More Time to Comment on Effect of New FDA Fees on Small Business
(World Trade Interactive)
The Food and Drug Administration has extended from Oct. 17 to Nov. 30 the deadline for comments on the burden of new fees on small business. These fees are associated with certain domestic and foreign facility reinspections, failures to comply with recall orders, and import reinspections and are mandated in the FDA Food Safety Modernization Act.
The facility reinspection fee will be assessed for a reinspection (a) conducted to determine whether corrective actions have been implemented and are effective and compliance has been achieved to FDA’s satisfaction at a facility that manufactures, processes, packs or holds food for consumption and (b) necessitated as a result of a previous inspection of the facility that had a final classification of Official Action Indicated when FDA determined that the non-compliance was materially related to food safety requirements of the Federal Food, Drug and Cosmetic Act. The fee for noncompliance with a recall order will be assessed for situations such as not initiating a recall as ordered by FDA, not conducting the recall in the manner specified by FDA in the recall order or not providing FDA with requested information regarding the FDA-ordered recall.
FDA also plans to impose a fee for import reinspection or re-examination in the following situations: (1) reconditioning of imported food to bring it into compliance, (2) importer request for admission of an article that has been detained , (3) request for removal from an import alert for detention without physical examination, and (4) destruction of food that has been refused admission. However, FDA has said it is not in a position to assess import reinspection fees until certain issues have been resolved.
FDA is seeking input on what burdens these fees might impose on small business, whether a reduction of fees or other consideration for small business is appropriate, and, if so, what factors should be considered for each. FDA has also requested comments on how small business should be defined or recognized. Comments submitted will be used to formulate a proposed set of guidelines on alleviating any identified burdens.
Date: October 18, 2011