Fins & Tails, Bits & Bobbers ... Vol 6-2
National INAD Program (NIP) Update: The NIP continues to be a tremendously successful program for the USFWS and partner facilities/agencies. The NIP not only assists fisheries managers in meeting program objectives, but also provides important efficacy and safety data in support of future aquatic species drug approvals. To date in 2010, there are 213 federal, state, private, and tribal facilities located in 45 different states and one U.S. territory participating in the NIP. Currently, 15 different INAD exemptions are open for enrollment.
Calendar year 2009 NIP study submission statistics: Last year was another busy year for conducting studies under INAD exemptions, and with your help, we were able to collect a wealth of very useful, real-world data. Here are some of the summary statistics from 2009 studies:
- Number of completed study reports submitted to the AADAP
Office – 563
- Number of reporting facilities - 145
- Number of INAD exemptions utilized - 13
- Number of treated fish – 60.2 million
- Species of fish treated – 20 salmonid species; 36 non-salmonid species; and 4 marine species
- Percentage of studies that appeared to result in efficacious
treatment = 89%
- Number of Quarterly Reports submitted to FDA/CVM – 54
- Number of Annual Reports to be submitted to FDA/CVM – 12
Thank you to everyone for your hard work in contributing data to the AADAP Office, and please remember that these data are being used to support new and/or expanded drug labels.
Attention managers needing to immersion mark fish: If you have been planning on using oxytetracycline hydrochloride (OTC) treatment to immersion mark fry and/or fingerlings this year, you are probably aware that the three FDA-approved OTC soluble powders are either no longer available (2 products) or difficult to administer (1 product). AADAP, FDA's Center for Veterinary Medicine (CVM), and PennField Animal Health (PAH) have worked out a solution! AADAP now has an OTC bath marking INAD (#9033) in place for which PAH is an authorized source of the drug. PAH's product (Pennox® 343) is a generic copy of Pfizer's Terramycin 343®, and hence, it is identical in composition and activity. Currently the label for Pennox® 343 does not include a fish marking claim, but PAH is currently working diligently with CVM to amend their existing label to ultimately include a claim for skeletal marking of finfish. Until such time that PAH obtains FDA approval for Pennox® 343, or any of the viable approved OTC skeletal marking products again become available, AADAP INAD #9033 will remain in effect and Pennox® 343 (without the fish marking claim on the label) may be used under the INAD to mark fry and fingerlings. Please direct any questions regarding participation in INAD #9033 to AADAP's Bonnie Johnson (email@example.com).
Oxytetracycline immersion therapy (OTIMM) INAD #9033 - New product available: Due to the lack of availability of Pfizer’s Terramycin 343®; FDA/ CVM has amended the Food-Use Authorization for the use of oxytetracycline hydrochloride soluble powder for immersion – therapy under INAD #9033. This authorization has been changed so that both Terramcyin 343® and Pennox® 343 may be used under the INAD. Please click on the following link for more information on where to purchase Pennox®343: http:// www.fws.gov/fisheries/aadap/9033bathmarking.htm.
SLICE® INAD 11-370 authorization received!!!: Some said it could not be done and others turned back; however, the AADAP Office remained determined that someday an INAD exemption for the use of SLICE®-medicated feed for the control of external parasites in freshwater fish would indeed become a reality. The AADAP Office recently received both the food-use and categorical exclusion authorizations for the investigational use of SLICE® under INAD 11-370! Any facility that would like to participate under this INAD will first need to 1) complete and submit a "Facility Specific Effluent-related Treatment Information Sheet” to the AADAP Office (click here to access); 2) receive a facility-specific categorical exclusion from the FDA; 3) obtain and document approval from your local NPDES Authority (or EPA) for the proposed use of SLICE® at your facility; and 4) send a copy of the approval from your NPDES Authority to the AADAP Office. After all requisite approvals are in place, facilities will be able to participate under the SLICE® INAD 11-370.Contract for the AADAP’s web-based INAD Program Management System (IPMS) finally signed: In the last issue of the AADAP Newsletter, we informed you of the delayed test-launch of the website automation program (on-line data reporting) for National INAD Program participants. We are delighted to say that finally the crucial contract with our webpage and database developers has been completed and signed, and the IPMS development is back on track. Although it is going to take us all a little bit of time to get back to where we left off last fall, it would probably still be safe to say that we should be able to have a beta version up on-line before the end of the calendar year. Stick with us, we will get there!