Food and Drug Administration

Executive Summary of FY 2000 Budget Request

	FY 1999 Current Estimate	Change	FY 2000 Request 1/
Program Level	$1,134,669	$216,350	$1,351,019
FTE	8,944	758	9,702
Budget Authority	$982,217	$172,883	$1,155,100
Additive User Fees	$152,452	$43,467	$195,919

^1/Iinclude $13.4 million and 49 FTE for Bioterrorism included as part of the Public Health and Social Services Emergency Fund.

The Food and Drug Administration (FDA) is the principal consumer protection agency of the Federal Government. In 1997, for the first time in history, Congress codified FDA's mission statement into the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA adds the role of health promotion to the Agency's historic mission of public health protection. FDAMA has presented FDA with the chance to bridge the gap between what FDA is required to do by statute and what it is able to accomplish with current resources. The FDA Plan for Statutory Compliance outlines bold and innovative approaches to meet the increasingly complex public health challenges of the 21st century. The successful implementation of this Plan depends on the commitment of resources by both FDA and its stakeholders.

FDA must address several key challenges now and in the future for the Agency to successfully meet its statutory requirements and to fulfill its health promotion and protection mission. These include: research and development-fueled pressures on regulatory responsibilities; greater product complexity driven by breakthroughs in technology; growth in recognized adverse effects associated with product use; unpredictable new health and safety threats; awareness of citizen-stakeholders and their more targeted needs; emerging regulatory challenges in the international arena; and increased volume and diversity of imports. The ability to formulate successful solutions to these challenges depends on innovative approaches used by FDA, creative collaboration with stakeholders, prioritization of FDA activities, and an adequate investment of resources to implement these approaches.

The first priority of the Agency is full and effective implementation of the FDA Modernization Act - both the letter and spirit of the law. Section 406(b) of FDAMA directed FDA to develop a plan for meeting these and other statutory requirements. The FDA Plan for Statutory Compliance was completed in November 1998 and submitted to Congress. It includes a complete listing of the Agency's statutory requirements. FDA was directed to meet and listen to different constituencies that represent our stakeholders who are many and often diverse in their expectations. The result of this type of activity is a better understanding of the public's expectations for the Agency.

Another major focus of the request is to restore and enhance the science base of the Agency. Science must underpin our decision-making process, and must support and guide the critical policy decisions that we make. We apply scientific principles to our product reviews. Our investigators and inspectors must be current in the technologies we regulate to make good decisions in the field. It is quite clear that the investments made in both basic and applied research by the National Institutes of Health and the pharmaceutical, biotech and medical device industries will result in a burgeoning growth of new products that will eventually come to the marketplace. FDA must have the scientific sophistication to 1)to address unanswered scientific questions and 2) understand and adequately evaluate these new products. Our scientific expertise must match the complexity of the new products moving toward the market.

Maintaining the safety of the nation's blood supply is another high priority. FDA is committed to the rigorous oversight of good manufacturing practices while remaining mindful of the consumers' need for products. FDA is a critical member of the Department's Blood Safety Committee, chaired by Surgeon General Satcher. In addition, the Agency has developed its own Blood Action Plan that focuses on a number of areas, emerging infectious agents, modernizing regulations, and new regulations for hepatitis C testing.

Implementation of FDAMA, restoration of the science base, and improving the safety of the blood supply, fit well within the Departmental initiative on Public Health Infrastructure. In addition, FDA is committed to the Presidential initiatives for Food Safety and Tobacco and Bioterrorism.

FDA is a pivotal player in the Administration's efforts to improve the safety of the food supply along with the Centers for Disease Control (CDC), Department of Agriculture (USDA) and Environmental Protection Agency (EPA). All of FDA's efforts are coordinated with the CDC and USDA to assure that the government's efforts are at a maximum level of effectiveness. Funding provided in FYs 1998 and 1999 enabled FDA to begin implementation of a food safety system to take the country into the next millennium, and focus resources on imports, particularly fresh produce. To provide a viable, long-term system that ensures the safety of food from microbiological contamination. However, more needs to be done. The FY 2000 request would provide funding to respond to the new data generated from initiatives begun in FYs 1998 and 1999.

Keeping tobacco products from children continues to be an important Presidential initiative. FDA is committed to working with other organizations within the Department of Health and Human Services -- the Substance Abuse and Mental Health Services Administration (SAMHSA) and CDC, and the 57 states and territories -- to reduce the access and appeal of tobacco products to young people.

Another critical Presidential initiative -- countering bioterrorism -- is presented within FDA's budget. It is included as part of the Public Health and Social Services Emergency Fund's (PHSSEF) budget request. FDA is requesting funds to ensure the expeditious development of new vaccines, safeguards for the food supply, and research for diagnostic tools and treatment of disease outbreaks that could result from bioterrorist activities.

FDA is committed to addressing these initiatives, and our everyday challenges -- a daunting task. By focusing on these priorities, finding new ways to improve ourselves, and working with the Administration and the Congress, FDA is better able to meet the challenges of promoting and protecting the public health of the nation.

PUBLIC HEALTH INFRASTRUCTURE -- + $ 95.5 MILLION, + 307 FTE

The FDA directly affects the health of every single person in this country. It is a complex network of people, science, and systems that are relied upon to prevent disease and promote health in communities across the nation. If FDA is strong, Americans can be assured that the blood supply is safe; that the food in restaurants, will not make us sick; and that our children are protected against tobacco.

FDA has undertaken a comprehensive analysis, as directed by FDAMA, to determine what more needs to be done to meet our statutory requirements. This analysis describes three broad programmatic areas: Injury Reporting, Product Safety Assurance, and Premarket Application Review. These areas, in conjunction with rebuilding the science base of the Agency all support the Secretary's initiative focused on the Public Health Infrastructure. We believe these are critical needs that should be addressed, beginning with the FY 2000 budget, to provide the level of public health protection expected by consumers, to enable the agency to meet its statutorily mandated goals, and tosupport improvements in the nation's public health.

FDA has estimated the resources needed to accomplish these challenges. The total level of estimated resources is substantial; full implementation is not feasible in one year.

Injury Reporting -- ($15.3 million, 11 FTE)

Problem Identification: All medical products have inherent safety risks that will never be completely eliminated. FDA receives thousands of reports of injuries and deaths every year associated with medical device misuse or product failure, although most errors are unreported. Most medical technology regulated by the FDA undergoes rigorous testing in the premarket period. However, the nature of the investigations does not allow the detection of all problems, especially rare problems, with these products. Continuous, accurate identification and measurement of risks are the only ways to assess the important risk/benefit ratio associated with all medical products, foods and cosmetics. Only after products are in widespread use, following approval for marketing, do their true risks become apparent.

