Burden of Food and Drug Administration Food Safety Modernization Act Fee Amounts on Small Business; Request for Comments

Resumen

The Food and Drug Administration (FDA) is announcing the establishment of a docket to obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as set forth in the FDA Food Safety Modernization Act (FSMA). FSMA provides the Agency with authority under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to assess and collect user fees, including those for costs associated with certain domestic and foreign facility reinspections, failure to comply with a recall order, and importer reinspections. The Agency is seeking public comment on what burdens these fees impose on small business, and whether and how the Agency should alleviate such burdens. In particular, the Agency is seeking public comments on whether a reduction of fees or other consideration for small business is appropriate, and if so, what factors the Agency should consider for each. In addition, the Agency is seeking public comment on how small business should be defined or recognized. FDA is establishing this docket in order to provide an opportunity for interested parties to provide data and share views that will inform future Agenc