Get Form Otcs-1 8nov2010.docx - Fws

Filling out Form OTCS-1 is essential for reporting investigational new animal drug shipments, particularly for poikilothermic food animals. This guide provides clear, step-by-step instructions to help users complete the form accurately and efficiently.

Follow the steps to successfully complete Form OTCS-1 online.

1. Press the ‘Get Form’ button to obtain the form and open it in the appropriate editor for editing.
2. Begin by entering the name of the drug. In this case, you will type 'Terramycin7 200 for Fish'.
3. Fill in the proposed use of the drug, which is to treat certain bacterial diseases in marine penaeid shrimp.
4. Input the INAD number, which is '8069'.
5. Record the date of the CVM authorization letter. This is a critical detail for verification.
6. Indicate the date of drug receipt as well as the amount of drug received.
7. Provide the drug lot number and the trial number associated with your study.
8. Enter the name and address of the investigator responsible for overseeing the trial.
9. Specify the location of the trial in the designated field.
10. Mark whether it is a pivotal study (no) or a non-pivotal study (yes).
11. Indicate the approximate number of treated and control animals involved in the study.
12. If any animals were used previously, fill in the respective number of animals.
13. Provide the study protocol date in the designated section.
14. Specify the approximate dates of the trial: both start and end dates.
15. Detail the species, size, and type of animals being included in the study.
16. Document the daily dose and duration of the treatment, which should be '4.5 g oxytetracycline per kg feed, fed to satiation for 14 days'.
17. Indicate the methods of administration as well as the withdrawal period listed in the correct fields.
18. Ensure that the investigator, study monitor, and sponsor sign and date the form where indicated.
19. After completing all necessary fields, review your entries for accuracy. You can then save changes, download, print, or share the filled form as needed.

Complete your document online today to ensure efficient and accurate reporting.