FDA's Implementation of the President's Management Agenda
The President's Management Agenda (PMA), announced in the summer of 2001, is an aggressive strategy for improving the management of the Federal government to deliver results to the American people. It reflects the Administration's commitment to achieve concrete and measurable results in the near term, while focusing on remedies to serious problems, and commits to implement them fully.
The five mutually reinforcing government-wide goals are Strategic Management of Human Capital, Competitive Sourcing, Improved Financial Performance, Expanded E-government, and Budget and Performance Integration.
For example, workforce planning and restructuring undertaken as part of Strategic Management of Human Capital will be defined in terms of each agency's mission, goals, and objectives--a key element of Budget and Performance Integration. Agency restructuring is expected to incorporate organizational and staffing changes resulting from Competitive Sourcing and Expanded E-government.
Budget and Performance Integration will reflect improved program performance and savings achieved from Competitive Sourcing and will benefit from financial and cost accounting and information systems which are part of efforts in Improved Financial Management. This review will give an update of the Agency's progress and achievements made during the past year.
Strategic Management of Human Capital
FDA is moving assertively to meet PMA goals and is firmly committed to the DHHS goals to significantly improving efficiency and controlling FTE growth. The Agency has already taken a series of important steps towards achieving these goals and will continue to do so to meet these initiatives.
The FDA has expanded its FAME [Formula for Achieving Managerial Excellence] leadership training created to assist supervisors, managers and team leaders in identifying and developing the critical management and leadership skills necessary to communicate effectively, manage successfully, and create and contribute to motivated high-performance teams. FAME has also been expanded to include a fourth course, Supervisory Potential Program, which was designed to address FDA's succession planning needs and supports the FDA's strategic workforce plan to build a strong FDA by identifying future supervisors early in their careers.
FDA widened its audience to include non-supervisory employees seeking the opportunity to explore supervision as a career. Post-course Forums are also recent additions to the FAME program. The Forums are designed to help FAME graduates transfer learning from the FAME courses to their jobs and to foster networking. One Forum is open to managers, supervisors and team leaders. The other Forum is open to non-supervisory employees who are graduates of the Supervisory Potential Program.
FDA also launched a new Leadership Development Program designed to groom internal employees at the GS-13-15 levels and equivalent, as future leaders of FDA. This program, an integral part of the FDA succession plan, includes a formal Senior Executive Development component that is delivered by George Washington University.
FDA is continuing to advance its strategic recruitment outreach initiative aimed at improving diversity among various minority populations; especially the Hispanic community. FDA is also developing an agency-wide "Diversity Recruitment Outreach and Retention Plan" to support workforce diversity.
Workforce Analysis and Workforce Planning
A strategic workforce restructuring plan was submitted during the 2005 budget process outlining FDA's on-going restructuring initiatives to right-size FDA's workforce, with a smaller, centralized unit providing administrative and support services customized according to component's needs and funded on a reimbursable basis.
In addition, the FDA is conducting an Organizational Assessment of the Office of the Commissioner (OC) in order to determine high-level alignment of resources to execute the OC's core functions and fulfill the OC mission. The goals of this initiative are to clarify the operational vision and priorities of the OC; manage within the OC annual budget; improve alignment of OC core functions with customer and stakeholder needs; and improving operational; efficiency and effectiveness.
FDA is also moving toward competency-based business processes that depend on the correct mix of skills and abilities. With improved business processes and realigned support services, FDA should be able to redirect its resources into more mission critical positions whose skills and abilities would enable the Agency to meet its performance commitments.
To improve upon our Human Capital Management Initiative, FDA prepared a Strategy for Human Capital Planning in order to identify key critical positions, forecast critical vacancies, analyze competencies of our leaders and mission critical staff, and develop a strategy for filling positions.
The Human Capital Strategy developed for FDA will provide a framework to improve FDA's business practices and ensure that FDA continue to have trained and competent employees, supervisors and managers to accomplish its mission and to guide its growth.
FDA continues to receive HR services from the Department's Rockville HR Center. FDA retained the strategic workforce planning and several customized programs tailored to Agency operations. These include the administration of the Peer Review System, Commissioned Corp HR liaison, performance management, and award ceremonies.
FDA also plans to offer Voluntary Separation Incentives to employees in FY 2006 in administrative positions.
In FY 2005, all FDA employee performance contracts and plans were linked to Agency and Departmental program goals and management objectives. This requirement will continue in FY 2006.
