The FDA Buildings and Facilities (B&F) appropriation provides needed repairs and improvements (R&I) to existing owned or leased facilities nationwide. In addition, as specifically provided, the B&F appropriation funds construction of new FDA special-purpose laboratory facilities.

INCREASES:

Public Health Infrastructure + $ 20.4 million

FDA has taken a comprehensive process to identify the "gap" between our current performance and what we would need to meet our statutory requirements. The programmatic areas, or "gaps" which support the Secretary's Public Health Infrastructure Initiative are: Injury Reporting, Product Safety Assurance, Premarket Application Reviews, and Current Services. FDA is requesting $20.4 million so that the Agency will be able to provide the level of public health protection expected by the American public and help meet our statutorily-mandated requirements. The request is for construction of new facilities, specifically the new Los Angeles Laboratory, for the field component of the FDA Office of Regulatory Affairs (ORA).

Construction Funding for the replacement Los Angeles Laboratory -- ($20.4 million). The $20.4 million requested will enable FDA to fund a portion of the construction of the Los Angeles Laboratory and Office project. This first phase will construct the core and shell of the project.

The FDA received $9.8 million in the FY 1996 appropriation for site acquisition and design of the laboratory. The Agency, through the Corps of Engineers, awarded an Architectural and Engineering (A&E) design contract to Zimmer, Gunsul, Frasca/HDR, and acquired 10 acres of land adjacent to the University of California at Irvine. The FDA and the A&E firm developed a design concept for the replacement laboratory and district office, housing 75 laboratory staff and 120 office personnel at an estimated construction cost of $40.4 million. This cost includes laboratory casework, fume hoods, construction management, and escalation costs to an assumed midpoint of construction. The estimated construction cost does not include funding for furniture, telecommunication systems, or security systems.

The existing Los Angeles laboratory is an outmoded facility in a high crime area. FDA is currently paying the additional costs of armed security guards to maintain the physical safety of personnel and property. The current contentious relations with the landlord have resulted in FDA assuming the costs of maintaining the existing facility in addition to lease payments. FDA does not believe it can remain in the present Pico Boulevard facility indefinitely, and if funding is not provided, the Agency will have to explore relocation options.

Requested funds will serve to consolidate three Los Angeles district sites (the laboratory on Pico Boulevard, the current district office in Irvine, and the San Pedro Resident Post) into one location, replacing three existing leases totaling $2 million annually.

Expected benefits from construction of the new Los Angeles laboratory include providing a much safer location and a vastly improved working environment for FDA and partnering state laboratory personnel, having a concentration of scientific talent available which will permit better management of the analytical workload and will provide significant improvement in operational efficiency. Also, better analytical coverage will be provided during emergencies. Additional benefits include a more efficient use of costly analytical equipment and better equipped laboratories in a state-of-the-art facility.

JUSTIFICATION OF BASE:

Construction:

This request includes $3.0 million which will go towards a portion of the third and final phase of the overall Arkansas Regional Laboratory (ARL) project at Jefferson, AR. The total estimated construction cost for Phase III is $13.34 million. FDA's FY 1999 appropriation included $3.0 million to begin Phase III. This phase provides for the renovation of the existing Building 50 in its entirety for joint ORA and NCTR administrative support space and the restoration of the laboratory project site. The joint use facility will provide space for information resources management (IRM) system support and other infrastructure needs commensurate with the addition of the laboratory and 100 plus staff to the NCTR campus.

In FY 1995, Congress authorized $2.5 million for A&E design for the ARL. The ARL A&E design was completed in March 1996. In FY 1996, $3.8 million was appropriated for the joint ARL/NCTR facility. The FY 1996 funds were used for construction of an animal quarantine facility. Total cost for Phases I & II of the ARL laboratory construction is now estimated at $37.9 million. Phase I construction funds of $13.0 million were approved in FY 1997. In FY 1998, $14.6 million was approved to complete Phase II - the fit out of Arkansas Regional laboratory. In addition, FDA received approval to reprogram up to $10.4 million of B&F funds from lower priority projects to complete construction of the laboratory only portion of the project. The laboratory portion of the ARL project is scheduled to be completed in December 1999.

