Viral/ Vector Type/ Origin virus (AAV) Expression MCMV control elements enhancer, (promoter, Chicken enhancer, B-actin regulatory promoter elements, etc) 1x 108 to Conc / titer of 1x1012 rDNA (i.p./ml) infectious particles/ml E. coli, Sure™, Host & Strain Mouse heart cells, in vivo Host (including any Human, other genetic mammalian cells alterations to host range) Is recombinant or synthetic DNA UF Powell made in your Gene Therapy Center lab? If not, where? What (approx.) % of original genome has 2/3 been deleted or substituted? Section 7: Dual Use Research of Concern (DURC) Does your research involve one or more of the agents or toxins listed below? Yes No influenza virus (highly pathogenic) Francisella tularensis Bacillus anthracis Marburg virus Botulinum neurotoxin Toxin-producing strains of Clostridium Burkholderia mallei botulinum Burkholderia pseudomallei Variola virus Ebola virus Variola minor virus Foot-and-mouth disease virus Yersinia pestis Please indicate whether your research project produces, aims to produce, or can be reasonably anticipated to produce any of the following experimental effects. The IRE should review descriptions of the research in question, the PI’s assessment of the applicability of the categories of experiments, and other relevant information, as warranted. Examples of materials to consider include the project proposal, any project reports, any outcomes of previous reviews for dual use, and examples of similar research in the literature. Enhances the harmful consequences of the agent or toxin Yes No Disrupts immunity or the effectiveness of an immunization against the agent or toxin withour clinical or agricultural justification Yes No
Vector Type/ Origin Viral/ virus (AAV) Expression control elements (promoter, enhancer, regulatory elements, etc) MCMV enhancer, Chicken B-actin promoter Conc / titer of rDNA (i.p./ml) 1x 108 to 1x1012 infectious particles/ml Host & Strain E. coli, Sure™, Mouse heart cells, in vivo Host (including any genetic alterations to host range) Human, other mammalian cells Is recombinant or synthetic DNA made in your lab? If not, where? UF Powell Gene Therapy Center What (approx.) % of original genome has been deleted or substituted? 2/3 Section 7: Dual Use Research of Concern (DURC) Does your research involve one or more of the agents or toxins listed below? Yes No influenza virus (highly pathogenic) Bacillus anthracis Botulinum neurotoxin Burkholderia mallei Burkholderia pseudomallei Ebola virus Foot-and-mouth disease virus Francisella tularensis Marburg virus Toxin-producing strains of Clostridium botulinum Variola virus Variola minor virus Yersinia pestis Please indicate whether your research project produces, aims to produce, or can be reasonably anticipated to produce any of the following experimental effects. The IRE should review descriptions of the research in question, the PI’s assessment of the applicability of the categories of experiments, and other relevant information, as warranted. Examples of materials to consider include the project proposal, any project reports, any outcomes of previous reviews for dual use, and examples of similar research in the literature. Enhances the harmful consequences of the agent or toxin Yes No Disrupts immunity or the effectiveness of an immunization against the agent or toxin withour clinical or agricultural justification Yes No
NAU%20IBC%20Registration%20Form%202016.docx