Office of Management
Budget Formulation and Presentation

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Headquarters and the Office of the Commissioner

Performance Goals

The following performance goal table summarizes the performance goals, yearly targets and actual reported data for the Office of the Commissioner.

Given the uncertainty of final FY 2007 appropriation levels at the time FDA developed the performance targets for the FY 2008 Congressional Justification, FDA has included FY 2007 targets at both the President's Budget and the Continuing Resolution funding levels.

Measure	FY	Target	Result
Long Term Goal: Strengthen the efficiency and effectiveness of program management through focused performance budget and financial management strategies, aligned with FDA and HHS business strategies.
1. Increase the number of Commercial Activities that will be reviewed for competitive sourcing. (19003) (Efficiency)	2008	Review and compete 154 FTE per "Green" Plan	01/09
	2007 PB	Review and Compete 154 FTE per "Green" Plan	01/08
	2007 CR	Review and Compete 154 FTE per "Green" Plan	01/08
	2006	Review and Compete 154 FTE per "Green" Plan	228 FTE
	2005	(combined with FY 2004) Conduct Clerical Study via competition of 350 FTE.	(combined with FY 2004)
	2004	(combined with FY 2005) Conduct Clerical Study via competition of 350 FTE	350 FTE
	2003	Review 145.7 FTE	167 FTE
	2002	Review 72.7 FTE	63 FTE
2. FDA's implementation of HHS's Unified Financial Management System (19017) (Efficiency)	2008	NA
	2007 PB	FDA will finalize its decision on an activity-based costing application and make it operational for its user fee programs. In FY 2007, the Indian Health Service will go live with UFMS. FDA will continue its participation in this phase of the UFMS implementation (document review, testing, etc.).	01/08
	2007 CR	FDA will finalize its decision on an activity-based costing application and make it operational for its user fee programs. In FY 2007, the Indian Health Service will go live with UFMS. FDA will continue its participation in this phase of the UFMS implementation (document review, testing, etc.).
	2006	FDA will pilot an activity-based costing application integrated with HHS UFMS project as part of Prescription Drug User Fee Act III. The UFMS and its FDA modules will be operational in FY 2005 allowing FDA's legacy system core financial system to be decommissioned during the first quarter of FY 2006. In FY 2006, the Program Support Center went live with UFMS. FDA participated in this phase of the UFMS project.	Goal accomplished through various activities discussed under Performance text.
	2005	FDA will implement a new core financial management system as part of the HHS UFMS project. The General Ledger and the Payroll interface will be implemented Oct. 1, 2004, and the remaining modules will be implemented April 1, 2005.	Goal accomplished through various activities discussed under Performance text.
	2004	FDA will hold a conference room pilot to prototype the design and configuration of UFMS. Begin development of FDA's unique interfaces and test global interfaces.	Goal accomplished through various activities discussed under Performance text.
Data Source: FDA Office of Management & Systems, 2001 FAIR Act Inventory. The agency will rely on the data from the Federal Procurement Data System (FPDS). The sources encompassed in the General Ledger & Federal Administrator, the Purchasing & Accounts Payable; and the Accounts Receivable. These sources are being prepared to transition to the Financial Business solutions systems.
Data Validation: FDA will ensure consistency in the tracking and reporting of the administrative management performance goals. In addition, FDA is taking steps to routinely monitor this data and take appropriate actions as needed. Data is from a variety of sources for these performance goals including the Annual Chief Financial Officer's Report, Civilian and Commission Corps personnel databases, monthly and annual full-time equivalent (FTE) reports and data-runs, the FDA FAIR Act Inventory and the FY 2001 FDA Workforce Restructuring Plan, monthly statements from bank card companies and the FDA Small Purchase System.
Cross Reference: These performance measures support HHS Strategic Goal 8. Measures 1 and 2 are Efficiency Goals.
Long Term Goal: Improve the infrastructure for problem detection and product information dissemination, to strengthen consumer protection and take timely, effective risk management actions with all FDA-regulated products.
Measure	FY	Target	Result
3. Improve FDA's ability to respond quickly and efficiently to crises and emergencies that involve FDA regulated products. (19008) (Output)	2008	Enhance functionality and continue deployment of the Emergency Operations Network Incident Management System throughout the Agency (HQ, Centers, Field offices). Coordinate FDA's participation in exercises. Conduct and participate in exercises and workgroups related to emergency preparedness and response and counterterrorism.	01/09
	2007 PB	Enhance functionality and continue deployment of the Emergency Operations Network Incident Management System throughout the Agency (HQ, Centers, Field offices). Coordinate FDA's participation in exercises, including TOPOFF 4 Conduct and participate in exercises and workgroups related to emergency preparedness and response, avian and pandemic influenza, and counterterrorism. Develop an FDA emergency response plan and exercise(s) for pandemic influenza.	01/08
	2007 CR	Enhance functionality and continue deployment of the Emergency Operations Network Incident Management System throughout the Agency (HQ, Centers, Field offices) --limited due to CR funding. Coordinate FDA's participation in exercises, including TOPOFF 4 -- limited due to CR funding. Conduct and participate in exercises and workgroups related to emergency preparedness and response, avian and pandemic influenza, and counterterrorism -- limited due to CR funding. Develop an FDA emergency response plan and exercise(s) for pandemic influenza.	01/08
	2006	Enhance functionality and continue deployment of the Emergency Operations Network Incident Management System throughout the Agency (HQ, Centers, Field offices). Revision of national and Agency emergency response and crisis management plans. Conduct and participate in exercises and workgroups related to emergency preparedness and response and counterterrorism.	Goal accomplished. EON IMS Version 2.4 with enhanced functionality was implemented, including GIS Mapping, in August 2006. The system has been deployed to OCM/OEO Emergency Coordinators located in FDA field offices. EON IMS has been used in the preparation and response to natural disasters and crises and emergencies related to FDA regulated products. OCM/OEO has conducted and participated in exercises and workgroups related to emergency preparedness and response, counterterrorism, hurricane preparedness, avian influenza and pandemic influenza.
	2005	Develop the Agency's Emergency Operations Network Incident Management System (EON IMS).	Goal accomplished. EON IMS version 2.2 was implemented in March 2005 and used during the April 2005 TOPOFF 3 Exercise.
	2004	Develop Crisis Management Plan for CT. Develop the Agency's Emergency Operations Network.	Goal accomplished through various activities discussed under Performance text.
Data Source: Office of Crisis Management/Office of Emergency Operations.
Data Validation: Data validation is based on a review of the past period's activities and the Emergency Operations Network Incident Management System project plan and schedule.
Cross Reference: These performance measures support Strategic Goal 2.

