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Notice to Applicants Submitting NDAs/BLAs to CDER/CBER
for Fiscal Year 2008
Congress has passed the Food and Drug Administration Amendments Act of 2007 and the President has signed the bill. The legislation states that the effective date for the assessment of fees for human drug applications will be October 1, 2007. Because of the delay in passage of the legislation, we have not yet issued the Federal Register notice establishing the fee rates for FY 2008, and explaining how those fee rates were calculated. This notice will issue soon. Nevertheless, applications and supplements will be submitted on and after October 1. To alert affected applicants, FDA is announcing the fee schedule for applications and supplements for fiscal year 2008 so that proper payment can be made starting on October 1. The fee schedule for application fees is:
Applications requiring clinical data $1,178,000
Applications not requiring clinical data $589,000
Supplements requiring clinical data $589,000
If you have further questions regarding the fee rates, or any other fee related questions, please contact Michael Jones or Beverly Friedman at 301-594-2041.
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Date created: September 27, 2007 |
