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The U.S. Fish & Wildlife Service’s Proposed National Aquatic Animal Drug Approval Partnership

The U.S. Fish & Wildlife Service’s Proposed National Aquatic Animal Drug Approval Partnership as it relates to INADs and Critical Treatment Drugs. 1. AADAP Overview. USFWS began AADAP proposal development in April 2001

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The U.S. Fish & Wildlife Service’s Proposed National Aquatic Animal Drug Approval Partnership

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  1. The U.S. Fish & Wildlife Service’s Proposed National Aquatic Animal Drug Approval Partnership as it relates toINADs and Critical Treatment Drugs 1

  2. AADAP Overview • USFWS began AADAP proposal development in April 2001 • IAFWA drug project scheduled to end Sept 2002, and FWS wanted to ensure continued progress • USFWS and its partners have aquatic animal drug needs, which we believe would benefit from our increased involvement • AADAP is essentially an expansion of our current NIO capabilities (i.e., INADs, and pivotal efficacy and TAS), with added NADA & information management components 2

  3. AADAP Overview • AADAP has received voiced support from: • USFWS – all the way up to & including Director Williams • USGS – BRD, USDA – ARS, and FDA – CVM • International Association of Fish & Wildlife Agencies • National Aquaculture Association • Freshwater Institute • Northwest Indian Fisheries Commission • numerous state resource agencies • various private aquaculture-related entities 3

  4. AADAP Overview • USFWS has publicly committed to initiate AADAP • start date contingent upon FY2003 budget • entails establishing an eastern component at Lamar Northeast Fishery Center • full implementation phased-in over approximately 3 years • 5 new staff & approximately 5X current NIO budget • Proposed AADAP also includes: • approximately 25-33% of budget for subcontracted work • elimination of fees for participation in USFWS INADs 4

  5. INAD and NADA Overview 5

  6. INAD and NADA Overview 6

  7. INAD and NADA Overview 7

  8. Piggybackin’ on FWS INADs 8

  9. October 2002?? 9

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