Annual
Report NRSP-7
1998
Dr. John G. Babish
National Coordinator
jgb7@cornell.edu
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
goal of the program, the research program has expanded or given additional
emphasis to aquaculture species, veal calves and sheep. To date 295 drug requests have been
submitted to the Minor Use Animal Drug Program for the development of data in
support of the submission of a New Animal Drug Approval (NADA). Working in conjunction with many universities,
25 Public Master files have been published in the Federal Register. These have supported FDA approval for 21
products. Currently there are 22 active
research projects are being conducted in 15 states involving 18 animal species
and 17 different drugs. Whereas a total
of 295 animal drug requests have been submitted to the NRSP-7 program since
1983, program funding has been available for only about one out of every five
requests.
In addition to
the escalating backlog and growing animal drug needs, the recent passage of the
Animal Medical Drug Use Clarification Act of 1994 (AMDUCA) enacted in 1996
legalized extra-label drug use by veterinarians and has significantly impacted
the use of approved animal drugs. This
legislation does not allow for extra-label use of a drug for medication in
feed, virtually the only route of drug administration for aquaculture, game
bird and several other industries.
Thus, there is an increasing need for research to provide veterinarians
with data, such as appropriate withdrawal times, necessary to make informed
decisions about extra-label use of unapproved drugs in minor species. Furthermore, the anticipated
reclassification by FDA/CVM of sheep as minor species, emerging new animal
industries such as ostrich and emus, and non-food species within agriculture
practices, disease transfer from non-agricultural species to domestic species,
and food and environmental safety are but a few of the increased demands on the
program.
Annual Report of the Minor Use Animal Drug Program
January 1, 1998 to December 31, 1998
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 Dr. J.
T. Neilson Dr.
R.G. Sasser Dr. W.W. Saylor Dr. J. G. Babish Dr. P.R. Bowser Dr. A. L. Craigmill Dr. R.E. Holland Dr. A.I. Webb Dr.
L.R. Miller Dr.
M.R.Oeller |
Missouri AES Florida AES Idaho AES Delaware AES New York AES New York AES California AES Michigan AES Florida AES USDA/CSRESS 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. This continues to remain the dominant goal
of the program. In recent years, the
research program has expanded or given additional emphasis to aquaculture
species, veal calves and sheep. In
addition, several new animal drugs requests were recently received for game
birds. The importance of environmental
assessment, residue withdrawals and occupational safety have increasingly been
given more attention during the approval process to help assure consumer
protection.
To date 295 drug
requests have been submitted to the Minor Use Animal Drug Program for the
development of data in support of the submission of a New Animal Drug Approval
(NADA). Working in conjunction with
many universities, 25 Public Master files have been published in the Federal
Register. These have supported FDA
approval for 21 products to date.
Currently there are 22 active research projects are being conducted in
15 states involving 18 animal species and 17 different drugs. Whereas a total of 295 animal drug requests
have been submitted to the NRSP-7 program since 1983, program funding has been
available for only about one out of every five requests.
In 1998 a Public Master File was completed and published for
clorsulon for the treatment of hepatic disease caused by Fasciola hepatica in
goats. Studies were completed that will
lead to the completion and submission of several Public Master Files in the
coming year. These include
oxytetracycline for bacterial pneumonia in sheep and goats, amoxicillin for
bacterial pneumonia in sheep and goats, and ivermectin pour-on for the
treatment of Ostertagia ostertagia in American bison.
Usefulness of Findings: 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 is cooperating and supporting this program to the fullest
extent. The program 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.
Work Planned for Next Year:
In addition to the escalating backlog and growing animal drug
needs, the recent passage of the Animal Medical Drug Use Clarification Act of
1994 (AMDUCA) enacted in 1996 legalized extra-label drug use by veterinarians
and has significantly impacted the use of approved animal drugs. AMDUCA attempts to define and delimit the
extra-label use of veterinary drugs.
Extra-label use primarily refers to the use of an animal drug product by
a veterinarian for a species or indication not listed on the label to treat
animals that are immediately threatened or suffering. However, this legislation does not allow for extra-label use of a
drug for medication in feed, virtually the only route of drug administration
for aquaculture, game bird and several other industries. Thus, there is an increasing need for
research to provide veterinarians with data, such as appropriate withdrawal
times, necessary to make informed decisions about extra-label use of unapproved
drugs in minor species.
