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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Examples of Notice of Intent to Use in a sentence

  • However, for activities involving more than one acre of construction that also require a NPDES stormwater construction general permit, submittal of the Notice of Intent to Use Generic Permit for Stormwater Discharge from Large and Small Construction Activities, DEP Form 62-621.300(4)(b), shall also serve as notice of commencement of construction under this chapter and, in such a case, submittal of Form 62-330.350(1) is not required.

  • 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)].

  • Fill out, sign and date a Notice of Intent to Use Generic Permit for Stormwater Discharge from Large and Small Construction Activities, (FDEP Form 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)].

  • Form number 62-621.300(5)(b), Notice of Intent to Use Multi-Sector Generic Permit for Stormwater Discharge Associated with Industrial Activity, effective October 22, 2000, is hereby incorporated by reference and made part of this chapter.

  • Form number 62-621.300(3)(b), Notice of Intent to Use Generic Permit for Discharges from Concrete Batch Plants, effective May 10, 2005, is hereby incorporated by reference and made part of this chapter.

  • 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).

  • Notice of Intent to Use the General Permit for Construction of Lead or Copper Corrosion Control, or Iron or Manganese Sequestration, Treatment Facilities for Small or Medium PWSs, effective August 28, 2003.

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 specified in Section 6.02(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 means the Notice of Sale of the Trust relating to the sale of the Series 2014A Bonds to be dated on or about April 28, 2014, substantially in the form attached hereto as Exhibit D.

  • 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.

  • Repudiation/Moratorium Extension Notice means a notice from the Calculation Agent to the Issuer (which the Calculation Agent has the right but not the obligation to deliver) that describes a Potential Repudiation/Moratorium that occurred on or prior to the Scheduled Maturity Date. A Repudiation/Moratorium Extension Notice must contain a description in reasonable detail of the facts relevant to the determination that a Potential Repudiation/Moratorium has occurred and indicate the date of the occurrence. The Potential Repudiation/Moratorium that is the subject of the Repudiation/Moratorium Extension Notice need not be continuing on the date the Repudiation/Moratorium Extension Notice is effective.

  • 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.

  • Notice of Lien means any "notice of lien" or similar document intended to be filed or recorded with any court, registry, recorder's office, central filing office or other Governmental Authority for the purpose of evidencing, creating, perfecting or preserving the priority of a Lien securing obligations owing to a Governmental Authority.

  • 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, regulatory exclusivity and equivalents thereof offering patent protection beyond the initial term with respect to any issued Patents.

  • 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.

  • Letter of Intent (LOI means an intimation by a letter to Bidder that their Tender has been accepted in accordance with the provisions contained in the letter and hence to take preparatory steps and compliance of formalities to commence the work from the date desired by Owner.

  • Opt-Out Notice has the meaning specified therefor in Section 2.02(a) of this Agreement.