NATIONAL COORDINATOR FOR AQUACULTURE
NEW ANIMAL DRUG APPLICATIONS (NADAs)
FIFTH ANNUAL REPORT OF ACTIVITIES
May 15, 1999 to May 14, 2000
Submitted by
Rosalie A. Schnick
National Aquaculture NADA
Coordinator
Michigan State University
3039 Edgewater Lane
La Crosse, Wisconsin 54603-1088
Phone: (608) 781-2205
Fax:
(608) 783-3507
E-mail: RozSchnick@aol.com
Website:
http://aquanic.org/aquadrugs/index.htm
ANNUAL SUMMARY OF
ACTIVITY HIGHLIGHTS FOR THE
NATIONAL COORDINATOR FOR
AQUACULTURE NEW ANIMAL DRUG APPLICATIONS
(May 15, 1999 to May 14,
2000)
! ChorulonÒ (human chorionic
gonadotropin) was approved on September 7, 1999 by CVM as a spawning aid by intramuscular
injections for all fish and requires a prescription under the direction of a veterinarian.
! The National NADA
Coordinator organized, chaired, and gave the keynote addresses at a session on worldwide
cooperation toward aquaculture drug approvals at the World Aquaculture ‘99, April
26-May 2, 1999 in Sydney, Australia and on international harmonization of antibacterial
approvals and sensitivity testing at the EAFP 9th International Conference,
September 19-24, 1999 in Rhodes, Greece.
! Currently, nearly all
technical sections needed for approvals have been submitted and/or accepted for:
< Copper sulfate for
control of Ichthyopthirius on all fish
< Formalin for control or
prevention of fungi on salmonids
< Hydrogen peroxide for
control or prevention of fungi on salmonid eggs
< Oxytetracycline for
otolith marking on all fish
< Oxytetracycline for
control of columnaris disease and coldwater disease on salmonids below 9°C
< Oxytetracycline for
control of Aeromonas sp. on coolwater fish
! Sponsor of florfenicol
submitted a new animal drug application (NADA) for the control of furunculosis in
salmonids in 1999.
! Efficacy initiatives are
underway to gain data for broad label claims for chloramine-T, copper sulfate, formalin,
hydrogen peroxide, oxytetracycline, and potassium permanganate.
! The antimicrobial
resistance issue is affecting the continued or original approvals of all oral
antibacterials needed for aquaculture; efforts being made to address this issue by the
National Aquaculture Association and the National NADA Coordinator.
! An Aquaculture Effluents
Task Force was formed to address EPA Effluent Guidelines Plan that is affecting all drugs
needing environmental assessments for original approvals and continued approvals of all
oral antibacterials currently approved for aquaculture use.
! Minor Use/Minor Species
legislation to expedite the development of all aquaculture drugs is to be submitted to
Congress in May 2000.
! Internationally
standardized sensitivity tests to allow testing for susceptibility of aquatic pathogens to
antimicrobial agents are being developed that will help with recommendations on therapies,
aid the approval process, and determine the potential for antimicrobial resistance in
aquatic and human pathogens.
! The National NADA
Coordinator pursued and obtained enough funding for this position for Year 6 (May 15,
2000-May 14, 2001) to continue on a full-time basis. Over 50 letters were sent out
requesting Year 6 funding.
! A website was established
for the National NADA Coordinator on April 12, 1999 at
http://ag.ansc.purdue.edu/aquanic/jsa/aquadrugs.htm and was updated several times during
Year 5.
! In Year 5, the NADA
Coordinator had four publications, one manuscript in press and two in review, presented 14
papers and talks, and wrote 33 reports.
! The National NADA
Coordinator will receive the FDA Commissioner's Citation Award at a ceremony in Rockville,
Maryland on June 9, 2000.
PROJECT OBJECTIVES
The overall goal of this
project is for the National Coordinator for Aquaculture New Animal Drug Applications
(National NADA Coordinator) to coordinate activities for investigational new animal drug
exemptions (INADs) and new animal drug applications (NADAs) to expedite approval for the
use of various drugs in aquaculture. Specific
objectives related to that goal are to:
! Serve as an information
conduit between INAD/NADA applicants and the U.S. Food and Drug Administration’s
Center for Veterinary Medicine (CVM);
! Identify and encourage
prospective INAD participants to become involved in specific investigational studies and
NADA approval-related research;
! Seek the support and
participation of pharmaceutical sponsors for INAD studies and NADAs and coordinate with
INAD/NADA sponsors to achieve CVM approval more quickly;
! Guide prospective and
current INAD holders on the format for INAD exemption requests and related submissions to
CVM;
! Identify existing data
and remaining data requirements for NADA approvals;
! Review, record, and
provide information on the status of INADs and NADAs;
Provide liaison and
coordination among all the federal agencies involved in the INAD/NADA process; and
! Provide public education
related to training and guidance in obtaining INAD exemptions and pursuing NADA approval.
PROGRESS AND PRINCIPAL ACCOMPLISHMENTS
The National NADA
Coordinator provided many information transfers this year and worked to obtain INADs,
NADAs and approvals for a number of drugs that are considered to be of high priority for
approval by the public and private aquaculture community.
THERAPEUTANTS
Amoxicillin (oral
antibacterial) ¾ Status: Two sponsors
have submitted INAD/NADA letters of intent; early development stage; antimicrobial
resistance issue needs to be addressed.
GB Research, one of the
sponsors of an INAD, is working with Kent Seafarms to be the new U.S. representative for
the development of its amoxicillin product.
The National NADA
Coordinator and a CVM official met on February 3, 2000 with a representative of Kent
SeaFarms at Aquaculture America 2000 to discuss development of amoxicillin for the hybrid
striped bass and tilapia industries.
Harry K. Dupree
Stuttgart National Aquaculture Research Center (HKD-SNARC) has agreed to help develop data
to gain approval of amoxicillin in aquaculture.
Chloramine-T
(external antibacterial) ¾ Status: Sponsor has
committed to INAD/NADA; major effort for NADA approval under the International Association
of Fish and Wildlife Agencies (IAFWA) Project and compassionate INADs. BOTTOM LINE: All submissions should be
completed in 2000 for control of mortalities associated with bacterial gill disease on
salmonids, in 2001 for control of mortalities associated with bacterial gill disease on
cool- and warmwater fish and external flavobacteriosis on salmonids, and in 2002 for
control of mortalities associated with external flavobacteriosis on cool- and warmwater
fish.
The National NADA
Coordinator met with representatives of Akzo Nobel Functional Chemicals on June 8, 1999 in
La Crosse, Wisconsin to discuss the remaining data requirements for chloramine-T, develop
a timetable to complete these requirements, and determine the market potential for all its
uses.
The National NADA
Coordinator is working with Akzo and CVM to finalize the protocols for the genotoxicity
studies on the marker residue of chloramine so that Akzo can complete the remaining
mammalian safety data requirements.
