The Food and Drug Administration (FDA) has issued a notice and request for comments about fiscal year 2012 fees under the Food Safety Modernization Act (FSMA). The fee rates, intended to “capture 100 percent of the costs of each activity,” will be assessed for facility reinspections, recalls and importer reinspections. If no foreign travel is required, the rate will be $224 per hour, and if foreign travel is required, the fee increases to $335 per hour. While a separate schedule has not been established for small businesses, FDA indicates that it will waive the fees “in limited cases . . . based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors.”
FDA has also established 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).” The agency is requesting public comment on the burdens “these fees impose on small business, and whether and how the Agency should alleviate such burdens.” Specifically requested are comments on whether the fees should be reduced for small business and how to define small business. Comments must be submitted by October 17, 2011. See Federal Register, August 1, 2011.