The Food and Drug Administration (FDA) regulates the safety of foods (including animal feeds) and cosmetics, and the safety and effectiveness of drugs, biologics (e.g., vaccines), and medical devices. With new authority that began in FY2010, FDA also regulates tobacco products according to their impact on public health. The Agriculture, Rural Development, Food and Drug Administration, and Related Agencies appropriations bill provides FDA's annual funding. The total amount that FDA can spend, its program level, consists of direct appropriations (which FDA calls budget authority) and other funds, most of them user fees. An appropriations bill specifies both the budget authority and user fee amounts each year. It dictates the total for each of FDA's major program areas (foods, human drugs, biologics, devices and radiological health, animal drugs and feeds, tobacco products, and toxicological research) and several agency-wide support areas (Office of the Commissioner and other headquarter offices, rents to the General Services Administration, and other rent and rent-related activities). Traditionally, the appropriations committees have used report language to recommend, urge, or request specific activities within major programs. The standard appropriations procedure involves congressional passage of 12 annual regular appropriations acts, of which agriculture (including FDA) is one. For 7 of the previous 11 fiscal years, Congress had not completed that standard process and had passed omnibus or consolidated appropriations legislation, as shown in Table 1 . Recent examples include FY2009, when Congress acted in the final days of FY2008 to provide appropriations for the start of FY2009 as part of the larger Consolidated Security, Disaster Assistance, and Continuing Appropriations Act, 2009 ( P.L. 110-329 , signed on September 30, 2008), and passed an omnibus FY2009 appropriations bill that included FDA ( P.L. 111-8 ) in March 2009. The FY2010 agriculture appropriations ( P.L. 111-80 ) followed the standard process except that final passage occurred after the start of the fiscal year. The process for FY2011 began on February 1, 2010, when the President released his budget request. In February of each year (except for when a new President has taken office the month before), the President presents a budget request to Congress. The annual Food and Drug Administration Justification of Estimates for Appropriations Committees contains program-level details of the President's request, while also highlighting successes, needs, and special initiatives for the coming year. Because the topics selected for discussion vary over the years, analysts cannot use this information to track exact changes over time. The program-level detail, however, provides a window into the priorities and activities of the agency. Table 2 displays the President's FY2011 request by major program area. For historical context, the table also has columns for FY2009-enacted appropriations, FY2009 actual appropriations (as of February 2010), and FY2010-enacted appropriations. The FY2011 request—$4.032 billion—is 22.8% higher than FY2010-enacted appropriations. The increase would be mostly in user fees. The request for $2.508 billion in budget authority (BA) is 6.2% higher than the FY2010 appropriations. For continuing user fee programs (prescription drug, medical device, animal drug, animal generic drug, tobacco product, mammography quality standards, export certification, and color certification fees), the requested $1.233 billion is 33.7% above FY2010. Tobacco product fees account for much of this increase as FDA ramps up the regulatory authority that Congress gave it in 2009. The requested increase in continuing user fee programs excluding tobacco product fees is 14%. The FY2011 request includes an additional $290 million in proposed new user fees that Congress has not yet authorized. These are generic drug user fee authority ($38 million), food export certification fees ($4 million), reinspection fees ($27 million), and food inspection and facility registration fees ($220 million). The total user request is for $1.523 billion, a 65.2% increase over FY2010. In addition to program-specific descriptions, which coincide with the program-specific funding shown in Table 2 , the budget justification documents describe major initiatives planned for the upcoming year. Initiatives . The budget justification documents describe major initiatives planned for FY2011 with all the requested funds. The three major initiatives cut across program areas. The first described is Transforming Food Safety . The agency outlines its plans to set standards for safety; establish an integrated national food safety system; enhance surveillance and improve risk analysis and research for food and feed safety; expand laboratory capability; increase inspection capacity; pursue pilot studies with industry using track and trace technology; and increase inspections of domestic and foreign facilities. In the Protecting Patients initiative FDA would seek to invest in new scientific tools and partnerships, modernize the agency's approach to supply chain safety for medical products, and expand its capacity to conduct medical product safety assessments. This would include launching an electronic drug registration and listing system to stop illegal drug imports and expanding foreign inspections. The third initiative, Advancing Regulatory Science for Public Health , involves FDA plans to build its scientific infrastructure, develop standards for new and emerging technologies, modernize