The National NADA
Coordinator met with Akzo Nobel Chemicals, Inc. on November 29, 1999 in La Crosse,
Wisconsin to discuss the remaining data requirements for chloramine-T and strategies to
meet those data requirements.
In April 25, 2000,
the National NADA Coordinator was informed that Akzo had sold its chloramine-T product to
two of its employees and the new company's name is Axcentive. All contacts, agreements,
and timetables will remain the same.
Progress on
Technical Sections:
< Product Chemistry ¾ Sponsor, Axcentive
(formerly Akzo Nobel Chemicals, Inc.), is committed to developing the product chemistry
technical section
< Mammalian Safety ¾ Sponsor is close to
signing an amended Cooperative Research and Development Agreement (CRADA) with the Upper
Midwest Environmental Sciences Center (UMESC) and, prior to that CRADA, initiated required
genotoxicity studies (the only mammalian toxicology studies now required by CVM)
< Environmental Safety
¾ Before the CRADA was
signed, the sponsor agreed to send their environmental data to UMESC for development of
the environmental assessment
< Model developed by UMESC
to estimate discharged environmental concentrations based on UMESC hatchery survey and a
point source dilution model from the U.S. Geological Survey; development of environmental
assessment by UMESC started April 2000
< Residue Chemistry ¾ Some residue chemistry
data developed by UMESC accepted by CVM; completevalidation of proposed method for marker
residue in 2000; marker residue depletion studies to start when tolerance established
based on results of genotoxicity studies that are underway
< Target Animal Safety
¾ Target animal safety
studies soon to be completed on all fish at the FWS Bozeman INAD Office and UMESC
< Efficacy ¾ Efficacy data
requirements are met for the control of external flavobacteriosis on salmonids in
freshwater at 12 to 20 ppm; pivotal efficacy data from Pennsylvania accepted for
prevention of bacterial gill disease in tiger muskellunge at 20 ppm; pivotal and
supporting efficacy data needed for control of external flavobacteriosis on cool- and
warmwater fish; in a recent commitment, the North Central Regional Aquaculture Center is
providing funds to Iowa for pivotal efficacy studies on percids for control of external
flavobacteriosis
Copper Sulfate
(external microbicide) ¾ Status: Sponsor has an
acceptable product chemistry technical section; major effort for approval under the IAFWA
Project. BOTTOM LINE: All submissions should be completed in 2000 for control Ichthyopthirius
on all fish. The claims for control or prevention of other external microbes on all
fish would be based on efficacy studies that would be completed in 2001 if stakeholders
are interested.
The sponsor of
copper sulfate, Phelps Dodge Refining Corporation, obtained acceptance of the product
chemistry technical section from CVM on May 4, 1999.
The National NADA
Coordinator prepared draft letters on July 14, 1999 that were submitted by Phelps Dodge
Refining Corporation to CVM concerning a request for exclusivity and for the writing of
the human food safety portion of the Freedom of Information (FOI) summary for copper
sulfate. CVM did not grant exclusivity but did prepare the FOI summary.
Progress on
Technical Sections:
< Product Chemistry ¾ Accepted by CVM from the
sponsor, Phelps Dodge Refining Corporation
< Mammalian Safety ¾ Accepted by CVM
< Environmental Safety
¾ Revised environmental
safety technical section for all fish in review at CVM; references related to the
environmental safety submitted by HKD-SNARL to CVM at the agency's request in April 2000
< Residue Chemistry ¾ Accepted by CVM
< Target Animal Safety
¾ Revised target animal
safety technical sections for all fish in review at CVM
< Efficacy ¾ Accepted by CVM for
control or prevention of Ichthyopthirius on all fish
< Supporting efficacy data
considered to be sufficient by HKD-SNARL include control and/or prevent fungi on fish;
control and/or prevent external flavobacteriosis on all fish; and control external
parasites (except Ichthyopthirius) on all fish; needed are supporting efficacy
studies to control and/or prevent fungi on all fish eggs and all fish
< Efforts underway by
HKD-SNARL to conduct pivotal efficacy studies to control and/or prevent fungi on fish
eggs; needed are pivotal efficacy studies to control and/or prevent fungi on all fish;
control and/or prevent external flavobacteriosis on all fish; and control external
parasites (except Ichthyopthirius) on all fish
< FOIs for efficacy and
target animal safety underway at HKD-SNARL
< When the target animal
safety and environmental safety technical sections are accepted by CVM, the data
requirements will be complete for control or prevention of Ichthyopthirius on all
fish
< HKD-SNARL committed to
complete any remaining data requirements necessary for approval for control or prevention
of Ichthyopthirius on all fish
Cutrine-Plusä (external microbicide) ¾ Status: Some interest by
potential sponsor; early development stage.
Diquat Dibromide
(external microbicide) ¾ Status: No commitment by
potential sponsor; early development stage.
Earth Tec
Algicide/Bactericideä (external microbicide) ¾ Status: Sponsor recently
submitted INAD/NADA letter of intent; early development stage.
Enrofloxacin (oral
antibacterial) ¾ Status: INADs inactive
in the U.S. because of fluoroquinolone issues; no sponsor interest.
Erythromycin (oral
antibacterial) ¾ Status: Sponsorship
needs to be resolved; all technical sections except sponsor product chemistry submitted;
risk assessment needed on potential for antimicrobial resistance in humans; near NADA
approval for bacterial kidney disease in salmonids if gain sponsor and resolve the
antimicrobial resistance issue.
Florfenicol (oral
antibacterial) ¾ Status: Sponsor recently
allowed the development of florfenicol for approval in U.S.; approved in Canada in August
1997 to control furunculosis in Atlantic salmon.
The National NADA
Coordinator met with a representative of Schering-Plough Animal Health during World
Aquaculture >99 to discuss the potential for drug approval of florfenicol in Chile and
worldwide.
A meeting was held on
July 20-21, 1999 with Schering-Plough Animal Health, FWS, the Upper Midwest Environmental
Sciences Center (UMESC), and the National NADA Coordinator to discuss the details in
initiating the efficacy studies through a FWS-INAD and in conducting the residue chemistry
studies.
Discussions on the
development of florfenicol were held with CVM at the FWS-INAD Coordination meeting in
Bozeman, Montana on August 4-5, 1999.
Schering-Plough Animal
Health submitted a data package to CVM for florfenicol to control furunculosis in
salmonids on September 30, 1999.
Schering-Plough Animal
Health reviewed the quality assurance and Good Laboratory Practices procedures at UMESC on
October 5-6, 1999.
Schering-Plough
Animal Health recently gained an approval in the United Kingdom for the use of florfenicol
to control furunculosis in Atlantic salmon in marine netpens.
Recent commitment
of financial support from North Central Regional Aquaculture Center to Iowa for pivotal
efficacy studies on percids for control of systemic flavobacteriosis.
