View Information Collection Request (ICR) Package

Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.

View ICR - OIRA Conclusion

OMB Control No: 0910-0650	ICR Reference No: 202606-0910-006
Status: Historical Inactive	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
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 11/06/2026
	Date Received in OIRA: 06/30/2026
Terms of Clearance: Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	04/30/2029	36 Months From Approved	04/30/2029
Responses	1,397	0	1,397
Time Burden (Hours)	520	0	520
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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