Rates Up, Guidance Absent: FSMA Re-inspection User Fees On Hold
This article was originally published in The Tan Sheet
Without a guidance for requesting fee reductions, FDA will not bill firms for re-inspections of facilities found non-compliant with manufacturing regulations or for costs linked to a firm failing to comply with a recall order.
You may also be interested in...
FDA will bill supplement and conventional food product firms $248 per hour for re-inspections in the US and $285 per hour outside the country in fiscal 2018, but as it has since Congress passed FSMA, the agency will not collect re-inspection and mandatory recall fees.
Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.
The first budget proposal by President Trump suggests research by FDA's National Center for Toxicological Research on food- and nutritional supplement-related issues will be curtailed as part of a $3m cut to the center's appropriation.