Earlier this year, the United States Food and Drug Administration (FDA) announced new fees for failure to comply with a recall order, importer re-inspections and some facility re-inspections. The U.S. FDA Food Safety Modernization Act (FSMA) amends the Federal Food, Drug and Cosmetic Act (FD&C Act) and mandates that the U.S. FDA contemplate the burden of these fees on small businesses. The fees are imposed as a means to capture the costs incurred by the U.S. FDA performing these activities each year. Effective October 1, 2011, these fees could result in large costs for companies exporting to the United States. These fees are especially concerning to small companies which might not have the means to pay.
What can be done to reduce the burden on businesses facing economic hardship?
Realizing the potential effect on businesses, the U.S. FDA requested permission to use emergency clearance procedures to obtain Office of Management and Budget (OMB) approval of the information collection related to the Economic Hardship Fee Reduction Guidance. If the U.S. FDA were to use the normal clearance procedures instead of emergency clearance procedures, the approval of the information collection would not be finalized in time to issue invoices for fees, as FDA intends, in January 2012. With its emergency request, the FDA is attempting to speed up the processing of the economic hardship fee reduction guidance.
When will the Guidance document be published for the Economic Hardship Fee Reduction?
The U.S. FDA is requesting OMB approval of this emergency processing by January 6, 2012. The Economic Hardship Fee Reduction Guidance will provide information to firms who may wish to apply for a reduction in fees that have been invoiced in FY 2012.
Is the Economic Hardship Fee Reduction Guidance the same as the Small Business Guidelines?
No. During fiscal year 2012, U.S. FDA will consider waiving some or all of an invoiced fee based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors. Independently, FSMA provides that U.S. FDA shall develop a proposed set of guidelines in consideration of the burden of fee amounts on small businesses. Currently, the Agency is reviewing the public comments received in response to the August 1, 2011, Federal Register notice seeking information to be used in developing these proposed guidelines, which U.S. FDA intends to publish for comment in fiscal year 2012.
For questions related to U.S. FDA fees or any U.S. FDA regulation, you can contact Registrar Corp 24/7 at www.registrarcorp.com/livehelp or call us at +1-757-224-0177.