About the Center for Biologics Evaluation and Research > User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act

About the Center for Biologics Evaluation and Research > User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act

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User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act
Updated: 3/29/2016

This list is intended to include all CBER user fee billable biologic products and potencies approved under Section 351 of the Public Health Service Act** and subject to the Prescription Drug User Fee Act (PDUFA).

A product fee is assessed for each potency in which the approved (non-revoked, non-suspended) product is manufactured in final dosage form. In certain circumstances, products which are not marketed but are still licensed are not assessed product fees. These products are identified on CBER's Discontinued List. Generally, a licensed product is added to the Discontinued List when the Applicant informs CBER that the product is not being marketed and submits a request to have the product placed on CBER's Discontinued List. 

The potency information contained in this list is based on current information in CBER's regulatory database. Companies are responsible for alerting CBER to any discrepancies regarding potency or proprietary name information. Any such discrepancies should be reported to CBER's PDUFA billing staff at CBERPDUFAStaff@fda.hhs.gov.

This list is updated bi-annually in September and March.

**A number of therapeutic biologic products are regulated by the Center for Drug Evaluation and Research (CDER).  To view the listing of CDER regulated biologics, see the CDER Billable Biologic Product List.