2024-16877. Food Safety Modernization Act Domestic and Foreign Facility Reinspection, Recall, and Importer Reinspection Fee Rates for Fiscal Year 2025

Table 1—Supported Direct FDA Work Hours in a Paid Staff Year in FY 2023

Total number of hours in a paid staff year	2,080
Less:
11 paid holidays	−88
20 days of annual leave	−160
10 days of sick leave	−80
12.5 days of training	−100
22 days of general administration	−176
26.5 days of travel	−212
2 hours of meetings per week	−104
Net Supported Direct FDA Work Hours Available for Assignments	1,160

Dividing the average fully supported FTE cost in FY 2025 ($369,046) by the total number of supported direct work hours available for assignment in FY 2023 (1,160) results in an average fully supported cost of $318 (rounded to the nearest dollar), excluding inspection travel costs, per supported direct work hour in FY 2025.

B. Adjusting FY 2023 Travel Costs for Inflation To Estimate FY 2025 Travel Costs

To adjust the hourly rate for FY 2025, FDA must estimate the cost of inflation in each year for FY 2024 and FY 2025. FDA uses the method prescribed for estimating inflationary costs under the Prescription Drug User Fee Act (PDUFA) provisions of the FD&C Act (section 736(c)(1) (21 U.S.C. 379h(c)(1))), the statutory method for inflation adjustment in the FD&C Act that FDA has used consistently. FDA previously determined the FY 2024 inflation rate to be 3.8896 percent; this rate was published in the FY 2024 PDUFA user fee rates notice in the Federal Register (88 FR 48881, July 28, 2023). Utilizing the method set forth in section 736(c)(1) of the FD&C Act, FDA has calculated an inflation rate of 3.8896 percent for FY 2024 and 4.1167 percent for FY 2025, and FDA intends to use these inflation rates to make inflation adjustments for FY 2025 for several of its user fee programs; the derivation of this rate will be published in the Federal Register in the FY 2025 notice for the PDUFA user fee rates.

The average fully supported cost per supported direct FDA work hour, excluding travel costs, of $318 already takes into account inflation as the calculation above is based on FY 2025 predicted costs. FDA will use this base unit fee in determining the hourly fee rate for reinspection and recall order fees for FY 2025 prior to including domestic or foreign travel costs as applicable for the activity. In FY 2023, FDA's Office of Regulatory Affairs (ORA) spent a total of $7,463,679 for domestic regulatory inspection travel costs and General Services Administration Vehicle costs related to FDA's Center for Food Safety and Applied Nutrition (CFSAN) and Center for Veterinary Medicine (CVM) field activities programs. The total ORA domestic travel costs spent is then divided by the 8,811 CFSAN and CVM domestic inspections, which averages a total of $847 per inspection. These inspections average 41.35 hours per inspection. Dividing $847 per inspection by 41.35 hours per inspection results in a total and an additional cost of $20 (rounded to the nearest dollar) per hour spent for domestic inspection travel costs in FY 2023. To adjust for the $20 per hour additional domestic cost inflation increases for FY 2024 and FY 2025, FDA must multiply the FY 2024 PDUFA inflation rate adjustor (1.038896) times the FY 2025 PDUFA inflation rate adjustor (1.041167) times the $20 additional domestic cost, which results in an estimated cost of $22 (rounded to the nearest dollar) per paid hour in addition to $318 for a total of $340 per paid hour ($318 plus $22) for each direct hour of work requiring domestic inspection travel. FDA will use these rates in charging fees in FY 2025 when domestic travel is required.

In FY 2023, ORA spent a total of $2,629,906 on 431 foreign inspection trips related to FDA's CFSAN and CVM field activities programs, which averaged a total of $6,102 per foreign inspection trip. These trips averaged 3 weeks (or 120 paid hours) per trip. Dividing $6,102 per trip by 120 hours per trip results in a total and an additional cost of $51 (rounded to the nearest dollar) per paid hour spent for foreign inspection travel costs in FY 2023. To adjust $51 for inflationary increases in FY 2024, and FY 2025, FDA must multiply it by the same inflation factors mentioned previously in this document (1.038896 and 1.041167), which results in an estimated cost of $55 (rounded to the nearest dollar) per paid hour in addition to $318 for a total of $373 per paid hour ($318 plus $55) for each direct hour of work requiring foreign inspection travel. FDA will use these rates in charging fees in FY 2025 when foreign travel is required.

Table 2—FSMA Fee Schedule for FY 2025

Fee category	Fee rates for FY 2025
Hourly rate if domestic travel is required	$340
Hourly rate if foreign travel is required	373