Laboratory analysts will be hired to support increased sample analysis functions including analysis for chemical and microbiological contamination. Employees hired for these positions include chemists, microbiologists, and physical science technicians. Compliance officers and domestic investigators will be hired to go to district offices to follow up on import enforcement needs and support domestic inspections. Additionally, these employees will work with industry to assist them in identifying potentially vulnerable access points in their manufacturing processes for possible terrorism acts; and, work with them to develop procedures and guidelines for minimizing vulnerability. Strategic Systems - OASIS - $5.0 million - Improve and enhance to provide improved targeting of initial and follow-up inspections and other surveillance activities thus supporting counter terrorism activities. This will involve the set up of a remote off-site production facility for OASIS and other supporting strategic systems. This will include development of a redundant processing and e-communications facility, with all necessary hardware to insure continuity of import entry review and management in the event of a disabling threat to existing facilities. This facility could also serve as a load sharing facility when not needed for the above reasons. Several configurations will be evaluated over course of a requirements definition period. Other Equipment and systems - $17.0 million - Includes purchase of several pieces of specialized scientific equipment and information technology systems that monitor imports and those that provide tools to compare pathogenic findings in the food supply. Systems: Expand the number of State health laboratories and capabilities of current of laboratories to the Electronic Laboratory Exchange Network (eLEXNET). The eLEXNET system will provide multiple government agencies engaged in food safety regulatory activities the ability to rapidly detect, compare and communicate unusual findings in laboratory analyses. This system will enable the laboratories to exchange data on select biological agents (possibly including Anthrax, botulinum toxin, brucellosis and other potential infectious diseases) and four food pathogens This system is the first Internet-based food safety system that consolidates a repository of pathogenic findings in the nation's food supply by Federal, State, and local government labs Equipment: Purchase rapid detection instruments - 1) a High Performance Liquid Chromatography (HPLC) needed for rapid analysis of suspect foods for Select Agents toxins and other agents that could be used in a terrorist event; 2) Bio sensors, that can be used in a variety of settings to detect food environmental and water borne pathogens. Speeding the development of new bioterrorism tools The proposal includes $40.750 million and 164 personnel to expedite the work of the FDA on bioterrorism vaccines, on the safety of blood, drug therapies, diagnostic tests and consultations with other agencies and private industry. FDA must review and give approval, at least on a temporary basis, to every drug, therapeutic, vaccine, anti-toxin that is to be administered to humans and every diagnostic tool that is to be used clinically must be reviewed and approved by FDA. Since this regulatory process is lengthy, complex and fraught at times with the unforeseen, it is essential, in the interest of national security and public health, that FDA engages in the process as early as possible with sponsors and organizations that are developing the therapeutics, vaccines and rapid diagnostics. This means that FDA must maintain a pro-active role and work with other organizations from the very outset, starting with outlining the individual steps that must be taken to obtain FDA approval, through pre-clinical toxicity testing, the development of protocols for conducting the clinical trials, to the review and analysis of the trial results, review of the proposed manufacturing procedures, inspection of the manufacturing process to assure compliance with Good Manufacturing Practices and post-marketing surveillance of adverse events. FDA must also participate in exercises related to responding to a bioterrorist attack. Biologics - $19.80 million and 107 personnel Funds will be used to expedite work on bioterrorism vaccines, and in support of blood safety activities. For vaccines FDA will provide consulting services to other Federal agencies and industry, accelerating emergency vaccine lot releases, and preparing to evaluate new vaccines whose efficacy cannot be tested buy exposing people to the pathogen. On blood safety FDA will expedite licensure issues related to storing of blood; expedite release of test kits and reagents use for blood screening and reviewing and processing expedited lot releases. Hiring New Employees $13 million The pay costs will be used to hire 107 FTE to ensure the safety and efficacy of biological products, to support the development, maintenance and deployment of stockpiles of medical counter-measures, to assist in assuring that sufficient quantities of medical products are available, and to support post-event follow-up and data collection initiatives for these products, some of which may be investigational. These activities are accomplished through the regulation of the development and licensure of new vaccines, therapeutics, and blood products for protection and treatment against bioterrorism-related threat diseases. The personnel hired will be targeted toward the range of disciplines necessary