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Total Budget: For FY 2010, the FDA requests a total budget of $3.2 billion. This amount is $511 million more than FY 2009 and represents a 19 percent increase – the largest ever in FDA history.
Budget Authority: The FY 2010 budget requests $2.35 billion in budget authority and contains a net increase of $295 million compared to FY 2009 for high priority initiatives. This represents a 14.4 percent increase.
User Fees: The FDA budget proposes $828 million in industry user fees, an increase of $215 million compared to FY 2009, including $141 million in proposed new user fees.
Specifics on FY 2010 Initiatives: The FDA's FY 2010 budget supports critical Administration priorities: Protecting America’s Food Supply, Safer Medical Products, User Fees, and Infrastructure to Support Critical Agency Operations.
Protecting America’s Food Supply (+$259.3 million): The budget includes more than $1 billion for food safety, and invests in priorities that strengthen the safety and security of the supply chain for foods. The initiative focuses on foreign and domestic sources of ingredients, components, and finished products at all points in the supply chain, including their eventual use by the American public. The initiative includes $75 million in new user fees to register food facilities and increase food inspections and $19 million for reinspection and export certification. The reinspection user fee will provide funding for increased inspections and help to defray costs related to ensuring compliance with safety standards by food facilities.
Safer Medical Products (+$166.4 million): This effort provides targeted resources to improve the safety of human and animal drugs, medical devices, vaccines, blood, and other medical products. It will allow the FDA to strengthen safety and security of the supply chain for medical products. The FDA is proposing $36 million in new user fees for generic drug review and $10.5 million in new fees to reinspect facilities that fail to meet safety standards.
Current Law User Fees (+$74.4 million): In addition to amounts for food safety and generic drug review user fees, the budget includes fee increases for safety and application review for human drugs (+$67.5 million), animal drugs (+$2.3 million), and medical devices (+$4.5 million).
Infrastructure to Support Critical Agency Operations: The budget requests an increase of $14 million in budget authority for rising General Services Administration rent and other rent related costs. The rental properties that provide office and laboratory space for the FDA’s 11,000 employees are essential facilities that allow the FDA to perform its vital public health mission. The FDA’s White Oak consolidation provides an environment that encourages efficiency, creativity, and superior performance, while strategically using the agency’s human capital.
Follow-on Biologics & Drug Importation: The budget proposes a new authority for the FDA to approve follow-on biologics through a regulatory pathway that protects patient safety and promotes innovation. The budget also includes $5 million for the FDA to develop policies to allow Americans to buy drugs approved in other countries.
The full details of the FY 2010 FDA budget request appear at:
http://www.fda.gov/oc/oms/ofm/budget/documentation.htm
Overview of FY 2010 Initiatives
Initiative |
Amount |
FTE |
Synopsis |
|---|---|---|---|
Budget Authority |
|||
Protecting America's Food Supply |
+$259.3 M |
678 |
This FDA food safety effort responds to recent food safety events, the dramatic growth in food imports, and changes in food processing and distribution practices. The FDA will invest in developing a system of preventive controls to avoid foodborne outbreaks; creating an integrated system with states on inspection and enforcement; conducting more domestic and foreign inspections; conducting more FDA import review and analysis; performing greater surveillance for food contamination; conducting additional laboratory analysis of food samples; and strengthening information technology to support food safety and security. |
Safer Medical Products |
+$166.4 M |
346 |
This effort will strengthen the safety of medical products that Americans rely on to prevent, treat, and cure serious diseases and conditions. The effort strengthens the FDA’s ability to monitor and assess the safety of domestic and imported medical products throughout their product life cycle, including their eventual use by patients. By focusing increased attention on the safety of products both before FDA approval and throughout the post-approval period, the FDA will improve the risk profile of medical products and reduce the risk of adverse events |
Critical Infrastructure |
+$14,0 M |
- - |
The budget requests an increase of $14 million in budget authority for rising GSA Rent and other rent related costs. The rental properties that provide office and laboratory space for FDA’s 11,000 employees are essential facilities that allow the FDA to perform its vital public health mission. The FDA’s consolidation at White Oak provides an environment that encourages efficiency, creativity, and superior performance, while strategically using our human capital. |
Current Law User Fees |
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Current Law User Fees |
+$74.4 M |
153 |
The budget request includes inflationary increases for FDA user fee programs as well as other increases authorized by law under the prescription drug, animal drug, and medical device user fee programs. These FDA user fee programs facilitate premarket review for human and animal drugs and human devices. Three other user fee programs support the mammography facilities inspection program and provide certification services for color additives and for drug and device products exported from the United States. |
Construction Grant |
-$3.5 M |
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The FDA budget request for FY 2010 does not include funding for construction at the National Center for Natural Products Research |
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Total Program Level Increase over FY 2009 |
+$510.6 M |
1,177 |
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