(May 15, 1998 to November 9, 1998)

• An amended New Animal Drug Application (NADA) was approved by the Center for Veterinary Medicine (CVM) on June 18, 1998 for the expansion of formalin use to control or prevent fungus on all fish eggs and external parasites on all fish.

• A meeting was held on August 26, 1998 between CVM and Schering-Plough Animal Health regarding the development of florfenicol ( a broad spectrum antibacterial) for aquaculture in light of CVM’s new policy on disease resistance issues. CVM indicated that they will schedule a November meeting to develop a broad-based policy on this issue for all animal drugs. This issue affects all animal drugs including any drugs developed for aquaculture uses.

• The sponsor of copper sulfate submitted the product chemistry technical section to CVM on March 12, 1998, received comments on April 15, 1998 and October 15, 1998, and responded with clarifications on July 31, 1998 and October 30, 1998. All technical sections for an approval of copper sulfate have been submitted to CVM for review or have been reviewed. Preliminary indications are that the label will only cover the control of Ichthyopthirius.

• Summary reports for the data call-in for the efficacy data on chloramine-T to control or prevent mortalities from bacterial gill disease were submitted to CVM on July 30, 1998 as technical sections for review.

• A draft proposal was sent on October 24, 1998 to the Center for Veterinary Medicine (CVM) to review and consider for approval of chloramine-T for exclusive use on early life stage fish at public aquaculture facilities. The acceptance of this course of action is critical if chloramine-T is to be approved for use by public aquaculture under the IAFWA Project.

• A meeting with CVM and the sponsor of hydrogen peroxide was held on June 18, 1998 to discuss the remaining data requirements for hydrogen peroxide. Discussions centered on the mechanisms for transferring the Canadian dossier to CVM and for setting up a Public Master File. Enough data may exist for an early approval in the United States. CVM determined that the human food safety data requirements are met.

• The efficacy and target animal safety technical sections for an NADA were submitted to CVM on September 18, 1998 for the use of hydrogen peroxide to control or prevent mortalities associated with saprolegniasis on all fish.

• A data package containing product chemistry, mammalian toxicology, human food safety, environmental assessment, efficacy, and target animal safety was submitted to CVM on September 3, 1998 by the sponsor of Pyceze™ for its use to control or prevent saprolegniasis on fish eggs.

• Comments were submitted to the Food and Drug Administration on August 21, 1998 regarding the FDA Modernization Act of 1997. The FDA was urged to increase the number of aquaculture reviewers and submit to Congress the document "Proposals to increase the availability of approved animal drugs for minor species and minor uses."

• The Drug Approval Oversight Subcommittee (DAOS) formed to aid the federal-state aquaculture drug approval partnership program (a project of the International Association of Fish and Wildlife agencies=IAFWA Project) to achieve its goal of obtaining drug approvals for U.S. public aquaculture held a meeting on September 11, 1998 in Savannah, Georgia to discuss progress, issues, and extend the IAFWA Project another three years to June 2002.

• The NADA Coordinator had two manuscripts in press, presented 4 papers and talks, and wrote 20 reports.

 

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 one-half 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)--Status: Two sponsors have submitted INAD/NADA letters of intent; early development stage

• The National NADA Coordinator met on October 19, 1998 with CVM and GB Research Inc.(a sponsor of amoxicillin)for a pre-submission conference regarding the development of data that will lead to an approved NADA for amoxicillin trihydrate. GB Research Inc. presented a plan for funding the necessary research and CVM provided insight on the technical sections needed for completion of a NADA submission.

