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FDA Finalizes FSMA Third-Party Certification User Fee Program

Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Section 808 of the Federal Food, Drug, and Cosmetic Act (added by Food Safety Modernization Act (FSMA)).

In November 2015, the FDA promulgated the final rule on “Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications,” which established a voluntary program to accredit third-party certification bodies, or auditors, to conduct food safety audits of foreign food entities and certify that foreign food facilities and food produced by such facilities meet applicable FDA food safety requirements.  (See last year’s blog on the Third Party Certification Rule here).

The final rule provides for a reimbursement, or user-fee, program to assess fees and require reimbursement for the work the agency performs to establish and administer the third-party certification program.  FDA will notify the public of the fee schedule annually. The fee notice will be made publicly available prior to the beginning of the fiscal year for which the fees apply, except for the first fiscal year in which this regulation is effective. Each new fee schedule will be adjusted for inflation and improvements in the estimates of the cost to FDA of performing relevant work for the upcoming year.

The agency also announced last week the fiscal year 2017 fee rate for accreditation bodies applying to be recognized in the third-party certification program. The fee is effective January 13, 2017, and will remain in effect through September 30, 2017:

Fee category

Estimated fee rates for FY 2017

Renewal application fee for recognized accreditation body

$18,855

Initial application fee for certification body seeking direct-accreditation from FDA

35,100

Renewal application fee for directly-accredited certification body

26,460

Annual fee for recognized accreditation body

1,579

Annual fee for certification body directly-accredited by FDA

20,208

Annual fee for accredited certification body

1,974

 

Although FDA will not be collecting these other fees in FY 2017, for transparency and planning purposes, the agency provided an estimate of what these fees could have been for FY 2017 based on the fully supported full time equivalent staff hourly rates for FY 2017, 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.

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