Injuries from the proper use of FDA-regulated products occur, although they are not adequately documented or sufficiently understood. In addition to adverse events associated with the appropriate use of medical products, accidental injury due to their misuse has been recognized for more than 40 years as a major source of morbidity and mortality.

Current estimates of the incidence of death and injury associated with proper use of medical products is staggering, and is projected to grow. For example, the number of adverse reaction reports related to FDA-regulated food products, such as dietary supplements and food additives, is growing. For Human Drugs, a recent article describing the incidence of adverse drug reactions (ADRs) in hospitalized patients published in the Journal of the American Medical Association (JAMA) estimated that in 1994, 106,000 deaths and 1.3 million serious injuries occurred. The requirement to report errors and accidents in the blood banks, applicable only to licensed manufacturers, has resulted over the past five years in an average of 12,000 reports per year. A recently proposed regulation expanding the requirement for reporting to include all biological product manufacturers regulated by FDA is expected to result in a ten-fold increase in reports per year.

It is estimated that nearly one million patient injuries and deaths each year can be attributed to user error with FDA regulated medical products.

No integrated system for the reporting, monitoring, and evaluation of adverse events and product defects associated with the full range of FDA-regulated products currently exists. We believe, current information systems, available to the Agency and others, are inadequate and are not systematically linked with any ability to share data electronically.

Goal: Reduce the incidence of deaths and disability resulting from injuries with FDA-regulated products.

FDA's Proposed Response: FDA is charged with protecting the health of the American public. The long-range strategic goals for solving this problem are to minimize injuries, illness and deaths occurring from the use of FDA-regulated products, and improve the quality of available health care. One of the primary objectives for FY 2000 will be the development and implementation of a system which will strengthen FDA's scientific efforts through improving the quality of information on adverse events and product defects associated with FDA regulated products.

Prompt identification of new, previously unrecognized problems with FDA-regulated products has the potential to decrease morbidity and mortality associated with those products and maximize the safety of approved products. Thousands of deaths and injuries could be avoided, or their consequences reduced, through a comprehensive strategy aimed at finding out why incidents occur and implementing strategies to prevent them from happening again. A full understanding of the causes of product-related deaths and injuries is necessary to ensure that causes attributable to product labeling, design, or composition are addressed in the premarket review programs where required. For products for which premarket review programs do not exist, such as dietary supplements and cosmetics, FDA needs information about the safety and usage patterns of such products after they have been approved in order to develop appropriate responses.

All of the funded projects are modules in the overall plan for FDA's injury reporting systems. FDA intends to move as rapidly as possible to an integrated, fully electronic adverse event reporting system. This will reduce overall costs by allowing reporters to submit electronically, directly into agency systems, and will eliminate or substantially reduce the data entry and record handling costs. In addition, the uniform coding and nomenclature systems being developed will allow regulated industry and other reporters to accurately describe their products and the events experienced, improving accuracy of reports and decreasing Agency costs for coding and additional follow-up. Use of uniform systems for submission and data handling across FDA will also manage costs.

Accurate, complete, and efficient operation of adverse event reporting systems is only the first step in the management of product injury. Reported events must be analyzed, and other sources of data must be accessed to make sense of the reports and to determine what action is needed. The need for access to various medical databases spans all FDA safety programs. Successful use of these databases requires investment of time by FDA project managers, programmers, and epidemiologists, as well as investment in computing equipment. Modest funding increases for both staff and contract access to databases are included in the proposal. In addition, funding for initiation of a sentinel site program for medical device adverse event reporting required by FDAMA is included. This active surveillance concept, if successful, could be used effectively by other program areas to significantly improve our understanding of the epidemiology of injuries due to FDA-regulated products.

Finally, increases in funding for outreach are requested. These are intended to improve the quality and scope of adverse event reporting by the health care community, and to communicate safety issues. Broader communications with health care professionals will be essential in ensuring that improved knowledge about product injuries actually improves people's health. FDA's objectives are to:

• Determine the extent of the problem with surveillance and epidemiology.
• Develop and maintain an integrated science-based system for reporting, monitoring and evaluating adverse events associated with FDA-regulated products.
• Develop a network of clinical facilities (sentinel sites) to participate in FDA injury reporting.
• Enhance capacity for collecting, monitoring and evaluating adverse events by improving the infrastructure with hardware/software upgrades, increasing epidemiology staff, and creating a series of links, not only within FDA but to other government and industry databases and existing surveillance systems wherever possible.
• Develop mechanisms to provide effective feedback to the health care community and the public through outreach and education.
• Improve the feedback loop to health care personnel and consumers to communicate safety issues.
• Improve the quality and scope of adverse event reporting by the health care community.
• Improve knowledge of product injuries through broader communications with health care professionals.
• Enhance the capacity to rapidly disseminate to relevant stakeholders findings related to injuries and educate the medical community.
• Develop strategies for the best, most effective responses to mitigate the negative public health implications, using the information described above as well as from research.
• Methodologic and surveillance research efforts designed to enhance understanding of the causes of and factors contributing to product-related injuries.
• Identify labeling and product interface design features which may cause or contribute to user error, a leading cause of avoidable deaths and injuries.

The overall plan for Injury Reporting envisions Agency databases that are accessible by all programs and that are served by powerful analytical tools. Funding for the analytical data warehouse as well as other components of AERS, will provide the building blocks for this project. The following table summarizes this request by program and activity area.

FY 2000 Funding Request -- Injury Reporting

Product Safety Assurance -- ($ 52.2 million, 155 FTE)

Problem Identification: FDA is a science-based organization that implements the Food, Drug and Cosmetic Act, and related acts, and regulations to protect consumers as well as industry. The Agency strives to achieve its objectives by ensuring the safety of goods and products for consumers, and ensuring honesty and fair dealing in the marketplace on behalf of industry. FDA's ability to inspect domestic and imported products has fallen considerably over the past few years, even as consumer expectations continue to rise with regard to our regulatory presence. This decline has occurred for inspections in all product areas.

