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. 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 also dictates the total for each of FDA's major program areas (Foods, Human Drugs, Biologics, Devices, Animal Drugs and Feeds, 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). It also authorizes collections and spending from several specific other funds (relating to mammography quality standards, and color and export certification). 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. Except that final passage occurred after the start of the fiscal year, the FY2010 agriculture appropriations followed the standard process. Table 1 provides a timeline of the administrative and congressional steps toward FY2010 appropriations for FDA. 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 2 . For FY2009, 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). In March 2009, Congress passed an omnibus appropriations bill that included FDA ( P.L. 111-8 ). 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 (e.g., drug safety, imports, bioterror countermeasures, inspections). 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. The FY2010 request—$3.178 billion—is 19% higher than FY2009-enacted appropriations. It includes increased funding for food and medical product safety activities and cost-of-living expenses. Data column 4 of Table 3 displays the President's FY2010 request by major program area. This follows columns for FY2008-enacted appropriations, FY2008 actual appropriations (as of April 2009), and FY2009-enacted appropriations. 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. On June 23, 2009, the full Committee on Appropriations reported H.R. 2997 , which the Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies had marked up on June 11, 2009. The bill matched the President's request but did not include the proposed new user fees. Data column 5 of Table 3 shows the committee-reported amounts. As it had in previous years, the committee included in the bill a provision to preclude FDA's closing or relocating its Division of Pharmaceutical Analysis outside the St. Louis, MO, area. In H.Rept. 111-181 , which accompanied H.R. 2997 , the committee highlighted the increased support for food and medical product safety that would cover, for example, more foreign and domestic inspections. The committee also noted that the increase would fund research in biomarkers; collection and analysis of data on foodborne illnesses; research on screening tests for bloodborne diseases; efforts to understand adverse events related to medical devices used in pediatric hospitals; evaluations of drug Risk Evaluation and Mitigation Strategies; and investment in information technology. The report also noted funding for congressionally directed spending items. In its report, the committee stated its intention to authorize FDA to collect and spend tobacco product user fee revenue once the tobacco legislation was signed into law. The committee also encouraged FDA to prioritize its review of products that would address neuroblastoma; to issue a final rule on over-the-counter sunscreen testing and labeling; to devise targeted communications strategies to allow consumers to use the findings of the upcoming Dietary Guidelines Advisory Committee report; and to remind honey manufacturers about the law's misbranding and adulteration provisions and to respond to a pending citizen petition proposing a standard of identity for honey. The House-passed bill included an anticipated amendment to allow the collection and spending of newly authorized tobacco product user fees. It would allocate most of the $235 million to a new Center for Tobacco Products and related field activities of the Office of Regulatory Affairs, reserving a small part for rent and rent related activities, GSA rent, and other activities, including the Office of the Commissioner. Data column 7 of Table 3 shows the House-passed amounts. On July 7, 2009, the Committee on Appropriations reported S. 1406 , although the subcommittee had not voted on and referred a bill. The budget authority and user fee amounts matched both the House committee-reported and the President's request amounts; it also included the St. Louis, MO, provision. Data column 6 of Table 3 shows the committee-reported amounts. The accompanying report, S.Rept. 111-39 , highlighted the increase related to food and medical product safety, which would allow additional inspections. The Senate committee also mentioned laboratory capacity; screening test development; adverse event data collection and analysis; research on bioequivalence standards of generic products; enforcement against fraudulent products; noninvasive techniques to better understand the risks of anesthetic use in children; and information technology systems. The committee specifically encouraged FDA to develop a program for increasing the inspection of imported shrimp for banned antibiotics; to issue guidance regarding antibiotic development and to work with others to promote development and appropriate use of antibacterial drugs for humans; and to continue its activities regarding antimicrobial resistance. The committee recommended a $2 million increase (approximately a 25% increase) to the cosmetics program. It directed the agency to use $18 million for its critical path initiative, with one-third going to partnerships, and to use at least $2 million of the critical path partnership funding to support research in treatment or rapid diagnosis of tropical diseases. The committee directed FDA to report quarterly on critical path spending. The committee also directed the agency to clarify the relationship of dietary supplements to a definition of food; recommended $3 million for demonstration grants for improving pediatric device availability; directed FDA to report on planned research involving bioequivalent anti-epileptic drugs; recommended $93 million for the generic drugs program, increasing the Office of Generic Drugs by $10 million; directed the Department of Health and Human Services (HHS) and FDA to resolve problems with the Rockville Human Resources Center and to report to the Committee; directed FDA to submit a report regarding infant formula products introduced in the past decade; recommended that $5 million in appropriated funds, as well as the $19 million in user fees, be used for Mammography Quality Standards Act activities; urged FDA to stimulate the development of products that could address orphan tropical diseases; and recommended $6 million for the Office of Women's Health. It also directed FDA to consider the need for regulations on the safe handling and processing of packaged ice; to continue priority attention to products for neuroblastoma; to work with states to more aggressively combat fraud in the seafood industry; to respond to a proposed standard of identity to prevent the misbranding and adulteration of honey. The committee instructed FDA to report quarterly on its use of appropriated funds in its implementation of the new tobacco program, and noted its intention to authorize the collection and use of fees. The Senate-passed bill included an anticipated amendment to allow the collection and spending of newly authorized tobacco product user fees. It also authorized the FDA commissioner to conduct and report on a study regarding addiction to certain types of food and addiction to classic drugs of abuse. Data column 8 of Table 3 shows the Senate-passed amounts. Another amendment authorized the commissioner to establish two review groups to recommend activities regarding products to prevent, diagnose, and treat rare diseases and neglected diseases of the developing world, and directed the commissioner to report to Congress on those recommendations and to develop review standards based on those recommendations.