Brief Summary of Minutes of Annual Meeting

1. Program Status:

The program is now a Multistate Research Coordinating Committee and Information Exchange Group, NECC1702: Establishment of a Formal Structure for the Minor Use Animal Drug Program, under the authority of the Northeastern Regional Association of State Agricultural Experiment Station Directors. Dr. Margaret Smith is the Administrative Advisor.

The group reviewed and discussed the Committee’s three Objectives:

1. Provide the formal structure necessary to maintain the 88 INADs held in the name of the MUADP.
2. Continue APHIS funded research on cattle fever tick and sheep drug approvals.

• In conjunction with NIFA and stakeholders, identify a stable funding source to work with the FDA/CVM to facilitate their approval of animal health products and provide information for the safe and efficacious use of these materials in specialty animal species.

As part of Objective 3, the group discussed various ways the program could elicit stakeholder involvement and support in the future:

• Regular (biannual, quarterly) newsletters to key trade associations
• Open meetings via teleconference to allow for engagement from a larger stakeholder base
• Outreach via the existing Facebook page
• Assuming the program maintains its past structure, the National Coordinator would spearhead these stakeholder engagement activities.

Dr. Smith explained that when a new Coordinating Committee is created within the Agricultural Experiment Station system, a notice is sent to all of the stations to invite interested parties to participate in the new committee. Dr. Enrique Escobar, Assistant Professor and Small Ruminant Extension Specialist at the University of Maryland Eastern Shore, has put his name forward to participate in the committee.

2. Program Structure:

During this time of transition, the group should take this opportunity to critically examine the structure of the program and design the best structure for completing work in the current regulatory landscape. In the past, most research was conducted by the Regional Coordinators at their respective universities. The group discussed old and new approaches for completing the work of the program, such as:

• Contracting out the research to third parties (either CROs or other university researchers), with the Regional Coordinators serving as a Sponsor Representative.
• Continuing with the historical approach, with certain regions providing a particular expertise necessary to complete the regulatory research. This approach led to the discussion of what level of Good Laboratory Practice (GLP) compliance would be needed at the 4 historical sites.

3. GLP compliance:

The program has historically conducted Target Animal Safety Studies and Human Food Safety studies (residue) in support of drug approvals. These 2 study types must be conducted under GLP standards. The group discussed the impact of conducting these studies in the university setting:

• Concerns with the difficulty in achieving and maintaining systems that are necessary for GLP compliance
• investment of resources (both initial and ongoing),
• issues with University management (understanding and support for GLP studies),
• Is it the best use of the program’s resources to have all 4 University sites maintain GLP compliance on a continuous basis?

To better understand the current status of GLP compliance, FDA/CVM/ONADE has offered to, in cooperation with the FDA Liaison, perform site feasibility visits of the 4 University sites. The site visits are intended to identify any gaps in the GLP infrastructure at the sites and will provide an opportunity for University management to gain a better understanding of GLP requirements. The goal is to provide support and compliance training/assistance, prior to the program moving forward with new GLP studies. The first 2 Universities slated for visits are Cornell and Iowa State, with plans to conduct the Cornell visit in November 2017. Based on the outcome of these first two visits, the group will discuss any identified gaps and determine how to best design the program’s GLP infrastructure.

4. Existing projects:

Group discussed need to complete the three highest priority projects:

1. Fenbendazole/pheasants:
   • Human Food Safety = COMPLETE
   • Target Animal Safety = COMPLETE.
   • Environmental Impact = Contracting with Eric Rosenblum to complete the Environmental Assessment.
   • Effectiveness = Work ongoing on White Paper to reaffirm the technical section complete letter received in 1998.
2. CIDR/goats:
   • Human Food Safety = COMPLETE
   • Target Animal Safety = COMPLETE.
   • Environmental Impact = COMPLETE
   • Effectiveness = Group discussed issues with study conducted at several commercial goat farms. Issues with data quality may require that the study be redone. Current plan is to write up the study and submit to ONADE. Based on what conclusions can be made from study, may be able to conduct a small scale study to provide substantial evidence of effectiveness.

• Erythromycin/salmonids:
  • Human Food Safety = COMPLETE
  • Target Animal Safety = COMPLETE
  • Environmental Impact = Environmental assessment requires administrative revisions.
  • Effectiveness = Work ongoing on White Paper to reaffirm the technical section complete letter received in 1998, so that the indication can be broadened to all salmonids, as opposed to only Chinook.

1. Status update for other projects:

• lasalocid – needs residue method; resubmit target animal safety
• strontium chloride – target animal safety currently under review
• ivermectin block – no progress made on this for several years; without significant progress on manufacturing and data access issues this project cannot be successful.

5. Future projects:

Group discussed considerations for how the program should choose projects in the future.

• How best can the program elicit and respond to our stakeholders needs for approved products? What constitutes a product request that is actionable?
• The program should consider only performing work on products for which there is already a complete manufacturing technical section. The exception to this rule would be for aquaculture projects.
• The program should consider only taking on 2-3 projects at a time, with focus on completing ongoing projects prior to initiating new projects.

6. Funding options:

Group discussed funding options during this time of transition and beyond.

• MUMS grants - The program could definitely qualify for MUMS grants to fund research. The impact of indirect costs charged by the universities was discussed. The recommendation was to describe such costs as part of the grant application.
• Possibility of being funded through the USDA-NIFA budget. The tactical sciences effort currently being explored could provide a long-term solution to the chronic funding woes. The report of the group is available at: https://nifa.usda.gov/resource/tactical-science-continuing-commitment.

In the meantime, USDA-APHIS is providing a small amount of funding for some exploratory work in sheep and goats through the North Central Region.