Decision by the
IAFWA Drug Approval Working Group on florfenicol--Decided at this time under the IAFWA
Project not to support efforts on the only new oral antibacterial drug available to
aquaculture because the development will take until at least 2002 and perhaps beyond to
obtain data for all fish and all potential label claims and resolve the antimicrobial
resistance issue; agreed to support florfenicol under a new funding initiative under
development by IAFWA and FWS; crop grouping research with florfenicol to still go forward.
The National NADA
Coordinator and representatives from FWS, CVM, and UMESC met with Schering-Plough Animal
Health on May 2, 2000 in Union, New Jersey to discuss the development of florfenicol for
aquaculture in the United States.
Formalin (external
microbicide) ¾ Status: IAFWA Project
drug; Supplemental NADA approved on June 18, 1998 for control of certain fungi on the eggs
of all finfish and certain external protozoa and monogenetic trematodes on all finfish. BOTTOM
LINE: All submissions should be completed in 2000 for control or prevention of
mortalities associated with fungal infections on salmonids and in 2001 for control or
prevention of mortalities associated with fungal infections on all fish.
Progress on
Technical Sections:
< Product Chemistry ¾ Accepted by CVM
< Mammalian Safety ¾ Accepted by CVM
< Environmental Safety
¾ Accepted by CVM
< Residue Chemistry ¾ Accepted by CVM
< Target Animal Safety
¾ Accepted by CVM
< Efficacy ¾ Fungal disease model
developed for efficacy studies by UMESC
CVM informally
accepted supporting efficacy for control or prevention of fungi on salmonids from FWS and
UMESC efforts; plans are underway to perform pivotal efficacy studies for control or
prevention of fungi on all fish; supporting efficacy data needed for control or prevention
of fungi on cool- and warmwater fish.
Fumagillin
(microsporidiosis control) ¾ Status: Sponsor recently
submitted INAD/NADA letter of intent; several efforts to collect efficacy data in public
and private sector; early development stage.
Hydrogen peroxide
(external microbicide) ¾ Status: Currently
considered as a low regulatory priority drug for use as a fungicide on fish and fish eggs
but CVM has encouraged the development of a NADA; one U.S. sponsor is interested in
gaining an NADA approval; IAFWA Project drug; human food safety data requirements are met.
BOTTOM LINE: All submissions should be completed in 2000 for control or prevent
mortalities associated with fungal infections on all fish eggs in the U.S., in 2001 for
control or prevent mortalities associated with fungal infections on all fish, and in 2002
for external flavobacteriosis and bacterial gill disease on all fish and to control
parasitic infestations on all fish.
The sponsor (Eka
Chemicals Inc.) has completed the negotiations with Syndel International Inc. to do the
marketing of hydrogen peroxide (Perox-Aidä) for fisheries use in
Canada.
A series of
meetings were held in July, August, October, and November 1999 at UMESC with the National
NADA Coordinator to discuss the development of the remaining data requirements, especially
environmental safety, to complete the submission of all the technical sections needed for
approval. Several conference calls were held with the sponsor as well during this time
period.
Progress on
Technical Sections:
< Product Chemistry ¾ Sponsor, Eka Chemicals,
Inc., submitted product chemistry technical section on July 12, 1999; additional data
required which the sponsor is committed to provide
< Mammalian Safety ¾ Accepted by CVM
< Environmental Safety
¾ Model developed by UMESC
to estimate discharged environmental concentrations based on UMESC hatchery survey and a
point source dilution model from the U.S. Geological Survey
< UMESC wrote an
environmental safety technical section for all fish and submitted it to CVM in March 2000
< Residue Chemistry ¾ Accepted by CVM
< Target Animal Safety
¾ Target animal safety
technical section on all fish eggs submitted by UMESC to CVM; safety accepted for dose
range of 500B1,000 ppm for northern pike, lake trout, and common carp; target animal
safety study on rainbow trout eggs and eggs of most sensitive warmwater species to be
completed in 2000
< Target animal safety
technical section on all fish to be submitted by UMESC to CVM in spring of 2000
< Efficacy ¾ Fungal disease model
developed for efficacy studies by UMESC
Efficacy technical
section on control or prevention of fungi on all fish eggs submitted by UMESC to CVM; CVM
accepted efficacy data for control or prevention of fungi on salmonid eggs; pivotal
efficacy studies planned by UMESC for control or prevention of fungi on cool- and
warmwater fish eggs; supporting data needed to support a claim for control or prevention
of fungi on cool- and warmwater fish eggs.
Pivotal efficacy
studies planned by UMESC for control or prevention of fungi on all fish; supporting data
needed to support a claim for control or prevention of fungi on all fish.
Pivotal efficacy
studies on control of external flavobacteriosis and external parasites on salmonids
submitted by UMESC to CVM in March 2000; supporting efficacy data needed for control of
external flavobacteriosis and external parasites on salmonids; both pivotal and supporting
data needed for control of external flavobacteriosis and external parasites on cool- and
warmwater fish; both pivotal and supporting data needed for prevention of external
flavobacteriosis on all fish.
Protocols for
supporting efficacy studies under an INAD at UMESC for control or prevention of fungi on
cool- and warmwater fish eggs and all fish submitted by UMESC to CVM in March 2000; other
protocols for supporting efficacy studies to be submitted soon for control or prevention
of flavobacteriosis on all fish and control of external parasites on all fish.
When target animal
safety on salmonid eggs and environmental safety technical sections are accepted and the
FOIs completed for efficacy and target animal safety, the data requirements will be
completed for control or prevention of fungi on salmonid eggs.
Neomycin sulfate
(vibriosis control) ¾ Status: Currently no
activity on this drug.
Oxytetracycline
(OTC, oral antibacterial) ¾ Status: Currently
approved for control of certain bacterial diseases in catfish, salmonids, and lobsters and
as a marking agent in Pacific salmon; IAFWA Project drug.
BOTTOM LINE: All submissions should be completed in 2000 for control of Aeromonas
sp. in esocids, in 2001 for systemic flavobacteriosis in salmonids, and in 2002 for
control of mortalities associated with systemic columnaris disease in cool- and warmwater
fish.
The National NADA
Coordinator is discussing the development of data to add tilapia to the OTC label with
HKDSNARC and the Northeastern region of the National Research Support Program Number
Seven (NRSP-7).
The sponsor, Pfizer
Inc., is in the process of selling its oxytetracycline products to a company that has
expressed an interest in aquaculture; the company has stopped production of its product
for aquaculture in Canada.
