CBER Plan Summary
CBER’s overall plan for the five years of PDUFA III totals $139.3 million. A year-by-year resource summary of CBER’s plan is on page 19. It has 6 principal components (1) enhanced training and staffing (2) risk management (3) continuous marketing applications (4) efficacy supplement resubmissions (5) first cycle reviews (6) expert outside consultants.
CBER’s plan shows a total increase of 59 FTEs. This number is offset by the reductions as a result of the transfer of the CBER therapeutic product review functions to CDER in FY 2004. CBER actually transferred 84 PDUFA additive positions and 82 appropriated base positions dedicated to the drug review process, and 42 positions not part of the drug review process. CBER’s appropriated base for human drug review is now reduced to 210 and PDUFA additive staff year number increases to 221, for a total of 414 PDUFA staff years by FY 2007.
In CBER’s plan the additional FTEs needed each year were arrayed with the specific PDUFA III goals.