2024-16880. Food Safety Modernization Act Third-Party Certification Program User Fee Rate 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 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 (July 28, 2023, 88 FR 48881). 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. FDA intends to use this inflation rate to make inflation adjustments for FY 2025; the derivation of this rate will be published in the Federal Register in the FY 2025 notice for the PDUFA user fee rates. The compounded inflation rate for FYs 2024 and 2025, therefore, is 1.08166 (or 8.166 percent) (calculated as 1 plus 3.8896 percent times 1 plus 4.1167 percent).

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 third-party certification program fees for FY 2025 prior to including travel costs as applicable for the activity. For the purpose of estimating the fee, we are using the travel cost rate for foreign travel because we anticipate that the vast majority of onsite assessments made by FDA under this program will require foreign travel. In FY 2023, the Office of Regulatory Affairs spent a total of $2,629,906 on 431 foreign inspection trips related to FDA's Center for Food Safety and Applied Nutrition and Center for Veterinary Medicine 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 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 factor mentioned previously in this document (1.08166 or 8.166 percent), which results in an estimated cost of $55 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 this rate in charging fees in FY 2025 when travel is required for the third-party certification program.

Table 2—FSMA Fee Schedule for FY 2025

Fee category	Fee rates for FY 2025
Hourly rate without travel	$318
Hourly rate if travel is required	373

III. Fees for Accreditation Bodies and Certification Bodies in the Third-Party Certification

Program Under Section 808(c)(8) of the FD&C Act

The third-party certification program assesses application fees and annual fees. In FY 2025, the only fees that could be collected by FDA under section 808(c)(8) of the FD&C Act are the initial application fee for accreditation bodies seeking recognition, the annual fee for recognized accreditation bodies, the annual fee for certification bodies accredited by a recognized accreditation body, the initial application fee for a certification body seeking direct accreditation from FDA, and the renewal application fee for recognized accreditation bodies. Table 3 provides an overview of the fees for FY 2025.

Table 3—FSMA Third-Party Certification Program User Fee Schedule for FY 2025

Fee category	Fee rates for FY 2025
Initial Application Fee for Accreditation Body Seeking Recognition	$53,520
Annual Fee for Recognized Accreditation Body	2,505
Annual Fee for Accredited Certification Body	3,131
Initial Application Fee for a Certification Body Seeking Direct Accreditation from FDA	53,520
Renewal Application Fee for Recognized Accreditation Body	32,802

A. Application Fee for Accreditation Bodies Applying for Recognition in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act

Section 1.705(a)(1) (21 CFR 1.705(a)(1)) establishes an application fee for accreditation bodies applying for initial recognition that represents the estimated average cost of the work FDA performs in reviewing and evaluating initial applications for recognition of accreditation bodies.

The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. These estimates represent FDA's current thinking, and as the program evolves, FDA will continue to reconsider the estimated hours. Based on data we have acquired since starting the program, we estimate that it would take, on average, 80 person-hours to review an accreditation body's submitted application, 48 person-hours for an onsite performance evaluation of the applicant (including travel and other steps necessary for a fully supported FTE to complete an onsite assessment), and 32 person-hours to prepare a written report documenting the onsite assessment.

FDA employees review applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel, $318 per hour, to calculate the portion of the user fee attributable to those activities: $318/hour × (80 hours (application review) + 32 hours (written report)) = $35,616. FDA employees will likely travel to foreign countries for the onsite performance evaluations because most accreditation bodies are anticipated to be located in foreign countries. For this portion of the fee, we use the fully supported FTE hourly rate for work requiring travel, $373 per hour, to calculate the portion of the user fee attributable to those activities: $373/hour × 48 hours ( i.e., two fully supported FTEs × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $17,904. The estimated average cost of the work FDA performs in total for reviewing an initial application for recognition for an accreditation body based on these figures would be $35,616 + $17,904 = $53,520. Therefore, the application fee for accreditation bodies applying for recognition in FY 2025 will be $53,520.

B. Annual Fee for Accreditation Bodies Participating in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act

To calculate the annual fee for each recognized accreditation body, FDA takes the estimated average cost of work FDA performs to monitor performance of a single recognized accreditation body and annualizes that over the average term of recognition. At this time, we assume an average term of recognition of 5 years. We also assume that FDA will monitor 10 percent of recognized accreditation bodies onsite. As the program proceeds, we will adjust the term of recognition as appropriate. We estimate that for one performance evaluation of a recognized accreditation body, it would take, on average (taking into account that not all recognized accreditation bodies would be monitored onsite), 22 hours for FDA to conduct records review, 8 hours to prepare a report detailing the records review and onsite performance evaluation, and 8 hours of onsite performance evaluation. Using the fully supported FTE hourly rates in table 2, the estimated average cost of the work FDA performs to monitor performance of a single recognized accreditation body would be $9,540 ($318/hour × (22 hours (records review) + 8 hours (written report))) plus $2,984 ($373/hour × 8 hours (onsite evaluation)), which is $12,524. Annualizing this amount over 5 years would lead to an annual fee for recognized accreditation bodies of $2,505 for FY 2025.