Improved Financial Performance
FDA has focused efforts on modernizing financial systems and improving its internal controls.
FDA participated in the DHHS' Recovery Auditing Work Group, to develop uniform policies and procedures for use across the Department in complying with the Improper Payment Improvement Act. FDA submitted a final Statement of Work for review. FDA also conducted improper payments risk assessments for its Foods, Human Drugs, and Medical Devices programs.
Financial Management Improvement
With the launching of the UFMS, the Division of Accounting reassigned staff and created a financial operation group composed of senior and journeyman subject matter experts responsible for the monthly close-out process, performing quality control, and other work necessary to ensure the integrity of various UFMS modules (including accounts receivable; accounts payable; general ledger; budget execution; and commitment and obligation). The financial operation group also collaborates with the Office of Shared Services for their purchasing and accounts payable activities.
FDA has been working through a temporary decline in office productivity stabilization associated with the UFMS implementation. FDA is making necessary changes in procedures and policies to adjust to the new system's operation.
During the agency's financial statement audit, the OIG determined that FDA's financial management systems do not substantially comply with Federal Financial Management Improvement Act (FFMIA). As UFMS achieves full stabilization, FDA believes compliance will be realized. No instances exist in which FDA's financial management systems do not substantially comply with Federal accounting standards and the U.S. Standard General Ledger at the transaction level.
In FY 2006, FDA plans to implement an ad hoc reporting tool while developing plans for a business intelligence model implementation in FY 2007. FDA will continue to streamline user fee business processes and reporting with E-GOV initiatives. FDA plans to implement the HHS E-travel system with a pilot in April/May 2006 and complete it by June 2006.
Financial Enterprise Solution
- The Agency completed implementation of the financial user fee solution. These included PDUFA, MDUFMA, ADUFA, MQSA, Color certification, and export certification payment information. These accomplishments include:
- Providing a web portal for industry customers to enter applicant user fee activity.
- Providing an interface for pertinent financial data to the accounts receivable module of the new financial system.
- Providing internal FDA components pertinent receipt and customer information to their data systems.
- Providing reports of user fee activities through a Business Objects solution.
- Completed the implementation of the Purchase Request Information System (PRISM) by:
- Working with FDA contracting staff to develop requirements for the contracts implementation, and,
- Completed the implementation of i-Procurement software with appropriate interfaces with PRISM and UFMS.
Travel Manager and the HHS-348 Sponsored Travel Module
- Completed implementation of the Travel Manager System that provides an automated travel system for the FDA traveler, reviewing officials, and travel audit staff.
- Completed implementation of the Sponsored Travel Module, as a primary subsystem within the Travel Manager, which is used for processing non-Federal sponsored travel.
- Worked with GSA in adapting FDA's Sponsored Travel Module for use in other Federal agencies to process non-federal sponsored travel in their Gov Trip Travel System.
Integrate Financial and Performance Management Systems
FDA has interfaced several FDA financial management applications (user fees, travel, property, procurement, requisitioning, payroll, and grants) with UFMS. These applications have met all federal financial management, certification and accreditation requirements.
OMB Circular A-11 requires the integration of performance and financial information for reporting purposes. Since there is no reporting capability identified in UFMS, FDA will be developing a customized reporting solution using the Oracle Federal Financial software. In FY 2006, FDA will pilot an activity-based costing application as mandated by the third reauthorization of PDUFA.
The purpose of this pilot is to improve the accuracy and reliability of cost information that is derived from expenditures used to perform the PDUFA drug review. The User Fee Financial Team collects cost information from PDUFA organizations (CDER, CBER, OC, and ORA). They analyze and provide information and decision-making support to agency leadership. Timely and accurate information on PDUFA costs may help FDA determine its annual fee requirements; make adjustments and take corrective action, including reprogramming actions; and enable the design of more responsive fee structure when it is negotiating user fee reauthorization every five years.
