Minor Use Minor Species Development of Drugs (R01) Clinical Trials Not Allowed

The Food and Drug Administration (FDA) is soliciting Research Project (R01) grant applications to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs. Eligible applicants include institutions or organizations that propose to develop or support the development of MUMS-designated drugs. • The organization must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug. • FDA/CVM's Office of New Animal Drug Evaluation (ONADE) must have reviewed and concurred with the proposed study protocol before an applicant can submit a grant application. • Eligible organizations include higher education institutions, nonprofits, for-profit organizations, governments, and other entities.