Refuse to Receive (RTR definition

Refuse to Receive (RTR means refusal to receive an ANDA for review. See 21 CFR314.101 and the guidance for industry ANDA Submissions – Refuse-to-Receive Standards (December 2016). See https://www.fda.gov/RegulatoryInformation/Guidances/default.htm.

Examples of Refuse to Receive (RTR in a sentence

  • Refuse to Receive (RTR) means refusal to receive an ANDA for review.

  • Applications that include appropriate and complete facility information in the establishment information section of Form FDA 356h will reduce the frequency of Information Request (IR), Refusal to File (RTF), and Refuse to Receive (RTR) actions and increase the efficiency of the application assessment process.

Related to Refuse to Receive (RTR

  • 107 Person" means any natural person, corporation, general ------ partnership, limited partnership, joint venture, proprietorship or other business organization.

  • Adhesive remover means a product designed to remove adhesive from either a specific substrate or a variety of substrates. “Adhesive Remover” does not include products that remove adhesives intended for use on humans or animals.

  • Refuse to cooperate means to obstruct the collection or testing process; to submit an altered, adulterated or substitute sample; to fail to show up for a scheduled test; to refuse to complete the requested drug testing forms; or to fail to promptly provide specimen(s) for testing when directed to do so, without a valid medical basis for the failure. Employees who leave the scene of an accident without justifiable explanation prior to submission to drug and alcohol testing will also be considered to have refused to cooperate and will automatically be subject to discharge.

  • Acceptance of Tender means the letter or memorandum communicating to the supplier the acceptance of his offer (Tender) and shall include advance acceptance of his offer i.e. Letter of Intent or Rate Contract.

  • Invitation to Negotiate means a written solicitation for competitive sealed replies to select one or more vendors with which to commence negotiations for the procurement of commodities or services.

  • In this award, unless the contrary intention appears:Act means the Fair Work Act 2009 (Cth)[Definition of agreement-based transitional instrument inserted by PR994486 from 01Jan10] agreement-based transitional instrument has the meaning in the Fair Work (Transitional Provisions and Consequential Amendments) Act 2009 (Cth)award-based transitional instrument has the meaning in the Fair Work (Transitional Provisions and Consequential Amendments) Act 2009 (Cth)[Definition of default fund employee inserted by PR546067 ppc 01Jan14] default fund employee means an employee who has no chosen fund within the meaning of the Superannuation Guarantee (Administration) Act 1992 (Cth)[Definition of defined benefit member inserted by PR546067 ppc 01Jan14] defined benefit member has the meaning given by the Superannuation Guarantee (Administration) Act 1992 (Cth)[Definition of Division 2B State award inserted by PR503736 ppc 01Jan11] Division 2B State award has the meaning in Schedule 3A of the Fair Work (Transitional Provisions and Consequential Amendments) Act 2009 (Cth)[Definition of Division 2B State employment agreement inserted by PR503736 ppc 01Jan11] Division 2B State employment agreement has the meaning in Schedule 3A of theFair Work (Transitional Provisions and Consequential Amendments) Act 2009 (Cth)[Definition of employee substituted by PR997772 from 01Jan10] employee means national system employee within the meaning of the Act[Definition of employer substituted by PR997772 from 01Jan10] employer means national system employer within the meaning of the Actenterprise award-based instrument has the meaning in the Fair Work (Transitional Provisions and Consequential Amendments) Act 2009 (Cth) [Definition of exempt public sector superannuation scheme inserted by PR546067 ppc 01Jan14] exempt public sector superannuation scheme has the meaning given by theSuperannuation Industry (Supervision) Act 1993 (Cth)[Definition of MySuper product inserted by PR546067 ppc 01Jan14] MySuper product has the meaning given by the Superannuation Industry (Supervision) Act 1993 (Cth)NES means the National Employment Standards as contained in sections 59 to 131 of the Fair Work Act 2009 (Cth)[Definition of on-hire inserted by PR994486 from 01Jan10] on-hire means the on-hire of an employee by their employer to a client, where such employee works under the general guidance and instruction of the client or a representative of the clientstandard rate means the minimum weekly wage for a Storeworker grade 4 in clause 15.1steel distributing employee means an employee working for an employer at a site in or in connection with receiving, unloading, storing, packing, sorting, handling, cutting material to order, preparation for dispatch, loading and dispatch of steel or any similar materialstorage services and wholesale industry means the receiving, handling, storing, freezing, refrigerating, bottling, packing, preparation for sale, sorting, loading, dispatch, delivery, or sale by wholesale, of produce, goods or merchandise as well as activities and processes connected, incidental or ancillary[Definition of transitional minimum wage instrument inserted by PR994486 from 01Jan10] transitional minimum wage instrument has the meaning in the Fair Work (Transitional Provisions and Consequential Amendments) Act 2009 (Cth)wholesale means the sale of commodities in large quantities other than to final consumers

  • Verification on oath or affirmation means a declaration, made by an individual on oath or affirmation before a notarial officer, that a statement in a record is true.

