Sentences with phrase «application for approval of»

On March 11,2017 Unites States Securities Exchange Commission (SEC) rejected an application for approval of Bitcoin ETF, filed by Winklevoss Twins.

SEC to re-examine Winklevoss» Twins Bitcoin ETF proposal On March 11, the United States Securities Exchange Commission (SEC) denied and rejected the application for approval of Bitcoin ETF.

The application for AMI approval shall be treated the same as an application for the approval of a driver education traditional course, and the AMI must deliver the school's approved curriculum as aligned with the Program of Organized Instruction for Driver Education and Traffic Safety.

An examination for the purposes of section 38.2 relating to an application for approval of an assessment or examination.

(c) before the insurer receives the report of a designated assessment, in the case of an application for approval of an assessment or examination under section 38.2, if the insured person is required to undergo a designated assessment.

(ii) prepared or approved a treatment confirmation form under section 37.1, a treatment plan under section 38 or an application for approval of an assessment or examination under section 38.2 for the person to be assessed, or

An assessment or examination conducted after the insurer notifies the insured person that, before the assessment or examination is conducted, the insurer does not require the submission of a treatment plan under section 38 or an application for approval of an assessment or examination under section 38.2.

(1) This section applies to a claim for a medical or rehabilitation benefit or an application for approval of an assessment or examination under section 38 if the insurer gives the insured person a notice informing the insured person that the insurer will pay the expenses without the submission of a treatment and assessment plan under that section.

The revised PD21 (with the latest, 45th, CPR update) requires that an application for approval of a settlement or compromise involving a protected party shall be dealt with by a master, designated civil judge or his nominee.

Bayer's application for approval of clothianidin was also rejected by French authorities.

Sierra Club retained Synapse to review Dayton Power and Light's (DP&L) application for approval of an electric security plan (Cases No. 16 -0395-EL-SSO, 16 -396-EL-ATA, and 16 -397-EL-AAM).

(Sec. 209) Requires the Secretary of HUD, in consultation with the Secretary, to issue regulations to: (1) prohibit any private contract, lease, or other agreement from impairing the ability of a residential property owner or lessee to install, construct, maintain, or use a solar energy system on that property; and (2) require that an application of approval for the installation or use of a solar energy system be treated in the same manner as an application for approval of an architectural modification.

Columbia is challenging both Duke's application for approval of a new gas plant in Ashville and the merger of Duke with Piedmont Natural Gas, another partner in the Atlantic Coast Pipeline.

(e) The board shall establish the information needed in an application for the approval of a charter school; provided that the application shall include, but not be limited to, a description of: (i) the mission, purpose, innovation and specialized focus of the proposed charter school; (ii) the innovative methods to be used in the charter school and how they differ from the district or districts from which the charter school is expected to enroll students; (iii) the organization of the school by ages of students or grades to be taught, an estimate of the total enrollment of the school and the district or districts from which the school will enroll students; (iv) the method for admission to the charter school; (v) the educational program, instructional methodology and services to be offered to students, including research on how the proposed program may improve the academic performance of the subgroups listed in the recruitment and retention plan; (vi) the school's capacity to address the particular needs of limited English - proficient students, if applicable, to learn English and learn content matter, including the employment of staff that meets the criteria established by the department; (vii) how the school shall involve parents as partners in the education of their children; (viii) the school governance and bylaws; (ix) a proposed arrangement or contract with an organization that shall manage or operate the school, including any proposed or agreed upon payments to such organization; (x) the financial plan for the operation of the school; (xi) the provision of school facilities and pupil transportation; (xii) the number and qualifications of teachers and administrators to be employed; (xiii) procedures for evaluation and professional development for teachers and administrators; (xiv) a statement of equal educational opportunity which shall state that charter schools shall be open to all students, on a space available basis, and shall not discriminate on the basis of race, color, national origin, creed, sex, gender identity, ethnicity, sexual orientation, mental or physical disability, age, ancestry, athletic performance, special need, proficiency in the English language or academic achievement; (xv) a student recruitment and retention plan, including deliberate, specific strategies the school will use to ensure the provision of equal educational opportunity as stated in clause (xiv) and to attract, enroll and retain a student population that, when compared to students in similar grades in schools from which the charter school is expected to enroll students, contains a comparable academic and demographic profile; and (xvi) plans for disseminating successes and innovations of the charter school to other non-charter public schools.

