NAGA News May/June 2015 18 T he shortage of drugs for food- producing minor species is a problem well recognized by animal producers, veterinarians, ani- mal scientists, and regulators. Minor food-producing species include animals such as game birds, sheep, goats, rabbits, ratites, fish, and deer; the major food-producing spe- cies are cattle, swine, chickens, and turkeys. The market for drugs used in minor food-producing species is often insufficient to justify costly research expenditures by a pharma- ceutical firm to obtain Food and Drug Administration (FDA) approval. The National Research Support Project #7 (NRSP-7), also known as the Minor Use Animal Drug Program (MUADP), is designed to address the shortage of minor use animal drugs by funding and overseeing the ef- fectiveness, target animal safety, and human food safety research and environmental assessment required for FDA approval. The scope of the program includes animals of agri- cultural importance and generally excludes companion animals. The missions of NRSP-7 are: • to identify animal drug needs for minor species and minor uses in major species (rare diseases) • to generate and disseminate data for safe and effective therapeu- tic applications • to facilitate FDA/Center for Veterinary Medicine (CVM) approvals for drugs identified as a priority for a minor species or minor use To accomplish these goals, NRSP- 7 coordinates the efforts of animal producers, pharmaceutical manu- facturers, FDA/CVM, USDA state Agricultural Experiment Stations and veterinary medical colleges through- out the country. HOW NRSP-7 WORKS Research is funded through a USDA special research grant and admin- istered by NRSP-7. NRSP-7 also receives support from pharmaceu- tical firms, universities, and State Agricultural Experiment Stations. Research projects are initiated by requests (usually from researchers or animal producers) to the program’s regional coordinators to address a particular minor use drug need. The form to make a drug request is available on the NRSP-7 website, www.nrsp-7.org. These requests are prioritized according to financial and regulatory feasibility, importance to the animal industry, and the phar- maceutical manufacturer’s commit- ment to the minor use drug approval. Once a request is accepted as a research project, study protocols are developed. NRSP-7 then conducts studies to address four of the re- quired technical sections: effective- ness, target animal safety, human food safety, and environmental im- pact. All safety studies are conducted in accordance with FDA’s Good Laboratory Practices regulations. Successful studies are submitted to FDA/CVM and placed in a public mas- ter file on the FDA website, www. fda.gov. A pharmaceutical sponsor may then reference, at no cost, the data in the public master file to sup- port a new animal drug application for the minor use. The final step in the process is FDA approval of this application from the pharmaceutical sponsor, so that the product may be labeled and sold for the minor use. ORGANIZATION The NRSP-7 technical commit- tee, which is made up of a National Coordinator, four Regional Coordinators, four regional Administrative Advisors, and liaisons from USDA and FDA, conducts the affairs of the program, including such matters as prioritizing projects, planning workshops, and funding and overseeing the progress of individual drug approval projects. ACCOMPLISHMENTS Since the first drug approval in 1984 under the former IR-4 pro- gram, NRSP-7 has been responsible for generating data to support 29 drug approvals (New Animal Drug Applications) for minor species. These approvals include drugs of importance to the game bird industry such as: • amprolium for coccidiosis in pheasants • thiabendazole for gapeworm in pheasants • bacitracin for ulcerative enteritis in quail • monensin for coccidiosis in quail • salinomycin for coccidiosis in quail • sulfadimethoxine/ormetoprim for coccidiosis in chukar partridges • lasalocid for coccidiosis in chukar partridges CURRENT PROJECTS NRSP-7 is currently conducting research to support the approval of six drugs, two of which are for use in game birds. Investigations are ongo- ing for the use of fenbendazole Type A medicated feed for the following two indications: (1) For the removal and control of adult Syngamus trachea (gapeworm) in pheasants (2) For the treatment of adult Heterakis gallinae and adult Capillaria spp. in quail Lasalocid Type A medicated feed is being investigated for the control of coccidiosis associated with Eimeria spp. in pheasants. For each of these game birds projects, two of the four required technical sections have been completed by NRSP-7 and work is presently ongoing to complete the public master files. Survival with Proper Medications by Amy Omer NRSP-7: Opportunities For New Animal Drug Approval “Humor keeps us alive. Humor and food. Don’t forget food. You can go a week without laughing.” ― Joss Whedon