Fees under the FSMA
New Fees under the FDA Food Safety Modernization Act
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.
The FDA Food Safety Modernization Act (FSMA), signed into law by President Obama on Jan. 4, enables FDA to better protect public health by strengthening the food safety system. FSMA specifically authorizes new fees to give FDA resources necessary to implement specific activities.
Building a new food safety system based on prevention will take time, and FDA is creating a process for getting this work done. Congress has established specific implementation dates in the legislation. The funding the Agency gets each year, which affects staffing and vital operations, will affect how quickly FDA can put this legislation into effect. FDA is committed to implementing the requirements through an open process with opportunity for input from all stakeholders.
Full Text of the Law Relating to Fees
Guidance, Rules, and Notices
VQIP
- Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2024
Docket Number: FDA-2023-N-2898 - Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2023
Docket Number: FDA-2022-N-1590 - Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2022
Docket Number: FDA-2021-N-0704 - Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2021
Docket Number: FDA-2019-N-3523 - Voluntary Qualified Importer Program User Fee Rate for Fiscal Year 2020
Docket Number: FDA-2019-N-3406
Third-Party Certification
- Third-Party Certification Program User Fee Rate for Fiscal Year 2024
Docket Number: FDA-2023-N-2897 - Third-Party Certification Program User Fee Rate for Fiscal Year 2023
Docket Number: FDA-2022-N-1592 - Third-Party Certification Program User Fee Rate for Fiscal Year 2022
Docket Number: FDA-2021-N-0702 - Third-Party Certification Program User Fee Rate for Fiscal Year 2021
Docket Number: FDA-2016-N-41195 - Third-Party Certification Program User Fee Rate for Fiscal Year 2020
Docket Number: FDA-2016-N-4119 - Third-Party Certification Program User Fee Rate for Fiscal Year 2019
Docket Number: FDA-2016-N-4119 - Third-Party Certification Program User Fee Rate for Fiscal Year 2018
Docket Number: FDA-2016-N-4119 - Third-Party Certification Program User Fee Rate for Fiscal Year 2017
Docket Number: FDA-2016-N-4119
Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection
- Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2023
Docket Number: FDA-2022-N-1591 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2022
Docket Number: FDA-2021-N-0701
Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2021
Docket Number: FDA-2018-N-2775 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2020
Docket Number: FDA-2018-N-2775 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2019
Docket Number: FDA-2018-N-2775 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2018
Docket Number: FDA-2017-N-4281 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2017
Docket Number: FDA-2016-N-0007 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2016
Docket Number: FDA-2015-N-0007 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2015
Docket Number: FDA-2013-N-0007 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2014
Docket Number: FDA-2013-N-0007 - Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2013
Docket Number: FDA-2012-N-0799 - Domestic and Foreign Facility Reinspections, Recall, and Importer Reinspection User Fee Rates for Fiscal Year 2012
Docket Number: FDA-2011-N-0528 - Proposed Rule: User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications
Docket Number: FDA-2011-N-0146
Other
- Guidance for Industry: Implementation of the Fee Provisions of Section 107 of the FDA Food Safety Modernization Act
Docket Number: FDA-2011-D-0721 - Burden of FDA FSMA Fee Amounts on Small Business
Docket Number: FDA-2011-N-0529