FSMA Fees and Burdens on Small Business on FDA Docket
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.
