FDA Raises Fees for Import & Facility Reinspections, Etc. for FY 2014; Still No Invoices

FDA 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 on hold until certain issues are resolved and FDA notifies the public (see 11100412), but these FY 2014 fee rates will be used to determine any importer reinspection fees that may be assessed in FY 2014. FDA is working on a guidance document on fees the agency may assess and collect from importers to cover reinspection-related costs, it said.

To Charge $238/hour for Domestic, $302/hour for Foreign; Up from FY 2013

The FY 2014 rates are $237/hour if no foreign travel is required and $302/hour if foreign travel is required. This is up from the FY 2013 rates of $221/hour if no foreign travel is required, and $289/hour if foreign travel is required.

The fees are effective Oct. 1, 2013, and will remain in effect through Sept. 30, 2014. 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 2013 and the invoice was issued in October 2013, the fee rate to be applied would be the FY 2013 rate (see 12073133). According to FDA, the invoice clearly itemizes the fiscal year, hours and rate used to calculate the total invoice amount.

Fees Due Within 90 Days of Invoice; Treated as U.S. Claim if 30 Days Past Due

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.

Domestic and Foreign Facility Reinspections

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.

(FSMA provides for the suspension of a food/feed facility’s registration if FDA is not permitted to inspect the facility or if FDA determines that food manufactured, processed, packed, or held by the facility has a reasonable probability of causing serious adverse health effects. In addition, imports into the U.S. from a facility with suspended registration are prohibited.)

Does Not Include Incorrect Font Size, Other Technical Violations

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.

Intends to Issue Guidance on Circumstances Materially Related to Food Safety

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.

Can Collect Fees from U.S. Agent of Foreign Facility

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.

Noncompliance with Recall Orders

Will Charge for FDA Activities When Firm Does Not Initiate or Conduct Recall as Ordered

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.

Activities Include Audit Checks, Reviewing Status Reports, Inspections, Etc.

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.

Fee Paid by Party that Receives Order, Whether Domestic Facility or Importer

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.

¹FDA said the following definition of “reinspection” will apply for purposes of assessing and collecting fees with respect to a foreign facility: “1 or more inspections conducted by officers or employees duly designated by the Secretary subsequent to such an inspection which identified non-compliance materially related to a food safety requirement of the FD&C Act, specifically to determine whether compliance has been achieved to the Secretary’s (and, by designation, FDA’s) satisfaction.”