1LHRHa Spawning Hormone Clinical Field Trials- INAD 8061 2008 Annual Summary Report on the Use of LHRHa in Clinical Field Efficacy Trials Prepared by:

Spawning aids such as luteinizing hormone-releasing hormone analogue (LHRHa), human chorionic gonadotropin, and common carp pituitary are routinely used in aquaculture to induce gamete maturation in fish to enhance fish propagation programs. The U.S. Food and Drug Administration has authorized the use of LHRHa under the Compassionate Investigational New Animal Drug (INAD) Exemption #8061 for the purpose of gathering efficacy data to support a new animal drug approval for LHRHa. In calendar year 2008 (CY08), 20 trials were conducted under this INAD to evaluate the efficacy of LHRHa to induce gamete maturation in a variety of fish species. Trials involved 190 treated fish and 67 control fish and were conducted at 11 different hatcheries, including three U.S. Fish and Wildlife Service fish hatcheries, three state hatcheries, four private hatcheries, and one tribal hatchery during this period. Efficacy was determined by whether or not treated fish produced or yielded more eggs or milt than untreated fish. Overall results from trials conducted in CY08 showed that 2treatments appeared efficacious in approximately 90 % of the trials and ineffective in 10 % of the trials