Abbreviated Application definition

Abbreviated Application means (a) an application submitted to the FDA under subsection (k) of Section 351 of the PHSA, or (b) any analogous application to an application set forth in clause (a) submitted to a Regulatory Authority.
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Abbreviated Application means the Abbreviated Application for a Certificate of Convenience and Necessity in FERC Docket No. CP12-351 allowing for Bi-directional flow of Natural Gas through the Facilities.
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Abbreviated Application means (a) any application submitted to the FDA under (i) subsection (k) of Section 351 of the PHSA (42 U.S.C. 262(k)) or (ii) Section 505(j) of the FD&C Act (21 U.S.C. 355(j)), or (iii) Section 505(b)(2) of the FD&C Act (21 U.S.C. 355), (b) any application submitted to the EMA under a provision of Articles 10, 10a, or 10b of Parliament and Council Directive 2001/83/EC as amended (including any application under Article 6.1 of Parliament and Council Regulation (EC) No 726/2004 that relies for its content on any such provision), or (c) any analogous application to those applications set forth in clauses (a) or (b) submitted to any Regulatory Authority in the US, European Union, or in another country or jurisdiction in the world.
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Examples of Abbreviated Application in a sentence

  • Abbreviated Application Procedures for Self-Verification (SV) (Minimum) Applicants must submit the information in Appendix B, which includes the Corps Secondary Impacts Checklist.

  • The application shall be submitted with a nonrefundable filing fee in the amount prescribed by Section 663.413(1), F.S., which is made payable to the Office of Financial Regulation (OFR).(2) Abbreviated Application to Establish an International Trust Company Representative Office.

  • ComplianceCan a late payment complaint be submitted anonymously?Yes.

  • Abbreviated Application Procedures (Minimum Impact Project)Applicants must submit the information in Appendix B, which includes the Corps Secondary Impacts Checklist.

  • Abbreviated Application: The abbreviated application involved the first 3 policies in modified form.

  • The first step is the submission of an application for funding, which will include the Federally required standard application documents and an abbreviated program narrative as outlined in Section IV.2 Content and Form of Abbreviated Application Submission of this funding opportunity announcement.

  • The Abbreviated Application contains fewer questions and documentation requirements than the Standard Application.

  • Providers eligible to complete the Abbreviated Application will be notified by the Commission.

  • In the same way Alpha Card, via its subsidiary ACMS, acts as an “acquirer” in its contracts with merchants (signs up the merchants, sets merchant discount rate, sets credit and financial criteria, manages receivables) pursuant to its license agreement with American Express.

  • Iroquois Gas Transmission Sys., L.P., Abbreviated Application for a Certificate of Public Convenience and Necessity, Docket No. CP20-48-000 (Feb.


More Definitions of Abbreviated Application

Abbreviated Application means (a) a Biologics License Application submitted to the FDA under subsection (k) of Section 351 of the Public Health Service Act (PHSA) (42 USC 262(k)), (b) an abbreviated New Drug Application submitted to the FDA under Section 505(j) of the FDC Act (21 USC 355(j)), or (c) any analogous application to those applications set forth in clauses (a) or (b) submitted to a Regulatory Authority outside the United States.
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Related to Abbreviated Application

  • Completed application means an application in the form and number and containing all the information required pursuant to 34 Administrative Code 9.1053 (Entity Requesting Agreement to Limit Appraised Value), that has been determined by the district and the comptroller to include all minimum requirements for consideration.

  • L/C Application means an application and agreement for the issuance or amendment of a Letter of Credit in the form from time to time in use by the L/C Issuer.

  • State Abbreviation means the following:

  • Licensed Application means an Application that (a) meets and complies with all of the Documentation and Program Requirements, and (b) has been selected and digitally signed by Apple for distribution, and includes any additional permitted functionality, content or services provided by You from within an Application using the In-App Purchase API.

  • Mobile Application means a specialized software program downloaded onto a wireless communication device.

  • Transfer Application means an application and agreement for transfer of Units in the form set forth on the back of a Certificate or in a form substantially to the same effect in a separate instrument.

  • Initial application means the Application first provided to MFA on or before an Application Deadline to request an allocation of Tax Credits.

  • Registration Application means an application for registration of this Agreement as a planning agreement on the title of the Land pursuant to Section 7.6 of the Act in a form approved by the Registrar General;

  • Server Application means an application developed by Licensee that a) utilizes the Runtime Product, b) allows more than one user to Use the Runtime Product through any middle tier application(s), and c) adds significant and primary functionality to the Runtime Product. A Client Application installed in a Windows terminal server environment (e.g. Citrix or Microsoft Remote Desktop Platform) is a Server Application.

  • Drug Application means a new drug application, an abbreviated drug application, or a product license application for any Product, as appropriate, as those terms are defined in the FDCA.

  • international application means an application filed under this Treaty;

  • Development Application means the development application identified in Item 5 of Schedule 1 and includes all plans, reports models, photomontages, material boards (as amended supplemented) submitted to the consent authority before the determination of that Development Application.

  • Electrostatic application means the application to a substrate of charged atomized paint droplets that are deposited by electrostatic attraction.

  • Bid Application Form means the form as specified in Annexure II of this E-Auction Process Information Document;

  • Fee Application means an application for allowance and payment of a Fee Claim (including Claims for “substantial contribution” pursuant to section 503(b) of the Bankruptcy Code).

  • Creation Application means an application by a Participating Dealer for the creation and issue of Units in an Application Unit size (or whole multiples thereof) in accordance with the Operating Guidelines and the Trust Deed.

  • New Drug Application means a New Drug Application filed with the FDA in accordance with Applicable Law.

  • Request for Applications (RFA) means the document (including all amendments and attachments) issued by the System Agency under which applications for Program funds were requested, which is incorporated by reference for all purposes in its entirety.

  • Planning Application means the application for [outline/full] planning permission dated [ ] bearing the Council’s reference number [ ];

  • Project Application means the federal Section 5311 operating assistance project application submitted by the Municipal Corporation to, and as approved by the Commissioner for the Project described in Appendix C of this Agreement, including all project supporting information submitted therewith.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Software Application means a digital product or service as defined in Article 2, point 13, of Regulation (EU) …/… [on contestable and fair markets in the digital sector (Digital Markets Act)];

  • Client Application means an application developed by Customer that a) utilizes the Runtime Product, b) is installed fully on an end user’s machine, with all report processing local to that machine, and c) adds significant and primary functionality to the Runtime Product.

  • Application Process means the online application process under which the Applicant applies for Hospitality Packages on the Webshop.

  • Permit Application has the meaning ascribed to it in Section 2.35.

  • 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.