MISSION

Rent is part of the Salaries and Expenses Appropriation and includes Rental Payments to GSA and Other Rent and Rent-Related Activities.  GSA Rental Payments includes charges for all of FDA's GSA space, both government-owned and GSA-leased.   The Other Rent and Rent-Related account includes rent and rent-related charges that are not part of the GSA account.

PROGRAM RESOURCE CHANGES

GSA Rent

User Fees

Prescription Drug User Fee Act III (PDUFA):  + $3,761,000 

PDUFA authorized the FDA to collect fees from the pharmaceutical industry to augment appropriations spent on drug review.  These additional resources were to be used to hire and support additional staff for the review of human drugs so that safe and effective drug products reach the American public more quickly.  The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 reauthorized the collection of user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments, and approved products.  The PDUFA amendments are effective for five years and direct FDA to strengthen and improve the review and monitoring of drug safety; consider greater interaction with sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and develop principles for improving first-cycle reviews.  The increases will contribute to meeting these mandated directives.  The increase of $3,761,000 will cover inflationary costs and rent costs for additional staff associated with the implementation of PDUFA.

Medical Device User Fee and Modernization Act (MDUFMA): + $178,000

Sound, risk based review processes are imperative to ensure that medical devices on the market are safe and effective. To strengthen FDA's medical device review process MDUFMA was authorized in FY 2002 as multi-year effort to improve the quality and timeliness of the medical device review process. This legislation authorizes the collection of user fees for the review of medical device applications from those who submit premarket applications, certain supplements to those applications, and premarket notifications. The funds, which supplement the appropriated portion of the medical device review program, will allow FDA to continue the following efforts:

• Promote public health with major improvements in review of expedited submissions for medical devices; and,
• Make major improvements in review performance in areas where fees are collected, while maintaining performance in other areas.

The increase of $178,000 will cover inflationary costs and rent costs for additional staff associated with the implementation of MDUFMA.

Animal Drug User Fee Act (ADUFA):  + $121,000 

Safe and effective animal drugs allow food animal producers to maintain healthy animals, and help ensure that resulting food products will be safe, wholesome, and free of drug residue, and that companion, service animals that assist the disabled, and other animals such as zoo animals will live healthier and longer lives.   The ADUFA program, under which new animal drug applicants, sponsors, and manufacturers incur a fee to expedite their applications, will help provide a cost-efficient, high-quality performance-driven review process.  Modeled after PDUFA, this fee has strong industry support and provides a complementary set of incentives to all stakeholders.  The $121,000 increase will cover inflationary costs and rent costs for additional staff associated with the implementation of ADUFA.

Other Rent and Rent Related Activities:

Budget Authority

Center for Drug Evaluation and Research (CDER) Move:   + $20,628,000 

This phase of CDER's move to White Oak includes relocation costs (furniture, records management consolidation, specialized library furnishings and relocation coordination and moving), internal communication (equipment, cabling and audiovisual) and security (infrastructure and equipment). Total resources for the CDER move to White Oak in FY 2005 is $33,081,000, including increases of $20,628,000 in new budget authority, $2,361,000 in recurring move costs from the FY 2004 appropriation, $3,000,000 from new PDUFA funds and $7,092,000 from PDUFA carryover balances that will be expended in the rent and rent related program line from PDUFA funds previously appropriated to CDER. The funds will complete the second phase of the relocation of approximately 1,700 CDER employees to White Oak and will cover costs to occupy and equip the first phase of the Central Shared Use facility.

User Fees

Prescription Drug User Fee Act III (PDUFA):  + $3,000,000 

The PDUFA authorized the FDA to collect fees from the pharmaceutical industry to augment appropriations spent on drug review.  These additional resources were to be used to hire and support additional staff for the review of human drugs so that safe and effective drug products reach the American public more quickly.  The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 reauthorized the collection of user fees to enhance the review process of new human drugs and biological products and established fees for applications, establishments, and approved products.  The PDUFA amendments are effective for five years and direct FDA to strengthen and improve the review and monitoring of drug safety; consider greater interaction with sponsors during the review of drugs and biologics intended to treat serious diseases and life-threatening diseases; and develop principles for improving first-cycle reviews.  The increases will contribute to meeting these mandated directives.

The Medical Device User Fee and Modernization Act (MDUFMA) of 2002 is patterned after the successful Prescription Drug User Fee Act (PDUFA), a successful example of a partnership between the Federal government and stakeholders to improve and expedite the review of applications.  MDUFMA is a multi-year effort to improve the quality and timeliness of the medical device review process.  It authorizes the collection of user fees for the review of medical device applications of those who submit premarket applications, certain supplements to those applications, and premarket notifications.  The funds continue the following FDA efforts begun in FY 2003 including:

• Acquire and train staff to meet a set of aggressive performance goals, for expediting the review of medical device applications;
• Promote public health with major improvements in review of expedited medical devices; and,
• Make major improvements in review performance in areas where fees are collected, while maintaining performance in other areas.

• Maintain additional space acquired to support more than 800 field and headquarters bioterrorism staff, acquired in FY 2002 and other staff hired to carry forward FDA's mission.

STRONG FDA

A strong FDA will ensure a world-class professional work force, effective and efficient operations and adequate resources to accomplish the mission of FDA.  FDA will continue to:

• Occupy over 5.3 million net square feet of space, including parking, which is under the Agency's Salaries and Expenses appropriation.  By the start of FY 2005, FDA will have acquired an additional 100,000 square feet of new and expansion space, but will also have vacated 100,000 square feet of GSA space by relocating to FDA-owned space.
• Receive GSA rent charges that are billed directly to the Agency and indirectly through other agencies, and include the charges for all of FDA's GSA space, both government-owned and GSA leased.  About 59 percent of the GSA rent charges are for government-owned or GSA-leased space in the Washington, D.C. area.  The largest individual rent charges are for the Parklawn Building complex, Module II in Beltsville, CFSAN's new College Park location, the new White Oak campus, and the Regional office and laboratory in Jamaica, NY.  The balance of the changes are for the Agency's field Regional Offices, District Office/Laboratory complexes, and over 150 leased offices which serve as resident posts for strategically placed field investigators.
• Commercial Rent and Related Services.  Consists of 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.  Includes recurring reimbursable services provided by GSA that are over and above the standard eleven hours that GSA covers in its rent charges.  Services include security systems, guard services, heating, ventilation, and air conditioning (HVAC) beyond the standard level funded by GSA; and,
• GSA Building Delegation Services account.  Provide 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.

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