Increase the number of Commercial FTE that will be reviewed for competitive sourcing. (19003)

Context of Goal: The goal of the FDA is to study at least 154 FTE per year based on the FAIR Act Inventory of 2003. To accomplish this goal the FDA conducts an intensive annual review of its FAIR inventory data from functional, organizational, geographic, and business perspectives. Once the review is completed, FDA evaluates all commercial positions that have not undergone a competitive sourcing study in order to identify a sufficient number of positions that would fulfill FDA's requirement in meeting the OMB and DHHS established goals. The commercial positions are presented to FDA senior management in the form of logical business units to determine what will be reviewed that year. The selected commercial business units are publicly announced and subjected to A-76 competitive sourcing competition either as one or more standard and/or streamline cost comparisons.
Performance: To date the FDA has completed seven cost comparison studies on 580 commercial FTE resulting in seven Most Efficient Organizations (MEOs). FDA successfully completed the FY 2006 goal by announcing the study of approximately 228 FTE in OITSS on September 15, 2006. With the addition of the OITSS study, the FDA will have competed 808 FTE of its 1542 commercial functions. By competing over 52 percent of its inventory in 5 years, the FDA has exceeded all of the established competition goals of OMB and DHHS. The FDA's Competitive Souring Plan for FY 2007 calls for FDA to study more than 180 additional FTE for competition. The preliminary planning for these competitive sourcing efforts will begin in the second quarter of FY 2007.

