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FY 2007 Table of Contents

INFRASTRUCTURE

GSA RENT, OTHER RENT AND WHITE OAK

          ^1/Contains budget authority rescission of 0.8 percent.

         ^2/ Excludes $12,092,000 in FY 2005 and $8,188,000 in FY 2007 in PDUFA carryover fees to fund the White Oak Consolidation Project.

* Excludes $12,092,000 in FY 2005 and $8,188,000 in FY 2007 in PDUFA carryover fees to fund the White Oak Consolidation Project.

Statement of Budget Request

FDA requests $208,020,000 in program level resources for rent activities and the resources needed to move to White Oak in FY 2007.  Rent Activities and White Oak are a part of the Salaries and Expenses Appropriation and include Rental Payments to GSA and Other Rent and Rent-Related Activities such as guard services, security systems and grounds maintenance.  White Oak funding will pay for the fit-out and move to newly constructed buildings for the FDA consolidation at White Oak, Maryland. 

Program Description

FDA rental properties provide office and laboratory space for the Agency's 10,000 employees.  These are essential facilities that allow FDA to perform its vital public health mission.  GSA Rental Payments includes charges for all of GSA space.  The Other Rent and Rent-Related account includes rent and rent-related charges that are not part of the GSA account.  These include Commercial Rent and Related Services, GSA Rent-Related Services and GSA Building Delegation Services account.  The agency currently occupies over 6.7 million square feet of GSA space, including parking.  Approximately half of the GSA rent charges for government-owned or GSA-leased space are for facilities in the Washington, DC 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 addition, FDA-occupied space includes over 200 leased offices, including District Offices, Regional Offices, laboratories and resident posts that are strategically placed across the nations.   

The White Oak campus will replace existing fragmented facilities with new, state-of-the art laboratories, office buildings and support facilities.  The consolidation of the remaining FDA headquarters is occurring at the government-owned White Oak site.  The design and construction of the new buildings at White Oak are funded through General Services Administration (GSA) appropriations, with FDA paying for building fit-out and move costs.

The consolidation at White Oak will allow FDA to standardize and modernize document handling and shared use activities such as libraries and conference areas.  We will also reduce redundancies in a wide range of administrative management tasks and achieve conversion to a single computer network.  This will create a stronger FDA by reducing operating costs, reducing travel time between FDA organizations and increasing convenient access to FDA by the public.  To date, approximately 1,850 employees are onsite at White Oak, and the last phase of the consolidation is currently scheduled for FY 2010.  

Program Resource Changes

Budget Authority

GSA Rent: +$10,468,000

FDA requests an increase of $10,468,000 over the FY 2006 level for GSA Rent.  This increase will help cover inflation on FDA's current GSA leased facilities and the increased rental costs for the White Oak facility.  The proposed increase will allow FDA to improve management and provide for rising GSA rent, without redirecting resources from core, mission-critical public health activities. 

White Oak Consolidation Project:  +$3,797,000

FDA requests an increase of $3,797,000 over the FY 2006 level for the White Oak Consolidation Project.  The proposed increase, along with the base funding and PDUFA carryover funds of $8,188,000, will allow FDA to continue core, mission-critical public health activities.  These funds will provide funding for the CDER Office II building, Shared Data Center and Auxiliary Facilities.  Detailed activities include:

• CDER Office Building II component: To fund relocation costs including: decommissioning vacated office space, relocation coordination and moves, furniture, document management equipment and, audio/video equipment.  It will also fund internal communications costs such as equipment, cabling, IT engineering support and desktop computer preparation and relocation.
• Consolidated Data Center component: To fund Phase II of the Central Shared Use I Building Data Center including communications equipment and services, project management services, uninterrupted power supply and data equipment services.
• Auxiliary Facilities component: To fund parking garage security and for furniture, move and security costs for Phase II of the Central Shared Use I Building.

