Following an exhaustive NRC safety review,
agency approval of standard designs is formalized via specific design certification rule making.
In Schroon Lake, for instance, residents waited for years for the provider to secure investment funding, which was followed by spells of waiting for Adirondack Park
Agency approval of pole replacements by the utility provider.
Not exact matches
Important factors that could cause actual results to differ materially from those reflected in such forward - looking statements and that should be considered in evaluating our outlook include, but are not limited to, the following: 1) our ability to continue to grow our business and execute our growth strategy, including the timing, execution, and profitability
of new and maturing programs; 2) our ability to perform our obligations under our new and maturing commercial, business aircraft, and military development programs, and the related recurring production; 3) our ability to accurately estimate and manage performance, cost, and revenue under our contracts, including our ability to achieve certain cost reductions with respect to the B787 program; 4) margin pressures and the potential for additional forward losses on new and maturing programs; 5) our ability to accommodate, and the cost
of accommodating, announced increases in the build rates
of certain aircraft; 6) the effect on aircraft demand and build rates
of changing customer preferences for business aircraft, including the effect
of global economic conditions on the business aircraft market and expanding conflicts or political unrest in the Middle East or Asia; 7) customer cancellations or deferrals as a result
of global economic uncertainty or otherwise; 8) the effect
of economic conditions in the industries and markets in which we operate in the U.S. and globally and any changes therein, including fluctuations in foreign currency exchange rates; 9) the success and timely execution
of key milestones such as the receipt
of necessary regulatory
approvals, including our ability to obtain in a timely fashion any required regulatory or other third party
approvals for the consummation
of our announced acquisition
of Asco, and customer adherence to their announced schedules; 10) our ability to successfully negotiate, or re-negotiate, future pricing under our supply agreements with Boeing and our other customers; 11) our ability to enter into profitable supply arrangements with additional customers; 12) the ability
of all parties to satisfy their performance requirements under existing supply contracts with our two major customers, Boeing and Airbus, and other customers, and the risk
of nonpayment by such customers; 13) any adverse impact on Boeing's and Airbus» production
of aircraft resulting from cancellations, deferrals, or reduced orders by their customers or from labor disputes, domestic or international hostilities, or acts
of terrorism; 14) any adverse impact on the demand for air travel or our operations from the outbreak
of diseases or epidemic or pandemic outbreaks; 15) our ability to avoid or recover from cyber-based or other security attacks, information technology failures, or other disruptions; 16) returns on pension plan assets and the impact
of future discount rate changes on pension obligations; 17) our ability to borrow additional funds or refinance debt, including our ability to obtain the debt to finance the purchase price for our announced acquisition
of Asco on favorable terms or at all; 18) competition from commercial aerospace original equipment manufacturers and other aerostructures suppliers; 19) the effect
of governmental laws, such as U.S. export control laws and U.S. and foreign anti-bribery laws such as the Foreign Corrupt Practices Act and the United Kingdom Bribery Act, and environmental laws and
agency regulations, both in the U.S. and abroad; 20) the effect
of changes in tax law, such as the effect
of The Tax Cuts and Jobs Act (the «TCJA») that was enacted on December 22, 2017, and changes to the interpretations
of or guidance related thereto, and the Company's ability to accurately calculate and estimate the effect
of such changes; 21) any reduction in our credit ratings; 22) our dependence on our suppliers, as well as the cost and availability
of raw materials and purchased components; 23) our ability to recruit and retain a critical mass
of highly - skilled employees and our relationships with the unions representing many
of our employees; 24) spending by the U.S. and other governments on defense; 25) the possibility that our cash flows and our credit facility may not be adequate for our additional capital needs or for payment
of interest on, and principal
of, our indebtedness; 26) our exposure under our revolving credit facility to higher interest payments should interest rates increase substantially; 27) the effectiveness
of any interest rate hedging programs; 28) the effectiveness
of our internal control over financial reporting; 29) the outcome or impact
of ongoing or future litigation, claims, and regulatory actions; 30) exposure to potential product liability and warranty claims; 31) our ability to effectively assess, manage and integrate acquisitions that we pursue, including our ability to successfully integrate the Asco business and generate synergies and other cost savings; 32) our ability to consummate our announced acquisition
of Asco in a timely matter while avoiding any unexpected costs, charges, expenses, adverse changes to business relationships and other business disruptions for ourselves and Asco as a result
of the acquisition; 33) our ability to continue selling certain receivables through our supplier financing program; 34) the risks
of doing business internationally, including fluctuations in foreign current exchange rates, impositions
of tariffs or embargoes, compliance with foreign laws, and domestic and foreign government policies; and 35) our ability to complete the proposed accelerated stock repurchase plan, among other things.