FDA sustained progress in the consolidation of its IT infrastructure through collaboration with HHS in achieving its "One HHS" goals and objectives; ongoing efforts to accomplish the IT consolidation goals mandated by the reauthorization of PDUFA; and the continued maturing of the IT Shared Services organization established in FY 2004 to manage the FDA's consolidated IT infrastructure. To this end, FDA has:
- Commenced on October 1, 2004, the Single Source Infrastructure Service Support Contract which will provide efficiencies and savings through consolidation of services and management of contractors; in fact, the contract consolidated 15 IT Infrastructure Service contracts, which will result in nearly $10 million in savings over the next five years;
- Launched the Enterprise Infrastructure Consolidation Program; in the first phase completed an assessment of servers and storage area networks deployed in the 30+ dispersed sites across the Metropolitan area that will eventually merge into the White Oak Data Center; from this assessment an acquisition plan has been derived, and the FDA is in the process of identifying the best approach for reducing its 700+ servers;
- Awarded the contract to develop the Electronic Submissions Gateway, which is intended to provide a single point of entry for electronic regulatory submissions to the FDA; the system will be in production for receiving electronic drug adverse event reports in September 2005 and PDUFA reports in October 2005;
- Gathered, through use of prototypes, the requirements for developing an IT cost reporting model that integrates with FDA financial applications, categorizes IT spending by investment/system/project and activity, and reveals the true cost of infrastructure services;
- Awarded the contract to implement electronic standards for structured product labeling (SPL) as part of the FACTS@FDA program, which provides the foundation for a number of Health Information Technology (HIT) initiatives including electronic prescribing, clinical decision support, and post marketing medication adverse event surveillance; release 1a, was implemented in October 20005 and includes the Substance Registration System (SRS) and the Electronic Labeling Processing System (ELIPS); and
- Acquired, as a result of an alternative analysis, a COTS tool to implement new Electronic Common Technical Document (eCTD) specifications, thus providing enhanced functionality for submitting and reviewing drug applications. Implementation was completed at the end of June 2005.
Enterprise Architecture (EA) — IT Projects
- Developed a draft target architecture that will be the planning framework for future enhancements to the IT environment; this also enabled FDA to meet GAO and OMB mandates for Agencies to demonstrate a level of maturity (level 3) in their EA processes;
- Finalized the System Development Life Cycle (SDLC) version 2 to further standardize systems development in the Agency and initiated stage gate reviews using the SDLC to ensure conformance;
- Implemented earned value management for major IT investments; this will provide a single view of cost and performance of a project for use in stage gate reviews and reporting to the CIO, HHS and OMB; and
- Launched parallel activities to enable FDA better command of the total cost of IT; one activity will focus on aligning cost to IT projects and activities; the other activity will provide more exact costs of the infrastructure services currently being provided by the IT Shared Services; both activities will leverage UFMS that is currently in production, with the target implementation date October 2005.
FDA has made significant contributions to this effort by providing key IT and technical personnel to actively participate on each DHHS project team. This collaborative effort also extends to the Enterprise Human Resource Planning project and HHS Corporate University. Agency IT staff has also made contributions as part of the development of the HHS 5-Year IT Strategic Plan.
FDA is continuing to contribute key IT and financial technical personnel in support of various Departmental projects. For example, FDA is participating with the Department, who is a managing partner, in the Federal Health Architecture initiative, which is a set of guiding technology and management principles that will impact the health industry by enabling innovation in care, reduced cost, and improved access and enhanced public health threat preparedness.
The Agency is involved in the Business Gateway E-Gov initiative by participating in design and implementation meetings and using the E-Forms Catalog to register FDA forms.
FDA assumed a leadership role in the Department for the Online Rulemaking Initiative — the formal launch of Phase I of www.regulations.gov was successfully held on January 23, 2003. Work has begun on structuring Module 2, and a team has been set up to provide continuing maintenance and web site change control.
FDA is positioned to migrate from an agency public comments system to a government-wide solution in FY 2006. This will require the replacement of FDA's Dockets system.
In addition to these activities, FDA supported various Departmental initiatives such as:
Secure One HHS - The goal of Secure One is "to create an enterprise-wide secure and trusted IT environment in support of the overall HHS mission". FDA has supported this goal by establishing a comprehensive security program that:
- Contains security performance measures and metrics, regularly monitored by the FDA Chief Information Systems Security Officer;
- Characterizes and categorizes systems and resources to identify what is most critical and vulnerable, in order to develop reliable and appropriate security plans;
- Institutionalizes an Agency-wide training program impacting both system managers and the general user; and,
- Makes use of a well-coordinated communications effort to highlight security as the highest priority of the FDA CIO and inform all levels of the FDA workforce.
In FY 2005, FDA documented in formal reports (Privacy Impact Assessments, Plan of Actions and Milestones, and Certification and Accreditation) outcomes demonstrating FDA successfully and fully met the goals of the Secure One HHS Program, with 100 percent of its operational systems certified and accredited as properly secured. FDA also developed and tested an IT Disaster Recovery plan, including a Disaster Recovery assessment of its operational systems.
