
281083	(Proposed Rule) Recurring - Foreign Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741	Form and Instruction	New	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
281082	(Proposed Rule) Recurring - Foreign Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Product List Spreadsheet"	Form and Instruction	New	Tobacco Product List Spreadsheet
281081	(Proposed Rule) Recurring - Foreign Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741	Form and Instruction	New	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
281080	(Proposed Rule) First Time - Foreign Waiver from electronic submission requirement		New
281079	(Proposed Rule) First Time - Foreign Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741	Form and Instruction	New	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
281078	(Proposed Rule) First Time - Foreign Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Product List Spreadsheet"	Form and Instruction	New	Tobacco Product List Spreadsheet
281077	(Proposed Rule) First Time - Foreign Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741	Form and Instruction	New	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
281076	(Proposed Rule) Recurring - Domestic Waiver from electronic submission requirement 1108.40		New
281075	(Proposed Rule) First Time - Domestic Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741	Form and Instruction	New	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
281074	(Proposed Rule) First Time - Domestic Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Product List Spreadsheet"	Form and Instruction	New	Tobacco Product List Spreadsheet
281073	(Proposed Rule) First Time - Domestic Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741	Form and Instruction	New	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
281072	(Proposed Rule) First Time - Domestic Waiver from electronic submission requirement		New
273233	(Proposed Rule Change) Recurring - Domestic Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Tobacco Product List Spreadsheet"	Form and Instruction	Modified	Tobacco Product List Spreadsheet
217656	Tobacco Product Listing Form FDA 3742, "Listing of Ingredients" Section 904(c)	Form and Instruction	Unchanged	Tobacco Ingredients Importer
217656	Tobacco Product Listing Form FDA 3742, "Listing of Ingredients" Section 904(c)	Form and Instruction	Unchanged	Tobacco Ingredients Manufacturer
217656	Tobacco Product Listing Form FDA 3742, "Listing of Ingredients" Section 904(c)	Form and Instruction	Unchanged	Tobacco Product Ingredients Importer form
217655	(Proposed Rule Change) Recurring - Domestic Establishment Registration (Renewal), the registration renewal of a tobacco product establishment	Form and Instruction	Modified	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
217655	(Proposed Rule Change) Recurring - Domestic Establishment Registration (Renewal), the registration renewal of a tobacco product establishment	Form and Instruction	Modified	Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments
217655	(Proposed Rule Change) Recurring - Domestic Establishment Registration (Renewal), the registration renewal of a tobacco product establishment	Other-TRLM NG Industry Creating a New Registration	Modified
191383	Obtaining a Dun and Bradstreet D-U-N-S Number	Other-Guidance; Listing of Ingredients in Tobacco Products	Unchanged
191382	Tobacco Product Listing Form FDA 3742, "Listing of Ingredients in Tobacco Products" Section 904(a)(1)	Form and Instruction	Unchanged	Listing of Ingredients in Tobacco Products
191382	Tobacco Product Listing Form FDA 3742, "Listing of Ingredients in Tobacco Products" Section 904(a)(1)	Other-TRLM NG Industry Creating a New Registration	Unchanged
191227	(Proposed Rule Change) Recurring - Domestic Establishment Registration (Initial), the initial registration of a tobacco product establishment	Form and Instruction	Modified	(Current) Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments
191227	(Proposed Rule Change) Recurring - Domestic Establishment Registration (Initial), the initial registration of a tobacco product establishment	Form and Instruction	Modified	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
191227	(Proposed Rule Change) Recurring - Domestic Establishment Registration (Initial), the initial registration of a tobacco product establishment	Other-Establishment Registration and Tobacco Product Listing	Modified

ICR Details

OMB Control No: 0910-0650	ICR Reference No: 202606-0910-006
Status: Received in OIRA	Previous ICR Reference No: 202412-0910-013
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Product Establishment Registration and Submission of Certain Health Information
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 06/30/2026

table that charts list comparision

	Requested	Previously Approved
Expiration Date	36 Months From Approved	04/30/2029
Responses	24,229	1,397
Time Burden (Hours)	15,819	520
Cost Burden (Dollars)	0	0

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Abstract: The Federal Food, Drug, and Cosmetic Act (FD&C Act), amended by the Tobacco Control Act of 2009, grants FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect the public health generally and to reduce tobacco use by minors. Section 905 of the FD&C Act requires the annual registration of any establishment in any State engaged in the manufacture, preparation, compounding, or processing of a tobacco product or tobacco products. Section 904 of the FD&C Act requires that each tobacco product manufacturer or importer submit a listing of all ingredients and additives that are added by the manufacturer to each tobacco product by brand and by quantity in each brand and sub brand. Section 904 also requires that a tobacco product manufacturer advise the FDA in writing prior to adding any new tobacco additive or increasing in quantity an existing tobacco additive. It also requires that a tobacco product manufacturer advise the FDA in writing prior to eliminating or decreasing an existing additive, or adding or increasing an additive designated by the FDA as not a human or animal carcinogen, or otherwise harmful to health under intended conditions of use.

