Fins & Tails, Bits & Bobbers ... Vol 6-3
2011 INAD Sign-up Forms are now available: Once again it is that time of year for renewal of your facility's INADs for Calendar Year 2011. All 2011 sign-up forms are available on our website at:
Please send completed sign-up forms to the AADAP Office by 31 December 2010. Invoices will be mailed out the end of January 2011. Fifteen (15) different INAD exemptions are open for enrollment.
Oxytetracycline hydrochloride (bath marking) INAD #9033: AADAP INAD #9033 will remain in effect for use for the skeletal marking of finfish through calendar year 2011, or until a viable FDA-approved product again becomes available. Pennox® 343 (without the fish marking claim on the label) can continue to be used under the INAD to mark fry and fingerling. Please direct any questions regarding participation in this INAD to AADAP's Bonnie Johnson (email@example.com).
End of the Year INAD Forms due: If you have not already done so, please send in all Form 2's (Drug Inventory Form) and Form 3's (Results Report Form) for each of the INADs that were used at your facilities for INAD Year 2010. Note: If your facility was signed-up to use an INAD, even though the INAD drug was not actually used, a Form 2 is still required showing either amount of drug on-hand or that no drug use occurred.
AADAP’s web-based INAD Program Management System (IPMS) progressing well: The final steps in making AADAP's “long-in-coming” IPMS a reality are underway. Our webpage and database developers have been working with the “pedal to the metal” since their contract was finalized. It appears that the time we lost in getting the contract in place has nearly been made up by our contractor (Massive Studios, Bozeman, Montana USA). And as we stated in the last Newsletter, we hope to be able to have a beta version up and on-line near the end of the calendar year. If your organization has been enrolled in AADAP's INAD program and you are interested in beta-testing our web-based IPMS, please contact Bonnie Johnson (phone 406-994-9905, email firstname.lastname@example.org) or Tom Bell (phone 406-994-9911, email email@example.com). Stay tuned for new developments!
Request for amended authorization of AQUAFLOR® INAD 10-697: Working collaboratively with Intervet/Schering-Plough Animal Health (ISP), AADAP has recently requested amended authorization for AQUAFLOR® INAD #10-697 to include the treatment of freshwater-reared salmonids diagnosed with bacterial coldwater disease (CWD; causative agent Flavobacterium psychrophilum) at a dosage of 15 mg florfenicol per kg fish per day for 10 consecutive days. Please note that although the current authorization for INAD #10-697 includes the treatment of a variety of fish species at a dosage of 10 or 15 mg florfenicol per kg fish per day for 10 consecutive days to control mortality caused by a variety of bacterial pathogens, current authorization does not include the use of florfenicol for indications for which AQUAFLOR® or AQUAFLOR®-CA1 are already approved, or conditionally approved, respectively. Hence, treatment of CWD is currently not allowed under INAD #10-697. This request is based on clinical experience that has suggested that while the currently approved dose rate of 10 mg florfenicol per kg significantly reduces mortality caused by CWD, a higher dose (i.e., 15 mg florfenicol per kg) may be required to achieve the expected level of long-term control. Assuming amended authorization for AQUAFLOR® INAD #10-697 is granted by FDA, AADAP and ISP intend to work together, along with other partners, to generate the data necessary to evaluate the efficacy of CWD-treatment at a dosage of 15 mg florfenicol per kg. Furthermore, if such data support enhanced long-term efficacy for this specific use-pattern, ISP has indicated that they will pursue an expanded label claim for the use of AQUAFLOR® at 15 mg florfenicol per kg fish per day for 10 consecutive days to control mortality caused by CWD in freshwater-reared salmonids. Stay tuned