GOAL AND OBJECTIVES

The overall goal of the National NADA Coordinator position is to coordinate activities for investigational new animal drug exemptions (INADs) and new animal drug applications (NADAs) to expedite approval for the legal use of priority drugs in aquaculture in the United States. 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.

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

   BACKGROUND

The federal Joint Subcommittee on Aquaculture (JSA) in the United States was created by Congressional legislation, the National Aquaculture Act of 1980, to serve as an interagency coordinating body whose mission is to increase the overall effectiveness of federal research, transfer, and assistance programs in aquaculture. The JSA chair is appointed by the Secretary of the U.S. Department of Agriculture (USDA), and representatives from 24 federal agencies sit on the committee. The JSA may establish working groups or task forces to address nationally important aquaculture issues, and these groups frequently include both public and private sector representatives.

The JSA recognized that additional approved safe and effective aquaculture drugs are necessary to manage production fish health and that this is one of the highest priorities facing the aquaculture industry. The JSA responded to this need by creating the Working Group on Quality Assurance in Aquaculture Production (Working Group) in 1990. The Working Group’s mission is to increase understanding of, and compliance with, Federal requirements regarding drugs, chemicals, and biologics used in aquaculture production in the United States. The mission is to be achieved through education and coordination of efforts of government, industry and academia, related to the development and implementation of quality assurance programs.

The Working Group, co-chaired by USDA and CVM, determined that there was a need for a national coordinator for INADs and NADAs. As a result, USDA solely funded a National INAD Coordinator office on a quarter-time basis from September 1992 to May 1995. USDA also realized that there was a great need for an office that was more directed to guiding the development of complete NADA packages on a national basis and provided some funds in 1995-1996 to that office. A document was prepared by CVM in 1994 with input from USDA and the National INAD Coordinator that expressed the need for an advocate person, association, or organization to seek resources and partners to accomplish the goal of NADA approvals. Based on that document, the Working Group estimated that approximately US$150,000 per year would be needed over a five-year period to employ a full-time National NADA Coordinator. There was no single source of funds available to provide this level of support. However, during 1995-1996, 15 different government agencies, private associations, and other organizations and companies contributed sufficient funds for a three-quarter time National NADA Coordinator. Since that first year, there has been enough new and continuing funding commitments from partnerships with leading organizations, agencies, and companies, and carryover funds from the previous year to permit an increase in the National NADA Coordinator position to full time from 1996-1997 to the present. One of the continuing objectives of the Working Group is to continue to facilitate the funding and support for the National NADA Coordinator from the public and private sectors.

CURRENT POSITION

The National Coordinator for Aquaculture New Animal Drug Applications (National NADA Coordinator) position is currently held by Rosalie (Roz) Schnick, Michigan State University, North Central Regional Aquaculture Center, 3039 Edgewater Lane, La Crosse, Wisconsin 54603-1088; telephone: 608-781-2205; fax: 608-783-3507; e-mail: RozSchnick@centurytel.net 

RESUME

INTERNATIONAL ACTIVITIES

The Federal Joint Subcommittee on Aquaculture (JSA), Working Group on Quality Assurance in Aquaculture Production (Working Group) has several goals and objectives related to international activities. These include:

• Foster international harmonization for the establishment of tolerance levels and for the processes needed for aquaculture drug approvals, chemical registrations, and biologic licensing;
• Appraise the potential national and international market value for aquatic health products to encourage pharmaceutical, chemical, and vaccine industry involvement; and
• Promote the participation of domestic and international agencies and producer groups in the activities of the Working Group on Quality Assurance in Aquaculture Production.

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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