FDA Announces FY 19 User Fee Rates for Third Party Certification Program

Yesterday, FDA announced in the Federal Register, the Agency’s 2019 user fee rate for recognized accreditation bodies and accredited certification bodies, and the fee rate for accreditation bodies applying to be recognized in the third-party certification program.

Under the current third-party certification program, as required by the Food Safety Modernization Act (FSMA), FDA established a system to accredit third party’s to conduct food safety audits and issue food and facility certifications to eligible foreign entities. Under the program, FDA may recognize accreditation bodies that accredit certification bodies. Alternatively, FDA may also directly accredit certification bodies.

The average employee hourly rate of $235 is based on a full time equivalent average employee cost of $273,139 per year, including adjustments for inflation. The hourly rate was adjusted up to $282 to account for travel costs. Based on the forgoing the FSMA fee schedule for FY 2019 is

Fee Category Fee Rates for FY 2019
Hourly rate without travel $235
Hourly rate if travel is required $282


Based on man hours and travel required, FDA used the above rates to calculate the user fees for accreditation bodies and certification bodies in the program for FY 2019. These include:

Fee Category Fee Rates for FY 2019
Initial Application Fee for Accreditation Body Seeking Recognition $38,211
Annual Fee for Recognized Accreditation Body $1,775
Annual Fee for Accredited Certification Body $2,219
Initial Application Fee for a Certification Body Seeking Direct Accreditation from FDA $38,211


The above 2019 user fee rates are effective October 1, 2018 until September 30, 2019.

FDA also provided projections for renewal applications (even though FDA will not yet collect such fees in 2019). These include:

Fee Category Estimated Fee Rates for FY 2019
Renewal application fee for recognized accreditation body $21,350
Renewal application fee for directly accredited certification body $28,999
Annual fee for certification body directly accredited by FDA  $21,056

 

The above fees must be paid within 30 days of FDA’s invoice date; otherwise the application will be considered incomplete and FDA will not review the application.

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