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Authorizing Statute(s): US Code: 21 USC 905 Name of Law: FFDCA
   US Code: 21 USC 904 Name of Law: FFDCA
   PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH59	Proposed rulemaking	91 FR 39168	06/29/2026

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 21

table that charts list of burden

IC Title	Form No.	Form Name
(Proposed Rule Change) Recurring - Domestic Establishment Registration (Initial), the initial registration of a tobacco product establishment	FDA 3741 , FDA 3741a	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution ,   (Current) Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments
(Proposed Rule Change) Recurring - Domestic Establishment Registration (Renewal), the registration renewal of a tobacco product establishment	FDA 3741a (Current), FDA 3741 (New)	Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments ,   Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
(Proposed Rule Change) Recurring - Domestic Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Tobacco Product List Spreadsheet"	FDA 3741b	Tobacco Product List Spreadsheet
(Proposed Rule) First Time - Domestic Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741	Form FDA 3741	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
(Proposed Rule) First Time - Domestic Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741	Form FDA 3741	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
(Proposed Rule) First Time - Domestic Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Product List Spreadsheet"	Form FDA 3741b	Tobacco Product List Spreadsheet
(Proposed Rule) First Time - Domestic Waiver from electronic submission requirement
(Proposed Rule) First Time - Domestic and Foreign Maintaining historical file
(Proposed Rule) First Time - Foreign Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741	Form FDA 3741	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
(Proposed Rule) First Time - Foreign Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741	Form FDA 3741	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
(Proposed Rule) First Time - Foreign Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Product List Spreadsheet"	Form FDA 3741b	Tobacco Product List Spreadsheet
(Proposed Rule) First Time - Foreign Waiver from electronic submission requirement
(Proposed Rule) Recurring - Domestic Waiver from electronic submission requirement 1108.40
(Proposed Rule) Recurring - Domestic and Foreign Maintaining historical file
(Proposed Rule) Recurring - Foreign Establishment Registration (Initial), the initial registration of a tobacco product establishment using Form FDA 3741	Form FDA 3741	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
(Proposed Rule) Recurring - Foreign Establishment Registration (Renewal), the registration renewal of a tobacco product establishment using Form FDA 3741	Form FDA 3741	Registration of Tobacco Product Establishments and Listing of Tobacco Products in Commercial Distribution
(Proposed Rule) Recurring - Foreign Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Product List Spreadsheet"	Form FDA 3741b	Tobacco Product List Spreadsheet
(Proposed Rule) Recurring - Foreign Waiver from electronic submission requirement
Obtaining a Dun and Bradstreet D-U-N-S Number
Tobacco Product Listing Form FDA 3742, "Listing of Ingredients in Tobacco Products" Section 904(a)(1)	FDA 3742	Listing of Ingredients in Tobacco Products
Tobacco Product Listing Form FDA 3742, "Listing of Ingredients" Section 904(c)	FDA 3742, eSubmitter; FDA Form 3742 , eSubmitter; FDA Form 3742	Tobacco Product Ingredients Importer form ,   Tobacco Ingredients Manufacturer ,   Tobacco Ingredients Importer

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ICR Summary of Burden

table that charts list 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	24,229	1,397	0	0	22,832	0
Annual Time Burden (Hours)	15,819	520	0	0	15,299	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: The information collections in the proposed rule would represent a significant expansion of current section 905 requirements to registration and listing requirements for foreign owners and operators. Currently, only domestic owners and operators of establishments engaged in manufacturing, preparation, compounding, or processing of tobacco products are required to register their establishments and list their products with the FDA, while foreign owners and operators remain exempt from these requirements, creating a substantial information gap for the Agency. This rule is accompanied with updated and improved online submission Forms FDA 3741 and Form FDA 3741b (submitted via TRLM-NG). With this rule, there would be a new associated burden for requesting a waiver from electronic format requirement. Submitters with an approved waiver would be able to submit by paper. Additionally, the proposed rule will newly include a recordkeeping element encompassing historical file containing a copy of all consumer information, labeling, and advertisements in use as of the effective date of the rule for all tobacco products contained in the product list for four years. This requirement will be for both domestic and foreign establishments. FDA estimates an overall increase in average hours per response associated with initial registration using Form FDA 3741 (from 100 minutes to 110 minutes), and the initial product listing spreadsheet (Form FDA 3741b) submission (from 20 minutes to 25 minutes) for domestic entities since the last extension of this collection. In addition, the increase in burden also reflects burden hours from foreign entities. Adjustments - All adjustments are the result of a deliberate federal action.

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Annual Cost to Federal Government: $2,122,208

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.     Yes

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

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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: 06/30/2026

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