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U.S. Department of Health and Human Services

Animal & Veterinary

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by Meg Oeller, D.V.M.
FDA Veterinarian Newsletter November/December 1998 Volume XIII, No VI

The Minor Use Animal Drug Program, National Research Support Project #7 (NRSP-7) held its semi-annual meeting of the technical committee on September 21 and 22 in Rockville, MD. The spring meeting is hosted each year by one of the four regions, but the fall meeting is usually held in Rockville to provide an opportunity for input from members of FDA’s Center for Veterinary Medicine (CVM).

The purpose of the NRSP-7 Minor Use Animal Drug Program is to address the shortage of minor use animal drugs by funding and overseeing the efficacy, animal safety, and human food safety research and environmental assessment required for drug approval. The scope of the program includes minor species of agricultural importance, and generally excludes companion animals.

The technical committee is made up of a National Coordinator, 4 Regional Coordinators, 4 Regional Administrative Advisors, and liaisons from USDA and FDA. The Regional Coordinators are Dr. Arthur Craigmill (University of California, Davis), Dr. Alistair Webb (University of Florida), Dr. Robert Holland (Michigan State University), and Dr. Paul Bowser (Cornell University). The Administrative Advisors are Dr. Bill Saylor (University of Delaware), Dr. John Nielson (University of Florida), Dr. Garth Sasser (University of Idaho), and Dr. Gerald Buening (University of Missouri). The USDA representative is Dr. Larry Miller (Washington, DC) and the FDA liaison is Dr. Meg Oeller (Rockville, MD). The meeting was also attended by reviewers and managers from FDA/CVM.

This meeting marked the transfer of the National Coordinator position from Dr. Robert Ringer of Michigan State University to Dr. John Babish of Cornell University. Dr. Ringer has served as the National Coordinator since 1993, when he retired from his professorial position at Michigan State University. Dr. Ringer has been with the project since its inception in 1982 and he served as the Regional Coordinator for the North-Central Region for the first 11 years. His extraordinary service to the program was remembered with a plaque and the gratitude of the committee members.

Dr. Babish served as the first Regional Coordinator for the Northeast Region from 1982 to 1993. In 1993, he left Cornell University for the private sector. Dr. Babish’s experience with the development of drugs for human and veterinary use, and his past experience as a Regional Coordinator for the Minor Use Program will be invaluable as he takes over the reins. Dr. Babish believes that the position requires the incumbent to be a facilitator and a promoter of the program. He intends to coordinate the efforts of other programs and individuals with the NRSP-7 projects. He will work closely with FDA and will try to identify delays in the product development process with the goal of streamlining the traffic pattern. He plans to expand electronic information transfer including the NRSP-7 website to enhance communication. He will also continue Dr. Ringer’s work to promote the program through participation in national and regional meetings, such as the Joint Subcommittee on Aquaculture’s working group on Quality Assurance. He intends to draw on committee members' expertise in the development of policies pertaining to issues such as "crop grouping" of species.

Dr. Stephen Sundlof, Director of CVM, provided an overview of several major issues facing the Center in his opening remarks. He gave an update on the progress of the Minor Use/Minor Species Document mandated by Congress under the Animal Drug Availability Act. The document, proposing ways to facilitate the approval of new animal drugs for minor uses, is currently under review at the Agency level. He also discussed antimicrobial resistance concerns and their potential effects on new animal drug approvals. The FDA Modernization Act, and CVM's recent successful stakeholders’ meeting were mentioned. The continuing struggle with a declining budget and workforce in the face of a heavy workload was also noted.

Dr. Larry Miller reported that there was a unanimous vote of the directors of the 4 regional experiment stations to renew the project for another 5 years. He also gave an update on the progress of the program’s appropriations through Congress. He also noted that under the reauthorization of the Farm Bill, special research grants now have a maximum life of 3 rather than 5 years.

There was an update on the status of the draft guidance document, "FDA Approval of Animal Drugs for Minor Uses and for Minor Species". This document has completed a 90-day public comment period. Seven comments were received. Some changes are being made in response to the comments. During the time that the document was available for comment, new environmental regulations were finalized. These have necessitated a rewrite of the environmental sections of the existing draft. This rewrite currently is under review within CVM. Until the document is finalized, the previous draft will remain available (guidance #61). A copy is available on CVM’s website (/cvm) or may be obtained from the FDA Veterinarian.

The Regional Coordinators reported on the progress of the active projects in their respective regions. NRSP-7 currently has 24 active projects funded. These are summarized in the table below. There are 6 additional projects pending.

Active NRSP-7 Projects

DrugRoute of AdministrationSpeciesIndication
Albendazoleoralgoatsliver flukes
Chloramine-Ttopicalsalmonidsbacterial gill disease
Amoxicillin trihydrateinjectiondairy goatsbacterial pneumonia
Oxytetracyclineinjectiondairy goats(non-lactating)bacterial pneumonia
Oxytetracyclineinjectionsheepbacterial pneumonia
Amoxicillininjectionsheepbacterial pneumonia
Erythromycinpremixsalmonidsbacterial kidney disease
Ceftiofurinjectiongoatsbacterial pneumonia
Ivermectinpour-onAmerican bisonGI parasites
Lasalocidoral (feed)pheasantcoccidiosis
Clopidoloral (feed)pheasantcoccidiosis
Tilmicosininjectionsheeprespiratory infections
ProgesteronCIDRsheepeestrus synchronization
Hydrogen peroxidetopicalvarious fishbacterial gill disease
Carp Pituitaryinjectionvarious fishspawning aid
Nitarsoneoral (feed)partridgeblackhead
Zoamixoral (feed)pheasantcoccidiosis
Fenbendazoleoral (feed)ostrichnematodes
Fenbendazoleoral (feed)pheasant, partridge & quailgapeworm, capillaria
MGA / GnRHfeed/injectablesheepestrus synchronization
OxytetracyclinetopicalSummer floundervibriosis
OxytetracyclinetopicaltilapiaStreptococcus infection

In order to foster better communication and cooperation on issues of common interest, the committee invited several people to make presentations to the group. Drs. Bernadette Dunham and Elizabeth Curry-Galvin described the structure and goals of the American Veterinary Medical Association. Dr. Curt Mann spoke about the American Association of Veterinary Medical Colleges. Dr. Mark Wood gave an excellent overview of the Animal Health Institute, an organization made up of the manufacturers of all types of animal health products. Rosalie Schnick, the National INAD/NADA Coordinator for Aquaculture gave an overview of the INAD program and an update on the status of the various projects under her direction. Dr. Shirley Wager-Page of the USDA’s Wildlife Services group described the needs of their biologists for the approval of immobilizing and contraceptive agents for use in wildlife.

Dr. Bert Mitchell of CVM stopped by to acquaint the committee with the newly formed group, The Aquaculture Partnership (TAP). This is an industry/FDA aquaculture partnership whose mission is to coordinate efforts to ensure that farm-raised seafood products are safe and wholesome through enhanced communication between industry and FDA.

The day-and-a-half meeting was an excellent opportunity to provide an update on the status of all aspects of the program as well as an opportunity to expand partnerships with other organizations.

The NRSP-7 Spring meeting will be hosted by the Southern Region and will be held at the end of February near Tallahassee, Florida.

For more information about NRSP-7, please visit our website http://bluehen.ags.udel.edu or call Dr. Meg Oeller (301) 827-7581.