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USFWS 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
Division of the National Fish Hatchery System
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USFWS Aquatic Animal Drug Approval Partnership
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
Division of the National Fish Hatchery System
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USFWS Aquatic Animal Drug Approval Partnership
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
Division of the National Fish Hatchery System
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USFWS Aquatic Animal Drug Approval Partnership
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
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USFWS Aquatic Animal Drug Approval Partnership
INAD and NADA Overview
DRUG
STATUS / COMMENTS
Chloramine-T
• efficacy Technical Section complete for 12 ppm for 1 hr per day on 3 consecutive or
alternate days
• TAS Technical Section complete for salmonids
• slaughter authorization not renewed by CVM due to p-TSA genotox concerns
(possible carcinogen or mutagen?)
• new data addressing CVM’s concerns was supplied by sponsor and accepted by
CVM as evidence of non- mutagenicity or carcinogenicity, however
• slaughter authorization not yet renewed
Diquat
• Service obtained INAD and slaughter authorization as of August 2002
• 2-18 ppm for 1-4 hr (1 to 4 treatments) or 19-28 ppm for 30-60 min (1 to 3
treatments)
• 74 species; 207 million fish
• 5 days withdrawal for CCF, MUE and NOP, 30 days for all other species
• Syngenta, current holder of EPA registration for Diquat, is very interested in gaining
FDA approval
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USFWS Aquatic Animal Drug Approval Partnership
INAD and NADA Overview
DRUG
STATUS / COMMENTS
Oxytetracycline
(feed)
• efficacy Technical Section complete for 3.75 g/100 ilbs for 10 days for columnaris in
steelhead trout (November 2000)
• efficacy Technical Section complete for 3.75 g/100 ilbs for 10 days for coldwater
disease in all salmonids (November 2001)
Florfenicol
• Service obtained non-compassionate INAD and slaughter authorization as of July
2001
• For supportive and pivotal studies only
• 15 species; 4 million fish, 16 facilities, amended in July 2002 to 8 million without
need for separately contained non-treated controls
• 21 day withdrawal for salmonids, 28 days for all others
• Schering Plough, has separate INAD, and is cooperating to gaing FDA approval
Division of the National Fish Hatchery System
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USFWS Aquatic Animal Drug Approval Partnership
INAD and NADA Overview
DRUG
STATUS / COMMENTS
Calcein
• Request for INAD and slaughter authorization submitted by Service in April 2002
• Slaughter authorization NOT approved
• Sponsor in place – Western Chemical
Aqui-S
• Service obtained INAD and slaughter authorization as of November 2000
• 85 facilities, 56 species; 100 million fish
• 21 day withdrawal period for all species
• CVM issued guidance on use of clove oil and eugenol in June 2002
• not approved nor are they LRP drugs
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USFWS Aquatic Animal Drug Approval Partnership
Piggybackin’ on FWS INADs
Division of the National Fish Hatchery System
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USFWS Aquatic Animal Drug Approval Partnership
October 2002??
Division of the National Fish Hatchery System
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