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OMB Control No: 0910-0654	ICR Reference No: 202508-0910-003
Status: Received in OIRA	Previous ICR Reference No: 202410-0910-011
Agency/Subagency: HHS/FDA	Agency Tracking No: CTP
Title: Tobacco Health Document Submission
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: 09/19/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	12/31/2025
Responses	32	132
Time Burden (Hours)	1,600	1,800
Cost Burden (Dollars)	0	0

Abstract: In the guidance document, FDA requests tobacco health document submissions from manufacturers and importers of tobacco products based on the statutory requirements and compliance dates. As indicated in the guidance, all manufacturers and importers of tobacco products are required to provide immediate and ongoing submission of health documents developed after June 22, 2009. However, FDA generally does not intend to enforce the requirement at this time with respect to all such health documents, so long as a specified set of documents, those developed between June 23, 2009, and December 31, 2009, are provided at least 90 days prior to the delivery for introduction of tobacco products into interstate commerce. Thereafter, manufacturers should preserve all health documents, including those that relate to products for further manufacturing and those developed after December 31, 2009, for future submission to FDA. Respondents submit information through a facilitative electronic form or in paper form using Form FDA 3743. In both forms, FDA requests information including: submitter identification, submitter point of contact, submission format and contents (as applicable), confirmation statement, document categorization (as applicable), document readability and accessibility, and document metadata. The information collected will inform FDA's regulatory processes and decision making such as, development of good manufacturing practices, review standards for new tobacco products, and regulation of modified risk tobacco products, among others.

Authorizing Statute(s): US Code: 21 USC 904(a)(4) Name of Law: FFDCA

Citations for New Statutory Requirements: PL: Pub.L. 117 - 103 111 Name of Law: The Consolidated Appropriations Act of 2022

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:
	90 FR 27640	06/27/2025
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 45218	09/19/2025
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	32	132	-100
Annual Time Burden (Hours)	1,600	1,800	-200
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: FDA has adjusted its burden estimates to remove the 200 hours that were associated with anticipated initial submission of health documents from NTN products, based on new authority provided by the Consolidated Appropriations Act, 2022. This appropriations statute revised the FD&C Act to include language that made clear the FDA has the authority to regulate tobacco products containing nicotine from any source, which includes synthetic nicotine. Therefore, as of April 14, 2022, firms engaged in the manufacture, preparation, compounding, or processing of tobacco products containing NTN were required to provide health documents to FDA or provide a declaration that they do not have health documents via Form FDA 3743. Because the compliance period for NTN manufacturers to either submit health documents or provide the declaration has passed, FDA has removed the estimated annual burden associated with these tobacco product manufacturers (100 respondents and 200 hours). We now estimate the annual burden for this collection to be 1,600 hours.

Annual Cost to Federal Government: $132,638

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: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

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