User Fees

Current Fees

Prescription Drug User Fee Act:  +$1,801,000 for GSA Rent

PDUFA authorized FDA to collect fees from the pharmaceutical industry to augment appropriations spent on drug review.  These fees expand the resources available for the process of reviewing human drug applications.  Fee resources pay for the salaries of scientists and other professionals who review drug applications, and for information management, space costs, acquisition of fixtures, furniture, equipment and other materials necessary to conduct drug product reviews and to ensure that safe and effective drug products reach the American public more quickly.  In 2002, the Bioterrorism Act included PDUFA III, which reauthorized FDA to collect user fees to enhance the review process of new human drugs and biological products.  PDUFA III also reauthorized fees for applications, establishments and approved products.  The GSA Rent and White Oak costs coved by PDUFA fees directly support the drug review process.  In FY 2007, PDUFA carryover fees will be used to cover costs associated with the White Oak project by supporting CDER review staff and a portion of the Central Shared Use building.  The increase of $1,801,000 will cover inflationary costs associated with the GSA Rent that is attributable to the drug review process.  In FY 2007, FDA will use $8,188,000 in PDUFA carryover fees to fund the White Oak Consolidation Project.

Medical Devices User Fee and Modernization Act:  +$67,000 for GSA Rent and $272,000 for Other Rent and Rent Related Activities

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), P.L. 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide FDA important new responsibilities, resources and challenges.  MDUFMA was signed into law October 26, 2002 and was amended by the Medical Device User Fee Stabilization Act of 2005. MDUFMA has three particularly significant provisions.  These provisions allow for the collection of user fees for premarket applications, allow establishment inspections to be conducted by third parties and place new regulatory requirements on reprocessed single use devices.  The revenues from these fees and the appropriated trigger amounts will allow FDA to pursue a set of ambitious performance goals that will provide patients earlier access to safe and effective technology, and will provide more interactive and rapid review to the medical device industry.  The GSA Rent and Other Rent costs coved by MDUFMA fees directly support the device review staff.   This increase of $67,000 for GSA Rent and $272,000 for Other Rent and Rent Related Activities will cover inflationary costs associated with the rent activities that are attributable to the device review process.

Proposed User Fees [Non-add]

Reinspection User Fee (Mandatory):  $1,800,000 for GSA Rent and $800,000 for Other Rent and Rent Related Activities

The Administration is proposing authorizing legislation that requires establishments to pay the full costs of reinspections and associated follow-up work when FDA reinspects facilities due to failure to meet Good Manufacturing Practices (GMPs) or other important FDA requirements.  Under this proposal, these activities will be reclassified as mandatory user fees in FY 2007.  FDA currently funds this activity through discretionary appropriations.  Imposing a fee would generate $22.0 million in revenue, an amount sufficient to fully fund reinspections.  The Rent Activities program component of this user fee is $1,800,000 for GSA Rent and $800,000 for Other Rent and Rent Related Activities and directly supports the reinspection program.

Justification of Base

FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21^st Century

GSA Rent

Through improving FDA's business practices, the Agency will ensure a world-class professional work force, effective and efficient operations and adequate resources to accomplish the mission.  The Agency currently occupies over 6.7 million square feet of GSA space, including parking.  Approximately half of the GSA rent charges for government-owned or GSA-leased space are for facilities in the Washington, DC 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 addition, FDA-occupied space includes over 200 leased offices, including District Offices, Regional Offices, laboratories and resident posts that are strategically placed across the nation. 

Other Rent and Rent-Related Activities

• Commercial Rent and Related Services: Recurring activities that FDA pays directly to non-Federal sources under the delegation of direct lease and service authority. Services include rental of space and all recurring services for building operations.
• GSA Rent-Related Services:   Recurring reimbursable services provided by GSA that are over and above the standard ten hour period that GSA covers in its rent charges.  Services include security systems, guard services, and HVAC beyond the standard level funded by GSA.
• GSA Building Delegation Services: Recurring services and one-time repairs to operate and maintain buildings delegated to FDA by GSA for management of day-to-day operations.  Services include utilities and all recurring services for building operation, such as janitorial, guard, grounds maintenance, and operation and maintenance of HVAC systems.

White Oak Consolidation Project

The White Oak Consolidation Program continues its coordinated efforts to execute the 2002 Master Plan design and to update the Master Plan to reflect and provide a new state of the art campus for the FDA at White Oak.   The campus will replace existing fragmented facilities with new, state-of-the art laboratories, office buildings and support facilities.  To date, approximately 1,850 employees are onsite at White Oak, and the final phase of the consolidation is currently scheduled for FY 2010.  The proposed increase, along with the use of base funding and PDUFA carryover funds of $8,188,000, will allow FDA to improve management, without redirecting resources from core, mission-critical public health activities.  These funds will provide funding for the CDER Office II building, Shared Data Center and Auxiliary Facilities and the decomissioning of leased laboratories vacated by CDRH.