to accomplish the activities described above and include: biologists, chemists, consumer safety officers, medical officers, microbiologists, compliance officers/ technicians, public affairs specialists/technicians, computer systems analysts, management analysts, personnel specialists/technicians and program support personnel. Contractual Services and Supplies and Equipment $6.8 million The $6.8 million will be used for contractual services that will provide the necessary support of active applied intramural programs. The programs are directed toward optimizing the availability of safe and effective new products for the treatment, prevention or cure of human diseases that result from exposure to biological terrorism agents and for supplies and equipment. Human Drugs - $14.25 million and 32 personnel Funds here will be used to assure product availability through an expansion of the drug shortage program as well as plans to develop protocols for the study of alternative therapies for biological agents. The latter will be conducted through contractual work to define animal model programs for relevant diseases (smallpox, pneumonic, plague) that provide early and proactive regulatory guidance to develop data for potential drug therapies. Additionally, the agency will need to develop a framework for addressing future regulatory applications that use a combination of vaccine and drug. Hiring New Employees $ 3.3 million It is anticipated the mix of the types of new employees in the 32 new hires in the counterterrorism request will closely match the current mix of employees in the review process, i.e., Medical Officers, Epidemiologists, Microbiologists, Pharmacokineticists, Mathematical Statisticians, Biologists, Consumer Safety Officers (CSOs), etc. However, the recruitment process will need to focus on finding employees with specialized training in infectious diseases, neuropharmacology, and radiologic products. Veterinarians with experience with primates and animal modeling will also be hired Contractual Services and Supplies and Equipment $10.95 million Human Drugs plans to enter into various research and development contracts and Interagency Agreements (LAGs) with other federal agencies, i.e., Department of Defense (DOD), National Institutes of Health (NIH), and Centers for Disease Control and Prevention (CDC), and private sector entities to develop protocols, conduct animal studies, and define reference databases on treatment and alternative therapies for infectious diseases caused by the intentional use of bioterrorist threat agents. Devices $1.50 million and 13 personnel Devices will accelerate review of new diagnostics testing for biological agents. Devices will hire personnel to respond to terrorist threats and attacks. This involves recruiting and training staff to review new devices, participating in standard development and recognition, developing guidances, predicting device shortages associated with an emergency response, and developing an outreach program focused on educating health professionals, consumers, and industry on using medical devices to counter terrorism. Contractual Services; Supplies and Equipment $ 0.25 million Funds will be used to improve internal scientific knowledge and capabilities, conduct research to assess in vitro diagnostic technology used to detect biothreat agents, conduct a market assessment to identify potential device shortages, and educate health professionals and consumers on the use of medical device biowarfare products. Other Activities $0.40 million and 4 personnel Funds will provide the Office of the Chief Council the funds needed to provide advice and counsel on legal matters, render opinions, and support rulemaking proceedings, legislative matters, policy deliberations, and domestic and international negotiations. Hiring New Employees $ 0.4 million Four personnel will be hired for the Office of the Commissioner and will be assigned to the Office of Chief Counsel. A combination of public health and law enforcement responsibilities requires Agency involvement in a number of aspects of the response to a bioterrorism event. Many facets of counter terrorism link to the Agency-s legislative mandate to protect the public health by ensuring the availability of safe and effective drugs, vaccines, blood products, medical devices, and animal health products, and by ensuring a safe food supply. FDA-s team of specialists will work to prepare the nation for current and future biological or chemical terrorist attacks, including the services of the Office of Chief Counsel (OCC). OCC will provide advice and counsel on legal matters, render opinions, and support rulemaking proceedings, legislative matters, policy deliberations, and domestic and international negotiations. Improve detection of the virulence, toxicity, and antibiotic resistance of pathogens; and improve diagnostic tools for food contaminants. Hiring New Employees $ 0.63 million Recruit additional expertise to include computer scientists (3), protein chemists (3) and microbiologists (2). Supplies and Equipment $ 4.17 million Upgrade designated laboratory facilities at NCTR to a BioSafety Level 3 (BSL-3) to support BSE/TSE and microbial bioterrorism research. BSL-3 facilities have containment capability that allows work with indigenous or exotic agents that may cause serious or potentially lethal disease such as potential bioterrorist agents. By utilizing the expertise of a contractor, the upgrade of designated laboratory space can be expedited thus allowing microbial bioterrorism research