School districts shall submit an annual application for approval of those programs.

Application for approval of the planned schedule for the decommissioning of Monju has been submitted to the Nuclear Regulation Authority (NRA).

Application for approval of this program has also been filed with the EMA.

The FDA had already rejected Arena's first application for approval of Belviq in September 2010 because the compound seemed to produce tumours in rats and because the company could not statistically rule out an increase in the risk of heart - valve problems.

Applications for approval of new, huge wind power projects now being filed with the Ontario Ministry of the Environment and Climate should be denied, says Wind Concerns Ontario.

Not exact matches

On Thursday, Bristol - Myers Squibb abruptly ditched an accelerated approval application for a combo of its rival immunotherapy Opdivo and an older drug called Yervoy.

More than 40,000 companies submitted H - 1B visa applications in fiscal year 2016 and the top 20 sponsors account for 37 % of all visa approvals.

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

The Danish pharmaceutical group and its Japanese partner, Takeda Pharmaceutical Co, have submitted an application to the U.S. Food and Drug Administration for approval of its antidepressant, vortioxetine, Lundbeck said on Tuesday.

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

«Precision medicine is already positively affecting providers (for example, by reducing ED visits by 30 % through application of molecular profiling treatment strategy); payers ($ 25 billion expected annual spending on genetic tests by 2021, and 45 % of FDA approvals were geared toward targeted therapies in 2013); and pharma (the pharmacogenomics market is expected to be $ 7.5 billion by 2017).»

The sponsor of a material threat medical countermeasure application that receives a priority review voucher under this section may transfer (including by sale) the entitlement to such voucher to a sponsor of a human drug for which an application under section 505 (b)(1) or section 351 (a) of the Public Health Service Act will be submitted after the date of the approval of the material threat medical countermeasure application.

Pre-qualification often isn't as intense as a loan application since it requires only basic financial information, and it can tell you your chances of loan approval, how much funding you could qualify for, as well as offer other financing options that might be a good fit for your situation.

According to Department of Justice policy, an application for a search warrant of a lawyer's office such as this is so serious that it usually requires approval of either the U.S. attorney for the district, or the assistant attorney general.

For example, a Supplementary Protection Certificate in Europe may be applied for approval to recover some of the time lost between the patent application filing date and the date of first marketing authorizatiFor example, a Supplementary Protection Certificate in Europe may be applied for approval to recover some of the time lost between the patent application filing date and the date of first marketing authorizatifor approval to recover some of the time lost between the patent application filing date and the date of first marketing authorization.

During the pre-approval process, your lender will take a complete loan application which includes performing an income and asset verification, and he will account for specific loan traits which may affect your final approval such as your personal credit scores, any required child support payments, and the availability of a co-signer, as examples.

Maintaining timely approvals for new drugs is vital for drugmakers, since there are dozens of drug approval applications awaiting assessment by the EU regulator in the next few years.

By having a line of credit for your business, you don't waste valuable time going through an application and approval process each time you need to borrow more money.

Going forward, changes will be made to funding agreements, application forms and approval letters for any funding doled out by the Heritage Department and the Canada Council of the Arts, requiring recipients to explicitly commit to providing a harassment - free workplace.

The case is In the Matter of the Application of TransCanada Keystone Pipeline LP for Route Approval of the Keystone XL Pipeline Project, 0p - 0003, Nebraska Public Service Commission (Lincoln).

Submit application and documentation of requirements to ACF for approval by: E-mail (preferred): [email protected] or Fax: [phone] or Mail to: American Culinary Federation, Inc., Attn: Certification Department, 180 Center Place Way, St. Augustine, FL 32095.

RESIST Agrochemical TNCs together with the All UP Academic Employees Union and NNARA — Youth UP Manila conducted a Round Table Discussion with civil society organizations regarding the imminent approval of Golden Rice application for direct use and open field testing.

«As a result, approval for Moon Lake's foreign investment application is the first to be subject to new conditions requiring it to comply with Australian taxation law...» Mr Morrison said, «A breach of these conditions could result in prosecution, fines and potentially divestment of the asset.»

Submit application and documentation of requirements to ACF for approval by: E-mail (preferred): [email protected] Fax: [phone] Mail to: American Culinary Federation, Inc..

