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Summary of FDA's FY 2009 Budget

Total Budget: For FY 2009, the FDA requests a total budget of $2.4 billion. This amount is $129.7 million more than FY 2008 and represents a 5.7 percent increase.

Budget Authority: The FY 2009 budget requests $1.77 billion in budget authority and contains a net increase of $50.7 million over FY 2008 for high priority initiatives. This represents a 2.9 percent increase.

User Fees: Finally, the FDA's budget proposes $628 million in industry user fees, an increase of $79.0 million over FY 2008. This represents a 14.4 percent increase.

Specifics on FY 2009 Initiatives: The FDA's FY 2009 budget advances the agency's core mission: promoting and protecting public health. The budget funds initiatives above FY 2008 in priority areas:

+$42.2 million for a total investment of $662 million to implement the Food Protection Plan. The FY 2009 investments in the Food Protection Plan will strengthen food safety by preventing foodborne illness outbreaks, intervening when food defense or food safety vulnerabilities emerge, and rapidly responding to food defense and food safety threats.
+$17.4 million for a total investment of $887 million for medical product safety and development. This initiative allows the FDA to improve the safety of medical products, including human tissues, blood and blood products, human drugs, medical devices, and animal drugs.
A savings of -$8.9 million due to administrative and management efficiencies, generated by productivity gains.
$25.0 million is included in the initiatives listed above to fund cost of living increases for the FDA's world-class workforce.

The full details of the FY 2009 FDA budget request appear at:
http://www.fda.gov/oc/oms/ofm/budget/documentation.htm

Overview of FY 2009 Initiatives

Initiative	Amount	FTE	Synopsis
*Budget Authority*
Protecting America's Food	+$42,232,000	94	This initiative supports the FDA's shift to a comprehensive, preventative, and risk-based approach to safeguard the food supply and the American homeland. The investment allows the FDA to implement major components of the Food Protection Plan, Import Safety Action Plan, the December 2007 agreements with China, and a possible FDA office in China. Includes a pay increase for agency personnel to sustain current services and conduct the FDA mission.
Medical Product Safety and Development	+$17,395,000	8	This initiative provides targeted resources to improve the safety of human and animal drugs, blood, human tissues, and medical devices. The investment will strengthen the FDA's ability to effectively monitor the safety of medical products, including imported products. The FDA will also assist medical product manufacturers to develop new products to treat life-threatening diseases and conditions. Includes a pay increase for agency personnel to sustain current services and conduct the FDA mission.
Administrative Savings and Management Efficiencies	- $8,918,000	- 11	In FY 2009 the FDA will redirect savings and management efficiencies to high priority activities.
*Current Law & Proposed User Fees*
Current Law User Fees	+$57,534,000	239	The budget request includes inflationary increases for FDA user fee programs as well as other increases authorized by law under the prescription drug and medical device user fee programs. Three 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.
Proposed Generic Drug User Fee	+$16,628,000	34	The proposed user fee for Generic Drug Review will provide additional resources to improve the generic drug review process and to respond to the growing number of Abbreviated New Drug Applications.
Proposed Animal Generic Drug User Fee	+$4,831,000	22	The proposed user fee for Animal Generic Drug Review will provide additional resources to improve the animal generic drug review process and to respond to the growing number of Abbreviated New Animal Drug Applications.
*Total Program Level Increase over FY 2008*	+ *$129,702,000*
*Proposed Mandatory User Fees (Non-Add)*
Reinspection User Fee	+$23,276,000 (Non-Add)	118	Re-proposed new user fees to reimburse for reinspection of FDA-regulated facilities.
Food and Animal Feed Export Certification User Fee	+$3,741,000 (Non-Add)	23	Re-proposed new user fees to reimburse for issuing food and feed export certificates.
*Mandatory User Fees*	*+$27,017,000*

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