  • Acceptance of Bid means the letter/fax or any memorandum communicating to the Bidder the acceptance of its Bid and includes an advance acceptance of his Bid.

  • Warranty Xxxx of Sale means the warranty (as to title) xxxx of sale covering the Aircraft executed by Manufacturer or an affiliate of Manufacturer in favor of Company and specifically referring to each Engine, as well as the Airframe, constituting a part of the Aircraft.

  • General purpose adhesive remover means a product designed or labeled to remove cyanoacrylate adhesives as well as nonreactive adhesives or residue from a variety of substrates. “General Purpose Adhesive Remover” includes, but is not limited to, products that remove thermoplastic adhesives; pressure sensitive adhesives; dextrine or starch-based adhesives; casein glues; rubber or latex-based adhesives; as well as products that remove stickers; decals; stencils; or similar materials. “General Purpose Adhesive Remover” does not include “Floor or Wall Covering Adhesive Remover.”

  • Request for Tender means the Request for Tender given to prospective tenderers inviting offers to tender for the supply of the Services of which these General Conditions of Contract form part.

  • civil servant means a person who is a member of a civil service of the Province, or who holds a civil post in connection with the affairs of the Province, but does not include-

  • civil service means the civil service of the State;

  • Notice of Tender means, in connection with an Optional Tender, a notice, substantially in the form attached to the Tender and Paying Agent Agreement, delivered by a Beneficial Owner or its Agent Member to the Tender and Paying Agent, indicating an intention to tender VRDP Shares for sale on a Purchase Date pursuant to Section 1 of Part II of this Statement.

  • Offer and disseminate means providing general information, including a description of the coverage and price, as well as processing the application, collecting premiums, and performing other nonlicensable activities permitted by the State.

  • Notice of Proposal to Negotiate has the meaning set forth in Section 10(c) hereof.

  • Institution of higher learning means an educational institution located within this state meeting all of the following requirements:

  • Surgery or Surgical Procedure means manual and / or operative procedure (s) required for treatment of an illness or injury, correction of deformities and defects, diagnosis and cure of diseases, relief from suffering and prolongation of life, performed in a hospital or day care centre by a medical practitioner.

  • Bill of Sale means a bill or bills of sale in a form substantially in conformance with the form attached as the Exhibit B hereto.

  • Appendix to Tender means the appendix comprised in the form of Tender annexed to these Conditions.

  • Locational Deliverability Area Reliability Requirement means the projected internal capacity in the Locational Deliverability Area plus the Capacity Emergency Transfer Objective for the Delivery Year, as determined by the Office of the Interconnection in connection with preparation of the Regional Transmission Expansion Plan, less the minimum internal resources required for all FRR Entities in such Locational Deliverability Area.

  • Contractor Selection of Leave Trees means crop and leave trees are unmarked and will be selected by the Contractor.

  • FAA Xxxx of Sale means the xxxx of sale for the Aircraft on AC Form 8050-2 executed by Manufacturer or an affiliate of Manufacturer in favor of Company and recorded with the FAA.

  • Medicaid Notification of Termination Requirements Any Contractor accessing payments for services under the Global Commitment to Health Waiver and Medicaid programs who terminates their practice will follow the Department of Vermont Health Access, Managed Care Organization enrollee notification requirements.

  • Additional Xxxx of Sale means each document, in the form of Attachment D hereto, executed by an authorized officer of VL Funding, the VL Funding Eligible Lender Trustee on behalf of VL Funding, Funding and the Interim Eligible Lender Trustee on behalf of Funding which shall: (i) set forth the list and certain terms of (a) Additional Loans offered by VL Funding and the VL Funding Eligible Lender Trustee on behalf of VL Funding and accepted for purchase by the Interim Eligible Lender Trustee for the benefit of Funding, including the Additional Loans Purchase Price for the Additional Loans being sold thereunder or (b) Substituted Loans substituted by VL Funding and (ii) sell, assign and convey to Funding and the Interim Eligible Lender Trustee, for the benefit of Funding, and their assignees, all right, title and interest of VL Funding and of the VL Funding Eligible Lender Trustee on behalf of VL Funding in the Additional Loans or Substituted Loans, as applicable, listed on the related Additional Xxxx of Sale and (iii) certify that the representations and warranties made by VL Funding and the VL Funding Eligible Lender Trustee on behalf of VL Funding pursuant to Sections 5(A) and (B) of these Master Terms, by the Servicer as set forth in Section 5(C) and by the Interim Eligible Lender Trustee as set forth in Section 5(D) are true and correct.

  • Acceptance of offer means issue of letter of intent/award or memorandum or detailed Order/Contract communicating the acceptance of offer, to the successful Tenderer.