Goals / Objectives Identify the animal drug needs for minor species and minor uses in major species
Critical and emerging needs will be identified by the Minor Use Animal Drug Program Technical Committee based on information obtained from stakeholders represented by animal industry groups and producer organizations, scientific and professional groups, literature surveillance, and research originating within the program. To further refine specific project objectives, contacts will be made with key, knowledgeable representatives from producer organizations, scientific and professional groups, government agencies, and pharmaceutical companies. Workshops and symposia also may be sponsored by the Minor Use Animal Drug Program to gather information about priority needs and emerging issues. p>Highest priority will be given to research projects that address drugs or compounds that are required to prevent or treat disease, or for reproductive management. Drugs intended for the prevention or treatment of disease or for the modification of specific physiological functions in minor species, or to treat or prevent minor diseases in major food animal species are selected over drug requests for nonfood animals.
Generate and disseminate data for the safe, effective, and legal use of drugs used primarily in therapy or reproductive management of minor animal species.
All projects are initiated by the submission of an Animal Drug Request (ADR) form to a the National or Regional Animal Drug Coordinator. The ADRs will be forwarded to the FDA/CVM to request comments regarding the extent of the data package that would be required for drug/compound approval (e.g. target animal safety, efficacy, residue depletion, and/or environmental assessment studies-see below). The appropriate pharmaceutical sponsor in cooperation with the efforts of NRSP-7 will seek to gain approvals of the drug compound. Pending favorable initial review by both parties, the ADR will be ranked according to priority for the funding by the program. Upon receipt of the reviews from FDA/CVM and the pharmaceutical sponsor, a decision can be made to fund the project. The project objectives may be directed toward generating sufficient data to seek FDA/CVM approval of the drug (Objective #3), or when that is not practicable, toward generating data sufficient to support safe, effective and legal use under the AMDUCA legislation. Research not conducted in the laboratories of the Regional Animal Drug Coordinators will be conducted under subcontracts, managed by the Coordinators, to scientists in qualified laboratories at other institutions.
Facilitate FDA/CVM approvals of drugs for minor species and minor uses.
Upon completion of each required study, reports of results and all raw data will be submitted to the Regional Animal Drug Coordinator for review prior to submission to FDA/CVM. Following acceptance of the data by FDA/CVM, a Public Master File will be established which is in the public domain, the notice of which will be published in the Federal Register. The pharmaceutical sponsor may refer to the Public Master File in support of a New Animal Drug Application (NADA), and ultimately the labeling of the drug for the use in the minor species, or for the minor use.
Moreover, NRSP-7 functions through the coordination of efforts among animal producers, pharmaceutical manufacturers, FDA/CVM, USDA/Cooperative State Research, Education, and Extension Service, universities, state agricultural experiment stations and veterinary medical colleges though out the country. The steps involved in this coordination of efforts are described in Table 1.