Phase I approval definition

Phase I approval means the Justification Phase involving the approval of a Phase I concept plan by the BOCC.
Sample 1

Examples of Phase I approval in a sentence

  • The Bachelor’s Honours Programme has a total student workload of 45 ECTS credit points, spread over the three years of the Bachelor’s programme.

  • These guidelines for PEI Statewide Programs provide Phase I approval for Planning Funds and Phase II approval to expend PEI statewide Funds on program implementation.

  • The applicant and FEMA may approve projects meeting the above pre-screening requirements for technical assistance under a Phase I approval.

  • Syed Dabeer, Interpreter Services, spoke regarding a letter the department staff sent to the CEO and COO regarding the working conditions and potential budget reductions.

  • If a Flood Insurance Rate Map (FIRM) amendment or revision will be necessary under the provisions of the National Flood Insurance Program (NFIP), the applicant and FEMA will provide the subapplicant with technical assistance to meet this requirement.• Refinement of the Cost-Effectiveness Assessment: Based on the revised design and cost estimates, the applicant and FEMA will refine the preliminary assessment of cost-effectiveness conducted prior to Phase I approval.

  • If a Flood Insurance Rate Map (FIRM) amendment or revision will be necessary under the provisions of the National Flood Insurance Program (NFIP), the applicant and FEMA will provide the subapplicant with technical assistance to meet this requirement.• Refinement of the Cost-Effectiveness Assessment: Based on the revised design and cost estimates, the applicant and FEMA will refine the preliminary assessment of cost- effectiveness conducted prior to Phase I approval.

  • In such case the most obvious strategy of broad- casting every message to all member exactly once re- mains optimal.

  • No CEMS may however be operated unless Phase I approval has first been obtained from the Department.

  • For multi-phased plans, building permits shall not be issued based on an approval date more than three (3) years from the date of Phase I approval.( Ord.

  • For multi-phased plans, building permits shall not be issued based on an approval date more than three years from the date of Phase I approval.

Related to Phase I approval

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Development approval means any written authorization from a

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Development Approvals means all permits, licenses, and/or other entitlements for the Development of the Property, including any and all conditions of approval, subject to approval or issuance by the City in connection with Development of the Property including:

  • FDA Approval means the approval by the FDA of a premarket approval application to market and sell a Product, as evidenced by the publication of such approval by the FDA.

  • Development Consent means the consent granted to the Development Application for the Development and includes all modifications made under section 4.55 of the Act.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Phase I Study means a study in humans which provides for the first introduction into humans of a product, conducted in healthy volunteers or patients to obtain information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the non-United States equivalent thereof).

  • Final Approval means the Court’s order granting final approval of the Settlement.

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Conditional approval means a time-limited status that results when an approved nursing education program has failed to maintain requirements as set forth in this chapter.

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Non-Approval Event means, in respect of the Benchmark:

  • Regulatory Approval means any approval or clearance by any governmental agency or agencies having authority to regulate the use or sale of any Licensed Product(s) in the pertinent jurisdiction or territory.

  • Works Approval means this Works Approval numbered W5913/2015/1 and issued under the Act; and

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale or use of a Product as a drug in a regulatory jurisdiction.

  • FCC Approval means the FCC’s grant of the FCC Applications; provided that the possibility that an appeal, request for stay, or petition for rehearing or review by a court or administrative agency may be filed with respect to such grant, or that the FCC may reconsider or review such grant on its own authority, shall not prevent such grant from constituting FCC Approval for purposes of the Plan.