Final Guidance

News & Analysis as of

The EBA’s New Remuneration Guidelines: Expanding the Scope of the Bonus Cap

On 21 December 2015 the European Banking Authority (“EBA”) published its final guidelines on sound remuneration policies (the “Guidelines”), together with its opinion on proportionality (the “EBA Opinion”)....more

New FDA Guidance Doubles-Down on 1980 Fortification Policy and Potential Misbranding Risks of “Inappropriate Fortification”

FDA recently released its Guidance for Industry: Questions and Answers on FDA’s Fortification Policy (Guidance) to “clarify the existing policy” in response to questions FDA has received from the food industry, other federal...more

FDA Stays Final Guidance on INDs for Foods and Dietary Supplement Studies

On October 30, 2015, the U.S. Food and Drug Administration announced that it was staying portions of its controversial Final Guidance relating to the types of studies that require compliance with Investigational New Drug...more

Intruder Alert – EPA Issues Final Technical Guidance on Vapor Intrusion

This summer, EPA issued two, long-awaited final technical guides for assessing and mitigating the intrusion of hazardous vapors from subsurface contamination into overlying buildings. EPA’s issuance of these technical guides...more

The Affordable Care Act’s Reporting Requirements for Carriers and Employers (Part 10 of 24): IRS Issues Final Form 2015...

The IRS recently issued final instructions for Forms 1094-B and 1095-B and Forms 1094-C and 1095-C . The 2015 Instructions for Forms 1094-B and 1095-B implement a suggestion we made in a previous post relating to the...more

Regulation A Roundup - September 2015

This week marks the three-month anniversary of the effective date of Regulation A. Of course, given this limited experience, it may be premature to comment on market developments. Instead, below we summarize significant...more

EPA Announces Availability of OCSPP Final Test Guidelines

On Tuesday, August 25, 2015, in a Federal Register notice, the U.S. Environmental Protection Agency (EPA) announced the addition of three Office of Chemical Safety and Pollution Prevention (OCSPP) final test guidelines to its...more

Changes to Obligations for Filing H-1B Amendment Petitions Under Matter of Simeio Solutions, LLC

As of August 19, 2015, full enforcement of a recent Administrative Appeals Office (AAO) decision in Matter of Simeio Solutions, LLC, 26 I&N Dec. 542 (AAO 2015) will commence. On April 9, 2015, the AAO—the appellate body...more

Six Things the Private Sector Should Know About EPA's Final Vapor Intrusion Guidance

The cumulative impact of the EPA guidance is to require the generation of more data, which means more sampling and analysis, more frequent and stringent remediation, and potentially higher remediation costs. At long...more

EPA Will Continue Review of Engineered Nanomaterials in Wastewater

On August 4, 2015, the U.S. Environmental Protection Agency (EPA) announced the availability of its Final 2014 Effluent Guidelines Program Plan. The Final Program Plan includes the following findings from EPA’s review of...more

FDA Issues Final Guidance on Use of Nanomaterials in Food for Animals

On August 4, 2015, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance document entitled “Guidance for Industry: Use of Nanomaterials in Food for Animals.” The Guidance is intended to...more

H-1B Update – Is an Employer Required to file an H-1B Amendment Petition Due to a Change in Work Location which Occurred Prior to...

USCIS, on July 21, 2015, issued final guidance as to the implementation of Matter of Simeio Solutions, LLC (Simeio). The Simeio decision requires employers to file an amended H-1B petition anytime an employee is moved to...more

USCIS Issues Final Guidance on Recent AAO Decision in Simeio

On Tuesday, July 21, 2015, U.S. Citizenship and Immigration Services (USCIS) issued its final guidance on the recent Administrative Appeals Office (AAO) decision in Matter of Simeio Solutions, LLC. Under Simeio, employers...more

Immigration Update: Precedent Decision Impacts H-1B Workers & Employers

USCIS has issued a final guidance memorandum in regards to the precedent AAO decision in the Matter of Simeio Solutions, LLC. Per the Simeio decision, an amended H-1B petition must filed with USCIS when there is a material...more

USCIS Releases Final Guidance on H-1B Job Site Changes

U.S. Citizenship and Immigration Services (USCIS) released final guidance on a recent Administrative Appeals Office (AAO) decision requiring amended or new H-1B petitions for workers who change job sites. These requirements...more

USCIS Releases Final Guidance on H-1B Job Site Changes

On Tuesday July 21, 2015, U.S. Citizenship and Immigration Services (USCIS) released final guidance on a recent Administrative Appeals Office (AAO) decision requiring amended or new H-1B petitions for workers who change job...more

FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved...more

Client Alert for H-1B Employers – Importance: High

Amended H-1B Petitions May be Required Immediately - Applies to: All employers with H-1B employees working at job sites other than those specified in H-1B filing. Action needed now: Verify that actual work site of...more

FCA’s Concurrent Competition Powers – Final Guidance and Handbook Amendments Are Published

The FCA has published final guidance on use of its new competition law powers, together with amendments to its Handbook introducing a specific competition law self-reporting obligation which will have significant...more

ALERT: NIST Issues Final Guidance on Federal Contractor Cybersecurity Standards for Controlled Unclassified Information

On June 19, 2015, the National Institute of Standards and Technology (NIST) published the final version of guidance for federal agencies to ensure sensitive information remains confidential when stored outside of federal...more

EBA Issues Guidelines on Management of Interest Rate Risk Arising from Non-Trading Activities

On May 22, 2015, the European Banking Authority (EBA) published its final guidelines on the management of interest rate risk arising from non-trading activities (EBA/GL/2015/08). The guidelines cover the management of...more

EBA Issues Guidance on the Implementation of Resolution Tools

The EBA has published three sets of final guidelines aimed at facilitating the implementation of resolution tools in the banking sector across the EU. The guidelines have been developed under Articles 39, 42 and 65 of the EU...more

ESMA Releases Final Guidance on the Definition of Physically Settled Commodity Derivatives Under MiFID I

On May 7, the European Securities and Markets Authority (ESMA) issued final guidelines (Guidelines) clarifying the definition of physically settled commodity derivatives under the Markets in Financial Instruments Directive...more

FDA Finalizes Guidance Documents on Biosimilars

Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved biologics, the Food and Drug Administration (FDA) continues to issue guidance...more

FDA Issues Three Biosimilar Final Guidances

On April 28, 2015, the federal Food and Drug Administration (FDA) finalized three guidances for industry on developing biosimilar drugs. The guidances, which follow the FDA’s first approval of a biosimilar drug in March, are...more

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