The recent FDA
approval for its herpes test was the first public sign the company is making headway on this goal, though the company and the FDA declined to comment to the WSJ on the status
of the more than 130 other tests it has submitted to the
agency.
But a less publicized move to replace the head
of a federal regulatory
agency will almost certainly slow federal
approval for new natural gas pipelines.
The
agency has been trying to make this better, or at least it has issued a report about making it better, but FDA
approval is by its very nature anti-Valley, the opposite
of moving fast and breaking things — which is why so many health trackers and similar devices (even apps) are very careful about their claims.
The FDA and Flatiron Health have been collaborating to explore how the FDA might be able to use real - world data (that clinical information Flatiron collects) to inform how drugs the
agency approves are used outside
of the clinical trials that are the basis for their
approval.
According to Estes, the SEC may worry the
agency's
approval of an ETF could lead to a bubble inflated by bitcoin novices — a bubble that could then pop.
The Food and Drug Administration (FDA) wasn't resting on its laurels in 2017: The
agency under new commissioner Scott Gottlieb approved 46 new medicines — i.e., completely new therapies, not just additional indications on already - approved drugs — the highest number
of approvals in more than two decades.
Expedia, the world's largest online travel
agency by bookings, said it expects the deal to close in the first quarter
of 2016 subject to regulatory
approval.
Among the grab bag
of goodies in the pharma - backed 21st Century Cures Act, which is meant to hasten FDA drug
approvals, is a provision that would essentially remove the
agency from the mobile health app and electronic medical records regulatory process.
While the Zarxio
approval affected a fairly small slice
of the drug market, the FDA's decision to approve Inflectra indicated that the
agency was gearing up to make more use
of the biosimilar pathway.
The executive memo «directs
agencies to expedite reviews and
approvals for the remaining portions
of this pipeline,» White House press secretary Sean Spicer clarified during Tuesday's news briefing.
The Japan Times wrote that the exchange's initial decision to list these coins had been one
of several reasons that the FSA had not yet granted it official
approval, signaling that the
agency's apprehensions around privacy coins date back to March, if not earlier.
Unlike funds listed on US stock exchanges, funds listed on OTC exchanges do not need
approval from the SEC, the regulatory
agency causing
of the delay
of the Winklevoss Twins» fund.
In 1982 and 1984, the Department
of Justice (DOJ) and the FTC issued new merger guidelines outlining the framework that officials would use when reviewing horizontal deals.135 The 1984 version included guidelines specific to vertical deals.136 Part
of a sweeping effort to overhaul antitrust enforcement, the new guidelines narrowed the circumstances in which the
agencies would challenge vertical mergers.137 Although the guidelines acknowledged that vertical mergers could sometimes give rise to competitive concerns, in practice the change constituted a de facto
approval of vertical deals.
Various permits are also being advanced with state and federal
agencies — such as water discharge, wetlands, air quality, water use and fish habitat permits and other
approvals that will give them right -
of - way access.
These types
of advisory boards make sense if they speed revenue generation or
approvals to regulatory
agencies.
In a statement issued earlier this month, U.S. Food and Drug Administration Commissioner Scott Gottlieb said the
agency had given B. Braun and Baxter temporary
approval to import products from some
of their overseas operations, including allowing Baxter to import product from Brazil.
As federal
agencies like FEMA and the US Department
of Housing and Urban Development were waiting for final
approval, Trump nixed the standards.
And without that final
approval, the
agencies won't be able to act on any
of Obama's recommendations.
While the CFDA works through a backlog
of applications around 300 files thick, BeiGene will begin marketing popular therapies from Celgene (NASDAQ: CELG) that have already earned the
Agency's
approval.
For example, the concept
of freedom speaks
of a condition where capital has the ability to embark and disembark in a country without any
approval or regulation from a social
agency in which individuals and community set different priorities to seek perfection in life.
Up until the latter half
of the last century, their terrorist activities were undertaken with the tacit
approval of a significant percentage
of the population and sometimes with the explicit support
of law enforcement
agencies in the southern states.
«FDA's acceptance
of our food additive petition marks the beginning
of the
agency's formal review process and we look forward to working with the FDA on achieving
approval for these proposed low - level uses
of PHOs.
The merger was previously cleared by other
agencies; in the EU
approval was subject to divestiture
of certain assets.
4.65 The Committee recommends the Productivity Commission considers, in its review
of national competition policy, the appropriateness
of separating the functions and powers
of the ACCC with the effect that separate
agencies are responsible for the
approval of mergers and the assessment
of whether concentration is subsequently excessive.