The FDA's statutory responsibilities underpinning product safety assurance and enforcement require a science-based, integrated, proactive approach to achieve an acceptable and expected level of consumer protection. The challenge to monitor the quality and safety of all regulated products from domestic and foreign sources, however, is growing. The agency, even in conjunction with its state regulatory partners, is able to annually inspect less than a third of the domestic firms within its purview. The number of FDA inspections for foods, drugs, and devices (excluding mammography), including inspections by state agencies under contract to FDA has decreased between 1991 and 1998. In the area of imports, the total volume of FDA-regulated imports is estimated to exceed $ 50 billion per year, with some categories of imports growing at an exceedingly rapid rate. Imports continue to grow in volume, complexity, and diversity of sources. FDA's ability to meet the postmarket monitoring objective is inherently related to the ability to meet enforcement obligations. Enforcement is an integral adjunct to outreach in such areas as injury reporting and product safety assurance, and an important stimulant for voluntary compliance and partnership programs. Unfortunately, in recent years, FDA's traditional enforcement actions have declined despite new challenges to public health protection. Moreover, new technologies such as the emerging use of cord blood stem cells, tissues and reproductive tissue banking and the use of materials of animal origin for transplantation will require new regulations aimed at ensuring quality and safety, for which FDA now lacks sufficient enforcement capability.

Goal: Increase the frequency of inspections across all product areas, bringing FDA in closer conformance to its statutory requirements.

FDA's Proposed Response: FDA will utilize the funds towards achieving statutory timeframes for inspections. Funding will enable the Agency to focus on technical assistance to enhance industry compliance, integrate public health regulation with the states through contracts, partnerships, training, and information sharing. The requested resources of $ 52.2 million and 155 FTE would allow the Agency to:

• Leverage the Agency's enforcement capability internationally by working toward regulatory agreements with the European Community and other nations so that imports entering this country will meet quality and safety standards that meet the high expectations of U.S. consumers.
• Increase the frequency of inspections for domestic products across the board (except for foods) to once every two years, as mandated by statute, through FDA inspections and additional state contracts. For drugs, biologics (registered blood banks), animal drugs, and medical devices, this would be inspecting each manufacturer every two years.
• Provide targeted efforts on those areas with the most potential for serious injuries.
• Advance the scientific basis of regulatory policy by continuing to develop new scientific methods and regulatory testing paradigms.
• Provide scientific support for the development and application of regulatory policy and decision making.
• Develop better methods for testing and analysis in support of the above initiatives.
• Construction funding for the replacement Los Angeles laboratory.

In considering the most effective inspection program for the 21st century, FDA is looking to develop an integrated system of consumer protection that leverages critical Agency expertise with state and local regulatory resources and private sector responsibility. FDA must refocus its efforts both internally and externally. Internally, we must strengthen the roles of standard setting and oversight; externally, we need to become teachers and auditors as we leverage resources with other entities in product safety assurance.

FDA must maintain a highly skilled, flexible workforce, fully capable of understanding and applying the science of the day to develop and apply standards and regulatory policy that are appropriate to industry. But FDA must also go beyond this and impart that knowledge to others who will use it to supplement our efforts and help assure the overall safety of products supplied to the American public and to the world at large.

The final piece of the request would fund certain laboratory construction. The request would fund the initial phase of a replacement laboratory for the current 30-plus year old facility, in Los Angeles at $ 20.4 million. The total estimate construction cost of the new Los Angeles Laboratory and office complex is $ 40.4 million. Requested funds will consolidate three Los Angeles district sites (the laboratory on Pico Blvd., the district office in Irvine, and the San Pedro Resident Post) into one location, replacing three existing leases totaling $ 2.0 million annually.

Additionally, of the funds included in the FY 2000 request for the Buildings and Facilities appropriation, FDA will spend $ 3.0 million towards a portion of the third and final phase of the overall Arkansas Regional Laboratory (ARL) project at Jefferson, AR.

The table below summarizes the request for Product Safety Assurance by program activity area:

FY 2000 Funding Request -- Product Safety Assurance

Premarket Application Review -- ($ 28.0 million, 141 FTE)

Budget Authority - ($ 11.0 million, 52 FTE)

New Proposed User Fees - ($ 17.0 million, 89 FTE)

Problem Identification: In an environment of increasingly complex products and high workload, FDA's job is to reduce total product development time, meet statutory performance requirements, expedite and add value to new technologies, maintain high quality interactive reviews, and target labwork to develop science-based standards, guidance and risk assessments, in-house expertise, methods evaluations, and bioequivalence methods. Though we are still short of statutory requirements in non-user fee programs, FDA has successfully made a number of innovative approaches and improvements which have improved performance.

Delays in getting new products on the market can postpone treatment to patients and access to the health care system of products (such as generic drugs) that can potentially save billions of dollars in health care costs. Delays in product approvals mean lower returns on investments, incentive to move research and development overseas, and a general chilling of investment in those industries. Based on FY 1997 data, the percentage of applications reviewed within statutory timeframes was as follows:

Statutory Requirements and Performance Gaps

1/ Represents an estimate of first actions (i.e., issue reject letters or publish a response in the Federal Register).

New blood products, animal drugs, medical devices, and food additives all suffer from lengthy review times. Based on current trends, new products are increasing at a rate of 12 percent annually. At this rate, the premarket application workload would double nearly every six years.

Goal: Improve review times for premarket approvals directed by statutory requirements.

FDA Proposed Response: FDA's FY 2000 request is a two-pronged approach which combines new appropriated funds across the board, in the amount of $ 11 million, but then supplements those funds with $ 17 million in proposed additive user fees in two areas of particular concern: food additive petitions and medical device reviews for Premarket Applications (PMAs).

FDA's goals are to reduce the total time for product development, meet statutory performance requirements, expedite and add value to new technologies, maintain high quality reviews, and target laboratory based standards development, guidance formulation, and consultation on emerging technologies.

We know how to fix the problem. The funding requested would allow the Agency to:

• Reengineer and automate review processes, including expanded information technology.
• Provide for more productive interactions with industry through up-to-date guidance review, industry education, and reviewer training.
• Increase assistance during the development process and during the post-filing review process to improve the quality of submissions, and hence, decrease the time needed for review.
• Target laboratory support on emerging technologies.
• Increase extramural contracts for the review of scientific data.
• Provide on-time, science-based interactive application reviews.
• Develop and publish comprehensive guidelines.
• Create multi-disciplinary teams to help rapidly resolve new and ongoing safety issues.
• Enhance infrastructure and document workflow system.
• Provide expertise for sponsor meetings.
• Undertake research in support of reviews.

In FY 2000, the Agency is also requesting authorization to collect additive user fees to provide a stable source of resources that will enhance the efficiency of the review processes for food additives and medical devices. The proposed user fees would be: $4.0 million for direct food additive petitions, $ 6.0 million indirect food additive (food contact substances) notifications, as authorized by FDAMA, and $ 7.0 million for medical devices for three application types: PMAs, PMA supplements, and complex 510(k) applications. These device applications involve high-risk devices that have the highest likelihood of significantly improving the treatment of patients.

