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U.S. Department of Health and Human Services

Animal & Veterinary

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NRSP-7 Holds Semi-Annual Committee Meeting, May 11, 2006

by Dr. Meg Oeller, DVM, Office of Minor Use and Minor Species Animal Drug Development
FDA Veterinarian Newsletter 2006 Volume XXI, No II

The U.S. Department of Agriculture’s (USDA) Minor Species Animal Drug Program, National Research Support Project #7 (NRSP-7), held its semi-annual meeting of the technical committee and Administrative Advisors on May 11 at the offices of the Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) in Rockville, MD. While the autumn meeting rotates among the four regions, the spring meeting is held in Rockville to facilitate the participation of CVM reviewers and minor species stakeholders, including producer groups and the regulated -industry.

The purpose of the NRSP-7 Minor Use Animal Drug Program is to address the shortage of animal drugs for minor species by funding and overseeing the effectiveness, target animal safety, and human food safety research and the environmental assessment required for the approval of a New Animal Drug Application (NADA). Commercial sponsors are able to use these data in conjunction with their own manufacturing and labeling information to pursue approval of an animal drug for an intended use in the minor species.

Minor species are those species other than humans that are not major species. The major species are horses, cattle, swine, dogs, cats, chickens, and turkeys.

The scope of the program includes minor species of agricultural importance, and generally excludes companion animals.

Opening remarks from Dr. Beaulieu

The Director of the CVM’s new Office of Minor Use and Minor Species Animal Drug Development (OMUMS), Dr. Andy Beaulieu, welcomed everyone and discussed issues of major importance to CVM. These issues include the implementation of the Minor Use Minor Species Animal Health Act (MUMS Act), animal drug user fees, minor use issues, and the upcoming personnel changes in OMUMS.

He reported that the drafting of implementing regulations for provisions of the MUMS Act is moving forward. The final rule for “designation” will publish soon, as will the proposed rule for “indexing.” The determination of “minor use in a major species” is being handled on a case-by-case basis until proposed rules are published to help clarify this issue.

Budget constraints may delay the establishment of a grant program for “designated” MUMS drugs. The MUMS Act authorized funding for a grants program once the designation final rule is published, but funds may not be appropriated for some time.

User fee waivers are available for minor species projects, and we hope the waivers will still be so when the fees are reauthor-ized by Congress.

The NRSP-7 committee presented Dr. Beaulieu with a special T-shirt and NRSP-7 coffee mug in appreciation for his long-standing support of the program.

The T-shirt listed the names of all committee members past and present. Dr. Beaulieu will be retiring from CVM in January 2007 after serving as a champion of minor use and minor species issues for many years. The new OMUMS Director will be Dr. Bernadette Dunham, currently deputy director of the Office of New Animal Drug Evaluation at CVM. She will begin working with Dr. Beaulieu this fall to provide a smooth transition.

Stakeholders’ presentations

The NRSP-7 program’s last 5-year review, which was done in August of 2003 and applies to the 5-year term that covers October 2004 through September 2009, recommended that the NRSP-7 committee do more outreach to stakeholders. To forward that goal, the committee decided to invite prominent members of minor species industries to speak at the spring meetings to foster better communication.

This year the committee invited Dr. C. Shane Donley, a veterinarian from Ohio who represented the farmed deer industry. From his early life growing up on a deer farm to his current life in veterinary practice with many deer farm clients, Dr. Donley is well versed in the practices and problems associated with raising deer. He provided an excellent picture of the deer industry that included husbandry practices and veterinary drug needs for management and disease treatment. His insightful and thorough presentation was very helpful to the NRSP-7 committee and will be invaluable in the selection of projects and the design of needed studies.

National Aquaculture NADA Coordinator Roz Schnick gave a presentation, “Aquaculture Drug Approval Highlights of Progress.” She described the achievements of several different entities, including the Upper Midwest Environmental Sciences Center, that are conducting studies to support drug approvals. Ms. Schnick reported significant progress on projects exploring claims for the anesthetic AQUI-S® (isoeugenol), chloramine-T, florfenicol, formalin, hydrogen peroxide, 17 alpha methyltestosterone, and oxytetracycline. She also described a survey that she conducted to identify unmet label claims in the public sector. The survey results will soon be distributed to the 38 participating States through the Drug Approval Working Group of the Federal-State Aquaculture Drug Approval Partnership, which is a separate group made up of State and Federal agencies and other aquaculture interests.

Ms. Schnick also described her internet-based drug matrix database, which provides general information and reports on the status of studies supporting aquaculture drug development.

Regional coordinators’ reports

There is great concern across the program about the continuing increase in data requested by CVM to support minor species drug approvals. NRSP-7 has not had any increase in funding for several years. More data for each project increase the cost and makes it more difficult for the program to serve the minor species community.

