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CDER SBIA Update: FY 2016 User Fee Rates for GDUFA, PDUFA, BsUFA, and Outsourcing Facilities

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The Information Source for Regulated Domestic and International Small Pharmaceutical Business and Industry

FDA/CDER's Small Business and Industry Assistance (CDER SBIA)

FY 2016 User Fee Rates

1. FDA Announces Fiscal Year 2016 Generic Drug Fees

Today the U.S. Food and Drug Administration (FDA) published the fiscal year (FY) 2016 generic drug user fees as required under the Generic Drug User Fee Amendments of 2012 (GDUFA) in the Federal Register. This announcement includes the rates for the abbreviated new drug application (ANDA), prior approval supplement to an approved ANDA (PAS), Type II active pharmaceutical ingredient drug master file (DMF), generic drug active pharmaceutical ingredient (API) facilities, and finished dosage form (FDF) facilities user fees.

GDUFA authorizes FDA to assess and collect user fees for certain applications and supplements for human generic drug products, on FDF and API facilities, and on type II active pharmaceutical ingredient DMFs to be made available for reference.

These fees are effective on October 1, 2015, and will remain in effect through September 30, 2016.

2. Prescription Drug User Fee Rates for Fiscal Year 2016

FDA is announcing the rates for prescription drug user fees for FY 2016. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (PDUFA V), authorizes FDA to collect user fees for certain applications for the review of human drug and biological products, on establishments where the products are made, and on such products. This notice establishes the fee rates for FY 2016.

Federal Register Notice

3. Biosimilar User Fee Rates for Fiscal Year 2016

FDA is announcing the rates for biosimilar user fees for FY 2016. The FD&C Act, as amended by the Biosimilar User Fee Act of 2012 (BsUFA), authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar biological products are made, and a biosimilar biological product fee for each biosimilar biological product approved in a biosimilar biological product application.

Federal Register Notice

4. Outsourcing Facility Fee Rates for Fiscal Year 2016

FDA is announcing the fiscal year FY 2016 rates for the establishment and reinspection fees related to human drug compounding outsourcing facilities (outsourcing facilities) that elect to register under the FD&C Act. The FD&C Act authorizes FDA to assess and collect an annual establishment fee from outsourcing facilities that have elected to register, as well as a reinspection fee for each reinspection of an outsourcing facility.

Federal Register Notice



The Small Business and Industry Assistance program in the Center for Drug Evaluation and Research (CDER SBIA) provides guidance and information to regulated domestic and international small pharmaceutical business and industry through its website, email notifications, and workshops. This notification system provides current information from CDER/FDA via e-mail on a biweekly basis that is relevant to small pharmaceutical business, which includes Federal Register notices, guidances, workshop announcements, etc. This is an automated message delivery system. Replying to this message will not reach the CDER SBIA staff. If you have comments or questions, please contact us Monday through Friday 8:00AM - 4:30PM.





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