Additive user fees would allow the Agency to:

• Increase the speed of the review process for direct petitions.
• More consistently meet established timeframes for these reviews.
• Provide assistance to improve the quality of submissions.
• Work closely with industry to reduce total product development time.
• Expedite reviews representing new technologies.
• Maintain high quality interactive reviews.
• Update guidance documents, and conduct timely preapproval and data audit inspections.
• Support contract staff which is critically important to the ongoing research.

The table following summarizes this request by program area.

FY 2000 Funding Request -- Premarket Application Review

PRESIDENTIAL INITIATIVES -- + $ 77.4 MILLION, + 220 FTE

FDA's FY 2000 budget request includes three initiatives that have the support of the President. These are the Food Safety Initiative, Youth Tobacco Prevention, and Bioterrorism. (Funding for Bioterrorism is requested centrally through the Public Health and Social Services Emergency Fund.)

Food Safety Initiative -- ($ 30.0 million, 156 FTE)

Problem Identification: Foodborne illness outbreaks continue to be a problem that affects the health of millions of Americans every year. Based on 1997 data from CDC, this surveillance showed that 50 cases of foodborne infection were diagnosed per 100,000 population, a rate that translates to 130,000 culture-confirmed cases in the entire U.S. population. Additional FoodNet surveys showed that these cases represent a fraction of the burden of foodborne illness. Based on these surveys, at least 60 more of these infections may have occurred for each one that was diagnosed, suggesting that there may have been about eight million cases of these bacterial infections in 1997 in the U.S.

Goal: Reduce the incidence of deaths and diseases resulting from foodborne pathogen contaminants.

FDA Proposed Response: The President announced in 1997 a major Food Safety Initiative directed at significantly reducing the rate and impact of foodborne illness on the health and well-being of American consumers. The Food Safety Initiative (FSI), emphasizes interagency coordination, more comprehensive and accurate data on the number and causes of foodborne illnesses, faster and more accurate analytical methods for detecting microbial pathogens and mycotoxins, more effective techniques for assessing the risk associated with foodborne contaminants, and the development of more effective strategies for educating industry and consumers on proper food handling procedures. FDA and its federal and state partners will be able to provide greater protection for consumers by responding more rapidly to food safety emergencies, and by more efficiently and effectively using available resources to prevent foodborne hazards.

Funding provided to FDA in FY 1998 enabled the Agency to begin implementation of a food safety system to take the country into the next millennium. Specific activities include implementation of seafood HACCP; development of the Good Agricultural Practices Guide for fresh produce; the Fight BAC! education campaign; and establishment of a foundation for food safety including monitoring of antibiotic resistance, a coordinated working group of various food safety organizations, a government-wide research agenda, a risk assessment consortium, food production preventive control systems, and an improved FoodNet/PulseNet surveillance system.

The President's FY 1999 budget request continues to strengthen this foundation, and also focuses resources on food imports, particularly fresh produce. To provide a viable, long-term system that ensures safety of food from microbiological contamination, however, more needs to be done. The FY 2000 request would provide funding to respond to the new data generated from initiatives begun in FYs 1998 and 1999.

In FY 2000, the FDA will:

• Increase its outbreak response work, tracing back through the food distribution and production chain to find the source of contamination that caused an outbreak. This work will increase as the FoodNet and PulseNet systems mature and an increased number of outbreaks are detected in FY 2000.
• Continue/expand research and risk assessment efforts, which provide a cornerstone for targeting scarce resources, to those areas that yield the most public health benefits.
• Focus on antimicrobial resistance. The identification and containment of resistance as a result of the monitoring programs will help ensure the continued effectiveness of both human and veterinary drugs, and aid in increasing the availability and distribution of effective drugs.
• Increase food production preventive controls systems work, including development of additional industry guidance and HACCP where appropriate.
• Work with states to achieve adoption of the Food Code by states. Available data indicate that foods prepared by retail food service are the source of a large number of outbreaks. Most retail food service outlets are regulated by the states.
• Develop performance standards for food service workers to assess state regulatory efforts.
• Provide education and training to support Food Code adoption and to change unsafe behaviors.
• Increase Federal inspections, focusing on high risk areas.
• Provide resources and training to state inspectors to conduct inspections that are complementary and additive to FDA inspections, with the goal of providing a nationwide, uniformly applied, integrated, food safety system that enhances consumer protection.
• Inspections on high-risk areas (beyond seafood) annually, beginning in FY 2001.
• Expand coverage of imported foods to additional products or practices.

• Develop educational programs for practitioners that will address the appropriate use of antimicrobial drugs in food animals, and educational efforts about international activities concerning prudent or judicial use of drugs and antimicrobial resistance. Clear understanding of the issues of veterinary drug usage can prevent future difficulties in international trade.

FY 2000 Funding Request -- Food Safety Initiative

Youth Tobacco Prevention -- ($ 34.0 million, 15 FTE)

Problem Identification: Every year 420,000 Americans die from diseases directly attributable to their use of tobacco. Every day three thousand children and adolescents become regular smokers. One-third of these young people will die prematurely because of smoking. Reducing young people's use of tobacco is an enormous undertaking with potential for great public health outcomes.

Prior to 1996, tobacco products were largely unregulated by the Federal government. In 1996, FDA issued regulations to reduce the access and appeal of tobacco products to young people. The President is fully supportive and has made both FDA's jurisdictional authority and need for funding to support its regulatory role a high priority within legislative negotiations and in Congressional budget submissions. The Agency remains committed to this program and fully intends to continue all activities within the extent allowed under the law and relevant court decisions.

Goal: Reduce usage of tobacco products by children and adolescents by 50 percent within seven years of the FDA rule being fully in effect.

FDA Proposed Response: The Administration's long-term goal is a 50 percent decline in young people's use of tobacco within seven years of program implementation. Full implementation of the final rule will significantly reduce usage, and comprehensive regulation will help reduce the hazards associated with use of tobacco products.

FDA is committed to working with other organizations within the Department of Health and Human Services -- the Substance Abuse and Mental Health Services Administration (SAMHSA), CDC and the 57 states and territories -- to reduce the access and appeal of tobacco products to young people.

The FY 2000 budget request would provide funding to:

• Increase the number of compliance checks performed at retail outlets to ensure that young people are not able to purchase cigarettes and smokeless tobacco products.
• Increase the number of retailers who receive information from FDA that assists them in understanding their responsibilities under FDA's tobacco rule, and increase the number of retailers who understand the age and identification provisions in the rule.
• To the fullest extent permitted under court order, establish the scientific and regulatory framework to address the challenges posed by new and novel nicotine containing tobacco products, as well as issues raised by current products and replacement therapies.

