This message was posted by a user wishing to remain anonymous
Hello,
There is no link for DMFs only.
The link for 2021 GDUFA fees: https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments
DMF facility fees for Fiscal Year 2021, staring October 1st, 2020: 69,921 USD.
At the link above you may find some clarifications about DMFs fees:
"When is a DMF fee incurred?
The owner of a DMF incurs the fee on whichever of the following dates occurs earlier: 1) the first time that a generic drug submission references that DMF by an initial letter of authorization on or after October 1, 2012, or 2) the date the DMF holder requests the initial completeness assessment.
Do holders of DMFs submitted and reviewed by FDA before October 1, 2012, have to pay a DMF fee?
GDUFA does not make a distinction between DMFs submitted before or after October 1, 2012. Holders of DMFs reviewed prior to GDUFA implementation must pay the one-time DMF fee if their DMF is referenced in a new generic drug submission after October 1, 2012.
Do DMF holders incur a fee each time their DMF is referenced?
No. The DMF fee is a one-time fee, incurred on first reference of the DMF on or after October 1, 2012, or when the DMF holder requests the initial completeness assessment, whichever occurs earlier. This fee is not incurred every time a DMF is referenced.
When are DMF fees due?
A drug master file fee shall be due on the date on which the first generic drug submission is submitted that references the associated Type II active pharmaceutical ingredient drug master file or the date the drug master file holder requests the initial completeness assessment, whichever occurs earlier.
Do DMF holders need to wait for a new ANDA applicant to request a letter of authorization before the DMF is assessed to be available for reference?
No. DMF holders can pay the fee before a letter of authorization is requested. The DMF will then undergo an initial completeness assessment, using factors articulated in the final guidance Completeness Assessments for Type II Active Pharmaceutical Ingredient Drug Master Files Under the Generic Drug User Fee Amendments. If the DMF passes the initial completeness assessment, FDA will identify the DMF on the Type II Drug Master Files – Available for Reference List.
Can an ANDA applicant pay the DMF fee for an API referenced in its submission?
Yes.
What is the penalty for failure to pay the DMF fee?
The DMF will be deemed not available for reference. Once the DMF fee becomes due, no generic drug submission submitted referencing the DMF will be received unless the fee is paid and the DMF is deemed available for reference.
>ANDA applicants that reference a DMF for which a fee is due but has not been paid will be provided notification of the DMF holder's failure to satisfy the user fee obligation. If the DMF fee is not paid within 20 calendar days after notification, the ANDA referencing the DMF will not be received."
Original Message:
Sent: 23-Sep-2020 12:05
From: Anonymous Member
Subject: GDUFA Facility Fee Payment
This message was posted by a user wishing to remain anonymous
Hello Everyone,
I am working on Site Re-Registration with GDUFA. The site is responsible for manufacturing of APIs n Excipients, I am wondering if anyone please share the links or any information for the procedure, I am checking various link but specially for DMFs I could not find. Any help would be really appreciated.
Thanks much!