Grants Consolidation — FDA is working with NIH staff regarding details of the migration to the eRA/IMPAC II Grants Management System. FDA has also participated in two DHHS subcommittees established to achieve efficiencies and uniform processes across the Department.
HHS enterprise-wide initiatives — Consolidation of like-services has been a linchpin of the "One HHS" strategy. FDA has provided expertise and resources, with special emphasis on the following projects:
- HHSnet — HHSnet is a department wide initiative to architect a comprehensive network design that encompasses all aspects of the HHS Enterprise Network including the build-out of the HHSnet Network Operation Center (HHS/NOC), while maintaining a strong security posture; the goals of the network redesign are to support intra-operational division communications, to ensure high performance and reliability of strategic systems; FDA assumed a leadership role in the effort, working closely with OPDIV and HHS counterparts, and meeting regularly with senior HHS leadership to discuss progress; also, FDA was the first OPDIV to transition to the new network, and then coordinated the deployment of other segments throughout HHS; finally, FDA relinquished control in October when the network became operational; and,
- Unified E-mail — Another consolidation strategy has been unifying e-mail systems across HHS in order to take advantage of economies of scale and common standards; FDA has been a strong participant, having appointed a team responsible for managing FDA's responsibilities from design to rollout; lastly the FDA has finalized, in cooperation with HHS, the design for its component of the Enterprise Email System (EES), with migration slated for FY2006.
FAIR Act Inventory
In accordance with the Federal Activities Inventory Reform (FAIR) Act of 1998, FDA submitted its 2005 FAIR Act inventory, which identified 1,495 FTE as commercial and 8,815 FTE as inherently governmental. The development of the FY 2005 FAIR Act inventory began in March 2005.
The A-76 Executive Steering Committee made a decision to study the Office of Information Technology Shared Services (OITSS) that was confirmed by Agency leadership in December 2005. The study of 175 FTE will begin by September 15, 2006. Preliminary planning has begun and a functional analysis of OITSS will start mid- January 2006.
Status of On-Going Activities
Clerical Support Services-- FDA finished the development of the Most Efficient Organization (MEO) for the 350 FTE Clerical Support Services Study and forwarded the agency tender to contracting office for source selection. The performance decision was announced in February 2005 awarding the competition to the FDA's MEO. This decision initiated a formal transition process beginning in May 2005. The team is currently defining the methodology for monitoring performance, cost, and workload that will be used by the MEO.
FDA clerical workforce will pilot the post-MEO monitoring system in early FY 2006. Phase-In of the Clerical Support Services MEO will begin on or about February 18, 2006, with full performance expected 60 days after the start of the Phase-In period. The first quarterly QAE inspection will occur one month later followed at three-month intervals by successive quarterly evaluations. Self reported clerical workload and task times will be collected by the web-based data collection system mentioned above.
Phase I and Phase II Studies — All Phase I and II cost competitions resulted in awards to in-house government proposals. FDA is performing post-MEO monitoring on all six of the MEOs. Initial Quality Control Plans and Quality Assurance Surveillance Plans for all studies were comprehensively reviewed and revised to configure them for use in monitoring MEOs. Quality Assurance Evaluator (QAE) inspections were conducted and formal reports were issued for all MEOs for the third and fourth quarters of the first performance period. QAE reports were given to the responsible Contracting Officer for inclusion as part of the official contract file. Quarterly Evaluations and Annual Audits will continue throughout the fiscal year.
Annual Audits for Six MEOs — FDA performed annual audits of the first performance period of each of the six MEOs. The audits confirmed the MEOs are performing successfully and, in most cases, were operating below the cost estimated for the first performance period. HHS conducted an independent audit of the savings reported in the FDA audits of the Bioscience Library and Real Property Management MEO. The independent audits validated the savings reported in the FDA audits.
|Function||Baseline in Dollars||Actual in Dollars||Savings in Dollars|
** TV Studio exceeded the MEO baseline due to pay retention provisions on some positions that are not included in the A-76 baseline.
