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IRO Review Reports Sample Clauses

IRO Review Reports. The IRO shall prepare a report based upon each IRO review performed (IRO Review Report). Information to be included in the IRO Review Report is described in Appendices A-B.
IRO Review Reports. The IRO(s) shall prepare a report (or reports) based upon the Arrangements Review performed. The Arrangements Review Report shall include the IRO’s findings with respect to: (a) whether Boston Scientific and/or Guidant/CRM, as appropriate, has generally implemented the Arrangements Procedures described in Section III.D.1; and (b) specific findings as to whether Boston Scientific and/or Guidant/CRM, as appropriate, has complied with the Arrangements Procedures and Arrangements Requirements with respect to each of the randomly selected Arrangements reviewed by the IRO. In addition, the Arrangements Review Report shall include any observations, findings, and recommendations on possible improvements to Boston Scientific’s and/or Guidant/CRM’s policies, procedures, and systems in place to ensure that all Arrangements do not violate the Anti-Kickback Statute.

Related to IRO Review Reports

  • Project Review A. Programmatic Allowances 1. If FEMA determines that the entire scope of an Undertaking conforms to one or more allowances in Appendix B of this Agreement, with determinations for Tier II Allowances being made by SOI-qualified staff, FEMA shall complete the Section 106 review process by documenting this determination in the project file, without SHPO review or notification. 2. If the Undertaking involves a National Historic Landmark (NHL), FEMA shall notify the SHPO, participating Tribe(s), and the NPS NHL Program Manager of the NPS Midwest Regional Office that the Undertaking conforms to one or more allowances. FEMA shall provide information about the proposed scope of work for the Undertaking and the allowance(s) enabling FEMA’s determination. 3. If FEMA determines any portion of an Undertaking’s scope of work does not conform to one or more allowances listed in Appendix B, FEMA shall conduct expedited or standard Section 106 review, as appropriate, for the entire Undertaking in accordance with Stipulation II.B, Expedited Review for Emergency Undertakings, or Stipulation II.C, Standard Project Review. 4. Allowances may be revised and new allowances may be added to this Agreement in accordance with Stipulation IV.A.3, Amendments. B. Expedited Review for Emergency Undertakings