Bioterrorism -- ($ 13.4 million, 49 FTE)

Problem Identification: Global geopolitical instability has increased the possibility that terrorists may use chemical or biological agents as weapons of mass destruction in the United States.

FDA is currently involved in a number of activities with regard to bioterrorism. The Agency participates in an interagency group formed by the Department's Office of Emergency Preparedness with the Department of Defense, Veterans Administration, the Centers for Disease Control and Prevention, and the National Institutes of Health to plan for responses in a civilian emergency. FDA is in the process of drafting a proposed regulation to amend its new drug and biological product regulations to identify the kind of evidence needed to demonstrate the efficacy of drug and biological products used to ameliorate or prevent the toxicity of chemical, biological, radiological, or nuclear substances.

FDA has been asked, in conjunction with DHHS and the Department of Defense, to develop a research agenda for the rapid development of diagnostic tools and treatment for disease outbreaks that might be caused by bioengineered biological weapons agents. The plan will include more focused development strategy for new vaccines and pharmaceuticals.

As part of the President's Biological Weapons initiative, FDA is contributing to development of a series of mandatory declarations about facilities and activities that are especially suited for possible biological weapons purposes.

Goal: Foster the national capabilities needed to respond to potential chemical and biological threats from bioterrorism, including development of new vaccines and drugs, safeguards for the food supply, and research for diagnostic tools and treatment of disease outbreaks.

FDA Proposed Response: FDA is requesting a total of $ 13.4 million for this Presidential initiative. In FY 1999, there is a proposal to provide FDA $ 3.3 million in funding to engage in relevant anti-bioterrorism activities, through a supplemental request. Funding for this initiative is included as part of the Public Health and Social Services Emergency Funds (PHSSEF) budget request. FDA is requesting funds to ensure the expeditious development and licensure of new vaccines, including anthrax, smallpox and botulinum. These resources are needed to support staff that would perform reviews of applications and research, which would lay the groundwork for the design of new types of vaccines for anthrax, smallpox, botulinum and other toxins.

An important aspect of the proposed program is that it would ensure the availability of experts in this area who would expedite the licensing process of these vaccines. The regulatory process, including preclinical testing, clinical trials, and the licensing application review, may proceed much faster if the product reviewers have hands-on experience with the products, and are involved in the early stages of product development. Expeditious development and licensing of these products is a primary goal of this initiative. These funds would be used to:

• Conduct application reviews of new vaccines, diagnostics and drug products as well as new uses of existing vaccines, diagnostics and drug products.
• Conduct research that will facilitate the approval of new vaccines, diagnostics and drug products.
• Provide an appropriate second response to a potential biohazard event with adequately trained and equipped investigators.
• Develop a 4-hour detection and decontamination methodology. The Agency has begun the process of developing protocols for C. botulinum decontamination and rapid method identification of botulinum, an organism that could be used in incidents of bio-terrorism. The Agency would begin the development of protocols for the identification and decontamination of other bioterrorism organisms.
• Develop mass spectrometric techniques for the rapid detection of biological agents.
• Arrange, pursuant to applicable statutory authority, for the seizure and disposition of adulterated or misbranded products. (Under Emergency Support Function (ESF) #8, FDA is the lead DHHS agency for assuring the safety of regulated foods, drugs, medical devices, and biological products.
• Train individuals and provide protective clothing and safety equipment and supplies for these activities.
• Develop techniques to deter the genetic modification of microorganisms and to confirm the results of less specific detection methods.

The request by program area follows:

FY 2000 Funding Request -- Bioterrorism

FDA has included the Agency's funding request for Bioterrorism. FDA will forward under separate cover a copy of the Department's total request for Bioterrorism for FY 2000.

AUTHORIZED USER FEES - + $ 13.8 million, 59 FTE

Prescription Drug User Fee Act II (PDUFA II) -- + $ 13.2 million, 59 FTE

The FDA Modernization Act (FDAMA) signed on November 21, 1997, reauthorized PDUFA for an additional five years. This will provide substantial additional resources and staffing for FDA to accelerate its drug evaluation process without compromising review quality. FDAMA commits FDA to faster review times for applications, new goals for meetings and dispute resolution, and the transition to electronic receipt and review of applications by the year 2002. FDA has developed a five-year plan for the strategic management of PDUFA II. This living document, to be updated annually, will help assure that PDUFA II achieves the same levels of success as PDUFA I. This increase includes $ 0.2 million in GSA rent for space utilized in support of PDUFA.

FDA's spending of PDUFA fees for FY 1998 was $ 101.6 million, $ 15.5 million less than the $ 117.1 million that had been appropriated. This was due to FDA's action to reduce spending of these fees when there was a reduction in the number of fee-paying applications being received, to assure that spending in this program was in line with the revenue being received. However, this was still a substantial increase over the $ 84.3 million spent of these fees in FY 1997, and enabled FDA to continue to meet its performance goals under PDUFA.

Mammography Quality Standards Act (MQSA) - + $ 0.4 million

The Mammography Quality Standards Act of 1992 was reauthorized in 1998 for an additional five years (Mammography Quality Standards Reauthorization Act of 1998, P.L. 105-298). To ensure that women continue to have access to quality mammography, an effective tool in reducing mortality from breast cancer, FDA requests an increase in MQSA authorized inspection user fees of $ 0.4 million to cover inflation, for a total of $ 14.8 million with 53 FTE. MQSA required that mammography facilities be certified by October 1, 1994, to remain in operation and inspected annually to ensure compliance with national quality and safety standards. In FY 2000, Federal and state personnel will continue to conduct annual inspections, as well as provide training for new inspectors. The fees collected will pay for the costs of the inspections.

Exports/Certification Fund/Freedom of Information - + $ 0.2 million

Currently authorized user fees include $ 1.0 million and 8 FTE for Export Certification, $3.8 million and 35 FTE for certification activities, and $ 1.0 million for Freedom of Information Act (FOIA) services. We are requesting inflationary increases of $ 0.2 million for these activities.

Other Requested Increases and Issues + $ 16.3 million

GSA Rent -- ($ 11.7 million). For FY 1998, FDA was appropriated $ 46.3 million to pay the GSA Rent bill. This amount only funds a portion of our total GSA rent bill, however. For FY 1999, Congress included an additional $ 42.0 million in FDA's appropriation to fully fund the estimated rent bill. For FY 2000, the Agency estimates that an additional $ 11.7 million (an additional $ 0.2 million is included in PDUFA user fees) will be needed, for a total of $ 100.2 million.