When the Chicago laboratory closed on July 1, 1997, Chicago's dioxin program, the high resolution mass spectrometer, (valued at $0.5 million), and associated glassware and supplies were moved into an interim laboratory facility. In late summer 1997, ORA started operations at the dioxin laboratory in an interim laboratory facility located in renovated space in NCTR's Building 14 and the ARL at this time has 10 staff in Jefferson, Arkansas, during 1997 - 1999. Other ORA personnel, programs and equipment are scheduled for transfer upon their lease expiration dates. Laboratories in Detroit, Minneapolis, Dallas, Denver, and Kansas City will also be transferred to ARL.

Repairs and Improvements:

FDA is also requesting base resources of $8.4 million to provide for minimally required maintenance, repairs and improvements (R&I) of existing FDA facilities. This funding covers costs of repairs and improvements to facilities, including Washington area headquarters components which are now located in some 40 buildings in fifteen separate locations, five regional offices, 21 field district laboratory/office complexes, including administrative and specialized laboratory facilities nationwide, more than 130 field resident posts, eight field criminal investigation offices, two distinct program laboratory complexes outside the Washington Metro area, and the National Center for Toxicological Research (NCTR) complex in Jefferson, Arkansas.

The Agency's ability to make and support sound scientific-regulatory decisions depends, to a great extent, on modern, well-equipped, optimally functioning facilities. Renovation and improvement costs have increased at a rate of about four percent annually for the last several years. While industry components that FDA regulates spend between nine percent and 12 percent of the value of their physical plants on maintenance, alteration, and repair, FDA has been spending about two percent of the value of its physical plant (laboratories and laboratory support facilities only) for the same purpose.

FDA has an obligation to fund repair and improvement projects designed to eliminate health and safety hazards in Agency laboratories nationwide, but has not always been able to do so because of competing demands for B&F funds. To reduce the number of facilities and associated repair and improvement costs, FDA has formulated facility plans including new construction, expansion, restructuring, and decommissioning, as well as personnel transfer plans which carry out the ORA 21 Laboratory Consolidation goals and coincide with current facility lease expiration dates. Despite these efforts, B&F costs continue to rise due to a number of factors.

While FDA projects a substantial savings from the consolidation of the original existing 18 field laboratories down to nine facilities, there are some initial costs associated with the process. The Agency has an requirement under the terms of GSA-held leases, and on FDA-held leases, for decommissioning of field laboratories planned for closure under the Agency's ORA 21 field laboratory consolidation plan. Decommissioning entails a clean up of all known areas where chemical spills occurred or any areas showing positive contamination during post re-location surveys. Expenditure of available funds on such clean-up projects takes large amounts of money away from other needed projects on those laboratories being retained by FDA.

Because of bidding conditions prevailing in construction trades related to demand, nationally there has been an increase in construction costs far beyond the cost growth predicted from Consumer Price Index escalation. The result is that fewer projects can be funded from the available R&I funds.

The following lists the planned repairs and improvements projects for the FY 2000 request of $8.35 million:

In 1994, FDA received approval from the Secretary of Health and Human Services to proceed with streamlining ORA field laboratory operations by closing nine of eighteen laboratories and consolidating resources into a more efficient network of five large multi-purpose laboratories in Seattle, Washington; Los Angeles, California; Jefferson, Arkansas; New York, New York; and Atlanta, Georgia; and four specialty laboratories in San Juan, Puerto Rico; Winchester, Massachusetts; Philadelphia, Pennsylvania; and Cincinnati, Ohio, over a 20-year period, thru 2014. FDA projects costs savings to the government of over $100 million from laboratory consolidation. FDA will maintain inspection, public affairs and enforcement operations at the current District offices and resident posts. To date, FDA has closed four laboratories -- Buffalo, Chicago, New Orleans and Cincinnati -- and restructured two laboratories in Philadelphia and Winchester, MA. The FY 1997 work plan comprehensively transferred the corresponding analytical programs and resources to the respective multi-purpose or specialty laboratories.

