FDA Submission and Safe to Proceed Notice Sample Clauses

FDA Submission and Safe to Proceed Notice. ♦ For studies under a new IND, the sponsoring agency will submit the application to the US Food and Drug Administration (FDA). For these studies, completion of a US FDA 30- day review period/safe to proceed notice is required prior to the study opening.
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Related to FDA Submission and Safe to Proceed Notice

  • Notice to Proceed (NTP Following the JOA and purchase order issuance, the County will issue a Notice to Proceed (NTP) that will provide the construction start date, the Work duration period, and the Substantial Completion date. The Contractor agrees to begin and complete construction within the dates specified on the NTP. The County must approve all extensions of time in writing. The County may also issue an Emergency Notice to Proceed (NTP). In the event the County requires the Contractor to respond to an immediate request for work, a Job Order will be created and an Emergency NTP will be issued. The Contractor will be required to perform the Scope of Work included with the Emergency NTP as directed by the County’s Project Manager or designee. The Detailed Scope of Work, Quotation, Subcontractor Listing, Shop Drawings and required Non Pre-priced backup documentation will be submitted upon completion of the emergency work in accordance with the Ordering Procedures detailed in Section III above.

  • Updated Information Submission by Interconnection Customer The updated information submission by the Interconnection Customer, including manufacturer information, shall occur no later than one hundred eighty (180) Calendar Days prior to the Trial Operation. The Interconnection Customer shall submit a completed copy of the Electric Generating Unit data requirements contained in Appendix 1 to the LGIP. It shall also include any additional information provided to the Participating TO and the CAISO for the Interconnection Studies. Information in this submission shall be the most current Electric Generating Unit design or expected performance data. Information submitted for stability models shall be compatible with the Participating TO and CAISO standard models. If there is no compatible model, the Interconnection Customer will work with a consultant mutually agreed to by the Parties to develop and supply a standard model and associated information. If the Interconnection Customer's data is materially different from what was originally provided to the Participating TO and the CAISO for the Interconnection Studies, then the Participating TO and the CAISO will conduct appropriate studies pursuant to the LGIP to determine the impact on the Participating TO’s Transmission System and affected portions of the CAISO Controlled Grid based on the actual data submitted pursuant to this Article 24.3. The Interconnection Customer shall not begin Trial Operation until such studies are completed and all other requirements of this LGIA are satisfied.

  • NOTICE TO PROCEED AND SCHEDULE The CONSULTANT shall begin the work to be performed under this Contract only upon receipt of the written notice to proceed from the LPA, and shall deliver the work to the LPA in accordance with the schedule contained in Appendix "C" which is herein attached to and made an integral part of this Contract.

  • Information Submission by Connecting Transmission Owner The initial information submission by Connecting Transmission Owner shall occur no later than one hundred eighty (180) Calendar Days prior to Trial Operation and shall include New York State Transmission System information necessary to allow the Developer to select equipment and meet any system protection and stability requirements, unless otherwise mutually agreed to by the Developer and Connecting Transmission Owner. On a monthly basis Connecting Transmission Owner shall provide Developer and NYISO a status report on the construction and installation of Connecting Transmission Owner’s Attachment Facilities and System Upgrade Facilities and System Deliverability Upgrades, including, but not limited to, the following information: (1) progress to date; (2) a description of the activities since the last report; (3) a description of the action items for the next period; and (4) the delivery status of equipment ordered.

  • Selection of Subcontractors, Procurement of Materials and Leasing of Equipment The contractor shall not discriminate on the grounds of race, color, religion, sex, national origin, age or disability in the selection and retention of subcontractors, including procurement of materials and leases of equipment. The contractor shall take all necessary and reasonable steps to ensure nondiscrimination in the administration of this contract.

  • Cost Responsibility for Interconnection Facilities and Distribution Upgrades 4.1 Interconnection Facilities 4.2 Distribution Upgrades

  • Accurate and Timely Submission of Reports a) The reports and administrative fees shall be accurate and timely and submitted in accordance with the due dates specified in this section. Vendor shall correct any inaccurate reports or administrative fee payments within three (3) business days upon written notification by DIR. Vendor shall deliver any late reports or late administrative fee payments within three (3) business days upon written notification by DIR. If Vendor is unable to correct inaccurate reports or administrative fee payments or deliver late reports and fee payments within three

  • Office of Inspector General Investigative Findings Expert Review In accordance with Senate Bill 799, Acts 2021, 87th Leg., R.S., if Texas Government Code, Section 531.102(m-1)(2) is applicable to this Contract, Contractor affirms that it possesses the necessary occupational licenses and experience.

  • Public Posting of Approved Users’ Research Use Statement The PI agrees that information about themselves and the approved research use will be posted publicly on the dbGaP website. The information includes the PI’s name and Requester, project name, Research Use Statement, and a Non-Technical Summary of the Research Use Statement. In addition, and if applicable, this information may include the Cloud Computing Use Statement and name of the CSP or PCS. Citations of publications resulting from the use of controlled-access datasets obtained through this DAR may also be posted on the dbGaP website.

  • CONTRACTOR’S SUBMISSION OF CONTRACT MODIFICATIONS In connection with any Contract modification, OGS reserves the right to:  request additional information  reject Contract modifications  remove Products from Contract modification requests  request additional discounts for new or existing Products

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