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YES NO ABO (or designee) reviews the Biosafety Summary and any additional materials necessary YES NO ABO (or designee) reviews the Biosafety Summary and any additional materials necessary

YES NO ABO (or designee) reviews the Biosafety Summary and any additional materials necessary - PowerPoint Presentation

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Uploaded On 2019-11-05

YES NO ABO (or designee) reviews the Biosafety Summary and any additional materials necessary - PPT Presentation

YES NO ABO or designee reviews the Biosafety Summary and any additional materials necessary to assess the likelihood that the proposed activity will harm humans animals or the environment according to internationally accepted biosafety risk assessment standards ID: 763643

activity biosafety risk abo biosafety activity abo risk review 211 ads environmental proposed assessment cor aor determination summary award

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YES NO ABO (or designee) reviews the Biosafety Summary and any additional materials necessary to assess the likelihood that the proposed activity will harm humans, animals, or the environment, according to internationally accepted biosafety risk assessment standards. (See ADS 211.3.5) 3. Biosafety Risk Assessment AM/AOR/COR completes environmental review as per ADS204, incorporating Biosafety Risk Determination recommendations and partner-country authorizing documents into the IEE , EA, and/or EMMP for the proposed activity.For activities requiring Biosafety Review, the ABO must clear on any 22CFR216 documentation prior to BEO /MEO/REA concurrence.(See ADS 211.3.7) 5. Environmental Review ….involving GE organisms.New NOFO.New award.New GE activity under existing award.Different organism, construct, location, scale, or protocol than previously approved under IEE for existing GE activity.(See ADS 211.3.1) Check with ABO to determine whether biosafety review is necessary. (See ADS 211.3.3) 1. Preliminary ABO Consultation AM/AOR/COR prepares and submits to the ABO the Activity Biosafety Summary document, which describes the proposed activity in sufficient detail & provides supporting data to inform biosafety risk assessment.(See ADS 211.3.4) 2. Activity Biosafety Summary “New” Activity… Continue with environmental review as per ADS204. Environmental Review ABO (or designee) summarizes the Biosafety Risk Assessment process in a written Biosafety Risk Determination, which recommends whether to approve (with or without conditions), modify, or reject the proposed activity. (See ADS 211.3.6) 4. Biosafety Risk Determination Where appropriate, the ABO may continue to provide follow-up technical assistance to the AM/AOR/COR and BEO/MEO/REA.(See ADS 211.3.8) 6. Follow-up Biosafety Support ADS211saa. Biosafety Review Process Flow Chart. (See ADS211.3 for full explanatory text.)