Other Technical Reports. The Contractor must prepare and disseminate, as directed in the Annual Work Plan and by the COR, other reports and deliverables needed to accomplish the purpose of this activity, such as studies of policy and other issues, products, sectors, markets, technologies, etc.Technical reports will be integrated with the AMELP’s activity learning agenda.
Other Technical Reports. 1. Draft Report for Clinical and Non-Clinical Studies and Final Report for Clinical and Non-Clinical Studies • The clinical trial reports shall follow the format of International Conference on Harmonization document ICH E3 “Guideline for Industry on Structure and Content of Clinical Study Reports” • Draft Final Report for Clinical and Non-Clinical Studies funded by this contract will be submitted to the COR and CO for review and comment within the time frames set forth in the table (“Summary of Contract Deliverables”) under ARTICLE F.2. • Subcontractor prepared reports received by the Contractor shall be submitted to the CO and COR for review and comment as set forth by the table in this Article. Contractor shall consider revising reports to address the CO’s and COR’s recommendations prior to FDA submission. • The Government shall provide written comments to the Draft Final Report for Clinical and Non-Clinical Studies in accordance with the dates set forth by the table in this Article. • The comprehensive Final Report for Clinical and Non-Clinical Studies will be submitted to the CO and the COR set forth by the table in this Article.
Other Technical Reports. (DD&A) The technical studies listed in Attachment A-1 will be professionally reviewed by qualified senior staff to determine if they are adequately prepared and can be incorporated into the Draft EIR. A peer review memo will be prepared identifying if appropriate standard methods and applicable agency protocols were used to complete the studies. Conclusions, impact significance thresholds, recommendations, and mitigation measures may be recommended for additional text for the technical studies, specifically to address if studies can be amended in certain areas to be in conformance with CEQA guidelines. Any identified mitigation measures recommended to avoid potential impacts will be identified. After the Applicant’s technical studies are reviewed, findings will be reported. If deficiencies or missing information is identified by the Contractor, the technical studies would then be revised by the Applicant’s consultant in response to any comments. Responses to Contractor’s comments would be reviewed along with any revisions to the reports. Revisions would be made to a level that would be considered acceptable to support the CEQA study. This review process assumes revisions would be limited to addressing minor comments and that the analyses would not be revised substantially that require a complete review of the studies. *As it is not yet known if all technical reports will be appropriate for full CEQA evaluation, preparation of specific technical reports are proposed as optional deliverables and task items, as shown in the budget, See “Optional Tasks”, below. Also, please refer to the technical scoping for these optional items (Attachment A-2) Deliverables: Peer review memorandums (one for each technical study) TASK 6.0 Environmental Documentation – Administrative Draft, Draft, and Final EIR Contractor will prepare an Administrative Draft EIR that provides a programmatic and project level analysis of the SVIP Project. The EIR will analyze the issues described under “Technical Issues,” which are provided at the end of this scope of work and in Appendix A (See attachment A-2) (Technical Sections of the EIR Scopes of Work).
