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U.S. Department of Health and Human Services

For Industry

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PDUFA II Five-Year Plan--FY 2001 Update (April 2001)

Prescription Drug User Fees

April 2001
The revised plan begins with a statement of purpose, provides background information on PDUFA and a summary of the PDUFA II goals, and discusses the 10 major assumptions on which the plan is based and how those assumptions have changed since the original plan was issued in 1998. Included is the assumption that this plan is dynamic and will be reassessed each fiscal year through 2002. This is the third updating of the plan since it was initially published in 1998.

The individual plans of Agency components with major PDUFA responsibilities are summarized, followed by a summary of associated expenditures and an Agency summary.

Below are links to the FY 2000 revision of FDA's PDUFA II Five-Year Plan:


In our continuing efforts to maximize the availability and clarity of information about our review processes and plans, we are sharing this plan with all who have an interest and making it available on the Internet. We welcome comments and will consider them in the future as annual adjustments are made to the plan

Interested persons may submit written comments on the plan to:

Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852.

Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the Docket Number 98-N-0495. The guidance document and received comments may be seen in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through Friday. Single copies of the plan may be obtained from:


Office of Management and Systems
Attention: Frank P. Claunts
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
(Please send a self-addressed adhesive label to assist that office in processing your request.)