Annual
Report NRSP-7
1999
NRSP-7 Mission
Statement
The mission of
NRSP-7 is:
·
to identify animal drug needs for minor species and minor
uses in major species,
·
to generate and disseminate data for safe and effective
therapeutic applications, and
·
to facilitate FDA/CVM approvals for drugs identified as a
priority for a minor species or minor use.
To accomplish these goals, 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.
Executive Summary
In 1999, two
Public Master Files were published in the Federal
Register indicating approval by CVM/FDA and four Public Master Files were
submitted for publication.
Sulfadimethoxine/ormetoprim for coccidiosis in Chukar partridges and
amoxicillin for bacterial pneumonia in sheep were approved by CVM/FDA on data
submitted by NRSP-7. Those Public
Master Files submitted included oxytetracycline of otolith marking of fish by
immersion, ceftiofur for bacterial pneumonia in goats, amoxicillin for
bacterial pneumonia in sheep and ivermectin pour-on for hypodemosis in American
bison.
Since the beginning of the program, 302 requests have been received from animal producers, universities and veterinarians for the development of data in support of the filing of a New Animal Drug Approval (NADA). Currently, data representing 28 Public Master Files (PMF), involving 14 animal species, have been published in the Federal Register since the beginning of the program providing approval for drug use. Working cooperatively with many universities, other Federal agencies, and numerous pharmaceutical companies, 24 research projects are now active and will be continued through 2000 to establish data for drug approvals.
Annual Report of the Minor Use Animal Drug Program
January 1, 1999 to December
31, 1999
Project: NRSP-7 A National Agricultural Program to
Approve Animal Drugs for Minor Species and Uses
Cooperating Agencies and Principal Leaders:
Dr. G. M. Buening Missouri
AES
Dr. J. T. Neilson Florida
AES
Dr. D. C. Robertson Idaho
AES
Dr. Kirklyn M. Kerr
Connecticut
AES
Dr. J. G. Babish New
York AES
Dr. P.R. Bowser New
York AES
Dr. A. L. Craigmill California
AES
Dr. R.E. Holland Michigan
AES
Dr. A.I. Webb Florida
AES
Dr. L.R. Miller USDA/CSRESS
Dr. M.R.Oeller
FDA/CVM
Progress of the Work and Principal Accomplishments:
The original
goal of the NRSP-7 Minor Use Animal Drug Program was to obtain approval by the
Food and Drug Administration for animal drugs intended for use in minor species
and for minor uses in major species.
While this continues to remain the dominant objective of the program,
the research has expanded or given additional emphasis to aquaculture species,
veal calves and sheep. In 1999, two Public Master Files were published in the Federal Register indicating approval by
CVM/FDA and data for four Public Master Files were submitted for review. Sulfadimethoxine/ormetoprim for coccidiosis
in Chukar partridges and amoxicillin for bacterial pneumonia in sheep were
approved by CVM/FDA on data submitted by NRSP-7. Those Public Master Files completed included oxytetracycline of
otolith marking of fish by immersion, ceftiofur for bacterial pneumonia in
goats, amoxiciallin for bacterial pneumonia in sheep and ivermectin pour-on for
hypodemosis in American bison.
Since the beginning of the program, 302 requests have been received from animal producers, universities and veterinarians for the development of data in support of the filing of a New Animal Drug Approval (NADA). Currently, data representing 28 Public Master Files (PMF), involving 14 animal species, have been published in the Federal Register since the beginning of the program providing approval for drug use. The PMF publication enables pharmaceutical companies to extend their label claims to minor species by referencing the published PMF in their NADA filing. Furthermore, these data also enter the public domain as presentations to professional groups, publication of peer-reviewed articles and inclusion in the Food Animal Residue Avoidance Databank (FARAD). Working cooperatively with many universities, other Federal agencies, and numerous pharmaceutical companies, 23 research projects are now active and will be continued through 2000 to establish data for drug approvals. The procedure for obtaining drug approval requires four separate studies per drug, human safety, target animal safety, environmental safety, and efficacy.
Program
funding has been available for only about one out of every five requests
submitted to the Minor Use Animal Drug Program. Of the remaining requests, approximately 75 percent are potential
projects for the minor use animal drug program. Limiting factors include the lack of an economic incentive for a
pharmaceutical company to sponsor the research, insufficient funds available
for research leading to the unavailability of research investigators, and the
fact that the drug is not approved in a major species. The scope of the program also has broadened
due to increased emphases on aquatic species, the classification of sheep as a
minor species, and the increasing needs of the game bird industry and various
expanding industries. Environmental
assessment, residue withdrawal data and human safety have been given more
attention during the approval process to help assure consumer protection.