Northeast Region: Dr. Paul Bowser

Although many of these projects are intended to support species grouping, the data will be accumulated to support individual drug approvals for the drugs under study. (Species grouping is the concept whereby, based on scientific evidence, a few species can represent a larger group of species for the purpose of drug approval. For example, one species of salmon and one of trout can represent all salmonid fish.) Current projects include oxytetracycline for finfish, Romet-30® (sulfadimethoxine/ormetoprim) for finfish, florfenicol for finfish, and Rofenaid® (sulfadimethoxine/ormetoprim) for pheasants. Plans for a study identifying the needs of the goat industry are in development.

This past year saw the publication of several articles and abstracts dealing with various pharmacokinetic and physiologic effects of oxytetracycline, florfenicol, and hydrogen peroxide.

Southern Region: Dr. Alistair Webb

Dr. Webb reported that current projects include ivermectin for rabbits, fenbendazole for deer, lasalocid for deer and goats, fenbendazole for gamebirds, and Crude Carp Pituitary, Ovaprim® (GnRH and domperidone), and metomidate for fish.

Dr. Webb also reported that scientists at his lab at the University of Florida have completed the setup of their Good Labora-tory Practices (GLP) lab. (GLP labs follow the rules in 21 Code of Federal Regulations, Part 58). The Ivermectin assay and the in vivo sections of the rabbit project have completed their GLP inspection. Dr. Webb is maintaining the NRSP-7 website (www.nrsp7.org), which includes the project tracking database for the use of the -committee.

Future projects are under consideration for deer.

North Central Region: Dr. Ronald Griffith

The major current project is the Controlled Internal Drug Release, Type G (CIDR-G) intravaginal progesterone device for sheep. The U.S. sheep industry lists this product as its number one need. Target animal safety and effectiveness studies are complete and the human food safety study is nearly done. A project to support approval for this device in goats is in its early stages. A new project for lasalocid for coccidiosis in pheasants is in development. New projects are under consideration for tulathromycin for respiratory disease in sheep and goats, for Regulin® (melatonin) to enhance early estrus in sheep, and for Bioclip® (epidermal growth factor) to induce wool-break in sheep. (Wool-break is breaking of the wool fibers, which causes sheep to shed their fleece without shearing.)

Western Region: Dr. Arthur Craigmill

Dr. Dr. Lisa Tell presented the region’s report on several projects. Several of these are cooperative projects with other regions, such as the CIDR-G for sheep and goats and species grouping of fish. A project concerning florfenicol for respiratory disease in sheep is on hold while additional data requirements are identified. The target animal safety study for the CIDR-G in goats is complete and the report is almost ready for submission to CVM.

Pirlimycin for mastitis in goats is early in development, as is ceftiofur for the same indication.

Work is continuing on species grouping for gamebirds.

The Western Region is also responsible for the recently approved project for tylosin and the in-progress project for lincomycin for American Foulbrood disease in honeybees.

The project for otolith marking of salmonids with strontium chloride immersion is still in the early stages.

The project concerning erythromycin for bacterial kidney disease in salmonids is in its final stages, mainly in need of an environmental assessment.

Collaboration

There is considerable collaboration across the four regions. Much of the analysis of samples from studies conducted in other regions is done in the laboratory at the University of California, Davis. Some projects are funded and conducted by more than one region to make the best use of equipment and expertise. The chart on page 11 lists the region with primary responsibility for each project.

Administrative Advisors’ report

The Administrative Advisors discussed the need for reexamination of the program’s mission statement in regard to increased requirements and costs for drug approval without corresponding increases in funding. In this climate, it may be necessary to reconsider the prioritization and number of -projects.

The Advisors also encouraged continued outreach to stakeholders noting that they can influence congressional support that the committee cannot.

They also encouraged development of a strong relationship between NRSP-7 and the OMUMS in CVM.

USDA representative’s report

Dr. Gary Sherman introduced his associate, Jillian Allen, who has been assisting him in his work with the NRSP-7 program. Dr. Sherman also provided an update on responsibilities and personnel changes in his office at USDA. He related that the program’s funding is expected to remain at the same level for the foreseeable future. He also discussed the timing and methods for managing NRSP-7 grants in the four regions.

This was the first NRSP-7 meeting for Dr. Sherman since replacing Dr. Larry Miller, who served in this role for many years. Dr. Miller was honored at a dinner with the committee that evening. His contributions to the program cannot be -overstated.

FDA’S NRSP-7 liaison report

Dr. Meg Oeller reported on the positive news that NRSP-7’s public master files (PMF) have been used to support NADA approvals for several oxytetracycline products for otolith marking of fry and fingerling fish. Another PMF for tylosin for American Foulbrood in honey bees also supported an approval this year.

