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Food and Drug
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Summary of Base Resources for Requested Increases in FY 2007 |
FY 2005 Actuals1 |
FY 2006 Enacted2 |
FY 2007 Request |
Requested Increase |
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Pandemic Preparedness |
4,735,000 |
24,793,000 |
55,283,000 |
30,490,000 |
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Food Defense |
149,952,000 |
158,352,000 |
178,225,000 |
19,873,000 |
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Critical Path |
- |
5,940,000 |
5,940,000 |
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Drug Safety3 |
24,600,000 |
34,500,000 |
38,460,000 |
3,960,000 |
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Human Tissues Safety |
6,578,000 |
6,512,220 |
8,987,220 |
2,475,000 |
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Trigger Needs for MDUFMA and ADUFA4 |
7,425,000 |
7,425,000 |
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Cost of Living |
20,267,000 |
20,267,000 |
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UFMS |
1,180,000 |
1,180,000 |
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Infrastructure |
14,265,000 |
14,265,000 |
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Strategic Redeployment |
(52,277,000) |
(52,277,000) |
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Buildings and Facilities |
(2,970,000) |
(2,970,000) |
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TOTAL BA INCREASES |
50,628,000 |
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User Fees: |
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PDUFA |
269,434,000 |
305,332,000 |
320,600,000 |
15,268,000 |
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MDUFMA |
27,161,000 |
40,300,000 |
43,726,000 |
3,426,000 |
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ADUFA |
8,489,000 |
11,318,000 |
11,604,000 |
286,000 |
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MQSA |
13,185,000 |
17,173,000 |
17,522,000 |
349,000 |
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Export Certification |
1,425,000 |
1,639,000 |
2,300,000 |
661,000 |
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Color Certification |
5,506,000 |
6,001,000 |
6,181,000 |
180,000 |
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TOTAL USER FEE INCREASES |
20,170,000 |
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TOTAL FDA INCREASES |
70,798,000 |
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1/ Includes 0.80 percent rescission from FY 2005 Appropriations. 2/ Includes 1.0 percent rescission from FY 2006 Appropriations and supplemental appropriations from PL 109-148. 3/ These amounts do not include field resources. For example, the amounts do not include field resources devoted to pre-market drug safety (e.g., clinical investigator and human subject protection inspections) or post-market drug safety (e.g., good manufacturing practices and adverse event inspections). In general, more than half of the staff resources in the FDA drug program are devoted to drug safety activities. 4/ The Medical Device and Radiological Health Program is the total for CDRH and the field estimate for the Device and Radiological Health Program. This amount is needed to meet one of the triggers for the MDUFMA program. |
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