Progress on
Technical Sections:
< All technical sections
except for some residue chemistry and efficacy are complete for new label claims to extend
to other fish species and to expand its use to other diseases not on the current label
(see below)
< Product Chemistry ¾ Accepted by CVM
< Mammalian Safety ¾ Accepted by CVM
< Environmental Safety
¾ Accepted by CVM
< Residue Chemistry ¾ Accepted by CVM for
coldwater species above 9°C and warmwater species
< Residue chemistry studies
submitted by UMESC to CVM for use below the label claim limit of 9°C; HPLC method accepted
to detect product in feed and fish tissue; bridging study to microbial assay method
accepted; residue chemistry study completed in one coolwater species and second study
planned
< Target Animal Safety
¾ Accepted by CVM
< Efficacy ¾ Efficacy technical
section from data call-in accepted as supporting data for control of Aeromonas sp. in
coolwater species and systemic flavobacteriosis in salmonids; pivotal efficacy data needed
for control of Aeromonas sp. in coolwater species and systemic flavobacteriosis in
salmonids; both pivotal and supporting efficacy data needed for control of systemic
flavobacteriosis in cool- and warmwater fish
< Several pivotal efficacy
studies completed by FWS to control systemic flavobacteriosis in salmonids; efficacy
technical section to be submitted soon to CVM; more studies are needed
< Recent commitment of
financial support from North Central Regional Aquaculture Center to Iowa for pivotal
efficacy studies in percids for control of columnaris disease
Pet Fish Therapeutants
(various drugs and pesticides) ¾ Status: Major effort to
resolve non-food fish issue for these drugs by private consultant
Potassium Permanganate
(external microbicide) ¾ Status: Sponsor recently
submitted an INAD/NADA letter of intent, product chemistry, and a request for categorical
exclusion for environmental safety; major effort for NADA approval under IAFWA Project. BOTTOM LINE: All submissions should be
completed in 2001 for control or prevention of mortalities associated with external fungal
infections on all fish and in 2002 for control or prevention of mortalities associated
with external flavobacteriosis and bacterial gill disease and control of parasitic
infestations on all fish.
Progress on
Technical Sections:
< Product Chemistry ¾ Sponsor, Carus Chemical
Company, submitted product chemistry technical section for all fish to CVM on December 8,
1998; additional data needed
< Mammalian Safety ¾ Data requirements
dependent upon results of residue chemistry review by CVM
< Environmental Safety
¾ Sponsor submitted
environmental safety technical section for all fish to CVM on February 23, 1998;
additional data needed; sponsor working on developing contract for an environmental
assessment but needs further information on data requirements from CVM
< Residue Chemistry ¾ Residue chemistry
technical section for all fish submitted by HKD-SNARL to CVM and informal response from
CVM is that there is no increase in manganese content as a result of exposure
< Target Animal Safety
¾ HKD-SNARL completed
target animal safety study on channel catfish (except for histopathology) and plans to
conduct a target animal safety on rainbow trout this spring
< Efficacy ¾ HKD-SNARL completed
pivotal efficacy studies that demonstrate efficacy to prevent Ichthyopthirius on
channel catfish and tilapia; HKD-SNARL initiating pivotal efficacy study for control of Ichthyopthirius
channel catfish and a scaled species; supporting efficacy data needed for prevention
of Ichthyopthirius on all fish
< Supporting efficacy data
considered to be sufficient by HKD-SNARL include control and/or prevent fungi on fish;
control external flavobacteriosis and control external parasites (including Ichthyopthirius)
on all fish; needed are supporting efficacy studies to control and/or prevent fungi on
all fish eggs and all fish
< HKD-SNARL to decide
whether to address adding other label claims: control and/or prevent external
flavobacteriosis and control external parasites (except Ichthyopthirius)
Praziquantel
(trematode and cestode control) ¾ Status: Some interest on
the part of potential sponsor in a U.S. NADA approval but needs positive marketing
information; has approval in several countries.
Pycezeä (external microbicide) ¾ Status: Sponsor recently
submitted an INAD/NADA letter of intent and summary of all major technical sections; early
development stage.
Quinine (internal
microbicide) ¾ Status: Some interest on
the part of potential sponsor in a U.S. NADA approval if market is large enough.
Sarafloxacin (oral
antibacterial) ¾ Status: Previously, most
of the NADA technical sections were submitted by Abbott Laboratories and accepted by CVM
for control of enteric septicemia in catfish. Recently, the Centers for Disease Control
and Prevention have presented concerns about the use of all fluoroquinolones in animal
health because of the perceived potential for developing pathogen resistance to drugs used
in humans. It is doubtful that a new NADA on
sarafloxacin or any fluoroquinolone will be allowed for aquaculture uses by CVM. Sarafloxacin was replaced by florfenicol as the
oral antibacterial and model drug for crop grouping research in January 1998 by a
unanimous vote of the IAFWA Project stakeholders.
Sea Lice Control (various
drugs and pesticides) ¾ Status: Various drugs
and pesticides (azamethiphos or Salmosanä, cypermethrin or ExcisJ) are being pursued by the
U.S. and Canada and are at various stages of registration and approval.
Trichlorfon
(external parasite control) ¾ Status: Some interest on
the part of potential sponsor in a U.S. NADA approval; has approvals in several countries;
Special Local Need registrations granted in 1998.
ANESTHETICS
Aqui-Sä/Aqui-S Plusä ¾ Status: Sponsor
proceeding with worldwide drug approval; major effort for NADA approval under IAFWA
Project. BOTTOM LINE: All submissions
should be completed in 2001 for zero or low withdrawal time anesthetic for Atlantic salmon
and in 2002 for all fish.
The National NADA
Coordinator met with representatives of the company that developed AQUI-Sä in Sydney, Australia
during World Aquaculture ‘99 and in Nelson, New Zealand on May 11, 1999 to discuss
the strategies for the development of the drug for the U.S. market and worldwide.
Progress on Technical
Sections:
< Product Chemistry ¾ Accepted elsewhere; no
current activity for U.S.
< Mammalian Safety ¾ Sponsor, AQUI-S New
Zealand LTD, conducted a review of the mammalian safety literature to determine whether to
continue with the original active ingredient in light of National Toxicology Program (NTP)
studies to test for its potential carcinogenicity scheduled for completion in July 2001;
sponsor concluded that the active ingredient is safe and presented these conclusions to
CVM on November 18, 1999; sponsor decided to proceed with the drug approval in the U.S.