FDA's Implementation of HHS' Unified Financial Management System. (19017)

Context of Goal: The Department announced in FY 2001 that it intended to establish a unified financial management system to replace its operating division's individual financial management systems. The goal of the UFMS project is to reduce costs, mitigate security risks, and provide timely and accurate information across DHHS. FDA, CDC, NIH, and the Program Support Center (which covers the remaining components other than CMS and its contractors) began the design of the UFMS.
Performance: UFMS has been fully implemented in FDA. Because UFMS is an integrated system and all OPDIVs must share it, FDA remains involved and participates in all future phased implementations of other OPDIVs in the Department. As such, in FY 2006, we participated in the Program Support Center's phased implementation of UFMS and will do so in FY 2007 for Indian Health Services.

Improve FDA's ability to respond quickly and efficiently to crises and emergencies that involve FDA regulated products. (19008)

Context of Goal: The Office of Crisis Management (OCM) includes the Office of Emergency Operations and the Office of Security Operations. OCM and its offices will continue to develop and implement goals that serve to improve and enhance the FDA's preparation and response capabilities to crises and emergencies that involve FDA regulated products, including terrorist attacks and natural disasters. These activities continue to include the development of the Emergency Operations Network Incident Management System (EON IMS) which will provide seamless access to all FDA offices to enable them to respond quickly to the full range of FDA emergencies. The EON IMS will facilitate FDA's ability to integrate emergency related data and expertise in response to an incident of national significance as required by the National Response Plan and National Incident Management System (HSPD-5 and HSPD-8).

The Network will be supported by an information technology infrastructure that will provide decision makers with quick access to emergency documents and information from all pertinent agency sources, as well as provide federal, state, local and international authorities with advisory information.

Other initiatives that enhance FDA's preparedness and response include:

Reviewing and revising the FDA Crisis Management Plan and Emergency Response Plans

Conducting inter and intra-Agency terrorism and emergency response exercises

Updating technology and equipment for the Office of Emergency Operations and the Office of Security Operations

Strengthening collaborations with science and public health, law enforcement, Intelligence and international communities

Continuing the development of the Agency's Emergency Operations Network Incident Management System

Performance: In FY 2006, the Emergency Operations Network Incident Management System (EON IMS) designed, developed and implemented production system version 2.4 and plans to release version 2.5 in September 2006. The system, fully certified and accredited in September, 2004, remains in use by the FDA Office of Crisis Management/Office of Emergency Operations. The FDA Office of Crisis Management/Office of Emergency Operations uses the EON IMS to assist in the management and coordination of FDA's response to incidents regarding FDA regulated commodities, including outbreaks, natural disasters, e.g., hurricanes and actual or potential product defects that pose a risk to human or animal health. OCM has partnered with FDA's Office of Regulatory Affairs (ORA) to geo-code locations of regulated firms and has used the mapping capabilities of EON IMS to generate geo-coded maps to support preparedness efforts for the 2006 hurricane season. The system has been used during the planning of FDA response to natural disasters. EON IMS has also been used to support preparedness exercises that have included international, federal, state and local partners.

In FY 2006, the Emergency Operations Center updated its technological infrastructure furthering the Agency's emergency preparedness capabilities in the event of a large-scale disaster or attack. Enhancements in FY 2006 and FY 2007 include the ability to communicate through video conferencing with more locations, and improved video display capabilities. The Office of Crisis Management continued to engage in partnerships and cooperative efforts resulting in drafting the HHS Strategic Exercise Plan and completing the Food and Agriculture Incident Annex to the National Response Plan. Continue to work with federal, state, local and international groups in emergency preparedness and response activities.

OCM also participated in the TOPOFF4 Command Post Exercise (CPX) in June 2006 and completed work on after action items from TOPOFF3 exercise.

FY 2005 Accomplishments: OCM issued the final version of FDA's Crisis Management Plan (Version 2.3) in March 2005. The plan provides the Agency with a structured methodology that enables FDA to respond to crisis situations that are beyond the capabilities of existing FDA emergency response resources. It incorporates elements describing the process by which the Agency identifies a crisis as well as the role of crisis communications in FDA's response to a crisis.

OCM participated fully in two major emergency preparedness and response exercises -- TOPOFF 3 and the HHS Public Affairs OPDIVs Exercise. As follow-up to TOPOFF 3 exercise, participated in three-day T3 Large Scale Game Exercise.

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Office of Management Budget Formulation and Presentation

Headquarters and the Office of the Commissioner

Performance Goals

Office of Management
Budget Formulation and Presentation