ORA Plan Summary
At this time ORA has no increases planned as a part of implementing PDUFA III. ORA expects to expend a total of 147 staff years on the drug review process in each year of the plan (41 staff years paid from PDUFA fees and 106 Staff years paid from appropriations). This is 33 fewer staff years paid from fees than were spent in most of the PDUFA II years.
This reduction in staff years reflects the fact that fewer pre-approval inspections are being ordered each year. This is occurring because, if recent inspections have been performed and reflect that the production facility is in compliance, then a pre-approval inspection is waived as part of the application approval process. It is also due to the fact that fewer applications were submitted over the past two years. The table on the next page reflects the cost of the 41 ORA staff years to be paid from fees for each of the next five years.