or this Dose (Y/N) in (e.g., Item) Body” Material* mg/kg, the Anesthesia, (Identify the CFU, Reason for Details Route Frequency specific agent, PFU, Diluent* or Administration “Main of or duration device, strain, number of Vehicle* and Expected Under admin of admin identify construct, cells, mCi) Effects tranquilization Further isotope, etc.) and and or (specify of Volume #”, (ml) ACORP “App Administration Location sedation, *Each material, diluent, or vehicle that is listed as FDA approved or is is pharmaceutical labeled “USP” grade. Check on-line for formulations that are FDA approved for administration to humans () or animals (). Designate with a * each material and each diluent or vehicle to be used that is not pharmaceutical grade. For each of these, explain here why the use of a non-pharmaceutical grade formulation is necessary, and describe how it will be ensured that the material is suitable for use. (See ACORP App. 3 Instructions, for specifics about the level of detail required.) ► Anesthesia, Sedation, or Tranquilization. Complete 3.a. and 3.b. below: For each material with in the last column of the table in Item 2 above, describe the “Y” entered anesthesia, sedation, or tranquilization to be used, identifying the anesthetic, sedative, or chemical tranquilizer, and detailing the dose, volume, and route of administration (Make sure that these agents are also included in Item 1 of this appendix, as materials to be administered): ► For each material with entered in the last column of the table in Item 2 above, explain why no “N” anesthesia, sedation, or tranquilization is necessary, or can be provided, and describe any alternate methods of restraint that will be used. ► Toxic Agents. Complete the table below for each of the materials listed as a in the table in “toxic agent” Item 1 above, checking the all of the properties that apply (see ACORP App. 3 Instructions, for details). Name of Toxic Agent d. Select Agent? a. b. e. – c.
Material* (Identify the specific agent, device, strain, construct, isotope, etc.) Dose (e.g., mg/kg, CFU, PFU, number of cells, mCi) and Volume (ml) Diluent* or Vehicle* Route of admin Frequency or duration of admin Reason for Administration and Expected Effects Location of Further Details in this ACORP (specify “Main Body” or “App #”, and identify the Item) Administration Under Anesthesia, sedation, or tranquilization (Y/N) *Each material, diluent, or vehicle that is listed as FDA approved or is labeled “USP” is pharmaceutical grade. Check on-line for formulations that are FDA approved for administration to humans () or animals (). Designate with a * each material and each diluent or vehicle to be used that is not pharmaceutical grade. For each of these, explain here why the use of a non-pharmaceutical grade formulation is necessary, and describe how it will be ensured that the material is suitable for use. (See ACORP App. 3 Instructions, for specifics about the level of detail required.) ► Anesthesia, Sedation, or Tranquilization. Complete 3.a. and 3.b. below: For each material with “Y” entered in the last column of the table in Item 2 above, describe the anesthesia, sedation, or tranquilization to be used, identifying the anesthetic, sedative, or chemical tranquilizer, and detailing the dose, volume, and route of administration (Make sure that these agents are also included in Item 1 of this appendix, as materials to be administered): ► For each material with “N” entered in the last column of the table in Item 2 above, explain why no anesthesia, sedation, or tranquilization is necessary, or can be provided, and describe any alternate methods of restraint that will be used. ► Toxic Agents. Complete the table below for each of the materials listed as a “toxic agent” in the table in Item 1 above, checking the all of the properties that apply (see ACORP App. 3 Instructions, for details). Name of Toxic Agent a. b. c. d. Select Agent? e. –
ACORP_Appendix3.docx