Through
this safe and efficient process, consumers can be assured that human health is
not jeopardized in any way. Moreover,
the Minor Use Animal Drug Program has averaged expenditures of only $200,000
for each of the drugs that have been approved for minor species.
The
Center for Veterinary Medicine of the Food and Drug Administration cooperates
with NRSP-7 personnel and fully supports this program. NRSP-7 is a prime example of Federal
interagency collaboration in coordination with academic institutions,
pharmaceutical industries and commodity interests to effectively meet an urgent
public health need.
Selected
categories of the Special Research Grants program address national/regional
initiatives. The overall objectives established cooperatively with FDA and
industry are still valid. However,
specific objectives continually are met and revised to reflect the changing
priorities for FDA, industry and consumers.
Research
projects for this program have involved 20 different animal and aquaculture
species with emphasis given in recent years to research on drugs for the
expanding aquaculture industry and increasing number of requests from the
sheep, veal calf, and game bird industries.
The minor use animal drugs program involves research on biological
systems that by their nature are ever changing and presenting new challenges to
agriculture. Now, with the increased
public sensitivities about food safety and environmental protection, there is
an even greater need for continuation of these ongoing projects.
The regional
coordinators and investigators expect to complete the research for several
additional animal drug studies in the next two years. It is anticipated that the research in progress will result in
four new minor use animal drug approvals in 1999 and 2000. Completed projects
under review by FDA/CVM include copper sulfate [anti-icth] in catfish. Projects in progress are ivermectin
[miticide] in rabbits, fenbendazole [anti helminth] in gamebirds, zoalene
[coccidiostat] in gamebirds, nitarsone [anti-histomoniasis] in partridge and
crude carp pituitary extract [spawning aid] in catfish.
The demands on
the program continue to increase for several reasons. New requests are received for additional species, including
non-food species and expanding industries such as ostrich and emu. There is increased pressure on the Minor Use
Animal Drug program to include the development of production drugs such as
spawning hormones for certain aquaculture industries.
Increased
costs also are being incurred due to the need for research laboratories to
comply with federal requirements for Good Laboratory Practices (GLP). More expensive analytical techniques and
sophisticated research are required especially to assure human and target
animal safety.
Research
on the active projects will continue into next year with the goal of publishing
Public Master Files and ultimately having the use placed on a manufacturer’s
label so that the animal industry can use an approved drug insuring safety of
the food product.
Publications Issued or Manuscripts Approved During the Year:
Baynes,
R.E., Martin_Jimenez, T., Craigmill, A.L., and Riviere, J.E. (1999) Estimating
provisional accepetable residues for extralabel drug use in livestock. Regul. Toxicol. Pharmacol. 29(3):287-299.
Modric
S, Webb AI and Davidson M. (1999)
Effect of respiratory tract disease on pharmacokinetics of tilmicosin in rats.
Lab Anim Sci.,49:248-253.
Payne, M.A., Craigmill,
A.L, Riviere, J.E., Baynes, R.E., Webb, A.I. and Sundlof, S.F. (1999) The Food
Animal Residue Avoidance Databank (FARAD).
Past, present and future. Vet
Clin North Am Food Anim Pract 15(1):75-88.
Robbins, P.K., Tell, L.A.,
Needham, M.L., and Craigmill, A.L. Pharmacokinetics of a single intramuscular
dose of piperacillin in red tailed hawks (buteo
jamaicensis) and great horned owls (bubo
virbinianus). J Zoo and Wildlife Med, In Press.
Saez, J.A. and P.R.
Bowser. The discharge kinetics of
hydrogen peroxide under practical field conditions. North American Journal of Aquaculture. (Submitted 23 February 2000)
Tort, M.J. (2000) Studies of Hydrogen Peroxide for the
Treatment of Bacterial Gill Disease in Fish.
PhD Dissertation, Cornell University, Ithaca, New York 185 pp.
Approved
John G. Babish, Ph.D.
Date
Chair, Technical Committee
Donald C. Robertson, Ph.D. Date
Chair, Administrative
Advisors