for original active ingredient based on their assessment of scientific data that the
active ingredient is not a carcinogen
< Environmental Safety
¾ Sponsor completed an
environmental biodegradation study in freshwater with good results
< Residue Chemistry ¾ On July 7, 1999, the
sponsor signed a CRADA with UMESC for residue chemistry studies; sponsor scheduled a total
residue depletion study on salmonids to be conducted by UMESC beginning in April 2000
< Target Animal Safety
¾ Preliminary toxicity
studies completed at UMESC on a variety of fish species; pivotal target animal safety
studies to begin soon at UMESC; sponsor is ready to submit target animal safety and
efficacy studies on salmonids completed in Canada to CVM
< Efficacy ¾ Preliminary efficacy
studies completed at UMESC on a variety of fish species; pivotal efficacy studies to begin
soon at UMESC; sponsor is ready to submit efficacy studies on salmonids completed in
Canada to CVM; INAD number established for FWS for collection of supporting efficacy data
at limited sites but experimental withdrawal time and slaughter authorization pending CVM
decision on residue depletion rates; sponsor submitted existing residue depletion rates to
CVM in December 2000 to gain an experimental withdrawal time for a compassionate INAD by
the U.S. Fish and Wildlife Service (FWS); CVM decision needed before FWS can proceed with
the compassionate INAD
The IAFWA Drug Approval
Working Group on AQUI-Sä decided to continue to
support current research on an active ingredient in AQUI-Sä whose status as a
potential carcinogen will not be known until July 2001 but whose sponsor concluded that
the active ingredient is safe based on: (1) an understanding of metabolic pathways that
support safety, (2) agreement on safety by independent experts, (3) preliminary results of
a parallel NTP study, (4) similar results on a related active ingredient, eugenol, and (5)
similar toxicological studies showed no effect.
Benzocaine ¾ Status: Major effort by
IAFWA Project for NADA approval terminated because of decision by IAFWA Project
stakeholders to select AQUI-Sä as the candidate
anesthetic in the U.S. public aquaculture sector; no known drug approval activities
underway.
MS-222 ¾ Status: Two approved
NADAs for MS-22 as an anesthetic with a 21-day withdrawal time.
Oil of Cloves ¾ Status: Oil of cloves
(eugenol) is considered Generally Recognized as Safe when used as a direct food additive
(21CFR184.1257); however, to use eugenol as an anesthetic on fish, it must be approved by
CVM for that purpose. A sponsor is required
to proceed toward approval and no sponsor has come forward; no known drug approval
activities underway.
SPAWNING AND GENDER
MANIPULATION AIDS
Common Carp
Pituitary (CCP) ¾ Status: Sponsor and
interested parties proceeding toward NADA approval. BOTTOM
LINE: All submissions should be completed in 2000 for use on all fish.
Progress on
Technical Sections:
< Product Chemistry ¾ With the help of the
National NADA Coordinator, the sponsor, Stoller Fisheries, submitted the product chemistry
technical section for CCP to CVM on September 21, 1999. The sponsor received a response on
November 22, 1999 from CVM that asked for more information
< Mammalian Safety ¾ Accepted by CVM
< Environmental Safety
¾ Accepted by CVM
< Residue Chemistry ¾ Accepted by CVM
< Target Animal Safety
¾ A literature review on
target animal safety of CCP was completed, presented onAugust 5, 1998 in Bozeman, Montana
and submitted to CVM in summer 1999 by the Southeastern region of NRSP-7. The National
NADA Coordinator is working with a researcher from Mississippi State University to
complete the needed target animal safety studies on CCP
< Efficacy ¾ A literature review on
efficacy of CCP was completed, presented on August 5, 1998 in Bozeman, Montana and
submitted to CVM in summer 1999 by the Southeastern region of NRSP-7
17 ß-estradiol
(estrogen) ¾ Status: Sponsor and
interested parties working on the development of an INAD; early development stage. BOTTOM LINE: Early development stage.
The National NADA
Coordinator began in June 1999 to work with the potential INAD sponsor for the development
of estrogen to gender manipulate American eels to all female populations. A draft letter was written by the National NADA
Coordinator for submission to CVM by the sponsor. Draft
protocols were reviewed and procedures delineated for gaining an approval.
An INAD (# 10-673
was obtained for 17ß-estradiol to gender manipulate American eels and summer flounder to
all female populations. A draft efficacy protocol was developed and submitted to CVM for
review.
A meeting was held
with CVM on March 16, 2000 to discuss development of 17ß-estradiol as a gender
manipulation aid for marine finfish species.
Gonadotropin
Releasing Hormone (GnRH) ¾ Status: Sponsor recently
submitted INAD letter of intent. BOTTOM LINE: Early development stage
Human Chorionic
Gonadotropin (hCG) ¾ Status: September 1999
NADA approval in the U.S.
ChorulonÒ (human chorionic
gonadotropin, hCG) was approved on September 7, 1999 by CVM as a spawning aid by
intramuscular injection for all fish and requires a prescription under the direction of a
veterinarian. This approval is significant
because it is the first original approval since 1986 when formalin was first approved for
fish and because it was approved for all fish.
Ovaplantä and Ovaprimä ¾ Status: Sponsor recently
submitted INAD letter of intent. BOTTOM
LINE: Early development stage.
17a-methyltestosterone
(MT) ¾ Status: Sponsor is
developing NADA package; INAD sponsors actively pursuing a NADA approval; environmental
assessment reviewed, revised, and resubmitted. BOTTOM
LINE: All technical section submissions should be into CVM by the end of 2000.
The National Aquaculture
NADA Coordinator and a CVM official met on February 3, 2000 with representatives of
Rangen, Inc. and Auburn University in February 2000 at Aquaculture America 2000 to discuss
the status of the development of MT as a gender manipulation aid.
Progress on
Technical Sections:
< Product Chemistry ¾ The sponsor, Rangen,
Inc., prepared a draft product chemistry technical section that the National NADA
Coordinator reviewed in May 2000
< Mammalian Safety ¾ Accepted by CVM
< Environmental Safety
¾ Auburn University
received a response from CVM on November 8, 1999 regarding the revised environmental
assessment for MT that requested additional information
< Residue Chemistry ¾ Accepted by CVM
< Target Animal Safety
¾ Target animal safety
study completed on percids by Southern Illinois University; literature review on other
species completed by Auburn University
< Efficacy ¾ Auburn University
coordinating compassionate INAD on tilapia; North Central Regional Aquaculture Center
representatives coordinating compassionate INAD on percids.
CHEMICAL MARKING AGENTS
Calcein ¾ Status: No sponsor; one
known publication on efficacy.
Oxytetracycline ¾ Status: FDA liaison to
NRSP-7 completed a Public Master File and submitted it to CVM in October 1999. BOTTOM LINE: All the technical section
submissions for OTC are completed for a supplemental NADA approval as a marking agent for
all fish by immersion.
Strontium Chloride ¾ Status: No sponsor; some
work completed in Alaska; some efficacy studies underway under Western NRSP-7
PUBLIC INFORMATION,
WORKSHOPS AND PRESENTATIONS
Federal-State
Aquaculture Drug Approval Partnership Program (IAFWA Project)
Major advances were
made toward communication and coordination of INAD/NADAs of high priority drugs important
to public fish production at a workshop held by the FWS in Bozeman, Montana on August 4-5,
1999. Discussions centered particularly on
the status of chloramine-T, AQUI-Sä, and florfenicol and the
general progress of the IAFWA Project.
