ࡱ> {` bjbjFF E,,!L....... F#F#F#X$ % 2I&****+,t8-<-H/H/H/H/H/H/H$JhL|SH.t-++t-t-SH..**4H222t-.*.*-H2t--H22E@..A*& `tF#P.@DLI02I@M/jM(AM.AT2t-t-t-SHSHr2|t-t-t-2It-t-t-t-   DF#   F#   ...... Appendix 2 - Substances and Materials Experimental substances and materials include radioisotopes, toxins, antigen, pharmacological agents, infectious agents, carcinogens or mutagens, biomaterials, prosthetic devices, and cells, tissues, or body fluids. This category also includes any potentially hazardous drugs or materials described in Appendix 1-Antibody Production or Appendix 4-Surgery. 1. Non-Hazardous Agents: List and characterize non-hazardous agents or materials whose administration are not covered elsewhere in this Application. TABLE 1  non-HAZARDOUS AGENTSAgent/materialDose and/or VolumeRoute of admin. FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       2. Toxic Agents: If toxic chemicals, toxic pharmacologic agents, known or suspected mutagens, carcinogens, teratogens, DNA-binding, or other similar agents will be used in animals, complete items 2.a and 2.b below. a. TABLE 2  TOXIC AGENTSAgent/materialNature of Hazard*Route of admin. FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       * mutagen, carcinogen, or teratogen, caustic etc b. Are any of the agents above on the CDC list of  Select Agents posing a bioterrorism risk?  FORMCHECKBOX  No.  FORMCHECKBOX Yes. You will be required to obtain a CDC Registration and Biosafety Committee approval prior to obtaining the agent and beginning your studies. 3. Infectious Agents: If bacterial, viral, rickettsial, fungal, protozoal, or other infectious agents will be used in animals, complete items 3.a. 3.b, and 3.c below. If the agent will have a radioactive label added, also complete item 5 below. Likewise, if the infectious agent contains recombinant nucleic acid, complete item 6 below. a. TABLE 3 INFECTIOUS AGENTSAgent and strain or constructCDC Biosafety Level of agent Route of admin. FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       b. Has an antibiogram, anti-viral drug sensitivity screen, or other appropriate drug sensitivity panel been determined for the agent(s) listed to assist physicians in selecting proper therapy if an inadvertent human infection occurs?  FORMCHECKBOX Yes  FORMCHECKBOX No c. Are any of these agents on the CDC list of Select Agents posing a bioterrorism risk?  FORMCHECKBOX  No.  FORMCHECKBOX  Yes. You will be required to obtain a CDC Registration and Biosafety Committee approval prior to obtaining the agent and beginning your studies. 4. Biological Materials: If serum, cell lines, tissue, nucleic acid or other biological materials are to be administered to animals, complete items 4.a and 4.b below. If any of the agents are radioactive or will have a radioactive label added, also complete item 5 for that agent. TABLE 4 BIOLOGICAL MATERIALSMaterial (e.g. fluid, cells, tissues)Route of admin. FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       b. Describe how these materials were screened for infectious agents. 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FORMTEXT       5. Radioactive Agents: If radioactive compounds or agents will be administered to animals, complete 5.a and 5.b below. a. TABLE 5  RADIOACTIVE AGENTSRadioactive Agent (include isotope) Agent dose Activity (e.g. mCi/kg)Route of admin.mg/kgmL FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       FORMTEXT       b. Which investigator has been given permission by the Radiation Safety Committee to utilize the isotope(s) indicated above?  FORMTEXT       6. 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FORMCHECKBOX Yes.  FORMCHECKBOX No. You must conduct the animal experiments involving recombinant nucleic acid according to the NIH Guidelines for Recombinant DNA and Gene Transfer. Consult with the Biosafety Committee and the Director of Animal Care. 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