Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies applying for direct FDA accreditation.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2026-N-7712] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or we) is announcing the fiscal year (FY) 2027 annual fee rate for recognized accreditation bodies and accredited certification bodies, and the initial and renewal fee rate for accreditation bodies applying to be recognized in the third-party certification program authorized by the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the FDA Food Safety Modernization Act (FSMA). We are also announcing the fee rate for certification bodies applying for direct FDA accreditation. DATES: The fees apply from October 1, 2026, through September 30, 2027. FOR FURTHER INFORMATION CONTACT: For Questions Related to FSMA Program Fees: FSMAFeeStaff@fda.hhs.gov . For Questions Related to This Notice: Olufunmilayo Ariyo, Office of Financial Management, Food and Drug Administration, 301-796-7900; or FDAUserFees@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background Section 808(b)(1)(A) of the FD&C Act ( 21 U.S.C. 384d(b)(1)(A) ) directed FDA to establish a recognition system for entities that accredit third-party certification bodies to conduct food safety audits and issue food and facility certifications to eligible foreign entities. (For the reasons explained in the third-party certification final rule ( 80 FR 74570 at 74578 to 74579, November 27, 2015), and for consisten…
Citation: 91 FR 48145
