Food and Drug Administration FY 2011 Congressional Budget Request Table of Contents

Food and Drug Administration FY 2011 Congressional Budget Request Table of Contents Page Narrative by Activity FDA Program Resources Table Program Description and Accomplishments Funding History Budget Request 325 326 329 330 323

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INFRASTRUCTURE GSA RENT, OTHER RENT AND WHITE OAK CONSOLIDATION The following table displays funding levels for FY 2009 through FY 2011. FDA Program Resources Table (Dollars in Thousands) FY 2009 Enacted 1 FY 2009 Actuals FY 2010 Appropriation FY 2011 Pres.Bud +/- FY 2010 Program Level $278,969 $275,704 $288,751 $339,026 $50,275 GSA Rent $158,750 $156,399 $171,526 $193,949 $22,423 Other Rent $78,938 $77,866 $75,729 $103,126 $27,397 White Oak $41,281 $41,439 $41,496 $41,951 $455 Budget Authority $234,656 $234,902 $237,180 $259,238 $22,058 GSA Rent $133,589 $133,590 $146,022 $153,999 $7,977 Other Rent $62,531 $62,533 $52,622 $66,703 $14,081 White Oak $38,536 $38,779 $38,536 $38,536 $0 User Fees $44,313 $40,802 $51,571 $79,788 $28,217 GSA Rent $25,161 $22,809 $25,504 $39,950 $14,446 PDUFA $19,879 $20,099 $17,252 $19,905 $2,653 MDUFMA $3,930 $1,982 $4,264 $4,626 $362 ADUFA $839 $628 $885 $996 $111 AGDUFA $305 $100 $305 $322 $17 Generic Drugs 2 $1,841 $1,841 2 Reinspection $2,240 $2,240 2 Food Registration and Inspection User Fees $3,885 $3,885 Tobacco $208 $0 $2,798 $6,135 $3,337 Other Rent $16,407 $15,333 $23,107 $36,423 $13,316 PDUFA $14,812 $14,226 $20,154 $23,253 $3,099 MDUFMA $1,268 $892 $1,376 $1,493 $117 ADUFA $153 $115 $162 $182 $20 AGDUFA $72 $100 $72 $76 $4 2 Generic Drugs $548 $548 Reinspection 2 $992 $992 2 Food Registration and Inspection User Fees $1,813 $1,813 Tobacco $102 $0 $1,343 $8,066 $6,723 White Oak $2,745 $2,660 $2,960 $3,415 $455 PDUFA $2,745 $2,660 $2,960 $3,415 $455 1 FDA updated the FY 2009 Appropriation to reflect a reallocation of $12.2 million in FY 2009 budget authority and $3.9 million in Prescription Drug User Fee Act fees from the FDA Salaries and Expenses account to the GSA Rent and the Other Rent and Rent-Related accounts. 2 Proposed User fee; the amount includes associated rent activity The FDA Infrastructure Program operates under the following legal authorities and executive orders. The following are legal authorities for GSA Rent and Other Rent and Rent Related activities: The Public Buildings Act of 1959 (40 USC 601-619) Public Buildings Act: Public Buildings Amendments of 1972 (P.L. 92-313, 86 Stat. 216) Public Buildings Cooperative Use Act of 1976 (P.L. 94-541, 90 Stat 2505) Public Buildings Amendments of 1988 (P.L.100-678, 102 Stat 4049) The Federal Property and Administrative Services Act of 1949 (40 USC 486[d] and [e]) Omnibus Appropriations Act of 2009 (P.L. 111-8, 123 Stat. 524) Energy Independence & Security Act of 2007 (P.L. 10-140, 121 Stat. 1492) 325

