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GUIDANCE DOCUMENT

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry Guidance for Industry June 2018

Final

This guidance is being distributed for comment purposes only.

Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 Guidance for Industry

Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research

This guidance provides stakeholders information regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the FDA Reauthorization Act of 2017. Because BsUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.


This guidance describes the types of user fees authorized by BsUFA II, the process for submitting payments to FDA, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment. This guidance also describes how FDA determines which products are subject to a fee and discusses certain changes to FDA’s policies under the new law. This guidance does not address how FDA determines and adjusts fees each fiscal year; nor does it address FDA’s implementation of other user fee programs (e.g., Prescription Drug User Fee Amendments, Generic Drug User Fee Amendments).2 Throughout this guidance, references to user fees or the user-fee program are to the user fee program for biosimilar biological products under section 744H of the Federal Food, Drug, and Cosmetic Act (FD&C Act).


Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.