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# GDUFA 2 Changes Benefit Small Businesses: SBIA
- URL: https://www.fdaweb.com/gdufa-2-changes-benefit-small-businesses-sbia/
- Published: 2017-01-26T12:00:00.000Z
- Updated: 2026-09-14T22:03:10.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5137838

The CDER Small Business and Industry Assistance (SBIA) program says that changes included in the GDUFA 2 agreement now awaiting congressional action address small business concerns that arose under GDUFA 1\. In an online *SBIA Chronicles*, CDER Division of User Fee Management and Budget Formulation generics branch chief **Gisa Perez** [says](http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM538414.pdf?ref=fdaweb.com) that one of the primary concerns with GDUFA 1 was that it did not provide any relief for small business. She reports that GDUFA 2 addresses this concern in three ways: 

- rather than facilities incurring an annual facility fee if they are simply referenced in a pending or approved ANDA as in GDUFA 1, under GDUFA 2 they will be assessed an annual fee only when they are identified in an approved submission;
- under the GDUFA 2 user fee structure, there will be three tiers for the annual program fee based on the number of approved ANDAs owned by a firm and its affiliates—large (20 or more approved ANDAs, paying 100% of the fee), medium (6-19 approved ANDAs, paying 40% of the fee), and small (5 or fewer approved ANDAs, paying 10% of the fee); and
- within the Finished Dosage Form facility category, GDUFA 2 carves out a subcategory for contract manufacturing organizations defined as independent facilities contracted by ANDA sponsors to manufacture their generic drugs, which will pay only one-third of the annual fee paid by firms that manufacture ANDA products at facilities which they or their affiliates own.