The following authorities establish the consolidation of FDA Headquarters facilities at the White Oak Campus: The Food and Drug Administration Revitalization Act (21 U.S.C. 379b) Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321-399) Treasury, Postal Service and General Government Appropriations Act (5 U.S.C.) Allocation Method: Direct Federal/Intramural Program Description and Accomplishments The Infrastructure Program supports FDA s mission of protecting the nation s public health by allowing the Centers and ORA to perform their critical program responsibilities. These accounts directly support the FDA workforce at headquarters and nationwide by providing secure and costeffective office and laboratory space for FDA employees to conduct mission critical work. The Infrastructure Program includes three areas: GSA Rental Payments, Other Rent and Rent-Related Activities and the FDA White Oak Consolidation. GSA Rental Payments Base Amount: $171,526,000 (BA: $146,022,000 / UF: $25,504,000) The GSA Rental account includes FDA rental payments to the General Services Administration (GSA) covering FDA s office and laboratory facilities, and to the Department of Homeland Security (DHS) for guard services and security systems at these facilities. FDA currently occupies over 7.2 million square feet of GSA space, which includes 2.2 million for parking. More than two-thirds of the GSA and DHS rent charges for GSA-owned or GSA-leased space are for facilities in the Washington, D.C. area. The largest amounts include charges for the Parklawn complex, Module II in Beltsville, CFSAN s College Park complex, and the newly occupied buildings at the White Oak, Maryland campus. In total, FDA-occupied space comprises approximately 280 leased buildings including District Offices, Regional Offices, laboratories, and resident posts across the nation and in Puerto Rico. In FY 2009, the GSA Rent program conducted numerous activities to ensure the FDA workforce has the space and security necessary to carry out FDA s mission of protecting the public health in an efficient and effective manner. In FY 2009, with the OC and CDRH migration to the FDA White Oak campus, FDA vacated space in six HQ locations but immediately backfilled these locations with increased staff requirements for OC, ORA, CVM, CDER, and the new Center for Tobacco Products. In addition to three new buildings on the White Oak campus, FDA acquired one new GSA-leased facility at HQ and expansion space at two HQ GSA-leased facilities. FDA's Office of Criminal Investigations (OCI) relocated and expanded one field location. ORA acquired one new field location, relocated eight field locations (one of which was due to damage from Hurricane Ike), and acquired expansion space at two locations. Additionally, ORA vacated one border station when it was determined this location did not require full time staffing. Finally, ORA vacated one direct lease location and relocated to a GSA-owned facility. 326

FDA is working with DHHS to promote maximum utilization of Federal workspace, consistent with mission requirements, and to maximize its value to the Government. We strive to be cost effective, energy efficient and to acquire space to meet the mission and nationally recognized standards. Other Rent and Rent-Related Activities Base Amount: $75,729,000 (BA: $52,622,000 / UF: $23,107,000) The Other Rent and Rent-Related Activities account includes commercial rent and rent-related charges that are not part of the GSA Rent account. These funds cover costs for operating and maintaining facilities that are FDA-owned, GSA owned or leased and FDA-managed, and FDAleased properties located nationwide. Costs include commercial rent, utilities (including renewable energy), operation and maintenance contracts, janitorial and grounds maintenance contracts, and security and guard services contracts. The account also includes costs for overtime utilities and other above-standard level services provided by GSA in GSA-managed facilities. These accounts directly support the FDA workforce in meeting its public health mission by providing safe, efficient and secure facilities. FDA is working on the implementation of numerous energy savings efforts that will decrease utility costs, increase the life span and efficiency of operating and maintaining facilities, and save energy overall. The implementation of these types of projects support and meet the requirements set forth in Executive Order 13423 Strengthening Federal Environmental, Energy, and Transportation Management. These projects contribute to meeting the requirements of the Department of Health and Human Services (DHHS) Efficient Energy Management Assessments, the Energy Policy Act of 2005, and the DHHS Sustainable and High Performance Buildings Policy, High Performance Buildings Implementation Plan and the 2006 Federal Leadership in High Performance and Sustainable Buildings Memorandum of Understanding. FDA awarded the first Utility Energy Service Contract (UESC) at the FDA Complex in July 2007 in Beltsville, MD. The contract was based on the implementation of 21 specific energy and water conservation measures (ECMs) including replacing 3 chillers and 1 cooling tower at MOD 1, converting laboratory air handling units to new variable air volume controls and upgrading and enhancing the Digital Direct Controls at the MOD 1 & 2 laboratories and the MOD 1 vivarium. All these ECMs will achieve an estimated $1,416,640 annual savings in water, sewer, electricity and fuel costs representing a 35% utility cost reduction for this FDA Beltsville Facility Complex for many years to come. This UESC project is scheduled to be completed in September 2009. FDA also awarded a UESC to Georgia Power in September 2008 for the South East Regional Laboratory in Atlanta, Georgia. The ECMs performed under this contract included replacing plumbing devices, installing passive infrared occupancy wall switches, installing vending misers, installing an energy management and control system, retrofitting the boiler plant and the autoclave units, and replacing multi-zone air handling units. These ECMs are estimated to save $152,202 in annual utility savings. Additional impacts include enhancing the indoor air quality by improving thermal comfort, ventilation and air distribution and indirectly resulting in an increase in productivity. FDA is considering an energy saving contract for the ORA District Laboratory in Irvine, CA with the Southern California Edison Electric Power Company. If determined to be cost effective and economically feasible, FDA will proceed to award. 327

