Regulatory Open Forum

Dear all, 

I have a question about DMF fee for Type II API DMF to be referenced in NDA submission.

To my knowledge, DMF fee is not mentioned under PDUFA and is only mentioned under GDUFA.

Under GDUFA, DMF fee is incurred either when the first time a generic drug submission is referenced -or- when the DMF holder requests the initial completeness assessment.

And, I understand that FDA will confirm that the DMF fee has been paid before assigning a DMF to a reviewer for a CA.

Neither GDUFA nor PDUFA mention a case when a DMF fee is incurred the first time DMF is referenced in a NDA submission.

Would DMF fee under GDUFA User Fee Rates need to be paid in order to request the initial completeness assessment and to have DMF number available?

I understand that this is not usually the case but I would like to know if anyone know/have experienced DMF filing prior to NDA submission and had requested the initial completeness assessment.

Thanks!