Furthermore, the anticipated reclassification by FDA/CVM of sheep as
minor species, emerging new animal industries such as ostrich and emus, and
non-food species within agriculture practices, disease transfer from
non-agricultural species to domestic species, and food and environmental safety
are but a few of the increased demands on the program. 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:
A.I. Webb (Editor) (1998)
Proceedings of the NRSP-7/FDA Workshop for Minor Use Drugs: Drug
availability for minor species in the 21st Century. Vet Human Toxicol, 40: suppl 1.
Griffin, B. R,; Hobbs, M.S, Gollon, J.L, Schlenk, D, Kadlubar,
F.F, and Brand, C.D. (1997) Effect of waterborne copper sulfate exposure
on copper content in liver and axial muscle of channel catfish. Journal of
Aquatic Animal Health 9(2); 144-150.
Oeler, M. (1997) Drug availability for minor species (1). The
Regulatory Affairs Journal, 8(12) 992-996.
Oeller, M. (1998) Drug availability for minor species (2). The
Regulatory Affairs Journal, 9(1) 4-8.
Oeller, M. (1998) NRSP-7 holds semi-annual committee meeting. FDA Veterinarian. XII(VI) 10-12.
Perkins,E.J., Griffin, B; Hobbs, M; Gollon, J; Wolford, L;
Schlenk, D. (1997) Sexual differences
in mortality and sublethal stress in channel catfish following a 10-week
exposure to copper sulfate Aquat. Toxicol.; 37:4, 327-339.
S. Modric and A.I. Webb. (1997) A comparison of tilmicosin
pharmacokinetics in the bovine and ovine, Proc 7th Eur Assoc Vet Pharmacol
& Toxicol Int Congress, [J vet
Pharmacol Therap, 20 (Suppl 1) 141]
Tell, L., Harrenstein, L., Wetzlich, S., Needham, M., Nappier, J.,
Hoffman, G., Caputo, J. and Craigmill, A.
(1998) Pharmacokinetics of ceftiofur sodium in exotic and domestic avian
species. J Vet Pharm Therap.
21(2)85-91.
Tort, M.J., A.J. Kuhl, G.A. Wooster and P.R. Bowser. (1998)
Modification of tolerance of walleye (Stizostedion vitreum) to bath treatment
with hydrogen peroxide. Journal of the
World Aquaculture Society. 29:499-504.
Abstracts and Dissertations:
Modric S. (1997)
Pharmacokinetic and Pharmacodynamic Properties of Tilmicosin in Sheep,
Cattle and Ratsî. PhD Dissertation,
University of Florida.
Tort, M.J., A.J. Kuhl, G.A. Wooster and P.R. Bowser. 1998.
Modification of tolerance of walleyes (Stizostedion vitreum) to bath
treatment with hydrogen peroxide.
Annual Meeting of the New York Chapter American Fisheries Society. 29-31 January 1998. Owego, NY.
Tort, M.J., G.A.Wooster and P.R.Bowser. 1998. Hydrogen peroxide
as a therapeutic compound for bacterial gill disease in fish. SETAC-Europe. 14-18 April 1998. Bordeaux. France.
Tort, M.J., G.A.Wooster and P.R. Bowser. 1998. Hydrogen peroxide
as a therapeutic compound for bacterial gill disease in fish. Annual Meeting of
the American Fisheries Society. 23-27
August 1998. Hartford, CT.
Tort, M.J. 1998. Risk assessment of
hydrogen peroxide use as a therapeutic compound for fish diseases in production
settings. RASS VII, 22-30 August 1998. Visby, Sweden.
Tort, M.J., G.A.Wooster and P.R. Bowser. 1998. Hydrogen Peroxide
as a Therapeutic Compound for Bacterial Gill Disease in Fish. Third International Symposium on Aquatic
Animal Health. 30 August - 3 September
1998. Baltimore, Maryland.
Tort, M.J., G.A. Wooster and P.R.Bowser. 1998. Hydrogen peroxide
as a therapeutic compound for bacterial gill disease in fish. SETC 19th Annual Meeting. 15-19 November 1998. Charlotte, North Carolina.
Approved
John G. Babish, Ph.D. Date
Chair, Technical Committee
William W. Saylor, Ph.D. Date
Chair, Administrative Advisors