The Drug Approval
Oversight Subcommittee (now the Drug Approval Working Group [DAWG]) formed to aid the
federal-state aquaculture drug approval partnership program (a project of the IAFWA
Project) to achieve its goal of obtaining drug approvals for U.S. public aquaculture held
a meeting in Killington, Vermont on September 16-17, 1999 to discuss the progress being
made on the IAFWA Project drugs and to support the extension of the IAFWA Project until at
least 2002. The group also met on March 26, 2000 in Chicago, Illinois to get an update on
the status of each drug and decide whether to continue with AQUISä (yes) and florfenicol
(no, but will support other funding possibilities later in 2000). See both drugs for
details.
Status of the crop
grouping research: Florfenicol replaced sarafloxacin as the model oral drug based on 1998
IAFWA Project stakeholder survey. Ohio State University is completing work on the model
water borne drug, benzocaine. Classical compartmental pharmacokinetic models are being
developed in five phylogenetically diverse species. Physiologically based pharmacokinetic
models have been developed in channel catfish and rainbow trout. UMESC will use these PBPK
models to support their work on florfenicol. Work on florfenicol will continue until the
end of the IAFWA Project. When completed, CVM will have a comprehensive data set from
which to make a decision on crop grouping.
Additional Efficacy
Studies for IAFWA Project Drugs
Situation:
< Need for additional
pivotal and/or supporting efficacy data for at least one label claim for all eight IAFWA
Project drugs
< Recent commitment of
financial support from North Central Regional Aquaculture Center to the state of Iowa for
pivotal efficacy studies on florfenicol, oxytetracycline, and chloramine-T
< UMESC, HKD-SNARL, and FWS
making efforts to fill both pivotal and supporting efficacy data needs but not enough to
cover all the needs
Solutions:
< A nationwide initiative
entitled “The Shortest Yard” to mainly private aquaculture sector implemented by
National Aquaculture NADA Coordinator
< A Drug Approval Working
Group to work with National Aquaculture NADA Coordinator to obtain pivotal efficacy data
from state agencies
< National Aquaculture NADA
Coordinator wrote article for Fish Health Section Newsletter requesting studies from the
members to gain both pivotal and supporting data for IAFWA Project drugs
Meetings and
Special Activities
A Web site was
established for the National NADA Coordinator on April 12, 1999 at
http://ag.ansc.purdue.edu/aquanic/jsa/Aquadrugs/index.htm.
Major items were added to the Web site in August 1999.
The National NADA
Coordinator organized, chaired, and gave the keynote address at a session on worldwide
cooperation toward aquaculture drug approvals at the World Aquaculture ‘99, April 26
to May 2, 1999 in Sydney, Australia.
In May 1999, Dr. Joan
Gotthardt replaced Dr. Tom Bell at CVM for reviewing aquaculture drug submissions.
The National NADA
Coordinator attended a meeting at the American Farm Bureau Association on June 29, 1999 to
bring stakeholders interested in forming a coalition to institute various provisions in
the MUMS document. The intent was to reach an
agreement on the priority provisions, develop specific strategies for implementing
priority items, identify collective and individual actions, and develop an appropriate
communication network.
The National NADA
Coordinator attended the American Fisheries Society annual meeting in Charlotte, North
Carolina on August 28-31, 1999 to finalize a manual on the administrative and technical
procedures for the use of rotenone in public and private waters. Rotenone is used by resource agencies and private
aquaculture facilities to control undesirable fish.
In its meeting on
September 8, 1999, the MUMS Coalition asked CVM a series of questions and supplied a list
of provisions it supports in general. CVM was
very supportive of all the provisions and answered all the questions raised by the MUMS
Coalition. On September 9, 1999 the MUMS
Coalition met to discuss the development of legislation to be called the Minor Animal
Species Health and Welfare Act of 2000 and the strategies for getting the legislation
through Congress. Several meetings and
conference calls in late 1999 and early 2000 were convened to move the draft bill forward.
A firm, Meyers and Associates, was hired to move the legislation through the U.S.
Congress.
The National NADA
Coordinator organized, chaired, and gave the keynote address at a session on international
harmonization of antibacterial approvals and sensitivity testing at the EAFP 9th
International Conference, September 19-24, 1999 in Rhodes, Greece.
On September 27,
1999, CVM hired a second technical reviewer for efficacy and target animal safety data
submissions for aquaculture drugs.
On November 4,
1999, the National NADA Coordinator participated in a one-hour conference call with the
Fish Disease Workshop at Ohio State University.
The National NADA
Coordinator was filmed on November 17, 1999 for the video being developed by the U.S. Fish
and Wildlife Service to help persons understand the reasons and procedures for INADs in
aquaculture.
In December 1999, the
National NADA Coordinator sent out 50 letters for funding and obtained enough funding for
this position for Year 6 (May 15, 2000 to May 14, 2001) to continue on a full-time basis.
On January 12,
2000, the National Aquaculture Association developed a response on antimicrobial
resistance to an October 18, 1999 memo from the Centers for Disease Control and Prevention
refuting the potential public health impact of the use of antimicrobial agents in
aquaculture. The National Aquaculture NADA Coordinator helped with the response.
The National NADA
Coordinator organized and chaired a special session on the Minor Use/Minor Species
legislation on February 4, 2000 at Aquaculture America 2000, New Orleans, Louisiana.
The National NADA
Coordinator attended a meeting of the National Catfish Information Database on February 4,
2000 at Aquaculture America 2000, New Orleans, Louisiana.
The Joint
Subcommittee on Aquaculture formed the Aquaculture Effluents Task Force to coordinate and
facilitate input of science-based information to assist in the development of national
effluent limitation guidelines and standards for aquaculture facilities by EPA. The task
force has had several meetings in 2000 to set the course of action. The National
Aquaculture NADA Coordinator is a member of this task force.
The National NADA
Coordinator gave an update on the antimicrobial resistance issue at a meeting of The
Aquaculture Partnership (TAP) convened at the Catfish Farmers of America Annual Meeting,
Albuquerque, Mew Mexico, February 18, 2000.
A bill entitled
“Minor Animal Species Health and Welfare Act of 2000” is almost ready for
submission to the U.S. Congress by the Minor Species/Minor Use (MUMS) Coalition. The bill
will include provisions for early life stages that should help expedite the approvals of
aquaculture drugs that are of interest to public and private fish production. The draft
bill is currently under review by CVM and should be introduced into Congress in May 2000.
The National NADA
Coordinator was informed on May 4, 2000 that she will be the recipient of the FDA
Commissioner's Citation Award to be presented on June 9, 2000 in Rockville, Maryland.
The National NADA
Coordinator hosted a meeting of the American Fisheries Society, Fish Management Chemicals
Subcommittee on the Rotenone Stewardship Program in La Crosse, Wisconsin, May 4-7, 2000.
