FDA has issued a proposed rule (“User Fee Rule”) to amend the previously-proposed rule entitled “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications” (“Accreditation Rule”) and to propose to establish a user fee program, as required by section 808(c)(8) of the Food, Drug, and Cosmetic Act. The purpose of the user fee program would be to assess fees and require reimbursement for the work performed to establish and administer the system for the Accreditation of Third-Party Auditors under the FDA Food Safety Modernization Act (FSMA). Under the proposed Accreditation Rule, a program would be established to provide for accreditation of third-party auditors/certification bodies to conduct food safety audits of eligible foreign entities and to issue food and facility certifications. FDA would use certifications issued by accredited certification bodies in deciding whether to admit certain imported food into the US that the agency has determined poses a food safety risk under the Food, Drug, and Cosmetic Act and in deciding whether an importer is eligible to participate in the Voluntary Qualified Importer Program for expedited review and entry of food imports.
The proposed User Fee Rule seeks to establish application fees for accrediting bodies applying for recognition, recognized accrediting bodies submitting renewal applications, certification bodies applying for direct accreditation, and certification bodies applying for renewal of direct accreditation. The proposed User Fee Rule would also establish annual fees for recognized accrediting bodies, certification bodies directly accredited by FDA, and certification bodies accredited by recognized accrediting bodies. The application fees would fund the agency’s review of the applications and the annual fees would support relevant monitoring activities. The agency intends to estimate the average number of hours that it would take for it to conduct relevant activities and multiply that by the appropriate fully supported FTE hourly rate to generate flat fees. Application fees are likely to be significantly higher than annual monitoring fees. The agency would notify the public of the fee schedule annually prior to the beginning of the fiscal year for which the fees apply. Each new fee schedule would be calculated based on the parameters in the rule, adjusting for improvements in the estimates of the cost to FDA of performing relevant work for the upcoming year, and inflation.
This proposed rule was published in the Federal Register on July 24. It provides details on the calculations for each of the proposed fees described above. FDA will accept comments for the next 75 days. The comment period on the proposed Accreditation Rule closed in January 2014 and FDA is still working on the final rule.