NRSP7: A National Agricultural Program for Minor Use Animal Drugs

(National Research Support Project Summary)

Status: Inactive/Terminating

SAES-422 Reports

Annual/Termination Reports:

[06/27/2019]

Date of Annual Report: 06/27/2019

Report Information

Annual Meeting Dates: 03/23/2016 - 03/24/2016
Period the Report Covers: 05/01/2015 - 03/30/2016

Participants

In person:
John Babish (National Coordinator);
Rod Getchell (Cornell University);
Ron Griffith (Iowa State University);
Amy Omer (FDA CVM);
Meg Oeller (FDA CVM);
Frank Galey (Admin Advisor, West);
Margaret Smith (Admin Advisor, Northeast);
Gary Sherman (USDA NIFA)

On telephone at times:
George Smith (Admin Advisor, North Central);
Mike Harrington (WAAESD);
Jim Richards (American Sheep Industry Association);
Paul Rodgers (American Sheep Industry Association);
Aubrey Schroder (American Sheep Industry Association);
Cindy Wolf (American Sheep Industry Association)

Brief Summary of Minutes

NRSP7 Business Meeting


 


Comments from Bernadette Dunham,Director of FDA Center for Veterinary Medicine


Noted that the group must showcase the complexity of getting any animal drug approved, and showcase the impact of minor species/minor use drug approvals for the public in addition to the animal agriculture industry.  Additionally there is need to articulate why "big pharma" cannot and/or will not do these types of approvals.


Status of NRSP7/MUADP with Ag Experiment Station Directors


Margaret Smith eviewed notes from a conference call the Administrative Advisors had with Clarence Watson (head, NRSP Review Committee) and Regional AES Executive Directors (Jeff Jaconben, Dan Rossi, and Eric Young). Option going forward include (1) applying for status as a multistate coordinating committee or development committee while pursuing longer-term options; (2) develop a NIFA planning or conference grant to bring together stakeholders and researchers for planning and seeking fiscal appropriation; or (3) pursue multistate funding through the Ag Experiment Stations (although the total available would not suffice to meet the needs).


Mike Harrington noted that concern from the NRSP Review Committee centered on how to bring about a sustainable funding situation for this program.


Next step will be to consider a multistate development committee proposal.


Report from American Sheep Industry Association


Association representatives expressed strong support for and desire to work with MUADP. Options and limitations of securing federal funding through stakeholder lobbying efforts were discussed. Sheep industry is well aware that industry drug sponosors "wouldn't spend a second talking about minor species,", highighting the importance of MUADP's mission.  


Rebional Coordinator Reports


Rod Getchell:  Strontium chloride target animal safety study on Chinook salmon fry was completed and submitted to ONADE in August 2015.  FDA/CVM aims to meet the needs for other technical sections through previously published data.  Future work may focus on target animal safety studies with Aqui-S 20E sedative for cold water marine species.


Ron Griffith: Goat CIDR effectiveness study has been completed and submitted.  Effectiveness was fine but reprpoductive safety data was mixed. Fenbendazole target animal safety study in pheasants is done.  Study on lasaloci target animal safety in pheasants is underway; there are issues with the human food safety method validation. Draxxin efficacy in goats was studied and next steps are in the hands of FDA/CVM and Zoetis. New work is being started on target animal safety for fenbendazole in quail.

Accomplishments

<p>Completed target animal safety studies for:</p><br /> <p>- Strontium chloride in Chinook salmon fry</p><br /> <p>- Fenbendazole in pheasants</p><br /> <p>Completed efficacy studies for:</p><br /> <p>- CIDRs in goats</p><br /> <p>- Draxxin in goats</p>

Publications

Impact Statements

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