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.
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.
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:
(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;
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.
Form FDA 3743 Tobacco Health Document Submission
0910-0654_Supporting Statement A_2025.docx
Health Document Submission Requirements for Tobacco Products; Guidance for Industry