Division of the National Fish Hatchery System USFWS Aquatic Animal Drug Approval Partnership The U.S. Fish & Wildlife Service’s Proposed National Aquatic

Division of the National Fish Hatchery SystemDivision of the National Fish Hatchery System

USFWS Aquatic Animal Drug Approval PartnershipUSFWS Aquatic Animal Drug Approval Partnership

The U.S. Fish & Wildlife Service’s Proposed

National

Aquatic Animal Drug Approval

Partnershipas it relates to

INADs and Critical Treatment

Drugs

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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

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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

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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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INAD and NADA Overview

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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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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




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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



Piggybackin’ on FWS INADs

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October 2002??

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Documents

Division of the National Fish Hatchery System USFWS Aquatic Animal Drug Approval Partnership The U.S. Fish & Wildlife Service’s Proposed National Aquatic