FDA Sets Fees for Import & Facility Reinspections, Etc. for FY 2015; Still No Invoices
The Food and Drug Administration set potential fiscal year 2015 fees for import reinspections, domestic and foreign facility reinspections, and recall activities performed by FDA if a firm fails to comply with a mandatory recall order, though it still isn't invoicing for services associated with the fees. The agency set FY 2015 fees of $217/hour for domestic services and $305/hour if foreign travel is required. Last year, the agency set FY 2014 at $237/hour and $302/hour, respectively. The fees are effective Oct. 1.
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FDA again said it will not send invoices for recall activity and foreign facility reinspection fees until it publishes a guidance to outline the process through which small businesses may request a fee reduction, although fees will be assessed at the fee level in effect at the time of the activity (unless fees are reduced).
Fees for importer reinspection are also still on hold until certain issues are resolved and FDA notifies the public (see 11100412), but these FY 2015 fee rates will be used to determine any importer reinspection fees that may be assessed in FY 2015. FDA is working on a guidance document on fees the agency may assess and collect from importers to cover reinspection-related costs, it said.
Fees Due Within 90 Days of Invoice; Treated as U.S. Claim if 30 Days Past Due
The fees will remain in effect through Sept. 30, 2015. The fiscal year in which the reinspection occurs dictates the fee rate to be applied, FDA said. For example, if a reinspection was conducted in September 2014 and the invoice was issued in October 2014, the fee rate to be applied would be the FY 2014 rate (see 12073133). According to FDA, the invoice clearly itemizes the fiscal year, hours and rate used to calculate the total invoice amount. FDA said this fee is to be paid by the responsible party for each domestic facility and by the U.S. agent for each foreign facility.
If fees are assessed, an invoice will be sent to the responsible party for paying the fee after FDA completes the work on which the invoice is based (FDA will not invoice until it completes its guidance for small business fee reductions). Payment must be made within 90 days of the invoice date in U.S. currency by check, bank draft, or U.S. postal money order payable to the order of the Food and Drug Administration. Detailed payment information will be included with the invoice when it’s issued, FDA said.
Any fee that is not paid within 30 days after it is due will be treated as a claim of the U.S. government subject to provisions of subchapter II of chapter 37 of title 31, U.S. Code, FDA said.
Will Charge Fee for Facility Reinspections Materially Related to Food Safety
The hourly fees will be assessed for domestic and foreign facility reinspections1 done to determine whether corrective actions have been implemented and are effective and compliance has been achieved to FDA’s satisfaction, when FDA determined that the original non-compliance was materially related to food safety requirements. FDA does not consider non-compliance of a technical nature (e.g. incorrect font size on a food label) to be non-compliance materially related to a food safety requirement, it says.
Determining when noncompliance is materially related to food safety may depend on the facts of a particular situation. FDA said it intends to issue guidance to provide additional information about the circumstances under which FDA would consider non-compliance to be materially related to a food safety requirement.
Noncompliance with Recall Orders
In addition, the hourly fees will be assessed for not complying with a mandatory recall order to cover recall activities performed by FDA associated with that order. Noncompliance may include: (1) not initiating a recall as ordered by FDA; (2) not conducting the recall in the manner specified by FDA; or (3) not providing FDA with requested information regarding the recall. Types of FDA activities could include conducting recall audit checks, reviewing periodic status reports, analyzing the status reports and the results of the audit checks, conducting inspections, traveling to and from locations, and monitoring product disposition.
The fee is to be paid by the responsible party for a domestic facility (as defined in Section 415(b) of the FD&C Act and an importer who does not comply with a recall order under Section 423 or under Section 412(f) of the FD&C Act. In other words, the party paying the fee would be the party that received the recall order.
Importer Reinspection Fees
FDA has in the past said importer reinspection fees would include at least the following four situations: (1) action on a reconditioning request; (2) action on a request for admission of detained articles; (3) action on a request to remove a product from import alert; and (4) action on a request for destruction.