Fill and Sign the Annexure8 Medical Report Form

Page 1 of 2 Form LHRHa-W: Worksheet for Designing Individual Field Trials Under LHRHa INAD 8061 INSTRUCTIONS 1. Investigator must fill out Form LHRHa-W for each trial conducted under this INAD before actual use of Luteinizing Hormone-Releasing Hormone analog. The Investigator is responsible that Form LHRHa-W is completed accurately. 2. Investigator should keep the original on file, and fax a copy to the Study Monitor for review. 3. After review, the Study Monitor will fax a copy to the AADAP Officefor assignment of the Study Number. 4. The AADAP Office will review the worksheet, and then fax the assigned trial Study Number to both the Investigator and Study Monitor, at which time the trial may be initiated. 5. Note: Both Investigator and Study Monitor should sign and date Form LHRHa-W. SITE INFORMATION Facility Address Investigator Reporting Individual (if not Investigator) Phone Fax FISH CULTURE AND DRUG TREATMENT INFORMATION Fish species to be treated Average fish size (in) Average fish weight (gm) Number of treated males Number of treated females Number of control males Number of control females Anticipated date treatment will be initiated Estimated total amount of drug for proposed treatments (mg) Intended LHRHa dosage (ug/kg) Female Male Method of administration Number of injections Female Male Injection interval (hrs or days) Drug manufacturer Western Chemical, Inc. Form LHRHa-W Worksheet for Designing Individual Field Trials Injection days Drug lot number Revised 10/08 Page 2 of 2 STUDY DESIGN: Describe in detail the purpose of the clinical trial. For example you might compare dosage, or treated fish compared to untreated fish. Study design must be carefully focused and lend itself to rigorous evaluation. If more space is required to describe study details, title additional page(s) "Study Design" and attach them to this Worksheet. Study designed by DISPOSITION OF TREATED FISH (Human Food Safety Considerations): Estimated time (days, months) from last treatment day to first possible harvest for human consumption Fish treated via injection will be maintained in culture facilities or captivity for at least 14 days following treatment before they are released or allowed to enter the food chain. Investigator should initial here to indicate awareness that fish disposition must be in compliance with FDAmandated withdrawal times as described in Section XV of the Study Protocol. WORKER SAFETY CONSIDERATIONS: Investigator should initial here to indicate that all personnel handling drug have read Material Safety Data Sheet for Luteinizing Hormone-Releasing Hormone analog and have been provided protective equipment, in good working condition, as described in the MSDS. Date Prepared: Investigator: Date Reviewed: Study Monitor: Form LHRHa-W Worksheet for Designing Individual Field Trials Revised 10/08