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Assumptions - Support of PDUFA II Fee Base Levels

Table of Contents: PDUFA III Five-Year Plan

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The fees collected during PDUFA II funded activities that became an integral part of FDA’s resources for reviewing human drug applications are referred to as the PDUFA II Fee Base. In FY 2002, over two-thirds of these funds were spent on pay and benefits for an additional 1088 staff years in CDER, CBER, ORA, and OC. These were above the staffing level FDA had been devoting to the review of human drug and biologic applications in FY 1992, the year before PDUFA was enacted. The remaining one-third of the funds was used to provide operating support, IT support, centrally funded support (for indirect costs such as utilities and telecommunications), rent, and overhead costs. The continuation of these 1088 staff years of effort each year is crucial to FDA’s ability to review drug and biologic applications efficiently and effectively. These resources are the foundation upon which the improvements mandated by PDUFA III are built.

The PDUFA II Fee Base staff years are allocated as follows:

PDUFA II Fee Base Staff Year Levels with Adjustments for Therapeutics Transfer

Fiscal Year	CDER	CBER	ORA	OC	Total
2003	678	246	41	123	1088
2004 and Beyond	762	162	41	123	1088

The difference of 84 staff years from CBER to CDER in FY 2004 and later years reflects the reorganization of the therapeutics products from CBER to CDER in FY 2004. In addition to these PDUFA fee-funded resources, appropriated funds and staff years were also reassigned from CBER to CDER as part of this reorganization.

The five-year estimated costs associated with the PDUFA II Fee Base are detailed in the table below and reflect:

Annual pay and benefit cost increases of these 1088 staff years
Operating and support costs for these staff years
Office of the Commissioner overhead costs is calculated as a percent of center/ORA pay and benefits. (Overhead calculations are discussed beginning on page 22.)
Information Technology, Central Account and Rent estimates are based on base year costs. (Information Technology, Central Account and Rent estimates are discussed beginning on page 26.)

PDUFA II Additive Base Fund Estimates ($000)¹

Item\Year	2003 Estimate	2004 Estimate	2005 Estimate	2006 Estimate	2007 Estimate	Five-Year Total
Pay and Benefits for Centers/ORA	$107,696	$112,295	$116,877	$121,645	$126,608	$585,121
Base Operating Funds--Centers/ORA	$22,598	$23,563	$24,524	$25,525	$26,566	$122,776
OC--Salaries and Operating/Contract $	$13,445	$14,019	$14,591	$15,186	$15,805	$73,045
Information Technology	$18,750	$19,551	$20,348	$21,179	$22,043	$101,870
Rent	$7,813	$8,147	$8,479	$8,825	$9,185	$42,451
Central Accounts	$9,197	$9,590	$9,981	$10,388	$10,812	$49,969
Total--PDUFA II Additive Base	$179,499	$187,164	$194,800	$202,748	$211,020	$975,232