White Oak Consolidation Base Amount: $41,496,000 (BA: $38,536,000 / UF: $2,960,000) FDA s headquarters consolidation to the White Oak complex will replace and centralize existing geographically disparate facilities with new, state-of-the art laboratories, office buildings and support facilities into one location. While the GSA appropriation will fund the design and construction of the new buildings at White Oak, FDA s appropriation and PDUFA user fees will fund building fit-out and move costs. FDA initiated relocation activities to White Oak in FY 2002. During FY 2009 approximately 1,500 employees moved to the White Oak Campus, including 174 Office of Commissioner employees to Historic Building 1 and 1,326 Center for Devices and Radiological Health (CDRH) employees to Building 66. The total number of employees currently working on the White Oak Campus is 4,470. During FY 2010 FDA plans to relocate another 1,026 employees to the White Oak Campus, for a total on Campus of 5,496. (Note that population totals have been adjusted slightly from previous submissions as construction modifications occurred and building capacities were revised accordingly.) In March 2010, components of the Office of the Commissioner and the Office of Regulatory Affairs (ORA) will move to Buildings 31 and 32 on the White Oak Campus. In addition, a Child Care Center will be completed in 2010. If the remaining need for GSA construction funds is appropriated in FY 2011, the current phase of the consolidation will conclude in FY 2013. With the approval of a proposed Master Plan Update anticipated in FY 2010, the Campus will accommodate 8,889 FDA employees. Construction of Office Building 66 was completed in May 2009. CDRH completed it s relocation to Building 66 in August, 2009 and became the first FDA Headquarters Center to be fully consolidated at White Oak. Construction of Office Buildings 31 and 32 began in December 2007, and are scheduled for occupancy in March 2010. Construction of the Northeast Parking Garage started in June 2008 and was completed in May 2009. In May 2008, design started for the Southeast Parking Garage and is now complete. It will be built pending appropriation of GSA construction funding. Design of Buildings 52 and 72, the Life Sciences Laboratories II and III, and the vivarium started in August 2008. Construction is anticipated to begin in early 2010 for Buildings 52, 72 and the vivarium. Buildings 71 and 75 are currently in design and construction is also scheduled to begin in early 2010. Buildings 25, 45 (Distribution Facility), and the Communications Facility are scheduled to be designed in FY 2011. From a GSA funding perspective, the White Oak Campus project is 70 percent complete (based on FY 2010 funding levels and the 2006 master plan). FDA is working with the General Services Administration to secure GSA construction funding for the remaining 15 office buildings and laboratories (and related facilities) in the current White Oak campus design. However, FDA is also experiencing an unprecedented and dramatic surge in staffing and facility needs that will cause FDA facility requirements to exceed the scope of the 2006 Master Plan. This staffing surge is based on FY 2008 and FY 2009 appropriation increases, budgeted increases for FY 2010, and growth associated with the Center for Tobacco Products. On June 22, 2009, the President signed the Family Smoking Prevention and Tobacco Control Act, giving FDA the authority to regulate the manufacturing, marketing and sale of tobacco products. Implementing 328

