It's been a few years since I handled user fees for my last company, but I believe you are correct. FDA sends you the forms already completed based on what they have in their data base from previous year. You then need to update based on any new approvals or removals from market. The application fee is paid when you submit a new drug/biologic application, but I assume you are asking about the annual fees for products already approved. FDA used to have Establishment Fees and Product Fees, but 1-2 years ago they got rid of these and replaced with a Program Fee. So your one product would likely incur a fee equivalent to one Program fee. In FY 2019 a Program fee was $309,915. Typically, but not always, fees go up slightly each year. I recall invoices were sent out by FDA around August with payment due by October of each year.
Here's a link to the FR Notice for FY 2019 User Fees. If a similar notice for FY 2020 isn't issued yet I would expect it would be soon or in August at the latest.
https://www.federalregister.gov/documents/2018/08/01/2018-16387/prescription-drug-user-fee-rates-for-fiscal-year-2019------------------------------
Tom
Senior Director, Regulatory Affairs CMC
Chicago
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Original Message:
Sent: 15-May-2019 05:03
From: Richard Vincins
Subject: User fee forms
Thanks for clarification Masa, unfortunately I am on the device side, so not sure about those user fee forms - hopefully someone else from the community can respond.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
Original Message:
Sent: 14-May-2019 17:06
From: Masa Razic
Subject: User fee forms
Hi Richard,
I am sorry for confusion. This is my first year doing this submission.
After I have done all research I realized that there is a difference attachments for drug vs medical device.
My drug is Biologic, so I have found online Attachment A and B as well as Costumer letter. My Manager is the primary contact person, so she might have received already these 3 documents from the FDA. She told me to educate myself as much as possible.
Since I found what I think I need, I do have another question.
When FDA sends you an email about User Fee submissions, do they send you filled out Attachments for your drug that you only need to verify or?
After I download Attachments A & B, I could not change content of the Attachment B.
I think what happens is that FDA sends you filled out information that you only need to verify.
And than how much money would be a fee for 1 formulation of 1 drug?
This is all we own.
Thank you so much for reaching out to me and trying to help.
Masa
Maša Razić Regulatory Affairs Specialist
PARTNER THERAPEUTICS
Original Message------
User Fee for what type of application? There are different forms for different applications your are making, i.e. drug versus medical device.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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