1996-1997 ANNUAL REPORT

MINOR USE ANIMAL DRUG PROGRAM (NRSP-7)

Background

In 1976, the Food and Drug Administration/Center for Veterinary Medicine (FDA/CVM) established a committee of animal producer groups, pharmaceutical industry personnel, U.S. Department of Agriculture (USDA) and FDA representatives to study the need for minor use animal drugs. This committee identified the scope of the problem, the major diseases in minor species and the principal minor diseases in the major species.

In 1982, the TR-4 Animal Drug Program was established as part of the overall IR-4 program. Since that start, the animal portion has developed into a means of securing approved drugs and a conduit between the animal industries and the FDA/CVM.

In 1990, the USDA requested a peer review of the overall IR-4 program and recommended a reorganization of the animal section. This change was carried out with the development of a separate Technical Committee that reported to the IR-4 Administrative Advisors.

In 1992, the IR-4 Administrative Advisors recommended that with the pending change from Interregional Projects to National Research Support Projects (NRSP) that the two programs (pesticide and animal) be separated into two distinct projects. In 1993, the Minor Use Animal Program (NRSP-7) was created.

Achievements

To date, 282 animal drug requests (ADRS) have been submitted to the Minor Use Animal Drug Program for consideration of funding and research support. Of these 282 ADRS, a total of 19 were requested in 1996 for review of their feasibility as NRSP-7 projects. These requests are listed below.

Of the 282 ADRS, all research necessary to provide FDA/CVM with sufficient data and meet their review criteria has resulted in 25 Public Master Files (PMFs) being published in the Federal Register supporting clearance for drug use in minor species. These PMPs involved research on 13 species of animals and one for a broader approval on finfish and their eggs. Nineteen PMFs have supported New Animal Drug Application (NADA) approvals. An NADA makes the drug available to the animal producers for disease control. Of the six PMFs not presently supporting an NADA, it is anticipated that four will receive an NADA approval in 1997 bringing the total to 23 NADA approvals. One additional PMF is currently under review by FDA/CVM for publication in the Federal Register (Albendazole in goats for the treatment of liver flukes). Thus, in 1996, the NRSP-7 Program has provided the public with five new animal drug PMFs for minor species and increased the NADA approvals by one (Ceftiofur in sheep for the control of respiratory disease).

Included in the 282 Animal Drug Requests are 24 active research projects currently under support of the NRSP-7 Minor Use Animal Drug Program. The projects are in various stages of completion and progress towards approval will continue into 1997. These projects are listed below.

1996 ANIMAL DRUG REQUESTS

Other accomplishments during 1996 included:

* Biennial workshop co-sponsored by NRSP-7 and the FDA/CVM was held in Bethesda, MD in September. The theme of the workshop was Drug Availability for Minor Species in the 21st Century.

* The revised Minor species Guidance Document of the FDA/CVM was finalized and replaces the 1986 Guidelines. This document will be published in the Federal Register in the near future and ADRS to the NRSP-7 Program new species and broadens the claims for drugs for minor species giving latitude to consider certain production drugs.

* NRSP-7 has instituted a computer tracking program for its research projects. This program will provide better tracking of progress in projects.

* Under the new 1996 legislation, Animal Medicinal Drug Use Clarification Act (AMDUCA), which regulates extra-label use of animal drugs, NRSP-7 may need to concentrate its priorities on medicated feeds for industries such as aquaculture and game bird production that rely on medicated feeds for disease control. This form of medication by extra-label use is illegal under this law.

ACTIVE PROJECTS

NRSP-7 MINOR USE ANIMAL DRUG PROGRAM