this legislation will require FDA to hire as many as 700 additional professionals to support the new Center for Tobacco Products. To accommodate this growth, FDA is working with the General Services Administration to secure GSA funding for designing and planning for facilities to support our growth due to recent budget increases, as well as facilities to support FDA's new Center for Tobacco Products. Where necessary, FDA will acquire temporary leased office space to accommodate Tobacco Program and other program growth until new facilities at White Oak are completed. FIVE YEAR FUNDING TABLE GSA RENT The following table displays funding levels from FY 2007 through FY 2011. Fiscal Year Program Level Budget Authority User Fees FY 2007 Actual $138,896,000 $126,871,000 $12,025,000 FY 2008 Actual $145,111,000 $130,611,000 $14,500,000 FY 2009 Actual $156,399,000 $133,590,000 $22,809,000 FY 2010 Appropriation $171,526,000 $146,022,000 $25,504,000 FY 2011 President s Budget Request $193,949,000 $153,999,000 $39,950,000 FIVE YEAR FUNDING TABLE OTHER RENT AND RENT- RELATED ACTIVITIES The following table displays funding levels from FY 2007 through FY 2011. Fiscal Year Program Level Budget Authority User Fees FY 2007 Actual $49,906,000 $42,000,000 $7,906,000 FY 2008 Actual $64,646,000 $50,278,000 $14,368,000 FY 2009 Actual $77,866,000 $62,533,000 $15,333,000 FY 2010 Appropriation $75, 729,000 $52,622,000 $23,107,000 FY 2011 President s Budget Request $103,126,000 $66,703,000 $36,423,000 FIVE YEAR FUNDING TABLE WHITE OAK The following table displays funding levels from FY 2007 through FY 2011. 329

Fiscal Year Program Level Budget Authority User Fees FY 2007 Actual $35,657,000 $25,552,000 $10,105,000 FY 2008 Actual $42,726,000 $38,536,000 $4,190,000 FY 2009 Actual $41,439,000 $38,779,000 $2,660,000 FY 2010 Appropriation $41,496,000 $38,536,000 $2,960,000 FY 2011 President s Budget Request $41,951,000 $38,536,000 $3,415,000 Budget Request The FY 2011 FDA request is $339,026,000 in program level funding for the Infrastructure Program. The request includes $259,238,000 in Budget Authority and $79,788,000 in User Fees. This represents an increase of $22,058,000 in Budget Authority and $28,217,000 in User Fees for FY 2011. The base funding for FDA s Infrastructure Program is $288,751,000, including $237,180,000 in Budget Authority and $51,571,000 in User Fees. GSA Rental Payments (Base: $171,526,000) FDA requests $193,949,000 for GSA Rental Payments, including a program level increase of $22,423,000. The increase includes $7,977,000 in Budget Authority and $14,446,000 in User Fees. The total request includes $153,999,000 in Budget Authority and $39,950,000 in User Fees. The rental properties that provide office and laboratory space for FDA s 12,000 employees are essential facilities that allow FDA to perform its vital public health mission. Base funding for GSA Rental Payments covers the cost of rental payments to GSA for FDA s five million square feet of GSA rented office and laboratory space, as well as payments to the Department of Homeland Security for guard services and security systems at these facilities. Other Rent and Rent-Related (Base: $75,729,000) FDA requests $103,126,000 for Other Rent and Rent Related, including a program level increase of $27,397,000. The increase is $14,081,000 in Budget Authority and $13,316,000 In User Fees. This total request includes $66,703,000 in Budget Authority and $36,423,000 in User Fees. It is important that FDA keep its infrastructure strong and provide a highly functional place to perform our regulatory mission. This request allows FDA to operate, maintain and secure its facilities in an appropriate manner. The requested increase in funding will cover the escalating costs in commercial rent, security, service contracts, and utilities. This increase will prevent FDA 330

from charging unavoidable costs to FDA programs, allowing them to fund enhanced mission focused activities in food safety and medical product development and safety. White Oak Consolidation (Base: $41,496,000) FDA requests $41,951,000 for White Oak Consolidation, including an increase of $455,000 in User Fees. This request includes $38,536,000 in Budget Authority and $3,415,000 in User Fees. FDA s consolidation at White Oak provides an environment that encourages efficiency, creativity, and superior performance, while strategically using our human capital. The request will allow FDA to fund infrastructure and fit out of Buildings 52 and 72, security and communication network, an expanded program and fit out in Office Buildings 31 and 32, and supporting facilities on the Campus. The request will also fund security, associated infrastructure and equipment for Building 45. Finally, it will fund the security and communication network for Building 71. 331

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