ORA 21 Multi-purpose Laboratories:

Arkansas Regional Laboratory (ARL). The laboratory portion of the ARL project is scheduled to be completed in December 1999. The Agency's long-term plan is to complete Phase III of the project which includes the renovation of the existing Building 50 in its entirety for joint ORA and NCTR administrative use and the restoration of the laboratory project site. In FY 1999 $3.0 million was included in FDA's budget to begin Phase III. The FY 2000 budget includes funds to continue work on Phase III. The total estimated construction cost for Phase III is $13.34 million. Due to the Chicago laboratory closure on July 1, 1997, Chicago's dioxin program, (five FTE), the high resolution mass spectrometer, (valued at $0.5 million), and associated glassware and supplies were moved into an interim laboratory facility in renovated space located in the NCTR's Building 14. The ORA started operations at the dioxin laboratory in late summer 1997. The ARL currently has 10 ORA staff on site. Other ORA personnel, programs and equipment are scheduled for transfer upon their lease expiration dates. Laboratories in Detroit, Minneapolis, Denver, Kansas City, and Dallas will be transferred to ARL.

New York -- Northeast Regional Laboratory, Northeast Regional Office and New York District Office -- Jamaica, Queens. An authorization for prospectus was approved in 1994 with a delineated area in the Borough of Queens. An A&E Program of Requirements was prepared for 75,000 net square feet of laboratory space and 100,000 net square feet for the regional and district office facility. In FY 1996, the General Services Administration (GSA) and the FDA finalized negotiations for the 4.5 acre site at York College, Jamaica Queens. GSA had intended to award the lease by April 1997, however, the lead offeror rescinded his proposal. GSA went to other offerors to continue the project and recently signed a contract to construct the facility. Work started on the new facility in January of 1998. FDA occupancy has been scheduled for late 1999.

Los Angeles -- University of California at Irvine. In FY 1995, $9.8 million was appropriated for A&E design and land acquisition. FDA, through the Corps of Engineers, awarded an A&E design contract, and acquired 10 acres of land adjacent to the University of California at Irvine. FDA and the A&E firm have developed a design concept for the replacement laboratory and consolidation of district office and local resident post staff, which is planned to house 75 laboratory staff and 120 office personnel. Design work is essentially complete. Construction funds for the first phase of the project are included in the FY 2000 request.

Southeast Regional Laboratory. In FY 1996, GSA issued a sole source Solicitation for Offer to construct 42,000 net square feet of laboratory and laboratory support space adjoining the current FDA complex at 8th and Peachtree Streets in Atlanta. GSA accepted beneficial occupancy of the facility in December, 1997 and the dedication ceremony occurred in July 1998.

Seattle Laboratory. In FY 1996, the project to expand the laboratory by 5,000 net square feet was completed.

ORA 21 Specialty Laboratories:

Cincinnati -- National Forensics Chemistry Center and Cincinnati District Office. The required decommissioning of the current facility began in 1996. A prospectus was approved for 31,170 net square feet laboratory space and 13,930 net square feet office space. All non-specialized work has been transferred to other laboratories and the Forensics Chemistry Center is complete.

Philadelphia. The GSA expanded the U.S. Customhouse facility in Philadelphia by 8,378 square feet to accommodate 16 - 20 additional laboratory staff. The FDA occupied new space on floors 10 and 12 and the new laboratory is fully staffed and operational. All non-drug work has been transferred to other laboratories.

San Juan. The FDA will renovate and expand the facility to house 20 - 25 total laboratory employees by the year 2000. All non-drug work has been transferred to other laboratories.

Winchester. FDA's building and facility funds were used to establish an American Association for Accreditation of Laboratory Animal Care, or AAALAC, facility. An additional AAALAC facility was established in early 1998.

