• Basic Information
• Additional Info

Basic Information

• Project No. and Title: NECC2202 : Formal Structure for the Minor Use Animal Drug Program
• Period Covered: 10/01/2023 to 09/30/2024
• Date of Report: 12/03/2024
• Annual Meeting Dates: 09/27/2024 to 09/27/2024

Participants

Amy Omer <Amy.Omer@fda.hhs.gov>, Cat Bens <Cat.Bens@colostate.edu>, John G. Babish <jgb7@cornell.edu> Margaret Smith <mes25@cornell.edu>, Rodman Guy Getchell <rgg4@cornell.edu>, Ronald Griffith <rgriffit@iastate.edu>, Van Schoick, A'ndrea"Andrea.VanSchoick@fda.hhs.gov

Accomplishments

Impacts

1. Data generated through MUADP research collaborations resulted in the completion of the Effectiveness, Target Animal Safety, and Human Food Safety technical sections for the use of fenbendazole in quail.
2. On August 13, 2024, MUADP requested a Target Animal Safety technical section complete letter for the designated indication: “For the treatment and control of adult Heterakis gallinae and Capillaria spp. in quail”; CVM has six months to review this request.
3. Dr. Pat Gorden of Iowa State University College of Veterinary Medicine received concurrence from FDA-CVM on a method validation study protocol to validate an analytical method for the detection and quantification of tulathromycin in caprine liver. He then received a Minor Use Minor Species (MUMS) grant to fund the method validation study.
4. Dr. Gorden (Iowa State University) received concurrence from FDA-CVM on a residue depletion study protocol. In September of 2024, he was awarded a MUMS grant to fund the study.
5. Dr. Amanda Kreuder of Iowa State University College of Veterinary Medicine received concurrence from FDA-CVM on a field study protocol to demonstrate effectiveness of tulathromycin injectable solution, indicated for the treatment of respiratory disease in goats associated with Mannheimia haemolytica, Bibersteinia trehalosi, and Pasteurella multocida.

Publications