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U.S. Department of Health and Human Services

For Industry

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PDUFA IV 5-Year Financial Plan (2008): ORA Plan Summary

Table of Contents

CBER Plan Summary Tables

At this time ORA has no increases planned as a part of implementing PDUFA IV, other than the restoration of 1 FTE to ORA’s PDUFA IV additive base—to restore it to the levels of previous years.  This should be sufficient to assure that pre-approval inspections are completed in a timely manner.

ORA is able to keep abreast of the increasing workload because fewer pre-approval inspections are being ordered each year.  This is occurring because, if a recent inspection has been performed and reflects that the production facility is in compliance, then a pre-approval inspection is waived as part of the application approval process.  The table on the next page reflects the cost of the 40 ORA staff years to be paid from fees for each of the next five years.

ORA Plan Summary Tables

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