Tobacco Product Establishment Registration and Submission of Certain Health Information

Forms and Documents

Document Name	Status
Form FDA 3741b Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Tobacco Product List Spreadsheet" Form and Instruction	New
Form FDA 3742 Tobacco Product Listing Form FDA 3742, "Listing of Ingredients" Section 904(c) Form and Instruction	Modified
Form FDA 3471 (Current) Establishment Registration (Renewal), the registration renewal of a tobacco product establishment Form and Instruction	Modified
Form FDA 3742 Tobacco Product Listing Form FDA 3742, "Listing of Ingredients in Tobacco Products" Section 904(a)(1) Form and Instruction	Modified
Form FDA 3741 Establishment Registration (Initial), the initial registration of a tobacco product establishment Form and Instruction	Modified
Net Changes from previous 3741 version.pdf Supplementary Document	2025-09-12
0910-0650_Supporting Statement A_2025.docx Supporting Statement A	2025-09-12

IC Document Collections

IC ID	Document Title	Status
273233	Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Tobacco Product List Spreadsheet" Form and Instruction	New
217656	Tobacco Product Listing Form FDA 3742, "Listing of Ingredients" Section 904(c) Form and Instruction	Modified
217655	Establishment Registration (Renewal), the registration renewal of a tobacco product establishment Form and Instruction	Modified
191383	Obtaining a Dun and Bradstreet D-U-N-S Number Other-Guidance; Listing of Ingredients in Tobacco Products	Modified
191382	Tobacco Product Listing Form FDA 3742, "Listing of Ingredients in Tobacco Products" Section 904(a)(1) Form and Instruction	Modified
191227	Establishment Registration (Initial), the initial registration of a tobacco product establishment Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0650	ICR Reference No: 202412-0910-013
Status: Received in OIRA	Previous ICR Reference No: 202303-0910-009
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: 09/15/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	10/31/2025
Responses	1,397	3,258
Time Burden (Hours)	520	962
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): PL: Pub.L. 111 - 111 31 Name of Law: Family Smoking Prevention and Tobacco Control Act
   US Code: 21 USC 905 Name of Law: FFDCA
   US Code: 21 USC 904 Name of Law: FFDCA
  

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:
	90 FR 5909	01/17/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 43455	09/09/2025
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 6

IC Title	Form No.	Form Name
Establishment Registration (Initial), the initial registration of a tobacco product establishment	FDA 3741 , FDA 3741a , FDA 3741	(Current) Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments ,   (Current) Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments ,   (New) Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments
Establishment Registration (Renewal), the registration renewal of a tobacco product establishment	FDA 3471 (Current), FDA 3741a (Current), FDA 3741 (New)	Registration and Listing for Owners and Operators of Domestic Tobacco Product Establishments ,   Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments ,   Registration and Listing for Owners and Operators of Domestic Deemed Tobacco Product Establishments
Obtaining a Dun and Bradstreet D-U-N-S Number
Product Listing (Initial), the initial listing of tobacco products (New) Form FDA 3741b, "Tobacco Product List Spreadsheet"	FDA 3741b	Tobacco Product List Spreadsheet
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

	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	1,397	3,258	0	0	-1,861	0
Annual Time Burden (Hours)	520	962	0	0	-442	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: Based on the combined impacts of program changes and adjustments, our estimated burden for the information collection reflects an overall decrease of 442 annual burden hours and a decrease of 1,861 annual responses.

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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: 09/15/2025

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