Final Guidance

News & Analysis as of

UK Payment Systems Regulator Publishes Final Guidance on the European Interchange Fee Regulation

The UK Payment Systems Regulator published the final Guidance on its approach to monitoring compliance with the EU Interchange Fee Regulation. The final Guidance consolidates the previous final Guidance published in March...more

Final EU Guidelines on Transaction Reporting, Order Record Keeping and Clock Synchronization Published

The European Securities and Markets Authority published a Final Report providing its responses to the feedback on the proposed Guidelines on transaction reporting, order record keeping and clock synchronization under the...more

Final EU Guidelines on Information regarding Commodity Derivatives and Spot Markets

The European Securities and Markets Authority published a Final Report and final Guidelines on information expected or required to be disclosed on commodity derivatives markets or related spot markets under the Market Abuse...more

The OCC Publishes Final Guidelines on Recovery Planning

On September 29, 2016, the Office of the Comptroller of the Currency (the “OCC”) published final guidelines establishing enforceable standards for recovery planning. The final guidelines generally apply to banks with average...more

NHTSA Releases Guidance on Enforcement of Safety-Related Defects in Automated Vehicle Technologies - Agency’s stance raises...

Last week, the National Highway Traffic Safety Administration (NHTSA) released its final Enforcement Guidance Bulletin on Safety-Related Defects and Automated Safety Technologies. The Guidance makes clear that the agency’s...more

The White House Final Greenhouse Gas Guidance Directs Federal Agencies to Consider Climate Change and Greenhouse Gas Emissions...

On August 1, 2016, the White House Council on Environmental Quality published its final guidance to federal agencies requiring the consideration of greenhouse gas (GHG) emissions and effects on climate change when evaluating...more

FDA Extends Deadline for Removal of NDC and NHRIC Numbers from Device Labeling and Packaging

On August 30, 2016, the US Food and Drug Administration (FDA) published final guidance in which the agency announced it does not intend to enforce its prohibition against the inclusion of National Health Related Item Code...more

ESMA Publishes Guidelines for UCITS V Remuneration Policy

The guidelines, which apply from 1 January 2017, seek to clarify the concepts of disclosure, governance, and risk alignment in respect of remuneration; in advance of this date, non-EU investment managers of UCITS should...more

EEOC Issues Retaliation Enforcement Guidance

Last month, the Equal Employment Opportunity Commission (EEOC) issued a final enforcement guidance on retaliation claims under the various federal civil rights laws administered by the agency. The guidance will replace...more

FDA Uses Summer to Issue Numerous Device Guidance Documents

The Agency shows no signs of slowing regulatory activity. Although the US Food and Drug Administration’s (FDA’s or the Agency’s) Center for Devices and Radiological Health (CDRH) has been very active throughout 2016, it...more

Final Rules and Guidance Issued on “Blacklisting” Executive Order - Controversial Mandate Requires Disclosure of Labor and...

On August 25, 2016, the Federal Acquisition Regulatory Council issued final rules and the Department of Labor (DOL) published final guidance implementing President Obama’s 2014 “Fair Pay and Safe Workplaces” Executive Order...more

Weekly Update Newsletter - August 2016 #3

GOVERNMENT CONTRACTS - Fair Pay and Safe Workplaces - DOD, GSA, and NASA issued a final rule amending the FAR to implement Executive Order 13673, Fair Pay and Safe Workplaces, which is designed to increase efficiency...more

White House Announces Release of Final Contractor Blacklisting Rules: Phased Implementation for Prime Contractors and...

The long wait for the so-called “contractor blacklisting” rules is over. According to a fact sheet released by the White House, final regulations and guidance will be released on August 24, 2016 and published in the Federal...more

White House Issues Final Guidance on Consideration of Greenhouse Gas Emissions in NEPA Reviews

After more than six years of review and the issuance of several draft guidance documents, the White House Council on Environmental Quality (CEQ) published on Aug. 5, 2016, its final guidance on considering greenhouse gas...more

Well, Well, Well – What Do We Have Here: FDA Eases Up On Regulating General Wellness Products

The Food and Drug Administration has issued guidance on general wellness products, which are low risk products it will not regulate as “medical devices.” A draft of the guidance was issued in January 2015, and the final...more

FDA Finalizes Wellness Product Guidance

The Food and Drug Administration Safety Innovation Act of 2012 (“FDASIA”) required a collaborative effort by the Food and Drug Administration (“FDA”), Federal Communications Commission and Office of the National Coordinator...more

NEPA guidance on greenhouse gas emissions

Federal agencies have new guidance on how to address the effects of greenhouse gas emissions and climate change as those agencies satisfy their duties under the National Environmental Policy Act. This month the White House...more

White House Issues Guidance Advising Agencies to Assess Climate Change in NEPA Reviews

On August 1, the White House Council on Environmental Quality (CEQ) issued its final guidance for federal agencies on considering greenhouse gas (GHG) emissions and the effects of climate change in National Environmental...more

Blog: All is Well:  FDA to Host Webinar on its Final Guidance for Low-Risk General Wellness Devices on September 1, 2016

The U.S. Food and Drug Administration (FDA) recently released final version of its guidance, General Wellness: Policy for Low-Risk Devices (Policy), with a webinar slated for September 1st as part of the rollout. While not...more

White House Issues Final Guidance on Climate Change Impact Analysis

On August 1, 2016, the White House Council on Environmental Quality (CEQ) released its final guidance on how and when federal agencies should consider the direct and indirect impacts from climate change, including from...more

FDA Issues Final Guidance on General Wellness Products

On July 28, 2016, the United States Food and Drug Administration (FDA) finalized guidance stating that the agency does not plan to regulate “general wellness products,” including software applications, provided they present a...more

White House Issues Final NEPA Guidance on Climate Change

On August 2, 2016, the White House Council on Environmental Quality (CEQ) issued its final guidance for federal agencies to assess the impact of their decisions on greenhouse gas emissions (GHGs) and also how such decisions...more

FDA Finalizes Guidance on Low Risk General Wellness Devices

On July 29, 2016, the US Food and Drug Administration (FDA) finalized General Wellness: Policy for Low Risk Devices Guidance (Final Guidance) detailing its risk-based regulatory approach to relax certain regulatory...more

CEQ Instructs Federal Agencies to Consider Climate Change Impacts During NEPA Reviews

On August 2, 2016, the Council on Environmental Quality (CEQ) released a Final Guidance for Federal Departments and Agencies on Consideration of Greenhouse Gas Emissions and the Effects of Climate Change in National...more

FDA Issues Final Guidance for General Wellness Devices

The final guidance confirms FDA’s enforcement discretion for many fitness and wellness technologies but raises issues for certain testing services. On July 29, the US Food and Drug Administration (FDA) announced the...more

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