PUBLICATIONS
Schnick, R.A. 1999.
Use of chemicals in fish management and fish culture: past and future. Chapter 1, pages
1-14. in D.J. Smith, W.H. Gingerich, and M. Beconi-Barker, editors. Xenobiotics in
fish. Kluwer/Plenum Publishers, New York.
Schnick, R.A., and
P. Smith. 1999. International harmonisation of antibacterial agent approvals and
susceptibility testing. EAFP Bulletin 19(6):293-294.
Schnick, R.A. 2000.
Efficacy data needed for high priority aquaculture drugs. American Fisheries Society Fish
Health Newsletter 28(2):3.
American Fisheries
Society, Fish Management Chemicals Subcommittee. 2000. Editorial--Importance of rotenone
as a management tool for fisheries. Fisheries 25 (5):22-23.
MANUSCRIPTS
Griffin, B.R., R.A.
Schnick, and W.H. Gingerich. In review. Update on the Federal-State Aquaculture Drug
Approval Project. Aquaculture Magazine.
Schnick, R.A. In press. Introduction. Chapter 1.0 in Task Force on Fishery
Chemicals, American Fisheries Society. Rotenone use in fish management: administrative and
technical guidelines manual. American Fisheries Society, Bethesda, Maryland.
Schnick, R.A. In
review. International harmonization of antibacterial sensitivity determination for
aquaculture drugs. Aquaculture.
Schnick, R.A., and
W. McClay. In review. Better fishing through management: how rotenone is used to help
manage our fisheries resources more effectively. American Fisheries Society.
SPECIAL REPORTS
Schnick, R.A. 1999.
Dates for all submissions for label claims [Caveat: Needed are adequate efficacy data,
timely sponsor submissions, and full funding]. Submitted
to the DAOS Chair, Mike Gibson, Hot Springs, Arkansas.
April 9, 1999. 1 pp.
Schnick, R.A. 1999.
National Coordinator for Aquaculture New Animal Drug Applications (NADAs). Fourth annual
report of activities, May 15, 1998 to May 14, 1999. Submitted to Ted Batterson, North
Central Regional Aquaculture Center, East Lansing, Michigan. April 23, 1999. 15 pp.
Schnick, R.A. 1999.
Annual report for Contract #97-106. Submitted to the Center for Tropical and Subtropical
Aquaculture, Waimanalo, Hawaii. April 23, 1999. 8 pp.
Schnick, R.A. 1999.
The bottom line (March 1999). Submitted to the DAOS Chair, Mike Gibson, Hot Springs,
Arkansas. April 23, 1999. 2 pp.
Gingerich, W.H., G.R.
Stehly, J.A. Bernardy, V.K. Dawson, M.P. Gaikowski, J.R. Meinertz, R.A. Schnick, and B.R.
Griffin. 1999. Approval of drugs for public fish production, a federal aid report of
progress for IAFWA Project years one through five. Biological Resources Division, USGS,
Upper Midwest Environmental Sciences Center,
La Crosse, Wisconsin. May 1999. 32 pp.
Schnick, R.A. 1999.
Proposed Project Area III: National Coordinator for Aquaculture New Animal Drug
Applications - Year Five. Submitted to the Center for Tropical and Subtropical
Aquaculture, Waimanalo, Hawaii. June 2, 1999 (revised October 6, 1999). 26 pp.
Schnick, R.A. 1999.
1999 annual report of the AFS Task Force on Fishery Chemicals. Submitted to the Governing
Board and AFS President, Bob Carline, Bethesda, Maryland. June 23, 1999. 6 pp.
Schnick, R.A. 1999.
Progress toward technical section submissions for IAFWA Project drug approvals (July 1994
to 1999). Submitted to Bob Miles, IAFWA, Washington, DC. July 7, 1999. 8 pp.
Schnick, R.A. 1999.
Quarterly report for Contract #98-113 (April 1, 1999 to June 30, 1999). Submitted to the
Center for Tropical and Subtropical Aquaculture, Waimanalo, Hawaii. July 7, 1999. 1 pp.
Schnick, R.A. 1999.
National issue: need for drug approvals for the whole aquaculture industry. Submitted to
Gale Peek, National Aquaculture Workshop, sponsored by National Oceanic and Atmospheric
Administration, August 11-13, 1999 in Silver Spring, Maryland. July 16, 1999. 4 pp.
Schnick, R.A. 1999.
Status of IAFWA Project drugs in August 1999. Submitted to Mike Gibson, Chair, IAFWA Drug
Approval Oversight Subcommittee, Hot Springs, Arkansas. August 10, 1999. 2 pp.
Schnick, R.A. 1999.
Status of the aquaculture drug approval process in August 1999. Submitted to Web site.
August 19, 1999. 5 pp.
Schnick, R.A. 1999.
List of drugs, sponsors, INAD/NADA numbers, and dates (August 24, 1999). Submitted to Web
site. August 24, 1999. 3 pp.
Gingerich, W.H.,
G.R. Stehly, V.K. Dawson, M.P. Gaikowski, G.E. Howe, J.R. Meinertz, J.J. Rach, R.A.
Schnick, and B.R. Griffin. 1999. Approval of drugs for public fish production: fifth
annual report of progress [performance period: July
1, 1998 to June 30, 1999]. Biological Resources Division, USGS, Upper Midwest
Environmental Sciences Center, La Crosse,
Wisconsin. August 29, 1999. 45 pp.
Schnick, R.A. 1999.
Minutes to the MUMS Meeting with CVM, September 8, 1999. Submitted to Randy MacMillan,
Chair of the MUMS Coalition, Buhl, Idaho, for transmission to the attendees and CVM for
comment. September 13, 1999. 6 pp.
Schnick, R.A. 1999.
MUMS provisions summary as of September 9, 1999. Submitted to Mike Gibson, Chair, IAFWA
Drug Approval Oversight Subcommittee, Hot Springs, Arkansas. September 15, 1999. 2 pp.
Schnick, R.A. 1999.
Antimicrobial resistance issues and aquaculture drugs. Submitted to Randy MacMillan, Chair
of the white paper on antimicrobial resistance, Buhl, Idaho. September 16, 1999. 10 pp.
Schnick, R.A. 1999.
Quarterly report for Contract #98-113 (July 1, 1999 to September 30, 1999). Submitted to
the Center for Tropical and Subtropical Aquaculture, Waimanalo, Hawaii. October 7, 1999. 1 pp.
Schnick, R.A. 1999.
National Aquaculture INAD/NADA Coordinator. Progress report for the period September 1,
1992 to August 31, 1999. Submitted to North Central Regional Aquaculture Center, East
Lansing, Michigan. October 29, 1999. 24 pp.
Schnick, R.A. 1999.