Chloramine-T (external antibacterial)--Status: Sponsor has committed to INAD/NADA; major effort for NADA approval under the IAFWA Project and compassionate INADs; at least two years from approval

• The Upper Mississippi Science Center (UMSC), under the federal-state drug approval partnership program [International Association of Fish and Wildlife agencies= (IAFWA) Project], issued a data call-in on November 14, 1997 for all the efficacy data on chloramine-T that can support a label claim to control or prevent mortalities related to external flavobacterial infections in cultured freshwater fish. Data were received January 15, 1998, organized in March 1998, evaluated in April 1998, and summary reports prepared to address efficacy technical sections to both prevent and control bacterial gill disease in selected species were submitted to the Center for Veterinary Medicine (CVM) on July 30, 1998.

• A draft proposal was sent on October 24, 1998 to the Center for Veterinary Medicine (CVM) to review and consider for approval of chloramine-T for exclusive use on early life stage fish at public aquaculture facilities. The acceptance of this course of action is critical if chloramine-T is to be approved for use by public aquaculture under the IAFWA Project. A major impediment to the approval of chloramine-T is the lack of several acceptable mammalian toxicology studies that, in the opinion of the reviewers at CVM, are required if a tolerance is to be established for the marker residue of chloramine-T in rainbow trout, para-toluenesulfonamide (p-TSA). These studies would cost the sponsor approximately $700,000, a sum that could not be recaptured in a reasonable period of time based on potential use by U.S. public aquaculture. If only the early life stages of fish were treated, no fish should be consumed with any residue resulting from chloramine-T treatments. This premise is based on setting an inherent withdrawal time, or time for clearance of residues resulting from the treatment of fry or fingerlings, well before the treated fish have entered a legal public fishery. After the preliminary review has been completed by CVM, the final proposal will be sent to CVM in November 1998, and a December 1998 meeting will be requested to discuss the implementation of the proposal.

• A regulatory analytical method for para-toluenesulfonamide in fish tissue to support residue depletion studies was submitted on May 15, 1998 to CVM for review.

• Based on a November 3, 1997 meeting held with CVM, Akzo Nobel Chemicals, Inc. collected information and data in the public domain on human and environmental safety during the summer of 1998 to support the approval of chloramine-T.

Copper Sulfate (external microbicide)--Status: Sponsor submitted INAD/NADA letter of intent and product chemistry technical section; major effort for approval under the IAFWA Project and compassionate INADs; one year or less from NADA approval

• Phelps Dodge Refining Corporation (El Paso, Texas) submitted an application for an INAD/NADA (INAD #10-046) on April 3, 1997, a request for two labels on the same package on October 24, 1997, and the product chemistry data on March 12, 1998. The product chemistry technical section was reviewed by CVM on April 15, 1998 and October 15, 1998 and the sponsor responded to the items on July 31, 1998 October 30, 1998.

• Efficacy and target animal safety data and the environmental assessment have been submitted to CVM by the Stuttgart National Aquaculture Research Center. All the data needed for an approval of copper sulfate have been submitted as of early 1998 and all the technical section packages are under review by CVM.

Cutrine-Plus™ (external microbicide)--Status: Some interest by potential sponsor; early development stage

Diquat Dibromide (external microbicide)--Status: No commitment by potential sponsor; early development stage

Earth Tec Algicide/Bactericide™ (external microbicide)--Status: Sponsor recently submitted INAD/NADA letter of intent; early development stage

Enrofloxacin (oral antibacterial)--Status: INADs inactive in the United States because of fluoroquinolone issues; no sponsor interest

Erythromycin (oral antibacterial)-Status: Sponsorship needs to be resolved; all technical sections except sponsor product chemistry submitted; risk assessment needed on potential for disease resistance; near NADA approval for bacterial kidney disease in salmonids if gain sponsor

Florfenicol (oral antibacterial)--Status: Sponsor recently allowed the development of florfenicol for approval in United States; approved in Canada in August 1997; IAFWA Project drug; at least two years from any NADA approval

• A meeting was held on August 26, 1998 between CVM and Schering-Plough Animal Health regarding the development of florfenicol ( a broad spectrum antibacterial) for aquaculture in light of CVM’s new policy on disease resistance issues. CVM indicated that they will schedule a November meeting to develop a broad-based policy on this issue for all animal drugs. This issue affects all animal drugs including any drugs developed for aquaculture uses.

