User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act

User Fee Billable Biologic Products and Potencies Approved Under Section 351 of the PHS Act

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**.

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 have been discontinued from marketing 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's user fee staff that the product is no longer marketed. Products may also be added if annual reports indicate the product is no longer marketed.

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 user fee billing staff at 301-827-3503.

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

**A number of therapeutic biologic products were transferred from CBER to the Center for Drug Evaluation and Research (CDER) on June 30, 2003. For further information see the CDER Billable Biologic Product List2.

open here please:
http://www.fda.gov/AboutFDA/CentersOffices/CBER/ucm122936.htm