the standards for evaluating products, and accelerate the development of essential medical therapies. Programs . The program-specific narratives highlight elements of these initiatives along with other activities. For the Food program, these include more closely integrating with state and local governments; working with public health organizations in foreign countries to shift burden of assuring imported food safety from the FDA to the foreign production/processing environment; developing tools to identify, evaluate, prioritize, and communicate risks; enhancing the reportable food registry and the consumer complaint reporting system; participating in the nanotechnology initiative; and hiring additional laboratory staff. For the Human Drugs program, the budget justification narrative includes expanding involvement with the science of nanotechnology and developing new biomarkers; implementing a quantitative risk-based program to target clinical site inspections; increasing inspections; improving human subject protection; completing and validating a new electronic drug registration and listing system, allowing information about specific drug products, specific ingredients, and specific facilities around the world; working with other countries' regulatory authorities; targeting high risk manufacturing facilities for inspections; continuing implementation of the National Sentinel System Network, a public-private collaboration; and staffing the Safe Use Initiative. Biologics program activities in FY2011 would include increasing outreach to improve industry practices and performance; building capacity to reduce the risk of disease transmission caused by infected tissues; evaluating the use of nanoparticles in analytic tests; developing analytic tests with stem cells to facilitate clinical translation of therapies; hiring and training investigators to conduct complex medical product inspections; and developing biological markers and other approaches to evaluate the safety of vaccines and vaccine components. For the Animal Drugs and Feeds program, the budget justification describes hiring and training scientific staff to build expertise to regulate new animal biotechnology products; expanding the National Antimicrobial Resistance Monitoring System, which would allow FDA to make more informed science based decisions; establishing an Integrated National Food Safety System with Strengthened Inspection and Response Capacity; and coordinating and increasing surveillance of state activities and data-sharing. The FDA-listed activities for the Devices and Radiological Health program include participating in the development and implementation of a national strategy for the best public health use of health-related electronic data; systematically integrating all available internal and external data involving the pediatric population; broadening targeted surveillance; building infrastructure to analyze pediatric postmarket device information; increasing oversight of foreign manufacturing facilities; developing standards for safe and effective CT scanners and fluoroscopes; and recruiting scientists in fields such as biostatistics, epidemiology, modeling, and risk sciences. FY2011 will be the second year of the Tobacco Products program at FDA. It is funded solely by user fees. Planned activities include conducting research and evaluation programs to better understand how the FDA regulations and tobacco control and prevention programs protect the public from the adverse health consequences of tobacco use; implementing a comprehensive framework for a research and testing program to support tobacco product standards development and other activities; developing comprehensive education and communications programs designed to reach the public; and contracting with states and territories to conduct inspections. The narrative for the National Center for Toxicological Research describes developing and deploying rapid detection tests; developing and training scientific staff; and engaging in collaborative and interdisciplinary research. To carry out these initiatives, as well as continue standard FDA activities, the agency would rely on direct congressional appropriations and user fee revenue. The appropriations committees in the House and the Senate each have subcommittees that parallel the 12 annual appropriations bills. The subcommittees on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies consider FDA appropriations. The textbook order of activity is as follows: In each chamber, the subcommittee considers the issues, perhaps holds hearings, and marks up a bill for the full committee's consideration. In each chamber, the full committee considers the subcommittee-marked bill or a version that the full committee chair presents, and reports a bill, perhaps with committee amendments, to the full House or the full Senate for consideration. The full House considers the House Committee on Appropriations-reported bill, perhaps amending it on the floor, and passes the bill; the full Senate considers the Senate Committee on Appropriations-reported bill, perhaps amending it on the floor, and passes the bill. If the House-passed and Senate-passed bills are not identical, each chamber assigns Members to meet in conference to work out one acceptable bill. Each chamber must vote to approve the conference bill; the second chamber that passes the conference bill sends it to the President for signing. The annual appropriations process began in February 2010 with the President's submission of his proposed budget for FY2011.