Relocation to College Park -- ($ 4.64 million). The Center for Food Safety and Applied Nutrition is scheduled to move to a new facility in FY 2001. The current GSA project schedule calls for dedication of the building in December 2000 and occupancy in early 2001. We have reviewed the anticipated costs associated with this move and are including items in the FY 2000 request that must be purchased. These are one-time costs of $ 4.64 million to cover the installation of the building's telecommunications system, and for some Security equipment.

Physicians' Pay Compensation

The FY 2000 request reflects the Administration's proposed cap on the increase of physicians' compensation at six percent. FDA's prorated share of the resulting reduction is $ 2.3 million which was taken from each of the affected program areas.

OTHER ISSUES

Transfer of the Seafood Inspection Program from the Commerce Department to the DHHS under FDA ($ 15.7 million, 172 FTE)

The Seafood Inspection Program under the National Marine Fisheries Service (NMFS)/National Oceanic Atmospheric Administration (NOAA)/U.S. Department of Commerce (USDC) provides voluntary inspections and certification services for fish and fishery products on a fee-for-service basis under the authority of the Agricultural Marketing Act of 1946, and also addresses issues of wholesomeness, economic integrity and quality.

The budget proposes: 1)a transfer of this program from the Commerce Department to the Department of Health and Human Services, under the purview of the Food and Drug Administration, through appropriations language; and 2) the transmittal of legislation to make this program into a Performance Based Organization (PBO), still under the auspices of FDA, but to run more like a business. A PBO - as identified by the Vice President's National Partnership for Reinventing Government -- is a quasi -government entity, located within a federal agency that is operated like a financially self-sustaining business with autonomy to run day-to-day operations. The transfer and subsequent conversion to a PBO will remove unnecessary bureaucratic constraints and allow the program to respond more promptly to the needs of its customers, thereby actively pursuing the goals of the Agricultural Marketing Act for the benefit of industry and consumers.

The resources identified would provide the following:

• $ 3.0 million in budget authority to train the SIP inspectors to conduct FDA/HACCP standard inspections ($ 1.5 million); educate the industry as to the transfer and subsequent transfer to a PBO ($ 0.3 million); other administrative/transitional costs ($ 0.2 million); and up to $ 1.0 million as a reserve fund to be used in the event that revenues do not cover the costs of the program.
• $ 12.7 million in user fees derived from the seafood industry for services provided. These user fees are to cover the entire costs of the program.

The 172 FTE represent personnel located at headquarters (Maryland) and in regional inspection areas across the country (Massachusetts, Florida, and California).

Other Activities

Review of Other Activities: No increases are included for Other Activities in the FY 2000 request. It should be noted that the Commissioner has initiated a review of the structure and functions of the Office of the Commissioner. This review is still under way, and the Committees will be notified of any needed reprogrammings before transfers are made.

Status of FDA's Year 2000 Efforts

In FY 1999, Congress appropriated $ 2.6 billion to address funding needs for the Year 2000 conversion effort. Of the amount set aside, FDA received $ 11.1 million, through the Public Health and Social Services Emergency Fund account. The Agency has focused attention and resources on the most critical date sensitive information and infrastructure systems, prioritized systems renovations, repair and replacement to meet the March 31, 1999 deadline. FDA has 34 mission critical systems. Of these, seven were deemed compliant. Seventeen were scheduled for and have been repaired. Ten systems were scheduled to be replaced; of these six have been replaced, and four remain to be replaced. Two of the four systems remaining to be replaced are scheduled for replacement by the end of January and the other two, by the beginning of March. All non-mission critical systems designated for repair and replacement are on track with OMB's milestones. FDA estimates it will use an additional $ 2 million in FY 2000 for further implementation and follow-up on Y2K initiatives.

Organization Chart

Budget by Activity

Summary

Program Level

Budget Authority

User Fees

Summary of Change

DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

Federal Funds

General and special funds:

SALARIES AND EXPENSES

For necessary expenses of the Food and Drug Administration, including hire and purchase of passenger motor vehicles; for payment of space rental and related costs pursuant to Public Law 92-313 for programs and activities of the Food and Drug Administration which are included in this Act; for rental of special purpose space in the District of Columbia or elsewhere; and for miscellaneous and emergency expenses of enforcement activities, authorized and approved by the Secretary and to be accounted for solely on the Secretary's certificate, not to exceed $25,000; [$1,103,140,000] $1,255,384,000, of which not to exceed [$132,273,000] $145,434,000 in fees pursuant to section 736 of the Federal Food, Drug, and Cosmetic Act may be credited to this appropriation and remain available until expended: Provided, That [fees derived from applications received during fiscal year 1999 shall be subject to the fiscal year 1999 limitation: Provided further, That none of these funds shall be used to develop, establish, or operate any program of user fees authorized by 31 U.S.C. 9701: Provided further, That of the total amount appropriated: (1) $231,580,000 shall be for the Center for Food Safety and Applied Nutrition and related field activities in the Office of Regulatory Affairs, of which, and notwithstanding section 409(h)(5)(A) of the Federal Food, Drug, and Cosmetic Act (21U.S.C. 301 et seq.), an amount of $500,000 shall be made available for the development of systems, regulations, and pilot programs, if any, that would be required to permit full implementation, consistent with section 409(h)(5) of that Act, in fiscal year 2000 of the food contact substance notification program under section 409(h) of such Act; (2) $291,981,000 shall be for the Center for Drug Evaluation and Research and related field activities in the Office of Regulatory Affairs; (3) $125,095,000 shall be for the Center for Biologics Evaluation and Research and for related field activities in the Office of Regulatory Affairs; (4) $41,973,000 shall be for the Center for Veterinary Medicine and for related field activities in the Office of Regulatory Affairs; (5) $145,736,000 shall be for the Center for Devices and Radiological Health and for related field activities in the Office of Regulatory Affairs; (6) $31,579,000 shall be for the National Center for Toxicological Research; (7) $34,000,000 shall be for the Office of Tobacco; (8) $25,855,000 shall be for Rent and Related activities, other than the amounts paid to the General Services Administration; (9) $88,294,000 shall be for payments to the General Services Administration for rent and related costs; and (10) $87,047,000 shall be for other activities, including the Office of the Commissioner, the Office of Policy, the Office of External Affairs, the Office of Operations, the Office of Management and Systems, and central services for these offices: Provided further, That funds may be transferred from one specified activity to another with the prior approval of the Committee on Appropriations of both Houses of Congress] no more than $100,180,000 shall be for payments to the General Services Administration for rent and related costs: Provided further, That effective October 1, 1999, (1) the functions and authorities related to fish or fishery products under such Act, including inspections and other activities authorized under section 203(h) of that Act, are transferred from the Secretary of Commerce to the Secretary of Health and Human Services (hereafter ''HHS'') acting through the Commissioner for Food and Drugs; (2) the Secretary of Commerce shall transfer to the Secretary of HHS (A) all personnel of the Seafood Inspection Division of the National Oceanic and Atmospheric Administration of the Department of Commerce and such other employees of the Department of Commerce as may be designated by the Secretary of Commerce, with the concurrence of the Secretary of HHS, all of whom shall become personnel of a voluntary seafood inspection unit within the Food and Drug Administration; and (B) all assets and liabilities of the Department of Commerce or its components pertaining to the activities specified in clause (1), which shall become assets and liabilities of such seafood inspection unit, including facilities, contracts, property, records, accounts payable and receivable, and unexpended and unobligated balances of funds; (3) all rules, regulations, administrative directives, grants, contracts, and other determinations and agreements in effect on such date with respect to (or to the extent they apply to) the functions and authorities specified in clause (1) shall remain in effect until modified, terminated, suspended, set aside, or repealed by the Secretary of HHS or the Commissioner of Food and Drugs; (4) the Secretary of HHS is authorized to promulgate, without need for comment, a final rule transferring to or duplicating in title 21 of the Code of Federal Regulations (as appropriate) regulations of the Secretary of Commerce necessary to carry out the functions specified in clause (1); (5) activities of such seafood inspection unit to carry out provisions of the Agricultural Marketing Act shall be funded exclusively from fees charged for, and other amounts specifically appropriated for, such activities, and fees collected and amounts appropriated for such activities shall not be used for any other purpose; and (6) for purposes of any reduction in the personnel complement of the Food and Drug Administration or of such unit on or before September 30, 2004, such unit will be deemed a distinct competitive area within the Food and Drug Administration, under 5 CFR 351.402: Provided further, That of the total amount appropriated, $3,000,000 shall be available until expended for the costs of transferring functions related to fish and fishery products (including costs of relocation, personnel training, and public information), and shall be deposited, together with fees derived from performance of such functions, into a separate account.