FDA is currently in approximately 40 buildings in more than 18 locations. Consolidation of the Food and Drug Administration's headquarters' programs, the long-held priority of Agency officials, was made possible when Congress passed the FDA Revitalization Act (P.L. 101-635) in 1990, which called for consolidation of area programs and authorized the Administrator of the General Services Administration (GSA) and the Secretary of Health and Human Services to work toward that end. In all cases funding is through GSA appropriations. On March 15, 1994, the Office of Management and Budget approved a consolidation plan for the headquarters programs of the FDA that called for laboratory, office and support space to be located in Montgomery County, and Prince George's County, Maryland.

Construction of FDA Headquarters (White Oak). Original funding for the Montgomery County project was $245 million. A significant portion, $228 million, was included in the rescission bill signed by the President in July 1995, thus restricting work to macro-programming, development of a site master plan, and special studies. In recognition of Congressional opposition to the cost of the project, a work group from the FDA, GSA and the design architect firm formulated a downsized consolidation project. To date, approximately $7.5 million out of the available $16.91 million appropriated to the General Services Administration (GSA) for Montgomery County has been spent on programming, special studies, and design services.

The Naval Surface Warfare Center is an approximately 700 acre site in White Oak, Maryland that was transferred to the GSA through the Base Realignment and Closure Act process. In FY 1997, $10 million was appropriated to the GSA for demolition of existing buildings and hazardous materials removal. The GSA has proposed a consolidation project that replaces the FDA's existing fragmented facilities which support the Office of the Commissioner, the Office of Regulatory Affairs, the Center for Drug Evaluation and Research, the Center for Devices and Radiological Health, and the Center for Biologics Evaluation and Research. The development will consist of new laboratories, office buildings and support facilities.

The Office of Management and Budget (OMB), the GSA, the FDA and the HHS have come to an agreement that the project will move forward in FY 2000 as direct Federal construction. In addition to $26 million in design funds, $30 million will be included in the GSA's FY 2000 budget request for construction of laboratories for the FDA Center for Drug Evaluation and Research. Remaining funds for consolidation will be requested in subsequent fiscal years.

Construction of FDA Headquarters (Prince George County). Full funding, consisting of $84 million for the Prince's County project was secured in the GSA budget in FY 1996. The new facility will be FDA leased, government owned, and will house the consolidated offices and activities of the FDA Center for Food Safety and Applied Nutrition (CFSAN). The new building will provide state-of-the-art laboratories for the CFSAN replacing the badly outmoded and deteriorating facilities at Federal Building 8 in Southwest Washington, D.C. The GSA, acting on behalf of the FDA, selected a site near the College Park Metro station for the facility, and acquired the site at a cost of $4.5 million. The foundation construction contract was awarded on September 24, 1997. The project is scheduled for completion in early FY 2001.