Laguna, Philippines - The recent release of Food Standards Australia New Zealand (FSANZ) approval report of International Rice Research Institute (IRRI) application for a Golden Rice «safety stamp» and trade liability clearance have garnered negative reactions and widespread critique.

5 February 2018 / In 2016, the International Rice Research Institute (IRRI) filed an application at the Food Standards Australia New Zealand (FSANZ) for the market approval of food derived from so - called Golden Rice (GR2) for import.

Unconscionable conduct (agrees with NFF that they have not provided protection and support reforms «to provide transparency in the supply chain» and recognise that «certain classes of suppliers... are predisposed to suffering from a special disadvantage...»; misuse of market power (legal framework must «level the balance of market power in negotiations...», «ensure transparency in the transmission of market prices» and «not allow for final market risks to be borne by the primary producer» and provide «transparency of contract processes» - specifically, Canegrowers supports effects test and a process giving ACCC greater power to «regulate anti-competitive behaviour and impose penalties», shifting «the decisions framework from the judicial system to a regulatory system» which would make it more accessible to small producers); collective bargaining (notes limits of Sugar Industry Act (Qld); authorisation and notification approval costly and limited and not a viable alternative - peak bodies should be able to «commence and progress collective bargaining with mills on behalf of their members» and current threshold too restrictive)» competitive neutrality (mixed outcomes - perverse outcomes in the case of natural monopolies - suggest remove «application of competitive neutrality provisions to natural monopoly essential services»)

When unlabeled bottled wine is transferred among two or more bonded wine premises for aging or labeling, the bottler must provide a copy of the approved Application For And Certification / Exemption of Label / Bottle Approval (COLA) TTB Form 5100.31 under which the wine was bottlfor aging or labeling, the bottler must provide a copy of the approved Application For And Certification / Exemption of Label / Bottle Approval (COLA) TTB Form 5100.31 under which the wine was bottlFor And Certification / Exemption of Label / Bottle Approval (COLA) TTB Form 5100.31 under which the wine was bottled.

Changes to competition laws (milk wars discussion and recommendations relating to MMP (introduce effects test), predatory pricing (recommend Minister direct ACCC to investigate Coles for breach of s 46 relating to predatory pricing), unconscionable conduct (suggest it be defined), statutory duty of good faith, unfair contract terms (seeks «recognition of the competitive disadvantage faced by farmers» and extension of unfair contract terms protection to small business), collective bargaining (seeks relaxation of public interest test for boycott approvals in agriculture markets, increase «ability for peak bodies to commence and progress collective bargaining and boycott applications» on behalf of members - and further dairy specific recommendations, ACCC divestiture power (wants ACCC to have similar divestiture powers to Comp Commission in UK - «simpler process of divestiture», ACCC monitoring powers (wants Minister to direct ACCC to use price monitoring powers to «monitor prices, costs and profits relating to the supply of drinking milk») and mandatory code of conduct (wants mandatory code and «Ombudsman with teeth to ensure compliance»)-RRB-.

Metallized Carbon Corporation, a global leader in the manufacture of oil - free, self - lubricating, carbon - graphite materials for severe service lubrication applications, announces that its Metcar Grade M - 58 has received approval from the FDA so that it can be used in food contact applications.

The application is not a substitute for a home study assessment approval, and does not screen for any laws specific to a state of residence other than Indiana.

To be eligible for funding, your grant application must be either submitted by or include the contact details of a member of the school (e.g. educator, administrator, support staff) who will serve as the primary contact person during the grant approval process.

Application has been submitted for approval of this course by the Lactation Education Accreditation and Approval Review Committee (www.leaapproval of this course by the Lactation Education Accreditation and Approval Review Committee (www.leaApproval Review Committee (www.learrc.org)

Remember, regardless of whom the presenter is, if the workshop announcements do not state APT approval with a provider number, APT will not approve it for RPT / RPT - S application or renewal.

According to Mr. Nkrumah, the management of ADB bank requested approval from significant shareholders of the bank for McDan's loan application.

In the same vein the CGI has delegated some of his responsibilities such as the approval of certain categories of passport applications to his Deputies and Assistants in order to reduce the work load for the CGI as well as facilitate the processing of passport.