In addition, fees pursuant to section 354 of the Public Health Service Act may be credited to this account, to remain available until expended.

In addition, fees pursuant to section 801 of the Federal Food, Drug, and Cosmetic Act may be credited to this account, to remain available until expended.

BUILDINGS AND FACILITIES

For plans, construction, repair, improvement, extension, alteration, and purchase of fixed equipment or facilities of or used by the Food and Drug Administration, where not otherwise provided, [$11,350,000] $31,750,000, to remain available until expended (7 U.S.C. 2209b). (Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 1999, as included in Public Law 105-277, section 101(a).)

(Legislative proposal, not subject to PAYGO)

Contingent upon the enactment of authorizing legislation, up to $17,000,000 derived from fees assessed for activities related to the review of direct and indirect food additive petitions and the review of medical device applications may be collected and credited to this appropriation, to remain available until expended for those activities.

1/ Legislation has been drafted to establish the Seafood Inspection Program as a Performance Based Organization (PBO) within FDA of the U.S. Department of Health and Human Services. This legislation will, among other things, transfer the employees of the SIP and the authorities of the Agricultural Marketing Act of 1946 to continue the services that are now being provided by the SIP under NMFS/NOAA/USDC.

The budget proposes: 1) for the short-term, a transfer of the Seafood Inspection Division of the National Oceanic and Atmospheric Administration from the Commerce Department to the Department of Health and Human Services, under the purview of the Food and Drug Administration; and 2) more permanently, the development of legislation to make this program into a Performance Based Organization, still under the auspices of FDA, but to run more like a business.

2/ FDA proposed additive user fees for the Foods and Medical Devices Programs. Fees collected under the Foods Program will be for petitions for food additives submitted and notifications for food contact substances. Additive user fees collected under the Medical Devices Program will be for premarket applications and premarket application supplement reviews.

Year	Budget Estimate to Congress	House Allowance	Senate Allowance	Appropriation
1988	454,109,000 1	450,504,000	454,109,000	450,504,000
1989	481,844,000 2	481,844,000	481,844,000	481,844,000 3
1990	556,571,000 4	550,171,000	581,871,000	567,079,000 5
1991	654,808,000 6	654,808,000	661,652,000	656,519,000 7
1992	737,604,000 8	725,962,000	704,734,000	725,962,000
1993	757,038,000 9	744,135,000	744,135,000	792,035,000 10
1994	867,339,000 11	867,339,000	692,339,000	870,123,000 12
1995	926,007,000 13	914,394,000	754,587,000	897,104,000 14
1996	965,462,000 15	917,694,000	917,694,000	917,694,000 16
1997	964,178,000 17	920,903,000	920,902,000	920,903,000 18
1998	987,735,000 19	866,467,000	978,227,000	962,671,000 20
1999	1,153,259,000 21	1,101,023,000 22	1,124,025,000 22	1,117,525,000 23
2000	1,345,051,000 24

¹ The FY 1988 request includes Amendments of +$8,880,000 for AIDS, -$2,357,000 for reduced FERS Agency contribution rate, and $33,800,000 proposed to be available from user fees.

² The FY 1989 request includes funding of $40,420,000 for AIDS-related work which was proposed to be funded in the AIDS Research and Education Account.

³ The FY 1989 appropriation does not include $5,000,000 added in the Anti-Drug Abuse Act.

⁴ The FY 1990 request includes $56,941,000 which was included in the proposed National HIV Program account, $13,900,000 requested as a supplemental appropriation, and $100,000,000 proposed to be available from user fees.

⁵ The FY 1990 appropriation includes $7,092,000 which was subsequently sequestered.

⁶ The FY 1991 request includes $157,175,000 proposed to be available from user fees.

⁷ The FY 1991 appropriation includes $8,868 which was subsequently sequestered.

⁸ The FY 1992 request includes $197,500,000 proposed to be available from user fees.

⁹ The FY 1993 appropriation request includes $200,000,000 proposed to be available from user fees.

¹⁰ The FY 1993 appropriation includes $1,900,000 to fund a clinical pharmacology pilot program; and a $3,000,000 supplemental for Mammography Quality Standards Act (MQSA) to be transferred from HCFA, NIH and CDC; and $36,000,000 for the Prescription Drug User Fee Act.

