29 Jul 2025
🏭FDA Notice on Tobacco Products User Fees and Data Submission Requirements
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Tobacco Products, User Fees, Requirements for the Submission of Data Needed To Calculate User Fees for Domestic Manufacturers and Importers of Tobacco Products
Summary
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The regulatory notice informs domestic manufacturers and importers of tobacco products about their compliance obligations regarding user fee data submissions, critical for business operations and financial assessments. The additional burden hours and response estimates imply increased administrative responsibilities and potential costs.