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AADAP NEWSLETTER July 2011

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AADAP NEWSLETTER July 2011 U.S. Fish & Wildlife Service The Aquatic Animal Drug Approval Partnership Program “Working with our partners to conserve, protect and enhance the Nation’s fishery resources by coordinating activities to obtain U.S. Food and Drug Administration approval for drugs, chemicals and therapeutants needed in aquaculture” Volume 7-2 AADAP NEWSLETTER July 2011 [email protected]) or Jim Bowker (email: [email protected]). Additionally, an ad hoc meeting entitled ―Discussion Session with CVM to Develop Strategies to Resolve Drug Approval and Post Approval Issues‖ (aka ―the listening session‖) is scheduled to be held on Monday, 1 August 2011. This meeting will be held at the nearby U.S. Fish & Wildlife Service’s Bozeman Fish Technology Center from 8:00 am to 4:00 pm. For more information on this meeting, contact Jesse Trushenski (email: [email protected]) or Jim Bowker (email: [email protected]) and/or refer to the Working Group on Aquaculture Drugs, Chemicals, and Biologics’ update section on page 2 of the Newsletter. TABLE OF CONTENTS As is always the case when the Workshop is held in Bozeman, the Sweet Pea Festival activities are WHAT’S SHAKIN’ 17th Annual Drug Approval Coordination Workshop .............................. 1 scheduled for the same week and the following Approved Aquaculture Drugs - Desk Reference Guide SOLD OUT ..... 1 weekend. And, for you veterans of the Workshop in Aquaculture Drugs, Chemicals & Biologics Working Group update ...... 1 Ray Brunson receives S.F. Snieszko Distinguished Service Award ..... 2 Bozeman, you may be interested in knowing that the AADAP DRUG UPDATES Welcome Social on Monday (1 August) will be held General ................................................................................................... 3 where it has usually been held in the past. Hope to see AQUAFLOR® (florfenicol) ....................................................................... 3 Channel catfish pituitary ......................................................................... 3 you’all here in Bozeman! AQUI-S® 20E (eugenol) & Benzoak® (benzocaine) ............................... 3 SLICE® (emamectin benzoate) .............................................................. 4 Check the AADAP website for more details, and be TERRAMYCIN® 200 for Fish (oxytetracycline dihydrate) ...................... 4 FINS & TAILS, BITS & BOBBERS sure to register on-line at http://tinyurl.com/3v2tyok. 2010 National INAD Program (NIP) Study Submission Statistics ......... 4 NIP Update ............................................................................................. 5 Approved Aquaculture Drugs - Quick Desk EDITORIAL Reference Guide - “SOLD OUT:” The long- Getting More Biological Value from Aquaculture Drug awaited AADAP - AFWA - AFS’s Quick Desk Efficacy and Target Animal Safety Trials ............................................... 5 Reference Guide To: Approved Drugs for Use in RELEVANT LITERATURE ........................................................................ 7 USGS’s CORNER ........................................................................................ 10 Aquaculture was made available on Tuesday, 24 USDA’s CORNER ...................................................................................... 10 May 2011. Unfortunately, in little over a week we MEETINGS, ETC. were completely ―sold out;‖ by Tuesday 31 May Upcoming meetings ............................................................................. 11 2011 all 1,000 copies had been spoken-for via our CVM’s NOTES ............................................................................................ 14 on-line request page. There is still hope for those that did not get their requests in quick enough - as WHAT’S SHAKIN’ we speak we are in the process of obtaining a second printing. Please check the AADAP website The 17th Annual USFWS Aquaculture Drug Approval for availability information. For those unaware of Coordination Workshop is almost here: This year what it is, the ―Desk Reference‖ comprises all the the Workshop will once again be held in Bozeman, information contained in the ―Approved Drugs for Montana USA, and this year the Workshop, per se, is Use in Aquaculture‖ poster, as well as examples of taking place from August 2nd through the 4th. Two other ―...how to calculate...