Q1. What DMFs incur fees?
Only DMFs that cover the manufacture of an API (Type II API DMFs) for use in a generic drug application incur fees. Specifically, each person that owns a Type II API DMF (DMF holder) that is referenced on or after October 1, 2012, in a generic drug submission by any initial letter of authorization shall be subject to a DMF fee.
Q2. What is a generic drug submission?
The phrase generic drug submission refers to an ANDA, an amendment to an ANDA, or a PAS to an ANDA.
Q3. When is a DMF fee incurred?
The owner of a DMF incurs the fee the first time that a generic drug submission references that DMF by an initial letter of authorization on or after October 1, 2012.
Q4. What is an "initial letter of authorization" as that term is used in this context?
An initial letter of authorization is one that an ANDA applicant has not previously relied on. This means that the DMF fee would be triggered the first time that a DMF is referenced by an ANDA applicant that has not previously relied on a letter of authorization for that DMF. For example, if ANDA applicant X submitted its ANDA (for Drug A) in September, 2012 and relied on a letter of authorization for DMF 11111, it would not trigger a fee for the DMF. If after October 1, 2012, ANDA applicant X amended or supplemented its application, it would not trigger a fee for the DMF. If, however, after October 1, 2012, ANDA applicant X submitted a new ANDA (for Drug B) with a letter of authorization to DMF 11111, it would trigger a fee for DMF 11111.
Furthermore, if a different ANDA applicant submitted a letter of authorization to DMF 11111 after October 1, 2012, it would trigger a fee for the DMF, if the fee had not already been paid for DMF 11111. Once a fee is paid for DMF 11111, no additional fee for this DMF will be assessed, regardless of how many letters of authorization for that DMF are referenced in one or more ANDAs.
Q5. 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 on or after October 1, 2012.
Q6. Will DMF holders be charged 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. This fee is not incurred every time a DMF is referenced.
Q7. How much is the DMF fee?
The DMF fee for fiscal year (FY) 2013 (October 1, 2012 to September 30, 2013) is $21,340. Additional information, including the methodology for calculating the fee, is available in Generic Drug User Fee – Abbreviated New Drug Application (ANDA), Prior Approval Supplement (PAS), and Drug Master File (DMF) Fee Rates for Fiscal Year 2013.
Fees for FYs 2014-2017 will be adjusted for inflation and other factors, including the projected number of DMFs that FDA expects to be referenced for the first time in a given year based on experience. Fees will be published in the Federal Register no later than 60 days before the start of each fiscal year.
Q8. When will the DMF fee be due?
In FY 2013, DMF fees will be incurred at the time of submission of a generic drug submission for all Type II API DMFs referenced for the first time by an initial letter of authorization on or after October 1, 2012. In general, fees will be due on the date the first generic drug submission is submitted that references the associated DMF.
On October 25, 2012, a notice was published in the Federal Register regarding FY 2013 generic drug user fee rates for Type II DMFs, ANDAs, and PASs. The notice was required by the GDUFA statute (PL 112-144), see FDCA §744B (a)(2)(C)(i), (a)(3)(B)(i). That statute sets the due date for fees for certain Type II DMFs and generic drug submissions 30 calendar days after publication of the notice, see §744B(a)(2)(E)(ii)(I), (a)(3)(C)(ii)(II). Thirty calendar days after October 25, 2012 is November 24, 2012, which is a Saturday. Given that this is not a business day for the U.S. Government, the fee due date will be the next business day. Fees received on or before Monday, November 26, 2012 will be deemed to have been submitted on or before the due date. Thus:
FY 2013 Type II DMF fees are due on or before the later of
- the date on which the first generic drug submission is submitted that references the DMF via an initial letter of authorization on or after October 1, 2012, or
- November 26, 2012.
Fees for FYs 2014-2017 will be due no later than the date on which the first generic drug submission that references the associated DMF holder’s file is submitted.
Q9. 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 outlined in Draft Guidance for Industry: Initial Completeness Assessments for Type II API DMFs Under GDUFA. If the DMF passes the completeness assessment, it will be placed on a publicly available list of DMFs available for reference.
Q10. What are the criteria for a DMF completeness assessment?
Q11. Can an ANDA applicant pay the DMF fee for an API referenced in its submission?
Q12. 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 on or after October 1, 2012, referencing the DMF will be received unless the fee is paid and the DMF is deemed available for reference.
Note: The DMF fee does not become due until FDA announces the amount of the fee. Please note that this is a change resulting from the recent enactment of the FDA User Fee Corrections Act of 2012 which enables collection of FY 2012 GDUFA user fees without enactment of an appropriations act.
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 pay. If the DMF fee is not paid within 20 calendar days after notification, the ANDA referencing the DMF will not be received.