• The National NADA Coordinator is working with the sponsor and CVM to identify existing data and outstanding requirements for approval of florfenicol in salmonids and with FWS to setup limited INADs at selected facilities.

Formalin (external microbicide)--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; at least one year away from expansion of the NADA for its use to prevent mortalities associated with external fungal infections on all cultured freshwater fish

• An amended NADA was approved by CVM on June 18, 1998 for the expansion of formalin use to control or prevent fungus on all fish eggs and external parasites on all fish.

Fumagillin (microsporidiosis control)--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)--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; efficacy (eggs and fish) and target animal safety technical sections submitted; human food safety data requirements are met; at least one year from NADA approval in the U.S. if data from Canada are acceptable.

• A meeting with CVM and the sponsor of hydrogen peroxide was held on June 18, 1998 to discuss the remaining data requirements for hydrogen peroxide. Discussions centered on the mechanisms for transferring the Canadian dossier to CVM and for setting up a Public Master File. Enough data may exist for an early approval in the United States. CVM determined that the human food safety data requirements are met.

• UMSC submitted efficacy and target animal safety data to CVM September 18, 1998 for review and comment to support an NADA for the use of hydrogen peroxide to control and/or prevent mortalities associated with saprolegniasis on all cultured freshwater fish.

• UMSC is in the process of completing experiments in collaboration with state hatcheries to determine the efficacy of hydrogen peroxide to control external parasitic infestations and to control mortalities associated with external flavobacterial infections on representative cultured freshwater fish.

Neomycin sulfate (vibriosis control)--Status: Currently no activity on this drug

Oxytetracycline (OTC, oral antibacterial)--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; near-term approval as marking aid on all cultured freshwater fish and as a control for bacterial diseases on shrimp; at least one year from NADA approval for certain extensions and expansions for cultured freshwater fish.

• A call-in of efficacy data was initiated on October 7, 1997 for any and all efficacy data on OTC that can support the extension and expansion of the NADA. Data were received November 18, 1997, organized in December 1997, evaluated in May 1998, and the summary report is in preparation for submission to CVM.

Potassium Permanganate (external microbicide)--Status: Sponsor recently submitted an INAD/NADA letter of intent; major effort for NADA approval under IAFWA Project; two to three years from approval

• A residue chemistry technical section was submitted to CVM for review in early summer 1998. The sponsor has agreed to prepare and submit the environmental assessment after a positive meeting with CVM on January 28, 1998.

Pet Fish Therapeutants (various drugs and pesticides)--Status: Major effort to resolve non-food fish issue for these drugs by private consultant

Praziquantel (trematode and cestode control)--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

Pyceze™ (external microbicide)--Status: Sponsor recently submitted an INAD/NADA letter of intent and all major technical sections; at least one year from approval

• A data package containing product chemistry, mammalian toxicology, human food safety, environmental assessment, efficacy, and target animal safety was submitted to CVM on September 3, 1998 by the sponsor of Pyceze™ for its use to control or prevent saprolegniasis on fish eggs.

Quinine (internal microbicide)--Status: Some interest on the part of potential sponsor in a U.S. NADA approval if market is large enough

Sarafloxacin (oral antibacterial)--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 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 an unanimous vote of the IAFWA Project stakeholders.

Sea Lice Control (various drugs and pesticides)--Status: Various drugs and pesticides ( azamethiphos or Salmosan™, cypermethrin or Excis™) are being pursued by the United States and Canada and are at various stages of registration and approval

Trichlorfon (external parasite control)--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-S™/Aqui-S Plus™--Status: Sponsor proceeding with worldwide drug approval; drug being assessed by the IAFWA Project; at least two years from approval in the United States

• The National NADA Coordinator urged the NADA sponsor to determine the formulation to be developed and on May 8, 1998 the sponsor determined that Aqui-S Plus™ was the formulation to be developed. The sponsor reversed its decision in June 1998 and determined that Aqui-S™ was the formula to be developed in the United States and worldwide.

