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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

	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

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.

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

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

Federal Register Notices & Comments
Did the Agency receive public comments on this ICR? No

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Adjustment in Estimate
Annual Number of Responses	24,229	1,397	22,832
Annual Time Burden (Hours)	15,819	520	15,299
Annual Cost Burden (Dollars)	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.

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

Agency Contact: Amber Sanford 301 796-8867 amber.sanford@fda.hhs.gov

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