¹¹ The FY 1994 request includes $54,000,000 for the Prescription Drug User Fee Act (PDUFA); $64,600,000 for Investment Initiatives; $200,000,000 proposed to be available from User Fees.

¹² The FY 1994 appropriation includes $56,284,000 for PDUFA ($2,284 which was a supplemental appropriation), and $40,000,00 for Investment Initiatives.

¹³ The FY 1995 1995 request includes $79,423,000 for PDUFA; $24,000,000 for Device User Fees; $6,500,000 for MQSA fee collections; and other user fees of $228,000,000. Also included is a transfer from Office of the Secretary, Office of General Counsel to FDA of $2,745,000 and 34 FTE.

¹⁴ The FY 1995 appropriation includes an amended S&E BA of $817,681,000 and $79,423,000 for PDUFA. The amount does not include anticipated collections of MQSA inspections fees of $6,500,000. The level reflects the amended appropriation which rescinded $2,290,000.

¹⁵ The FY 1996 request includes S&E BA of $828,999,000; $84,723,000 for PDUFA; $13,000,000 for MQSA fee collections; $23,740,00 for MDUFA; and $15,000,000 for Import fees.

¹⁶ The FY 1996 appropriation includes S&E BA of $819,971,000; $84,723,000 for PDUFA; and $13,000,000 for MQSA fee collections.

¹⁷ The FY 1997 request includes S&E BA of $823,771,000; $87,528,000 for PDUFA; $13,403,000 for MQSA fee collections; $24,476,00 for MDUFA; and 15,000,000 for Import fees.

¹⁸ The FY 1997 appropriation includes S&E BA of $819,971,000; $87,528,000 for PDUFA; and $13,403,000 for MQSA fee collections.

¹⁹ The FY 1998 request includes S&E BA of $750,922,000; $91,204,000 for PDUFA; $13,966,000 for MQSA; $131,643,000 for new user fees. Does not reflect proposed PDUFA Supplemental request of $25,618,000 requested with the FY 1999 President's Budget.

²⁰ The FY 1998 appropriation includes S&E BA of $857,501,000; $91,204,000 for PDUFA; and $13,966,000 for MQSA fee collections.

²¹ The FY 1999 request includes S&E BA of $878,884,000; $132,273,000 for PDUFA; $14,385,000 for MQSA; and $127,717,000 for new user fees.

²² The FY 1999 House Action, Senate Action and Appropriation included the GSA Rent within the S&E Appropriation (BA of $82,866,000; PDUFA of $5,428,000).

²³ The FY 1999 appropriation includes S&E BA of $888,001,000; GSA Rent of $82,866,000 $132,273,000 for PDUFA; and $14,385,000 for MQSA fee collections.

²⁴ The FY 2000 request includes S&E BA of $1,109,950,000 (including $94,537,000 of GSA Rent, $3,000,000 for Seafood Transfer); $145,434,000 for PDUFA; $14,817,000 for MQSA; $12,700,000 for Seafood Transfer User Fees, $17,000,000 for new user fees, and $13,400,000 for Bioterrorism.

Table of Estimates And Appropriations
Rental Payments to GSA

Year	Budget Estimate to Congress	House Allowance	Senate Allowance	Appropriation
1988	34,495,000	25,612,000	34,495,000	25,612,000
1989	25,612,000	25,612,000	25,612,000	25,612,000
1990	25,612,000	25,612,000	25,612,000	25,612,000
1991	25,612,000	25,612,000	25,612,000	25,612,0001
1992	25,612,000	25,612,000	25,612,000	25,612,000
1993	25,612,000	25,612,000	25,612,000	25,612,000
1994	48,575,000	48,575,000	48,575,000	48,575,0002
1995	48,575,000	46,294,0003	46,294,000	46,294,0004
1996	46,294,000	46,294,000	46,294,000	46,294,0005
1997	46,294,000	46,294,000	46,294,000	46,294,0006
1998	46,294,0007	46,294,000	46,294,000	46,294,0007
1999	88,294,0008	88,294,0009	88,294,0009	88,294,0009
2000	100,180,00010

¹ Does not reflect $333 which was subsequently sequestered.

² Includes $15,000,000 reserved for use by FDA for repairs and improvements to facilities.

³ Reflects a GSA rent reduction of $2,281,000 to the rent cap.

⁴ Includes an authorized reduction of GSA rent payments of $3,970,000 to cover FDA's Building Delegation expenses.

⁵ Includes an authorized reduction of GSA rent payments of $3,957,000 to cover FDA's Building Delegation expenses.

⁶ Includes an authorized reduction of GSA rent payments estimated to be $4,705,000 to cover FDA's Building Delegation expenses.

⁷ Includes an authorized reduction of GSA rent payments estimated to be $4,832,000 to cover FDA's Building Delegation expenses.

⁸ Includes an authorized reduction of GSA rent payments estimated to be $4,917,0000 to cover FDA's Building Delegation expenses and $5,428,000 of PDUFA collections.

⁸ In FY 1999, Congress included GSA Rent in the S&E Appropriation. Includes an authorized reduction of GSA rent payments estimated to be $4,917,0000 to cover FDA's Building Delegation expenses and $5,428,000 of PDUFA collections.

¹⁰ Includes $5,643,000 of PDUFA collections.

¹ Funding of facilities projects - 1984 through 1992 - was included in the Program Expenses request but appropriated in this account.

² Does not include $200,000,000 provided to GSA in the Treasury, Postal Service, General Government Appropriation Act of 1992 for consolidation of FDA headquarters facilities.

³ Does not include $73,900,000 provided to GSA in the Treasury, Postal Service, General Government Appropriation Act of 1994 for consolidation of FDA headquarters facilities.

⁴ Does not include $45,000,000 provided to GSA in the Treasury, Postal Service, General Government Appropriation Act of 1995 for consolidation of FDA headquarters facilities.

⁵ Includes $9,800,000 to purchase land and begin engineering and design work for replacement of FDA's Los Angeles District office and laboratory.

⁶ Includes $3,800,000 for continuing work on an Arkansas Regional Laboratory at Jefferson, AR.

⁷ Includes $13,000,000 for continuing modernization of Arkansas Regional Laboratory at Jefferson, AR.

⁸ Includes $14,550,000 for continuing modernization of Arkansas Regional Laboratory at Jefferson, AR.

⁹ Includes $3,000,000 for continuing modernization of Arkansas Regional Laboratory at Jefferson, AR.

¹⁰ Includes $20,400,000 for construction of Phase I of the new Los Angeles Laboratory and $3,000,000 for continuing modernization of Arkansas Regional Laboratory at Jefferson, AR.