to proceed within FY2002. Outfit upgraded laboratory facilities with infrastructure to include containment hoods, and appropriate filtering and monitoring devices. This will allow identification and rapid detection and assignment of bacterial strains of bioterrorist agents (pathogens /chemicals). ($1.2M) To conduct these studies, FDA/NCTR will require agents/chemicals and laboratory supplies, which will allow researchers to characterize multiple strains, construct a library/database of constituent proteins and test the library/database to find toxin related markers. ($0.67) Physical Security $13.25 million and 3 personnel $8.75 million requested in the emergency supplemental to improve FDA security: $5.45 million is for additional guard services at a number of locations. This will facilitate not only increased guard surveillance, but also allow for timely access to FDA buildings by employees and others while allowing for increased security screening of individuals, belongings, and vehicles. $2.0 million of this request is for hydraulic bollards at the entrances to buildings and parking lots to limit vehicle access without proper clearance. FDA's computerized security system software needs to be updated to include recent enhancements, at a cost of $1 million. This request also includes $0.3 million for three employees to monitor security standards at all facilities, develop plans for improved security measures and procedures, and assure effective coordination with all FDA components and building managers. Annualization of the $1.75 million equates to $4.50 million FDA received $1.75 million in the first release of emergency funding for immediate security improvements at 17 laboratories that house chemical and biological agents for 90 days. The funding was for guards at $1.5 million for 90 days and included $.250 million for safety equipment. We need to annualize the $1.5 million for the guards at an additional cost of $4.5 million or $6.0 million for the whole year. The President's FY 2003 Budget Justification includes a total request of $159.048 million in Counter Terrorism funding for FDA, an increase of $1.176 million over the FY 2002 Current Estimate level of $157.872 million. The FY 2002 Current Estimate level includes base funds of $6.772 million and a supplemental increase in FY 2002 of FY 2003 Budget Food Safety $98.048 million - The FY 2003 Budget includes a total of $98.048 million for Food Safety Counter Terrorism related activities. This funding will be used to focus on activities that protect the U.S. border against the potential vulnerabilities to the nation's food supply and will increase the number of food physical examinations at the border from 12,000 in FY 2001 to 48,000 in FY 2003. We expect total hires to be 673 FTE and made up of import investigators, import criminal investigators, compliance officers, domestic investigators and laboratory analysts. In addition, the funding will enable FDA to invest in new technology and scientific equipment to detect select agents and monitor imports. Approximately 85 of the additional personnel will be stationed in New York. The FDA and CDC will also work together to enhance surveillance activities with regard to diseases caused by foodborne pathogens. These activities will assist in the protection of the U.S. border against the potential vulnerabilities of the nation's food supply. These funds will pay for the personnel costs of 673 FTE at an estimated total of $82 million. This figure includes all of the costs associated with hiring full time employees: salaries, benefits and support costs (support includes training; supplies; space costs; travel costs; cell phones; computers; special contamination suits, vehicles, etc.). The 673 FTE fall into the four following categories: 400 employees will be assigned to help assure the safety of imported products. Initial training will concentrate on specific import/border duties. These duties include working with Customs personnel; learning how to collect, package and ship samples; fill out collection reports; conduct field examinations of shipments, including such activities as visual inspections for the appearance or smell of a product, swollen can seams, etc. These employees should be able to contribute to basic assignments within two months. 151 laboratory analysts will be available to support increased sample analysis functions, including analysis for chemical and microbiological contamination. Employees hired for these positions include chemists, microbiologists, and physical science technicians. 84 compliance officers and domestic investigators will be available to go to district offices to follow-up on import enforcement needs and support domestic inspections. Additionally, these employees will work with industry to assist them in identifying potentially vulnerable access points in their manufacturing processes for possible terrorism acts, and work with them to develop procedures and guidelines for minimizing vulnerability. 38 employees will be utilized by the Centers for Foods and Animal Drugs to conduct risk assessments, develop compliance policy for imported animal drugs and feeds, and foods, collaborate on the development of new methods, and conduct risk assessments of the results of laboratory analyses of imported products. $16 million for Equipment and IT Costs. The Agency will devote $5 million for the field's Operational and Administrative System for Import Support (OASIS) computer software. These funds will allow for a real-time screening interface with multi-agency |