Only forward facing child seats that display no defects and that carry a visible seal
of approval awarded by the European Union or an official government
agency may be taken aboard.
Only child seats that display no defects and that carry a visible seal
of approval awarded by the European Union or an official government
agency may be taken aboard.
A child seats may show no defects and must carry a visible seal
of approval for use on board an aircraft by the European Union or an official government
agency.
Actually, the USDA memo on the two year waiver on 100 % whole grain rich foods states that «school districts that wish to take advantage
of this two - year flexibility must obtain
approval from their state
agency by demonstrating that they experienced significant challenges in preparing and serving whole grain - rich pasta products in their schools».
Developers
of the Four Seasons Sunrooms store were granted
approval on the condition that a flood plain on part
of the 1 - acre parcel be redefined by the Federal Emergency Management
Agency so that construction would be allowed, said Village Trustee Thomas Dubelbeis.
Before a cleanup plan gets state
approval, the
agency wants to see the utilities» health and safety plan for cleaning up Barrie Park, identifying where material must be removed from and how they will dispose
of and treat hazardous materials.
The Lagos State Commissioner for Health, Dr. Jide Idris, who spoke at a joint briefing organised by the state
agency and the Federal Ministry
of Heath, said the airline did not obtain the necessary
approval to bring in the body from the Ebola - ravaged country.
On what FEC discussed, Senator Udoma said that Council gave
approval for various Ministries, Departments and
Agencies, MDAs
of government to fast track the processes for the capital budgets to restore the economy.
Congress is always skeptical
of programs that want to have earmarked funds from
agencies that don't have to come back for budget
approval every year.
They are expected to complete the registration process by submitting the endorsed appointment letters to the heads
of the user
agencies they have been posted to for
approval before they officially begin the service.
The states «have a substantial interest in avoiding the vast disruption in state and local labor relations that would occur if the Court were now to overrule Abood's
approval of public sector collective bargaining arrangements utilizing
agency - fee rules,» lawyers for the states argue.
He said companies must update their licenses within 10 business days
of any management changes, and that requires
agency review and
approval first, and that process has not even begun because the
agency has not received a request yet.
Members
of the Tompkins County Industrial Development
Agency who are also members
of the Tompkins County Legislature shall be appointed annually by the Chair
of the County Legislature subject to the
approval of the Legislature, and shall serve at the pleasure
of the Legislature.
The resolution, called «Blanket
Approval of Purchases Through Contracts
of the City
of New York and Its
Agencies,» asked the panel to weaken one aspect
of a power it was granted last year under the mayoral control law, its ability to approve or veto all contracts that are not competitively bid.
The
agency also increased the value
of the sales tax incentives it granted to developer Mark H. Trammel's Pilgrim Village Associates housing project near the Buffalo Niagara Medical Campus to $ 2.1 million to reflect rising costs since the board gave its original
approval to the incentives in December.
Tawil told the county
agency during a special meeting last week that he wanted to avoid having to seek the
approval of the Syracuse Common Council for the property tax exemptions.
Ben Carson, secretary
of the U.S. Department
of Housing and Urban Development, said in an interview Thursday his
agency is requiring the New York City Housing Authority to get HUD's
approval for any expenditures out
of its capital fund.
Adirondack Park
Agency Executive Director Terry Martino said, «Governor Andrew Cuomo's
approval,
of this Adirondack Park State Land classification package, represents significant protection for critical natural resources while balancing opportunities for outdoor recreation within the Adirondack Park.
Two state
agencies that supported and provided key
approvals for state energy projects involved in a federal investigation into improper lobbying and undisclosed conflicts
of interest — NYSERDA and the PSC — have been subpoenaed as part
of the probe.
Under the order,
agencies will be permitted to renew certain PSCs only if the contractor agrees to the reduction or with the
approval of the director
of State Operations (Howard Glaser).
Sometimes the President initiates them and explains to some aide what he wants and the aide in association with other aides drafts it, and sometimes an
agency that needs an executive order initiates the drafting
of it it and then presents it to the President for
approval with an explanation.
This was the case in the United States up until 1980, when the administration
of Jimmy Carter interpreted the 1884 Antideficiency Act to limit the power
of federal
agencies in the lack
of congressional
approval.
Quigley said that he had a letter from the corporation counsel
of the City
of Kingston, Andrew Zweben, indicating they had no legal standing; The Kingston Common Council had hoped the need for the
approval of the Kingston Board
of Water Commissioners for Niagara to draw water from Cooper Lake reservoir in Woodstock would give be enough for them to have involved
agency status, but Zweben felt otherwise.