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Except as provided in paragraphs (3) and (4) of this section, any person making a submission of a generic drug application to FDA shall be subject to an application fee for each such submission in the amounts specified by this subpart. The total amount of the application fee payable for the submission of an application shall not exceed $5,000,000, but the amount of such fee may be adjusted within the general limits set forth in this subpart based on the experience of the applicant. Such fee may be reduced for the purpose of assisting in the development of generic drugs by providing incentives to the applicant (as determined by FDA) for the use of a particular method of analysis.

The applicant for a new drug, an agency application for a new drug, or a person submitting a simple amendment received for a drug previously approved by FDA for marketing shall be subject to a new drug application fee for each such submission in the amounts specified by this subpart. The total amount of the new drug application fee payable for the submission of a simple amendment shall not exceed $500,000.

The Biological Products Advisory Committee (BPAC) has recommended that the total amount of BPAC fees should be $13,875,000 for the 2012 Biologics License Application (BLA) review cycle and $13,825,000 for the 2013 BLA review cycle. The BPAC recommended that $1,250,000 of the 2012 BLA fee be available for reduction in the BLA review cycle for generic pharmaceutical product applications. However, the BPAC recommended that the remaining amount of the 2012 BLA fee be set aside and not allowed to be carried forward into the 2013 BLA review cycle. The BPAC determined that $13,925,000 of BPAC fees should be provided for the 2013 BLA review cycle. The total amount of the BPAC fee may not exceed: d2c66b5586