Supplemental Tables

Authorizing Legislation

Distribution of FDA Resources by Activity - page 1

Distribution of FDA Resources by Activity - page 2

Object Class

Program Level

Budget Authority

User Fees – FY 1998 Actuals

User Fees – FY 1999 Appropriation

User Fees – FY 2000 Request

Amounts Available for Obligation

Total Resources Available

Analysis of User Fee History

Salaries and (Administrative) Expenses

Detail of Full Time Equivalent Employment by Grade

Detail of FTE

Resources for AIDS by Function and Activity

	Grade	Number	Annual Salary
BUDGET AUTHORITY:
Injury Reporting (11)
Consumer Education Specialist	13	1	81,000
Consumer Safety Officer	11/12	9	513,000
Veterinary Medical Officer	12/13	1	68,000
Product Safety Assurance (155)
Consumer Safety Officer	5,7,9,11	37	1,406,000
Consumer Safety Officer	12/13	12	816,000
Chemist	5,7,9,11	1	38,000
Chemist	11/12	8	456,000
Consumer Systems Analyst	11,12,13	9	702,000
Quality Management Systems Monitor	7,9,11,12	12	684,000
Industrial Hygienist	11,12,13	4	272,000
Bio Science Aide	7,9	3	114,000
Management Analyst	11,12,13	3	204,000
Microbiologist	5,7,9,11	2	76,000
Compliance Officer/Tech	7,9,11,12,13	1	57,000
Interdisciplinary Scientist	13/14	14	324,000
Consumer Safety Officer	7/9/11/12/13	10	570,000
Consumer Safety Inspector	5/7	10	155,000
Microbiologist	7/9/11/12/13	11	627,000
Mgt/Operations Research Analyst	7/9/11/12/13	8	456,000
Consumer/Public Affairs	11/12/13	2	138,000
Program Support	5/7/9	8	304,000
Premarket Approvals (52)
Computational Chemist	12/13	1	68,000
Biochemist	12/13	5	340,000
Consumer Safety Officer	5,7,9,11	3	152,000
Computer Systems Analyst	11/12	2	114,000
Interdisciplinary Scientist	13/14	8	648,000
Interdisciplinary Scientist	15/SBRS	2	302,000
Program Support	7/9	6	228,000
Microbiologist	7/9/11/12/13	11	627,000
Chemist	11/12	13	741,000
Food Safety Initiative (156)
Consumer Safety Officer	5	15	465,000
Consumer Safety Officer	7	15	570,000
Consumer Safety Officer	9	10	470,000
Consumer Safety Officer	11	23	1,311,000
Consumer Safety Inspector	5,7,9	9	348,000
Microbiologist	5,7,9,11	14	532,000
Microbiologist	12/13	2	138,000
Consumer Systems Analyst	12	1	68,000
Quality Management Systems Monitor	7,9,11,12	5	235,000
Industrial Hygienist	11,12,13	8	816,000
Bio Science Aide	7,9	9	383,000
Compliance Officer/Tech	7,9,11,12,13	12	684,000
Interdisciplinary Scientist(micro/chem)	13,14	2	176,000
Training Specialist	11,12,13	2	136,000
Public Affairs Specialist	11,12,13	2	136,000
Management Analyst	11,12,13	2	136,000
Interdisciplinary Scientist	12,13,14	22	1,782,000
Consumer Education Specialist	13	2	162,000
Mathematical Statistician	12/13	1	68,000
Tobacco (15)
Budget/Program Analyst	14	1	95,000
Consumer Safety Officer	12	1	68,000
Program Analyst	11	2	114,000
Program Analyst	12	1	68,000
Information Technology Specialist	13/14	1	81,000
Office Automation Clerk	05	1	31,000
Office Automation Clerk	06	1	34,000
Office Automation Clerk	07	1	38,000
Scientific Reviewer	13/14	1	81,000
Attorney/Para-legal	9/13	3	141,000
Administrative Officer	13/14	1	81,000
Senior Contracts Specialist	15	1	112,000
USER FEES:
Foods Direct Petitions (14)
Consumer Safety Officer	11	5	285,000
Consumer Safety Officer	12	5	340,000
Microbiologist	11/12	4	228,000
Food Contact Substances (30)
Consumer Safety Officer	11	10	285,000
Consumer Safety Officer	12	10	340,000
Microbiologist	11/12	4	228,000
Chemist	11/12	4	228,000
Program Analyst	11/12	2	114,000
Medical Devices Premarket Review (45)
Consumer Safety Officer	7,9,11	5	235,000
Consumer Safety Officer	11/12/13	4	272,000
Computer Systems Analyst	11/12	2	114,000
Interdisciplinary Scientist	13/14	28	2,268,000
USER FEES:
Program Support	7/9/11	6	228,000
Seafood Inspection Transfer (172)
Consumer Safety Inspector	11/12	121	6,897,000
Microbiologist	9/11	10	470,000
Industrial Hygienist	9/11	10	470,000
Management Analyst	11/12	2	136,000
Program Analyst	11/12	2	136,000
Bio Science Aide	7/9	10	380,000
Program Support	5/7	17	527,000
PDUFA - Human Drugs (59)
Consumer Safety Officer	12/13	10	680,000
Medical Officers	14/15	19	1,805,000
Biologist	12	1	62,000
Microbiologist	12	1	62,000
Computer Specialists	9/11/12	4	228,000
Program Support	5/7	4	124,000
Technicians	5/7/9	10	380,000
Chemist	12/13	10	680,000