Semi-annual report for Contract No. #98-113 (National Coordinator for Aquaculture New
Animal Drug Applications): reporting period, May 1, 1999 through October 31, 1999.
Submitted to Center for Tropical and Subtropical Aquaculture, The Oceanic Institute,
Waimanalo, Hawaii. December 13, 1999. 12 pp.
Schnick, R.A. 1999.
Status of the aquaculture drug approvals in the United States in December 1999. Office of
the NADA Coordinator, Michigan State University, La Crosse, Wisconsin. December 23, 1999.
5 pp.
Schnick, R.A. 2000.
2000 Midyear report of the AFS Task Force on Fishery Chemicals. Submitted to AFS
President, Christine Moffitt. January 29, 2000. 4 pp.
Gingerich, W.H.,
G.R. Stehly, V.K. Dawson, M.P. Gaikowski, G.E. Howe, JR. Meinertz, J.J. Rach, R.A.
Schnick, and BR. Griffin. 2000. Approval of Drugs for Public Fish Production: Sixth
midyear report of progress [performance period: July 1, 1999 to December 31, 1999].
Biological Resources Division, USGS, Upper Midwest Environmental Sciences Center, La
Crosse, Wisconsin. January 28, 2000. 39 pp.
Schnick, R.A. 2000.
Justification for continuing the Federal-State Aquaculture Drug Approval Project.
Submitted to Submitted to the IAFWA Drug Approval Working Group, Hot Springs, Arkansas.
February 17, 2000. 1 pp.
Schnick, R.A. 2000.
Additional justification for the proposal “Collection of pivotal field efficacy data
and tissue residue depletion data in support of a new animal drug approval for
florfenicol, oxytetracycline, and chloramine-T” by the Iowa Department of Natural
Resources. Submitted to USDA, Washington, DC and the North Central Regional Aquaculture
Center, East Lansing, Michigan. February 28, 2000. 4 pp.
Schnick, R.A. 2000.
Minutes to a meeting on 17ß-estradiol with the Center for Veterinary Medicine, Anguilla
Culture Technology, Inc. and the National Aquaculture NADA Coordinator. Submitted to the
Center for Veterinary Medicine, Rockville, Maryland. April 3, 2000. 4 pp.
Schnick, R.A. 2000.
“The Shortest Yard.” Submitted to Web site. April 6, 2000. 4 pp.
Schnick, R.A. 2000.
Draft--Status of technical sections for joint minor use/minor species drug approvals
coordinated through the National Aquaculture NADA Coordinator and NRSP-7 as of April 21,
2000. Submitted to NRSP-7. April 21, 2000. 4 pp.
Schnick, R.A. 2000.
Combined table--Pivotal and/or supporting efficacy studies for IAFWA Project drugs that
have been accepted as complete, submitted for review, completed but not submitted for
review, planned, in the literature, or needed. Submitted to the Upper Midwest
Environmental Sciences Center, La Crosse, Wisconsin. April 21, 2000. 2 pp.
Schnick, R.A. 2000.
Annual report for Contract No. #98-113 (National Coordinator for Aquaculture New Animal
Drug Applications): reporting period, May 1, 1999 through April 1, 2000. Submitted to
Center for Tropical and Subtropical Aquaculture, The Oceanic Institute, Waimanalo, Hawaii.
April 30, 2000. 19 pp.
Gingerich, W.H.,
R.A. Schnick, and B.R. Griffin. 2000. Amended grant proposal for Project Years 7 and 8
(Approval of Drugs for Public Fish Production, a project of the International Association
of Fish and Wildlife Agencies=IAFWA). Submitted to the IAFWA Drug Approval Working Group,
Hot Springs, Arkansas. May 2000. 14 pp.
Schnick, R.A. 2000.
National Coordinator for Aquaculture New Animal Drug Applications (NADAs). Fifth annual
report of activities, May 15, 1999 to May 14` 2000. Submitted to Ted Batterson, North
Central Regional Aquaculture Center, East Lansing, Michigan. May 18, 2000. 20 pp.
PRESENTATIONS
Schnick, R.A. 1999.
Keynote address: International cooperation toward aquaculture drug approvals. World
Aquaculture >99, Sydney, Australia, April 25-30, 1999.
Schnick, R.A. 1999.
USA programs related to aquaculture drug approval development and issues. Australian
Department of Agriculture, Fisheries and Forestry, Canberra, Australia, May 3, 1999.
Schnick, R.A. 1999.
Overview of NADA Coordinator activities. USFWS - INAD Coordination Workshop, Bozeman,
Montana, August 4-5, 1999.
Schnick, R.A. 1999.
Aquaculture NADA Coordinator update. Meeting
of the JSA Working Group on Quality Assurance in Aquaculture Production, Washington, DC,
September 9, 1999.
Schnick, R.A. 1999.
International harmonisation of antibacterial agent approvals and susceptibility testing.
Chaired Workshop at EAFP 9th International Conference “Diseases of Fish
and Shellfish,” Rhodes, Greece, September 19-24, 1999.
Schnick, R.A. 2000.
National Coordinator for Aquaculture New Animal Drug Applications update. Working Group on
Quality Assurance in Aquaculture Production at Aquaculture America 2000, New Orleans,
Louisiana, February 2, 2000.
Schnick, R.A. 2000.
Introduction and background to the MUMS legislation. Special Session “Future drug
approval process: MUMS opportunities,” Aquaculture America 2000, New Orleans,
Louisiana, February 2-5, 2000.
Schnick, R.A. 2000.
You can make a difference. Special Session “Future drug approval process: MUMS
opportunities.” Aquaculture America 2000, New Orleans, Louisiana, February 2-5, 2000.
Schnick, R.A. 2000.
Drug approvals. Mid-Continent Warmwater Fish Culture Workshop, Council Bluffs, Iowa,
February 7-8, 2000.
Schnick, R.A. 2000.
New drug approval progress. Missouri Aquaculture Association Annual Meeting, Cape
Girardeau, Missouri, February 22-23, 2000.
Schnick, R.A. 2000.
Report of the National Coordinator for Aquaculture New Animal Drug Applications. NCRAC
Annual Program Planning Meeting, Kansas City, Missouri, February 25-27, 2000.
Schnick, R.A. 2000.
Fish anesthetics and other drugs. Minnesota Fisheries 2000 Training Session, St. Cloud,
Minnesota, February 29-March 2, 2000.
Schnick, R.A. 2000.
Update on the Federal-State Aquaculture Drug Approval Project. International Association
for Fish and Wildlife Agencies, Drug Approval Working Group Meeting, Chicago, Illinois,
March 26, 2000.
Schnick, R.A. 2000.
Update on the activities of the National Coordinator for Aquaculture New Animal Drug
Applications. National Research Support Program Number Seven (NRSP-7) Spring Meeting,
Indianapolis, Indiana, April 17-19, 2000.