# Revise to add the Pacific Supervisor to the actual costs.
Budget and Performance Integration
FDA continues to make progress in achieving the intent of the Budget and Performance Integration initiative. The OMB PART evaluation and Agency follow-up efforts have improved performance management throughout FDA components. Specific activities include:
Evaluation of Performance Management Framework and New Strategic Planning Effort
Based on a review of current business processes and core mission activities, FDA identified areas where the existing performance management framework could be improved to better address the requirements of the PART evaluation process as well as the requirements specified in OMB Circular A-11 on strategic and performance planning. FDA envisions a multi-year improvement effort that will allow sufficient time to create long-term outcome goals that cover FDA's mission areas more completely, while providing adequate time to develop baseline performance information so that measures and targets are specified appropriately.
During the early part of 2005, FDA held a series of strategic planning sessions to develop the outline of the revised strategic and performance management framework. FDA revised its formulation of strategic goals so that they align more directly with three core business processes and a crosscutting goal for transforming FDA operations to achieve greater productivity and implement e-Government initiatives. The resulting four strategic goals encompass all aspects of FDA's public health mission. FDA also drafted a second tier of long-term goals and objectives within each strategic goal area, which clarifies how FDA plans to implement the strategy and provides a basis for establishing performance measures and targets to guide agency activities. For example, FDA's vital counter-terrorism responsibilities, which cut across all of FDA's programs, are addressed through long-term goals and objectives in each strategic goal area.
In FY 2006, FDA plans to complete a new strategic plan that will include long-term goals and objectives. Over the next few years, FDA will work to bring its annual goals and long-term outcome goals into closer alignment with the new strategic goal framework.
Senior Management Using Performance Information for Decision-making
Center and agency leadership have used performance information as one of the many criteria for making resource decisions. For example, FDA programs that implement user fee programs (e.g., drugs, medical devices, and animal drugs) carefully monitor their performance information to ensure compliance with their commitments made under PDUFA, MDUFMA, and ADUFA. All FDA centers hold regular management team meetings during which they use performance information to monitor program performance, make resource adjustments, and evaluate staffing plans.
Marginal Cost Pilot
FDA developed a marginal cost methodology that enables program managers to determine performance and cost impacts of various budget scenarios. The Animal Drugs and Feeds Program was selected as the agency pilot, using the animal drug user fee program as the basis for estimating marginal improvements in performance that could be achieved through increases in funding. The methodology showed that an increase in resources obtained through the collection of user fees provided to the new animal drug review program yielded significant decreases in review times needed for evaluating various types of new animal drug applications, thereby making new animal drug therapies available on the market sooner. Decision-makers are now equipped with a useful tool for evaluating program initiatives based on projected performance and resource levels. OMB requested FDA to continue to track progress in using the marginal cost methodology in the agency pilot program. Animal drug review program performance and cost information will be provided annually through the ADUFA annual reports and FDA's performance budget submissions.
FDA plans to formally complete the marginal cost pilot in FY 2008, when the performance and cost data for FY 2007 become available. In the mean time, FDA will continue to apply the methodology internally in the course of annual performance budget decision making and strategic planning.
Using PART Ratings to Justify Performance Budget Requests
FDA received a rating of moderately effective after its FY 2005 PART evaluation. Building on this success, FDA leadership instituted a series of improvements intended to monitor agency progress in meeting the PART outcome goals promised to OMB and to DHHS; and to understand how the agency's performance framework contributed to the outcome goals' accomplishment. FDA has included the FY 2005 PART rating in its justification material for each successive budget year.
Improving Performance Presentation in the Budget Submission
FDA's effort to create an integrated performance budget for the FY 2006 congressional justification submission received recognition from OMB and DHHS for having successfully incorporated performance information throughout the document. Nevertheless, the document's size was identified as a target for further improvement, through streamlining, greater integration, and consolidation. FDA conducted a post-cycle evaluation, found opportunities for consolidation, and made changes in conformance with DHHS FY 2007 budget instructions. This resulted in a streamlined budget submission for FY 2007 that consolidated performance information, tailored and highlighted budget information, and pruned material contained in the budget overview. This budget submission was revised to communicate Agency performance and resource needs in a more concise manner. FDA will conduct a post-cycle evaluation after the submission of the congressional justification to evaluate and improve the integration and presentation of performance and budget information.
Beginning in FY 2004, FDA changed its performance appraisal system to link the Departmental and Agency goals to its performance contracts — starting with FDA senior executives and now cascaded to all employees. All individual performance appraisals now provide a document containing a listing of the HHS goals and objectives which links the employee's work plan to the HHS goal(s). The accomplishment of the employee's work contributes to the ultimate achievement of the HHS goals.