Notice of Intent to Use definition

Notice of Intent to Use means notification to the FDA not later than ninety (90) days prior to the submission of a human drug application of the intent to use the Priority Review Voucher to obtain Priority Review of a human drug application, as described in 21 U.S.C. § 360ff(b)(4)(B)(i).
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Notice of Intent to Use means notification to the FDA not later than ninety (90) days prior to the submission of a human drug application as defined in section 735(1) of the FDC Act (21 U.S.C. 379g(1)) of the intent to use a Priority Review Voucher for the human drug application, as described in section 529(b)(4) of the FDC Act (21 U.S.C. § 360ff(b)(4)).
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Examples of Notice of Intent to Use in a sentence

  • Absent agreement by all parties concerning the introduction of depositions into the record at the hearing, any party wishing to introduce all or part of a deposition at hearing for any purpose other than impeachment, must file a Notice of Intent to Use Deposition no later than the last day to conduct discovery in this docket as set forth in Section IX of this Order.

  • Absent agreement by all parties concerning the introduction of depositions into the record at the hearing, any party wishing to introduce all or part of a deposition at hearing for any purpose other than impeachment, must file a Notice of Intent to Use Deposition no later than the last day to conduct discovery in this docket as set forth in Section VIII of this Order.

  • Within 30 days of commencing the work of such repair or replacement, however, the owner or operator shall submit to the Department a completed Notice of Intent to Use Generic Permit for Stormwater Discharge from Large and Small Construction Activities [Form Number 62-621.300(4)(b)].

  • Within thirty (30) days of commencing the work of such repair or replacement, however, the owner or operator shall submit to the Department a completed Notice of Intent to Use Generic Permit for Stormwater Discharge from Large and Small Construction Activities [Form Number 62-621.300(4)(b)].

  • Such information shall include, at a minimum, if applicable, the Florida Department of Environmental Protection Permit number issued pursuant to a completed Notice of Intent to Use General Permit for Wastewater Collection/Drinking Water Distribution System {Form No. 17─555.910(7)} and a copy of the latest applicable Operation and Maintenance Performance Report and, if applicable, Capacity Analysis Report prepared pursuant to Florida Administrative Code Chapter 17─600.405 or any successor regulation(s).

  • The Contractor must obtain a Notice of Intent to Use Noticed General Permit for Short Term Construction Dewatering (Form 40C-22-0590-1) prior to the commencement of any dewatering.

  • Neither Seller nor any of its Affiliates has filed or submitted to the FDA a Notice of Intent to Use the Priority Review Voucher to obtain a Priority Review.

  • The CONTRACTOR shall be responsible for compliance with the FDEP Notice of Intent to Use the Generic Permit for Discharge of Groundwater from Dewatering Operations (FDEP Document 62-621.300(2)(b), which can be found at xxxxx://xxxxxxxxxx.xxx/forms).

  • Buyer may, on or after the Effective Date and prior to Closing, submit a Notice of Intent to Use the Priority Review Voucher substantially in the form attached hereto as Exhibit F to the FDA of its intent to use the Priority Review Voucher to obtain Priority Review of a human drug application of Buyer’s choice in accordance with the applicable provisions of the FDC Act and the Priority Review Voucher (a “Pre-Closing PRV Notice”).

  • Notice of Intent to Use Personal Leave Notice of intent to use Personal Leave shall be provided by the member to his/her immediate supervisor on the prescribed form at least five (5) days in advance of the anticipated absence.

Related to Notice of Intent to Use

  • Notice of Intention means a notice to commence mining operations, including revisions to the notice.

  • Notice of Intent means a notice that an environmental impact statement will be prepared and considered. The notice shall briefly:

  • Notice of Intent to Cure has the meaning assigned to such term in Section 6.15(b).

  • LETTER OF INTENT/FAX OF INTENT means intimation by a Fax/Letter to Tenderer(s) that the tender has been accepted in accordance with the provisions contained in the letter.

  • Notice of Appeal means a notice given pursuant to Condition 6.2.

  • Notice of Extension has the meaning specified in Section 2.20.

  • statutory notice means a notice served by the company under the Companies Acts requiring particulars of interests in shares or of the identity of persons interested in shares.

  • Notice of Motion means a notice setting out the text of a motion, which it is proposed to move at the next relevant meeting;

  • Notice of Dissent means a notice of dissent duly and validly given by a registered holder of Company Shares exercising Dissent Rights as contemplated in the Interim Order and as described in Article 4.

  • Renewal Application means a document used to collect pertinent data for renewal of permits

  • Notice of Sale The meaning ascribed thereto in Section 4.16.

  • Notice of Hearing means a notice containing the information set out in Schedule VIII;

  • Denial notice means a board notification denying an application for the issuance or renewal of a license as required by the Act.

  • Applications means all of the following: “New Drug Application” (“NDA”), “Abbreviated New Drug Application” (“ANDA”), “Supplemental New Drug Application” (“SNDA”), or “Marketing Authorization Application” (“MAA”), the applications for a Product filed or to be filed with the FDA pursuant to 21 C.F.R. Part 314 et seq., and all supplements, amendments, and revisions thereto, any preparatory work, registration dossier, drafts and data necessary for the preparation thereof, and all correspondence between the Respondent and the FDA related thereto. The term “Application” also includes an “Investigational New Drug Application” (“IND”) filed or to be filed with the FDA pursuant to 21 C.F.R. Part 312, and all supplements, amendments, and revisions thereto, any preparatory work, registration dossier, drafts and data necessary for the preparation thereof, and all correspondence between the Respondent and the FDA related thereto.

  • Email Notice means the legal notice summarizing the proposed Settlement terms, as approved by Class Counsel, Facebook’s Counsel, and the Court, to be provided to Class Members (including Minor Subclass Members), under Section 3.3 of this Agreement via electronic mail or the Facebook domain of xxx.xxxxxxxx.xxx. The Email Notice must be substantially similar to the form attached hereto as Exhibit 3.

  • Notice of Breach means a written notice delivered to the other party within the time period required under the definition of “Cause” or “Good Reason,” as applicable, that (a) indicates, as applicable, the specific provision in this Agreement that the party contends the other party has breached or the specific clause of the definition of “Cause” or “Good Reason” that the party alleges to exist, and (b) to the extent applicable, sets forth in reasonable detail the facts and circumstances Executive or the Company, as applicable, claims provide the basis for such breach or other condition.

  • Patent Application means an application for patent protection for a CRADA Subject Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the corresponding patent-issuing authority of another nation.

  • Client Application means an application developed by Licensee 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.

  • Xxxxx Notice means the Notice of Grant of Stock Option accompanying the Agreement, pursuant to which Optionee has been informed of the basic terms of the option evidenced hereby.

  • Notice of Renewal has the meaning specified in Section 2.01(b).

  • Patent Term Extension means any term extensions, supplementary protection certificates and equivalents thereof offering Patent protection beyond the initial term with respect to any issued Patents.

  • Patent means (a) all patents and patent applications in any country or supranational jurisdiction in the Territory, (b) any substitutions, divisionals, continuations, continuations-in-part, provisional applications, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such patents or patent applications, and (c) foreign counterparts of any of the foregoing.

  • Rejection Notice has the meaning specified in Section 2.05(b)(v).

  • Renewal Notice As defined in Section 1.4(a).

  • FOIA Notice means a decision notice, enforcement notice and/or an information notice;

  • Notice of Revocation means, in connection with the revocation by a Beneficial Owner or its Agent Member of its Notice of 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 revoke the tender of some or all of the VRDP Shares for sale on a Purchase Date pursuant to Section 1 of Part II of this Statement.