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. 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). 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. 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). Initiatives . On September 29, 2010, neither the full Senate nor the full House had approved an agriculture appropriations bill for FY2011, nor had Congress passed any other of the regular FY2011 appropriations bills. The Senate amended and approved H.R. 3081 , the Continuing Appropriations Act, 2011, which would allow federal operations, including the FDA, to generally continue at FY2010 levels from October 1, 2010, the start of FY2011, through December 3, 2010. The House passed the continuing resolution early on September 30, 2010, and the President signed it later that day as P.L. 111-242 . Representative DeLauro stated that the bill would include $2.571 billion in budget authority for FDA; including user fee revenue, the total FDA program level would be $3.773 billion for FY2011, as shown in data column 6 of Table 2 . Senate

The Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies of the Senate Committee on Appropriations held a hearing on March 9, 2010, on the President's FY2011 budget request for FDA. On July 15, 2010, the Senate Committee on Appropriations reported S. 3606 . For FY2011, the bill would provide $2.516 billion in budget authority and $1.233 billion in user fees for a total FDA program level of $3.75 billion. Updates to this report will track legislative activity.
The President's budget request for FY2011 included $4.032 billion for the Food and Drug Administration (FDA). The total is made of $2.508 billion in direct appropriations (which FDA calls budget authority) and $1.523 billion in user fees. Overall, the request is 22.8% more than the enacted FY2010 total appropriation, with budget authority up 6.2% and fees up 65.2%. Most of the increase would come from proposed new user fees to support generic drug activities, food export certification, reinspection, and food inspection and facility registration. For continuing user fee programs (prescription drug, medical device, animal drug, animal generic drug, tobacco product, mammography quality standards, export certification, and color certification), the $1.233 billion request is 33.7% above FY2010.
Budget justification documents describe FY2011 agency initiatives in food safety, medical product safety, and regulatory science. They also show the program-level budget request (both budget authority and user fees) and describe activities in each of FDA's program areas: human drugs, biologics, animal drugs and feeds, devices and radiological health, tobacco products, and toxicological research.
The Commissioner of Food and Drugs has testified to the subcommittees on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies of both the Senate and House Committees on Appropriations. On June 30, 2010, the House subcommittee approved Chair Rosa DeLauro's mark, copies of which were not made public. It included, for FY2011, $2.571 billion in budget authority for FDA. It recommended a total FDA program level, including user fees, of $3.773 billion. The Senate Committee on Appropriations reported S. 3606 on July 15, 2010. It would provide FDA with $2.516 billion in budget authority and $1.233 billion in user fees for a total FY2011 program level of $3.75 billion.
On September 29, 2010, neither the full Senate nor the full House had approved an agriculture appropriations bill for FY2011, nor had Congress passed any other of the regular FY2011 appropriations bills. The Senate amended and approved H.R. 3081, the Continuing Appropriations Act, 2011, which would allow federal operations, including the FDA, to continue at FY2010 levels from October 1, 2010, the start of FY2011, through December 3, 2010. The House passed the continuing resolution early on September 30, 2010, and the President signed it that day as P.L. 111-242.
Updates to this report will track legislative activity.