• The FWS plans to initiate an INAD on Aqui-S™ to cover all public and private facilities in early 1999.

Benzocaine--Status: Major effort by IAFWA Project for NADA approval terminated because of decision by IAFWA Project stakeholders to select Aqui-S™ as the candidate anesthetic in the U.S. public aquaculture sector; no known drug approval activities underway

MS-222--Status: Two approved NADAs for MS-22 as an anesthetic with a 21-day withdrawal time

Oil of Cloves--Status: Oil of cloves (eugenol) is considered Generally Recognized as Safe (GRAS) 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

• The National NADA Coordinator responded to several requests for information on the regulatory status of oil of cloves in 1998 because of a recent article on its apparent regulatory allowance by CVM.

SPAWNING AND GENDER MANIPULATION AIDS

Common Carp Pituitary (CCP)-- Status: Sponsor and interested parties proceeding toward NADA approval; at least one year from NADA approval

• A literature review was completed on the efficacy and target animal safety of common carp pituitary and presented on August 5, 1998 in Bozeman, Montana at the FWS-INAD Coordination Workshop. Plans are being made to prepare the document for submission to CVM in late 1998.

Gonadotropin Releasing Hormone (GnRH)--Status: Sponsor recently submitted INAD letter of intent; early development stage

Human Chorionic Gonadotropin (hCG)--Status: Near-term NADA approval in the United States

• The National NADA Coordinator contacted CVM to determine the status of hCG in the review process--hCG continues to be under review and is a high priority.

• The 1996 interim regulatory policy on the use of hCG was revised so that producers could use the drug under a veterinarian’s prescription along with notification of CVM. This policy was renewed in 1998 and will continue until hCG gains approval.

Ovaprim™--Status: Sponsor recently submitted INAD letter of intent; early development stage

17 -methyltestosterone (MT)--Status: Sponsor is developing NADA package; INAD sponsors actively pursuing a NADA approval; NADA approval anticipated when environmental and product chemistry requirements are met

• On June 9, 1998, CVM responded to the environmental assessment that was submitted on November 7 and 26, 1997. A response is being prepared for submission to CVM to include revisions to the calculations and assumptions made in the original submission.

• The NADA sponsor is working on the product chemistry section of the NADA.

PUBLIC INFORMATION, WORKSHOPS AND PRESENTATIONS

Federal-State Aquaculture Drug Approval Partnership Program (IAFWA Project)

• The Drug Approval Oversight Subcommittee (DAOS) formed to aid the federal-state aquaculture drug approval partnership program (a project of the International Association of Fish and Wildlife agencies=IAFWA Project) to achieve its goal of obtaining drug approvals for U.S. public aquaculture held a meeting on September 11, 1998 in Savannah, Georgia to discuss progress, issues, and extend the IAFWA Project another three years to June 2002.

Meetings and Special Activities

• The Bozeman National INAD Office expanded its scope in May 1998 to include other entities (other public agencies and private producers) under their INAD exemptions that had been in the Western Regional INAD Project. By January 1999, FWS plans to include all states and the private sector under their INADs.

• Comments were submitted to the Food and Drug Administration on August 21, 1998 regarding the FDA Modernization Act of 1997. The FDA was urged to increase the number of aquaculture reviewers and submit to Congress the document "Proposals to increase the availability of approved animal drugs for minor species and minor uses."

• The National NADA Coordinator was asked and accepted the lead editor to the subject area "Drug/Pesticide Usage/Labeling" in the National Catfish Information Database (NCID) on September 3, 1998.

