Information Technology, Rent and Central Accounts
The funds in three important areas are centrally managed in PDUFA III. These areas are Information Technology, Rent, and Central Accounts. This section provides a summary of each one, and ends with a chart summarizing the year by year planned spending in each area.
The complete PDUFA III Five Year Information Technology Plan is included as Appendix A to this document. Only a high level summary of that plan is included here.
The first year of PDUFA III is a period of considerable transition. Many near-term fundamental activities and strategic issues must be resolved by the Agency as a foundation for long-range systems development plans for the out years of PDUFA III. For example FDA is conducting studies to determine a strategy for consolidating IT infrastructure and services. Similarly, FDA is working to shift its IT decision-making and governance to an Agency-wide, less de-centralized model. Further, FDA must resolve security issues with standard, Agency-wide solutions for secure submissions, secure e-mail, and electronic signatures. In the first year to 18 months of PDUFA III, FDA will focus on completing these efforts to ensure that they are developed, published, and widely understood. Once this is done, FDA will be able to expand planning of specific systems development and infrastructure projects into the out-years.
This plan represents only a portion of the overall IT work to be accomplished at FDA, but it is imperative that these PDUFA activities map clearly to overall Agency business and IT strategic planning. Several of the strategies must be accomplished not only to meet PDUFA III IT goals, but also Agency and DHHS goals. Therefore, the strategies presented here must be applied consistently across the Agency to achieve the maximum benefit of the efforts.
Many levels of planning efforts are underway within the Department of Health and Human Services, the FDA, the Centers and Offices, and within the PDUFA Program. The strategies outlined in the plan are presented to show their alignment with overall Department, Agency, and Program goals and objectives. One strategy that supports goals and objectives at all levels is the establishment of a formal IT governance process at FDA. Within this governance process, FDA will centralize accountability and funding for all PDUFA IT initiatives/activities for CBER, CDER, ORA and OC under the leadership of the Chief Information Officer (CIO). The FDA CIO is responsible for ensuring IT investments support the Agency’s common IT goals, fit into a common computing environment, and follow IT industry standard management practices and capability maturity model principles. Establishing a formal PDUFA IT investment governance process that incorporates the oversight and approval by both the Agency CIO and Agency management is critical to the success of PDUFA IT investments.
The strategies FDA is pursuing within the PDUFA III IT Program are aligned and presented in plan according to the CIO’s PDUFA Program goals:
- Provide a governance framework, management, and oversight of IT decision-making
- Review the efforts within the Electronic Regulatory and Submission Review (ERSR) Program and move the Program forward; and
- Increase the efficiency of IT programs and services to better support all of its customers.
A table at the end of the Executive Summary in Appendix A summarizes the strategies the FDA will pursue in FY 2003-2004 and shows a mapping of those strategies to PDUFA III, Center/Office, Agency, and Departmental goals.
The summary IT/Rent/Central Plan Summary Tables reflect the five-year IT costs in three places. The first is in the top portion of the chart that reflects the PDUFA II Additive Base Costs—starting with $18.8 million in FY 2003. The second place is the Electronic Submissions line, which reflects anticipated expenditures on IT enhancements each year. The last place is near the bottom of the chart where two IT subtotals are given. The IT subtotal for FY 2003 is $23.7 million, increasing to $30.3 million by FY 2007.
The General Services Administration charges rent to FDA for the Federal buildings that FDA occupies. This rent is charged at different rates depending on the type and location of the space provided. Since rent is an essential support cost for the process for human drug review, part of those charges are paid from appropriations and part from PDUFA fees. The amount of rent FDA pays is directly related to the number of employees that must be housed. Under PDUFA III the agency will be hiring additional employees, and the cost of acquiring and maintaining space for those additional employees is reflected in the rent estimates.
The summary IT/Rent/Central Plan Summary Tables reflect the five year Rent estimates in three places. The first is in the top portion of the chart that reflects the PDUFA II Additive Base Costs—starting with $7.8 million in FY 2003. The second place is a separate rent line in each of the goal areas. In each goal area, the first line shows of the cumulative additional staff years associated with the goal area for each year—additional staff years to be hired during PDUFA III. The number of additional staff years that must be housed each year drives the amount of increased rent each year. The last place is near the bottom of the chart where two rent subtotals are given. The rent subtotal for FY 2003 is $8.8 million, increasing to $13.0 million by FY 2007.
The Central Account pays for shared agency-wide services such as telecommunications, training, printing, mail and document management, IT systems including maintenance, employee health units, and other support and miscellaneous services. Also included in this account are recurring costs that FDA pays directly to non-Federal sources under the delegation of direct lease and service authority. These services include rental of space, and all recurring services for building operations such as overtime utilities, janitorial, guard, and ground maintenance. Like rent, the amount of central account support FDA pays is directly related to the number of employees that must be serviced. PDUFA provides the increased resources for these costs for the additional staff associated with the implementation of PDUFA.
The summary IT/Rent/Central Plan Summary Tables reflect the five-year Central Account estimates in three places. The first is in the top portion of the chart that reflects the PDUFA II Additive Base Costs—starting with $9.2 million in FY 2003. The second place is a separate central account line in each of the goal areas. In each goal area, the first line shows the cumulative additional staff years associated with the goal area for each year—additional staff years hired during PDUFA III. The number of additional staff years that must be supported each year drives the amount of increased central account costs each year. The last place is near the bottom of the chart where two central account subtotals are given. The central account subtotal for FY 2003 is $10.5 million, increasing to $16.4 million in FY 2007.