Selected FY2005 Accomplishments

FDA Strategic Goal: Transforming FDA Business Operations, Systems, and Infrastructure to Support FDA's Mission in the 21^st Century

Rent Activities

FDA is continually striving to improve its business practices. This will help ensure a world class professional workforce, effective and efficient operations and adequate resources to accomplish the mission. Accomplishments in Rent Activities include:

• Negotiated with GSA to delay rent start for the White Oak CDER Office Building I until August 1.  This saved FDA approximately $2,166,000 in FY 2005.
• Negotiated a settlement agreement with the lessor for termination of the direct lease for 1521 West Pico Blvd in Los Angeles.  This saved FDA $122,000 in FY 2005.
• Negotiated with GSA and the lessor for a succeeding lease at Crawford and Annex I in Atlanta.  This saved FDA $14.7 million over the 12-year remaining lease term, averaging $1.2 million per year.
• Turned back space to GSA and renovated the remaining space at two locations, saving the Agency $431,300 annually in rent.
• Relocated nine ORA Resident Posts due to lease expirations.  Space was also acquired for three new Resident Posts and one resident post was expanded.
• Acquired expansion space and built out CVM document control unit related to animal drug review at 7519 Standish Place.
• Expanded Moffett Center in Bedford Park, IL.
• Expanded Office of Criminal Investigation's San Diego Field Office.
• Expanded Bio Safety Level 3 laboratory in Cincinnati, OH. Certification for the laboratory was received.
• Acquired temporary emergency replacement space in Nashville, Lafayette, Mandeville, and Metairie to accommodate ORA District Office staff evacuated from New Orleans following Hurricane Katrina;
• Completed decommissioning at 12709 Twinbrook Parkway in order to turn the lease upon its expiration on December 31, 2005.

White Oak Consolidation Project

The White Oak campus will replace existing fragmented facilities with new, state-of-the art laboratories, office buildings and support facilities. The consolidation of the remaining FDA headquarters is occurring at the government-owned White Oak site. The design and construction of the new buildings at White Oak are funded through General Services Administration (GSA) appropriations with FDA paying for building fit-out and move costs. The LABQUEST coalition was established to support community planning and redevelopment of the White Oak site after the BRAC Commission announced the closure of the Federal Research Center (FRC) at White Oak in 1994. FDA participates in LABQUST by:

• Attending monthly meetings that bring together the local community, members of the Maryland Delegations, local business representatives, NTEU representatives, and FDA and GSA employees.
• Discussing the relocation of the FDA to the FRC; the necessary transportation; housing; and, amenities to accommodate FDA's employees, scientists, vendors and visitors to the area. 

The White Oak Consolidation Program Continues its coordinated efforts to execute the 2000 Master Plan design to provide a new state of the art facility for the FDA at White Oak.

• Dedicated the Life Sciences Laboratory, a state-of-the-art chemistry, bioscience and animal research facility dedicated in December 2003. It was the first building to be occupied on the site.  This laboratory provides approximately 124,000 gross square feet of research space, for 120 employees from the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH).
• Completed relocation of employees to the CDER Office Building I in fall 2005. This building provides 560,000 gross square feet of modern office space to accommodate the Office of New Drugs, comprised of approximately 1,700 scientists, medical reviewers and support staff.  The facility also includes a 60,000 square foot efficient document storage center, mail room and support space.
• Continued construction of the Engineering and Physics Laboratory; completion expected in early 2007.  This building will provide approximately 128,000 square feet of high tech laboratories engaged in evaluating electromagnetic and medical devices, radiological instruments and radiation-generating consumer appliances.  The facility consists of numerous vibration isolation slabs, electromagnet shielding, an anechoic chamber and laser devices especially dedicated to the program science. 
• Commenced construction of the CDER Office Building II; completion expected in early 2008.  This approximately 291,000 gross square foot facility will accommodate the Center Director's office and the balance of the CDER scientific and support staffs.  This uniquely designed office building will be equipped with an under-floor ventilation system.  This design feature provides for more offices benefiting from natural daylight, taller windows, more efficient distribution of air and electrical wiring along with IT/Telecom and security wiring.

FY 2007 Table of Contents

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