‖ the proper dose or related professional activities are being planned to be concentration of approved drugs as per label held in conjunction with this year’s Workshop. The instructions. The ―Desk Reference‖ can be ordered American Fisheries Society - Fish Culture Section’s (free of charge, when it is available) or downloaded Working Group on Aquaculture Drugs, Chemicals and via AADAP’s website at: http://www.fws.gov/ Biologics will be held during the Workshop (planned for fisheries/aadap/desk-reference_introduction.htm. Wednesday morning, 3 August 2011). For more information on this meeting, click here for a general Progress update from the American Fisheries agenda, and/or contact Jesse Trushenski (email: Society - Fish Culture Section’s (AFS-FCS) Working Group on Aquaculture Drugs, Activities and projects like the listening session are Chemicals, and Biologics (WGADCB): Since drawing attention and plenty of positive feedback meeting in New Orleans earlier this year, the from various allied organizations, including the U.S. WGADCB leadership has been working hard to Aquaculture Society (USAS) and the Fish Health organize a ―listening session‖ or stakeholders’ Section (FHS) of the American Fisheries Society. meeting with key representatives of FDA CVM to To encourage broader participation in the discuss strategies to improve the approval process WGADCB, USAS Board Member Andy Lazur has for drug approvals. The meeting is scheduled for been appointed as a WGADCB Co-Chair. This is Monday, August 1, 2011 from 8 am - 4 pm at the an important step toward recognizing the common USFWS Bozeman Fish Technology Centers' Piper interests of the USAS in aquaculture drug Building. Please note that the WGADCB meeting is approvals and use. Welcome Andy—we look scheduled just before the 17th Annual USFWS forward to your participation! The FHS has also Aquaculture Drug Approval Coordination expressed interest in having a seat at the Co- Workshop, also taking place in Bozeman the 1st Chairs table, and we look forward to bringing them week of August—one-stop shopping for into the fold as partners in the WGADCB. As more aquaculture drug info! and more individuals and entities become involved in the WGADCB, it is likely that some administrative Originally planned as an AFS congressional arrangements will have to change to grow with the briefing, it was decided during an early planning group and allow us to stay nimble and responsive meeting that a listening session would be a more to emerging aquaculture drug issues. Nonetheless, productive approach to addressing challenges to we think this is a very positive development and getting new drugs approved for use in fish culture. look forward to working with our partners, new and Over the past few months, a series of talking points old, in supporting the development, approval, were developed to articulate these challenges, availability, and judicious use of drugs, chemicals ranging from data requirements to establish and biologics for use in aquaculture. efficacy and safety for aquaculture drugs to complexities associated with labeling and For more information on current WGADCB packaging restrictions. After being refined and activities, please see the meeting minutes (click distributed to WGADCB participants for comment, here), contact one of the co-chairs, or better yet, the talking points were distributed to the relevant come to our next meeting! The next meeting of the groups within CVM to identify issues that could be WGADCB will be held in conjunction with the 17th readily addressed during the first listening session. Annual USFWS Aquaculture Drug Approval Although an extensive list of issues was compiled Coordination Workshop in Bozeman, Montana at from input by many stakeholders, it was mutually 10:30 AM, Wednesday 3 August 2011. Stay tuned decided that the first meeting will focus on issues to the AADAP website for WGADCB meeting that can be readily addressed by the CVM staffers scheduling announcements. in attendance. To this end, a travel request has Text provided by Jesse Trushenski; been submitted by CVM staff to their management Fisheries and Illinois Aquaculture Center; requesting travel funds for a relatively large Southern Illinois University Carbondale; contingent of CVM staff (including a meeting Carbondale, Illinois USA. facilitator) to attend and participate. CVM staff and WGADCB Co-chairs will narrow the list of Talking Ray Brunson receives S.F. Snieszko Distinguished Points to an agenda of items which can be Service Award: At the recent combined Western Fish addressed directly and hopefully resolved during Disease Workshop and annual meeting of the American the 1st meeting. Unresolved issues will not be left Fisheries Society - Fish Health Section, Ray Brunson by the wayside, but rather slated for subsequent (recently retired Director of the meetings. Staff at CVM are encouraging broad U.S. Fish & Wildlife Service’s participation to this meeting so that as large a Olympia Fish Health Center) group as possible hears information directly from received the Fish Health the source. In you are interested in attending the Section’s most prestigious listening session, please contact WGADCB Co- award, the S.F. Snieszko Chair
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