She noted acceptance of some significant studies for active projects. Also, the full transcript of the NRSP-7/FDA International Workshop on Minor Use and Minor Species is posted on the FDA/CVM website along with copies of the slide presentations. (Go to the “MUMS” page of the CVM website [www.fda.gov/cvm], and look under “meetings.”) The possibility of a translation into Spanish is being explored.

On the other hand, a problem remains with timely submission of data. Each regional coordinator was strongly encouraged to pressure investigators to complete study reports and notices of drug shipment as quickly as possible.

She also gave an update about the expected timing of the publication of regulations to implement the MUMS Act as well as the personnel changes in the OMUMS.

National coordinator’s report

Dr. Dr. John Babish reported on the need for more outreach to -stakeholders to solicit increased funding of the program. He led a discussion about increasing needs in a time of decreasing resources.

Conclusion

The 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 and stakeholders.

For more information about NRSP-7, please visit the website www.nrsp7.org. For more information on Minor Use & Minor Species issues at FDA, please visit the website www.fda.gov/cvm/-minortoc.htm or call Dr. Meg Oeller at (240) 276-9005.

---[Beaulieu photo caption text]---

Dr. Andy Beaulieu, Director of the CVM’s new Office of Minor Use and Minor Species Animal Drug Development, will be retiring at the end of this year, so the NRSP-7 technical committee and administrative advisors presented Dr. Beaulieu this shirt during the May 11 meeting to highlight his contributions to the work of the NRSP-7.

---[Miller photo caption text]---

Dr. Larry Miller served for a number of years at the U.S. Department of Agriculture representative to the NRSP-7 meetings. He recently retired, and was honored by the NRSP-7 Committee at a dinner following the May 11 meeting.

DrugRoute of AdministrationSpeciesIndicationRegion
Ivermectininjectionrabbitsear mitesS
Erythromycinoral (feed)salmonidsbacterial kidney diseaseW
Fenbendazoleoral (feed)deerGI parasitesS
Lasalocidoral (feed)pheasantscoccidiosisNC
ProgesteroneCIDR-G®sheep/goatsestrus synchronizationNC
Carp Pituitaryinjectionvarious fishspawning aidS
Sulfadimethoxine/ormetoprimoral (feed)pheasantsbacterial infections and coccidiosisNE
Fenbendazoleoral (feed)pheasants, partridges & quailgapeworm, capillariaS
Oxytetracyclineoral (feed)finfishbacterial infectionsNE
Lasalocidoral (feed)deer/goatscoccidiosisS
Strontium chlorideimmersionfinfishotolith markingW
Florfenicoloral (feed)finfishbacterial infectionsNE
PirlimycinintramammarygoatsmastitisW
Lincomycinsoluble powderhoney beesAmerican FoulbroodW
Florfenicolinjectionsheeprespiratory infectionsW
Sulfadimethoxine/ormetoprimoral (feed)finfishbacterial infectionsNE
CeftiofurintramammarygoatsmastitisW
Tulathromycininjectionsheep/goatsrespiratory infectionsNC
Ovaprim®injectionornamental fishspawning aidS
Metomidateinjectionornamental fishanestheticS

NRSP-7 Representatives

Attendance at Recent Meeting

The National Research Support Project #7 (NRSP-7) technical committee is made up of a National Coordinator, four Regional Coordinators, four regional Administrative Advisors, and liaisons from the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA).

Here are the representatives to NRSP-7.

The National Coordinator

  • Dr. John Babish (Cornell University).

The Regional Coordinators

  • Western Region – Dr. Arthur Craigmill and Dr. Lisa Tell (University of California, Davis)
  • Southern Region – Dr. Alistair Webb (University of Florida)
  • North Central Region – Dr. Ronald Griffith (Iowa State University)
  • Northeast Region – Dr. Paul Bowser (Cornell University)

The Administrative Advisors

  • Dr. Kirklyn Kerr (University of Connecticut)
  • Dr. Garry Adams (Texas A&M)
  • Dr. David Thawley (University of Nevada)
  • Dr. John Baker (Michigan State University)

The USDA representative

  • Dr. Gary Sherman (Washington, DC)

The FDA liaison

  • Dr. Meg Oeller (Rockville, MD)
  • (Dr. Craigmill was unable to attend and the Western Region was represented by Co-Coordinator, Dr. Tell. Dr. Kerr was also unable to attend.)

The May 11 meeting was attended by the National Aquaculture New Animal Drug Application Coordinator, Rosalie “Roz” Schnick, as well as by other stakeholders and several reviewers and managers from FDA’s Center for Veterinary Medicine.