Susan Thaul
Specialist in Drug Safety and Effectiveness
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.
Date of Report: October 1, 2010
Number of Pages: 14
Order Number: R41288
Price: $29.95
Follow us on TWITTER at http://www.twitter.com/alertsPHP or #CRSreports
Document available via e-mail as a pdf file or in paper form.
To order, e-mail Penny Hill Press or call us at 301-253-0881. Provide a Visa, MasterCard, American Express, or Discover card number, expiration date, and name on the card. Indicate whether you want e-mail or postal delivery. Phone orders are preferred and receive priority processing.
Specialist in Drug Safety and Effectiveness
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.
Date of Report: October 1, 2010
Number of Pages: 14
Order Number: R41288
Price: $29.95
Follow us on TWITTER at http://www.twitter.com/alertsPHP or #CRSreports
Document available via e-mail as a pdf file or in paper form.
To order, e-mail Penny Hill Press or call us at 301-253-0881. Provide a Visa, MasterCard, American Express, or Discover card number, expiration date, and name on the card. Indicate whether you want e-mail or postal delivery. Phone orders are preferred and receive priority processing.
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