C. Annual Fee for Certification Bodies Accredited by a Recognized Accreditation Body in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act

To calculate the annual fee for a certification body accredited by a recognized accreditation body, FDA takes the estimated average cost of work FDA performs to monitor performance of a single certification body accredited by a recognized accreditation body and annualizes that over the average term of accreditation. At this time, we assume an average term of accreditation of 4 years. This fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. We estimate that FDA would conduct, on average, the same activities, for the same amount of time to monitor certification bodies accredited by a recognized accreditation body as we would to monitor an accreditation body recognized by FDA. Using the fully supported FTE hourly rates in table 2, the estimated average cost of the work FDA performs to monitor performance of a single accredited certification body would be $9,540 ($318/hour × (22 hours (records review) + 8 hours (written report))) plus $2,984 ($373/hour × 8 hours (onsite evaluation)), which is $12,524. Annualizing this amount over 4 years would lead to an annual fee for accredited certification bodies of $3,131 for FY 2025.

D. Initial Application Fee for Certification Bodies Seeking Direct Accreditation From FDA in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act

Section 1.705(a)(3) establishes an application fee for certification bodies applying for direct accreditation from FDA that represents the estimated average cost of the work FDA performs in reviewing and evaluating initial applications for direct accreditation of certification bodies.

The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. These estimates represent FDA's current thinking, and as the program evolves, FDA will reconsider the estimated hours. We estimate that it would take, on average, 80 person-hours to review a certification body's submitted application, 48 person-hours for an onsite performance evaluation of the applicant (including travel and other steps necessary for a fully supported FTE to complete an onsite assessment), and 32 person-hours to prepare a written report documenting the onsite assessment.

FDA employees are likely to review applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel, $318 per hour, to calculate the portion of the user fee attributable to those activities: $318/hour × (80 hours (application review) + 32 hours (written report)) = $35,616. FDA employees will likely travel to foreign countries for the onsite performance evaluations because most certification bodies are anticipated to be located in foreign countries. For this portion of the fee, we use the fully supported FTE hourly rate for work requiring travel, $373 per hour, to calculate the portion of the user fee attributable to those activities: $373/hour × 48 hours ( i.e., two fully supported FTEs × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $17,904. The estimated average cost of the work FDA performs in total for reviewing an initial application for direct accreditation of a certification body based on these figures would be $35,616 + $17,904 = $53,520. Therefore, the application fee for certification bodies applying for direct accreditation from FDA in FY 2025 will be $53,520.

E. Renewal Application Fee for Accreditation Bodies Participating in the Third-Party Certification Program Under Section 808(c)(8) of the FD&C Act

Section 1.705(a)(2) establishes a renewal application fee for recognized accreditation bodies that represents the estimated average cost of the work FDA performs in reviewing and evaluating renewal applications for recognition of accreditation bodies.

The fee is based on the fully supported FTE hourly rates and estimates of the number of hours it would take FDA to perform relevant activities. These estimates represent FDA's current thinking, and as the program evolves, FDA will reconsider the estimated hours. We estimate that it would take, on average, 43 person-hours to review an accreditation body's submitted renewal application, 24 person-hours for an onsite performance evaluation of the applicant (including travel and other steps necessary for a fully supported FTE to complete an onsite assessment), and 32 person-hours to prepare a written report documenting the onsite assessment.

FDA employees are likely to review renewal applications and prepare reports from their worksites, so we use the fully supported FTE hourly rate excluding travel, $318 per hour, to calculate the portion of the user fee attributable to those activities: $318/hour × (43 hours (application review) + 32 hours (written report)) = $23,850. FDA employees will likely travel to foreign countries for the onsite performance evaluations because most certification bodies are anticipated to be located in foreign countries. For this portion of the fee, we use the fully supported FTE hourly rate for work requiring travel, $373 per hour, to calculate the portion of the user fee attributable to those activities: $373/hour × 24 hours ( i.e., fully supported FTE × ((2 travel days × 8 hours) + (1 day onsite × 8 hours))) = $8,952. The estimated average cost of the work FDA performs in total for reviewing a renewal application for recognition of an accreditation body based on these figures would be $23,850 + $8,952 = $32,802. Therefore, the renewal application fee for recognized accreditation bodies in FY 2025 will be $32,802.

IV. Estimated Fees for Accreditation Bodies and Certification Bodies in Other Fee Categories for FY 2025

Section 1.705(a) also establishes application fees for certification bodies applying for renewal of direct accreditation. Section 1.705(b) also establishes annual fees for certification bodies directly accredited by FDA.

Although we will not be collecting these other fees in FY 2025, for transparency and planning purposes, we have provided an estimate of what these fees would be for FY 2025 based on the fully supported FTE hourly rates for FY 2025 and estimates of the number of hours it would take FDA to perform relevant activities as outlined in the Final Regulatory Impact Analysis for the Third-Party Certification Regulation. Table 4 provides an overview of the estimated fees for other fee categories.

Table 4—Estimated Fee Rates for Other Fee Categories Under the FSMA Third-Party Certification Program

Fee category	Estimated fee rates for FY 2025
Renewal application fee for directly accredited certification body	$32,802
Annual fee for certification body directly accredited by FDA	25,096