FDA Finalizes Guidance on PDUFA Fee Waivers, Reductions and Refunds
The US Food and Drug Administration (FDA) finalized guidance providing advice to drug and biologic sponsors looking to apply for Prescription Drug User Fee Act (PDUFA) fee waivers, reductions and refunds.
The guidance finalizes a draft version released for comment in June 2018, which in turn was an update to the agency’s previous final guidance on the topic from 2011. The guidance is nearly identical to the draft version with only a few minor additions and editorial changes.
The guidance explains the various types of fee waivers, reductions and refunds offered to industry, such as those for pressing public health needs, small business entities and when paying the fee would be a significant barrier to an applicant’s ability to develop a drug.
On refund requests, the final guidance explains that the deadline for requesting a program fee refund is 180 calendar days from the date the fee is due, even if the applicant has submitted a citizen petition that may pertain to their claim for a refund.
FDA also explains that if a pending refund request “does not expressly cover a subsequent time frame for which an applicant wishes to claim a refund,” the applicant would be required to submit another request for a refund that covers the subsequent timeframe.
“For example, if an applicant has a request for a FY 2019 program fee refund that is pending at the time of a program fee assessment for FY 2020, and the applicant believes it is also eligible for a refund for FY 2021 and wishes to claim a FY 2019 refund, a timely request for a refund for FY 2020 must be submitted,” FDA writes.
Another change to the final guidance includes the addition of instructions for small businesses that are granted a fee waiver for an application they ultimately do not submit to contact the Division of User Fee Management and Budget Formulation within the Center for Drug Evaluation and Research for further guidance on qualifying for a fee waiver on a future application.
The final guidance also adds a section with instructions for where and how to submit written requests for fee waivers, reductions and refunds, whether by email or by post.
Additionally, the final guidance includes an appendix containing Form FDA 3971, which is to be used by small businesses for requesting a fee waiver or refund.
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