• The National NADA Coordinator will give an overview presentation on international aspects of antibiotic sensitivity determination and the need for harmonization in aquaculture medicines at the Workshop on minimum inhibitory concentration methodologies used in aquaculture, November 24-27, 1998, Weymouth, UK.

• The National NADA Coordinator is organizing and chairing a producers session on compassionate INADs at Aquaculture America‘99, Tampa, Florida, January 27-30, 1999.

• The National NADA Coordinator is organizing and chairing a session on worldwide cooperation toward aquaculture drug approvals at the World Aquaculture ‘99, April 26 to May 2, 1999 in Sydney, Australia.

•  

PUBLICATIONS, MANUSCRIPTS, PAPERS PRESENTED, AND REPORTS

Publications

None

Manuscripts

Schnick, R.A. (In press). Approval of drugs and chemicals for use by the aquaculture industry. Veterinary and Human Toxicology.

Schnick, R.A. (In press). Use of chemicals in fish management and fish culture: past and future. In D.J. Smith, W.H. Gingerich, and M. Beconi-Barker, editors. Xenobiotic Metabolism in Fish. Plenum Publishing Corporation, New York.

Special Reports

Schnick, R.A. 1998. Package on extension of the IAFWA Federal-State Aquaculture Drug Approval Partnership Project. Submitted to Mike Gibson, Chair, IAFWA Drug Approval Oversight Subcommittee, Hot Springs, Arkansas. May 18, 1998. 8 pp.

Schnick, R.A. 1998. Minutes to the hydrogen peroxide meeting (April 11, 1997). Submitted to the Center for Veterinary Medicine, Rockville, Maryland. May 20, 1998. 2 pp.

Schnick, R.A., W.H. Gingerich, and B.R. Griffin. 1998. Approval of Drugs for Public Fish Production: Year 4 Progress to Date (July 1, 1997 to May 15, 1998) and Year 5 projected work (July 1, 1998 to June 30, 1999). Biological Resources Division, Upper Mississippi Science Center, La Crosse, Wisconsin. May 22, 1998. 15 pp

Schnick, R.A. 1998. Worldwide aquaculture drug approvals through partnerships in the United States. Submitted to Dow Agrosciences LLC, Indianapolis, Indiana. June 9, 1998. 10 pp.

Schnick, R.A. 1998. Year 12 Proposed Project Area IV: National Coordinator for Aquaculture New Animal Drug Applications - Year 4. Submitted to CTSA Administrative Center, Waimanalo, Hawaii for funding. July 10, 1998. 15 pp. (Revised September 4, 1998; October 8, 1998).

Schnick, R.A. 1998. 1998 annual report of the AFS Task Force on Fishery Chemicals. Submitted to AFS President, Bill Taylor. July 23, 1998. 5 pp.

Schnick, R.A. 1998. Response to FDA objectives on the FDA Modernization Act of 1997 (Docket No. 98N-0339). Submitted to the U.S. Food and Drug Administration, Washington, DC. August 21, 1998. 8 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. 1998. Approval of Drugs for Public Fish Production: Fourth annual report of progress [performance period: July 1, 1997 to June 30, 1998]. Biological Resources Division, Upper Mississippi Science Center, La Crosse, Wisconsin. August 27, 1998. 47 pp.

Schnick, R.A. 1998. Aquaculture drug approval progress in the United States in September 1998. Office of the NADA Coordinator, Michigan State University, La Crosse, Wisconsin. September 3, 1998. 3 pp.

Schnick, R.A. 1998. Report to the Working Group on Quality Assurance in Aquaculture Production. Submitted to the Working Group on Quality Assurance in Aquaculture Production, Washington, DC. September 4, 1998. 5 pp.

Gingerich, W.H., and R.A. Schnick. 1998. Approval of Drugs for Public Fish Production: Year 5 Project Work Plan and updates of Project status. Submitted to the IAFWA Drug Approval Oversight Subcommittee (DAOS), Savannah, Georgia. Biological Resources Division, Upper Mississippi Science Center, La Crosse, Wisconsin. September 11, 1998. 9 pp.

