Generic Drug User Fee Rates for Fiscal Year 2018

Generic Drug User Fee Rates for Fiscal Year 2018

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II), authorizes FDA to assess and collect fees for abbreviated new drug applications (ANDAs), drug master files (DMFs), generic drug active pharmaceutical ingredient (API) facilities, finished dosage form (FDF) facilities, contract manufacturing organization (CMO) facilities, and generic drug applicant program user fees.

The FDA is announcing fiscal year 2018 rates for GDUFA fees:

Applications:

ANDA ($171,823)

DMF ($47,829)

Facilities:

Domestic API facility ($45,367)

Foreign API facility ($60,367)

Domestic FDF facility ($211,087)

Foreign FDF facility ($226,087)

Domestic CMO facility ($70,362)

Foreign CMO facility ($85,362)

GDUFA Program:

Large size operation generic drug applicant program ($1,590,792)

Medium size operation drug applicant program ($636,317)

Small business generic drug applicant program ($159,079)

These fees are effective on October 1, 2017, and will remain in effect through September 30, 2018.

To pay the ANDA, DMF, API facility, FDF facility, CMO facility, and GDUFA Program Fee, you must complete a Generic Drug User Fee Cover Sheet, available through https://www.fda.gov/gdufa and at https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and generate a user fee identification (ID) number.

Please find details in the Federal Register Notice.