Approvable definition

Approvable means that which can be approved by Department staff, with only minimal revision.
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Approvable is the word they use. See, this document only has the reporting district. You need to see the document that is the next page that says what the action is, and that is not on this document. Maybe it is not in your document, but I was shown -- my counsel, when I asked to see 505438, was able to show me that. That is it, "District decision, AE." That is approvable. [109] Xx. Xxxxx appears to have equated 'approvable' with 'approved'. On cross-examination, he stated that Uquifa was GMP approved by the FDA in 1990, when in fact, it appears that it was not. I do not know to what extent this assumption impacted Xx. Xxxxx'x conclusion that Glaxo's GMPs did not lead to any differences in quality, safety or efficacy of Glaxo's API compared to the generic API. [110] Dr. Xxxxx Xxxxx, who became a director of logistics within Glaxo's pharmaceutical arm around 1990 and 1991, also seems to have equated 'approvable' with 'approved'. In response to questioning, he said that he was aware that Uquifa had been approved by the FDA, but that the deficiencies listed in the FDA Form 483s showed that they were still having problems as late as 1995.
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Approvable means that which can be approved by Department staff with only minimal revision. To facilitate the preparation of the restoration plan, I encourage respondents to discuss the development of the restoration plan with Department staff prior to the plan’s submission.
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Examples of Approvable in a sentence

  • Approvable procedures include breast reconstruction after mastectomy, or the repair of other injuries resulting from physical trauma.

  • Locally Approvable projects may also choose to make their Plan electronically available in accordance with Section 4(c)(2)(N) of this general permit.

  • Recommendation on Phase 4 (Post-Marketing) Commitments, Agreements, and/or Risk Management Steps, if Approvable.

  • Intended outcome: Approvable LS in R2-2108943 Deadline: Tuesday 2021-08-24 0800 UTC This email discussion continues to discuss the possible content for the Reply LS.

  • The construction stormwater general permit dictates separate compliance procedures for Locally Approvable projects and Locally Exempt projects (as defined in the permit).

  • Performance guarantees shall be in a form approved by the city attorney Approvable methods of performance guarantee include irrevocable standby letters of credit to the benefit of the city issued by a recognized lending institution, certified checks, dedicated bank accounts or allocations of construction loans held in reserve by the lending institution for the benefit of the city.

  • DHSEM will forward the plan to FEMA Region VIII for review and Approvable Pending Adoption (APA) status.

  • Amount Approvable will be no more than two (2) dwelling units on one (1) recorded parcel (lot) of record or a total of two (2) dwelling units on two (2) adjacent lots of record under same ownership, including partnerships in a LLC.

  • Refer to 4000.1.II.A.5- Approvable Ratio Requirements (Manual) for requirements.

  • This monthly update may also include plans approved, plans nearing expiration, or other status categories as deemed appropriate by FEMA.Upon completion of a Plan review, FEMA will prepare and forward a notification in the form of a "Requires Revisions", "Approvable Pending Adoption (APA)" or "Approval" letter to the State.


More Definitions of Approvable

Approvable site means a site that may be developed for low and moderate income housing in a manner consistent with the rules or regulations of all agencies with jurisdiction over the site. A site may be approvable although not currently zoned for low and moderate income housing.
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Related to Approvable

  • Approval of a vehicle means the approval of a vehicle type with regard to sound;

  • type-approval means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

  • 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.

  • 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:

  • Reimbursement Approval means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in the Territory.

  • 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.

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

  • the Approved Guidance means such guidance on the obtaining, recording and maintaining of information about costs and on the breaking down and allocation of costs by reference to Approved Reporting Currencies as may be published by Monitor; “Approved ReportingCurrencies” means such categories of cost and other relevant information as may be published by Monitor; “other relevant information” means such information, which may include quality and outcomes data, as may be required by Monitor for the purpose of its functions under Chapter 4 (Pricing) in Part 3 of the 2012 Act.

  • Government Approval means any authorization, consent, approval, waiver, exception, variance, order, exemption, publication, filing, declaration, concession, grant, franchise, agreement, permission, permit, or license of, from, or with any Governmental Authority, the giving of notice to, or registration with, any Governmental Authority, or any other action in respect of any Governmental Authority.

  • Development approval means a document from a governmental entity which authorizes the commencement of a development.

  • Approval Letter means the letter from WRAS to the Applicant confirming the grant of WRAS Approval in respect of a Product;

  • Special Approval means approval by a majority of the members of the Conflicts Committee.

  • Approval Authority means the authority of a Member State with competence for all aspects of the approval of a type of vehicle, system, component or separate technical unit or of the individual approval of a vehicle; for the authorisation process, for issuing and, if appropriate, withdrawing approval certificates; for acting as the contact point for the approval authorities of other Member States; for designating the technical services and for ensuring that the manufacturer meets his obligations regarding the conformity of production;

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

  • CAISO-Approved Meter means any revenue quality, electric energy measurement meter furnished by Seller, that (a) is designed, manufactured and installed in accordance with the CAISO’s metering requirements, or, to the extent that the CAISO’s metering requirements do not apply, Prudent Electrical Practices, and (b) includes all of the associated metering transformers and related appurtenances that are required in order to measure the net electric energy output from the Generating Facility.

  • Approval Notice means, with respect to any Eligible Loan Asset, the written notice, in substantially the form attached hereto as Exhibit A, evidencing the approval by the Agent, in its sole discretion, of the conveyance of such Eligible Loan Asset by the Transferor to the Equityholder pursuant to the terms of the First Tier Purchase and Sale Agreement and by the Equityholder to the Borrower pursuant to the terms of the Second Tier Purchase and Sale Agreement and the Assignments by which the Transferor effects such conveyance.

  • 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.

  • Developmentally appropriate means suitable to the chronological age range and developmental characteristics of a specific group of children.

  • Validation as used in WAC 222-20-016, means the department's agreement that a small forest landowner has correctly identified and classified resources, and satisfactorily completed a roads assessment for the geographic area described in Step 1 of a long-term application.