|  Dear Sir or Madam, - Fiscal Year (FY) 2022 BPD/Program Fee Invoices were emailed on August 13, 2021. Please note that the invoices are only sent to firms who have biosimilar biological products in development in the BPD program or have BsUFA user fee eligible biosimilar biological products. If you do not receive your invoice by August 16, 2021, and believe you should have received an invoice, please contact BsUFA User Fee staff at CDERCollections@fda.hhs.gov.
- The FY 2022 BsUFA fee rates were published in the Federal Register (FR) on July 28, 2021. The fee rates for FY 2021 and FY 2022 are shown below:
| User Fee Type | FY 2021 | FY 2022 | | Biosimilar Biological Product Development (BPD) Fee | Initial BPD | $102,494 | $57,184 | | Annual BPD | $102,494 | $57,184 | | Reactivation | $204,988 | $114,368 | | Application Fee | Clinical Data Required | $1,746,745 | $1,746,745 | | Clinical Data Not Required | $873,373 | $873,373 | | Program Fee | $304,162 | $304,162 | *Fiscal Year (FY) = October 1 through September 30 - For more information, please see the FR notice 2021-16084 published on 7/28/2021.
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