FY 2003 Annual Performance Plan

Department of Health and Human Services
U.S. Food and Drug Administration
Congressional Justification
FY 2004 Annual Performance Plan
FY 2003 Revised Final Performance Plan
FY 2002 Annual Performance Report

Summary of Program Assessment Rating Tool (PART) Evaluation of FDA Centers

The Office of Management and Budget (OMB) developed a program assessment process in preparation for the FY 2004 budget review. The program assessment flows from the Administration's efforts to link program performance with the budget process, and was seen in the FY 2003 President's Budget when it included explicit assessments of program performance. Twenty percent of all federal programs were selected for evaluation.

A common analytic tool, "Program Assessment Rating Tool (PART)," was created to develop information that would enable OMB to evaluate the effectiveness of Agency's programs and their budget request. The PART instrument examines the program purpose, strategic planning, program management, and program results.

OMB reviewed the five FDA programs: Foods, Human Drugs, Biologics, Animal Drugs and Feeds, and Medical Devices and Radiological Health. OMB's numerical scores for the five programs ranged from 54.8 to 58.9. While the five programs scored well on the program purpose section, OMB identified strategic planning, program management, and program results as areas for improvement. The results have enabled FDA to begin exploring various possibilities for developing long term outcome goals, examining potential program strategies and various mechanisms to achieve the goals, and strengthening the linkage between the budget and performance plan.

Based on feedback from the OMB on FDA's responses to the PART, FDA leadership has begun to explore the possibility of developing long term outcome goals in the areas of expanding national laboratory capacity; medical countermeasures; and, Bovine Spongiform Encephalophy (BSE). While these may not be the actual areas where FDA finally commits to positive long term outcomes, these areas are candidates being examined.

With the recent appointment of a new Commissioner, FDA leadership is developing a long-range strategic plan to formulate ways in which Agency activities can contribute to positive public health outcomes. These efforts include developing Agency and program strategies that will improve the likelihood that long-term outcomes will be achieved, identifying intermediate outcome measures which could serve as good leading indicators of ultimate health outcomes, identifying databases that will serve as valid and reliable sources of information in selected areas and, conducting analyses and evaluations to strengthen our understanding of the relationship between FDA program efforts and intermediate and long term public health outcomes.

There is still much work to be done. The Agency strategies for pursuing these goals are included in FDA's FY 2004 Performance Plan submission to Congress.