Schnick, R.A. 1998. Quarterly report for Contract No. #97-106 (National Coordinator for Aquaculture New Animal Drug Applications: reporting period, April 1, 1998 to September 30, 1998. Submitted to Center for Tropical and Subtropical Aquaculture, The Oceanic Institute, Waimanalo, Hawaii. September 30, 1998. 1 pp.

Schnick, R.A. 1998. Status of the aquaculture drug approvals in the United States (as of October 7, 1998). Office of the NADA Coordinator, Michigan State University, La Crosse, Wisconsin. October 7, 1998. 3 pp.

Schnick, R.A. 1998. Status of the IAFWA Project Study Plans (as of October 7, 1998). Office of the NADA Coordinator, Michigan State University, La Crosse, Wisconsin. October 7, 1998. 53 pp.

Schnick, R.A. 1998. Semi-annual report for Contract No. #97-106 (National Coordinator for Aquaculture New Animal Drug Applications): reporting period, April 1, 1998 through September 30, 1998. Submitted to Center for Tropical and Subtropical Aquaculture, The Oceanic Institute, Waimanalo, Hawaii. October 10, 1998. 7 pp.

Schnick, R.A. 1998. Minutes to Hydrogen Peroxide Meeting with the Center for Veterinary Medicine (June 18, 1997). Submitted to Eka Chemicals for transmittal to the Center for Veterinary Medicine, Rockville, Maryland. October 14, 1998. 3 pp.

Schnick, R.A. 1998. Aquaculture drugs (INADs/NADAs): Progress report for the period, September 1, 1992 to August 31, 1998. Submitted to North Central Regional Aquaculture Center, Michigan State University, East Lansing, Michigan. October 23, 1998. 18 pp.

Schnick, R.A. 1998. Minutes to the pre-submission conference on amoxicillin with CVM, GB Research Inc. and the National NADA Coordinator (October 19, 1998). Submitted to the Center for Veterinary Medicine, Rockville, Maryland. October 24, 1998. 3 pp.

Schnick, R.A. 1998. Draft proposal to gain aquaculture drug approval of chloramine-T under the early life stage policy. Submitted to the Center for Veterinary Medicine, Rockville, Maryland. October 24, 1998. 20 pp.

Schnick, R.A. 1998. National Coordinator for Aquaculture New Animal Drug Applications (NADAs): Mid-year report of activities, May 15, 1998 to November 9, 1998. Submitted to North Central Regional Aquaculture Center, Michigan State University, East Lansing, Michigan. October 30, 1998. 9 pp.

PRESENTATIONS

Schnick, R.A. 1998. Overview of NADA Coordinator activities. Presented at the FWS-INAD Coordination Workshop, Bozeman, Montana, August 4-5, 1998.

Schnick, R.A. 1998. NADA Coordinator update. Presented via speaker phone at the meeting of the JSA Working Group on Quality Assurance in Aquaculture Production, Washington, D.C., September 4, 1998.

Schnick, R.A. 1998. Overview of the activities of the National Coordinator for Aquaculture New Animal Drug Applications and suggestions for enhancing dialogue with the Minor Use Animal Drug Program. Presented at the meeting of the Minor Use Animal Drug Program Technical Committee for NRSP-7, Rockville, Maryland, September 22, 1998.

Schnick, R.A. 1998. The effect of the Animal Drug Availability Act of 1996 and the FDA Modernization Act of 1997 on approvals of animal health products for minor species/minor uses. Presented at the 1998 Animal Health Institute Joint Meeting, San Diego, California, November 9, 1998.

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The National Coordinator for Aquaculture New Animal Drug Applications is attempting to carry out these goals and objectives through this web site. Please use the e-mail address, RozSchnick@centurytel.net  , to contact her for input and questions.

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