Guidance Update

News & Analysis as of

PTC “Start of Construction” Clarifying Guidance Expected in a Week or Two

General Electric (GE) stated on its quarterly earnings call today that it expected that the clarification to the Internal Revenue Service’s (IRS) production tax credit (PTC) “start of construction” guidance would be released...more

FDA Proposes Guidelines for Posting Medical-Product Information Online

A lot can be misconstrued in the silent world of the Internet. While online technology has changed the communications paradigm, it also has resulted in bad information, embarrassing typos, factual errors and malfeasance....more

SEC Clarifies Certain Proxy Voting Responsibilities of Investment Advisers and Availability of Exemptions from Proxy Rules for...

On June 30, 2014, the Securities and Exchange Commission’s (SEC) Divisions of Investment Management and Corporate Finance released joint guidance to address certain issues regarding proxy voting responsibilities of investment...more

SEC Staff Provides Guidance on Custody Rule Compliance When Private Funds Use SPVs and Escrow Accounts

The staff of the SEC’s Division of Investment Management issued IM Guidance Update No. 2014-7 (the “Guidance Update”) to provide guidance on how Rule 206(4)-2 under the Investment Advisers Act of 1940 (the “Custody Rule”)...more

SEC “Likes” Social Media for Investment Advisers

The SEC staff views social media as a useful tool that helps consumers conduct their own due diligence on investment advisers. In a recent Investment Management Guidance Update, the staff stated that, under certain...more

New SEC Guidance on Application of Custody Rule to SPVs and Escrow Accounts

The Securities and Exchange Commission (SEC) recently issued a guidance update (Update) on Rule 206(4)-2 of the Investment Advisers Act of 1940 (Custody Rule), which regulates the custody practices of registered investment...more

Observation 1.0.1 on the Volcker Rule: With Summer Comes the First Wave — Of Guidance

A set of frequently asked questions, developed jointly and adopted in substantively identical form by the federal banking agencies (the Office of the Comptroller of the Currency (OCC), the Federal Reserve Board (FRB) and the...more

SEC Staff Closes Loophole on BDC Asset Coverage Requirements

In a Guidance Update published on June 30, 2014 by the SEC’s Division of Investment Management, the staff closed a loophole that allowed business development companies (BDCs) with wholly owned Small Business Investment...more

Docs @ BIO: USPTO Provides Update on Myriad-Mayo Guidance

At last week's BIO International Convention in San Diego, Andrew Hirshfeld, USPTO Deputy Commissioner for Patent Examination Policy, and June Cohan, a Legal Advisor with the USPTO's Office of Patent Legal Administration, took...more

SEC Issues Guidance on Application of Custody Rules to Special Purpose Vehicles and Escrows

The Division of Investment Management of the Securities and Exchange Commission (the SEC) recently released an IM Guidance Update with respect to the custody rule, Rule 206(4)-2 (the Custody Rule) under the Investment...more

Additional Guidance for California Energy Commission Nonresidential Building Energy Use Disclosure Program

The second phase of the California Energy Commission’s (CEC) Nonresidential Building Energy Use Disclosure Program takes effect on July 1, 2014 (the first phase took effect on January 1, 2014 and applies to nonresidential...more

Docs @ BIO: BNA Issues Report on PTO's Patent Eligibility Guidance

Sounding an appropriately alarmist note, the Bureau of National Affairs (BNA) Life Sciences Law and Industry Report issues the results of a study on how the U.S. Patent and Trademark Office is administering its March 4, 2014...more

Under the Dome: Inside the Maine State House

Governor, Attorney General Disagree Over General Assistance - In what has been characterized by some as capitalizing on a national political issue, the Department of Health and Human Services has issued guidance to...more

IRS Begins Section 409A Compliance Initiative

The Internal Revenue Service (IRS) is getting ready to ramp up enforcement of Section 409A of the Internal Revenue Code. The federal agency recently announced the launch of a new project to assess the level of taxpayer...more

SEC Releases Guidance on Affiliated Transactions of Series Investment Companies

On June 6, the Securities and Exchange Commission’s Division of Investment Management released a Guidance Update clarifying that separate series of a series investment company are each considered an individual company for the...more

IRS Issues Revenue Ruling on Applicability of Section 457A to Options and Stock Appreciation Rights

On June 10, 2014, the IRS issued Revenue Ruling 2014-18, which holds that nonqualified stock options, as well as stock-settled stock appreciation rights (SARs), do not constitute nonqualified deferred compensation subject to...more

New CA Privacy Disclosure Requirements Clarified By AG

California has a number of privacy notice requirements for businesses collecting data from California residents, including as of January 1 of this year a requirement that websites, mobile apps and online services make certain...more

Senate Committee Questions FDA's Use of Draft Guidances

In a letter to the Food and Drug Administration, a group of U.S. senators from the Committee on Health, Education, Labor & Pensions expressed "significant" concern about the agency's apparent reliance on a process of issuing...more

FDA Releases Draft Guidance on Biosimilars - Sets Forth Clinical, Pharmacology Data Sufficient to Support Biosimilarity

The Food and Drug Administration has released the first new Guidance relating to its evolving standards for satisfying the biosimilarity requirements of the Biologics Price Competition and Innovation Act (BPCIA) since its...more

FDA Releases New Guidance for Biosimilar Applications

Yesterday, the U.S. Food and Drug Administration provided further clarity as to how it will evaluate applications for approval of biosimilars when it released a draft guidance document outlining the types of clinical...more

USPTO Request for Comment by June 30, 2014 re: Patent Subject Matter Eligibility

On March 4, 2014, the US Patent and Trademark Office (PTO) issued a guidance entitled, “Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Natural Principles, Natural Phenomena, And/Or...more

Guest Post: How to Patent Grapefruit Juice -- The New USPTO Guidance for Patent Eligible Subject Matter Is Both Sticky and Sour

What does grapefruit juice, or more specifically pomelo juice, have to do with all this? I will get to that connection in just a bit. For those of you not in the know, a pomelo is a large, grapefruit-like citrus fruit with...more

SEC Staff Guidance: Companies Must File Conflict Minerals Disclosure With Modifications

In response to the U.S. Court of Appeals for the District of Columbia Circuit’s recent opinion upholding the conflict minerals statute and rule, but finding First Amendment violations, the Director of the SEC’s Division of...more

A Snake in the Grass No More? DOL Proposes New COBRA Forms

As part of its continuing efforts to update the sleepier corners of the employee benefits world to conform to the Patient Protection and Affordable Care Act (ACA), the U.S. Department of Labor (DOL) recently proposed new...more

Final Regulations Issued For Investment Advisory Fees and Other Costs Incurred By Trusts and Estates Subject to the 2-Percent...

On May 8, 2014, the Internal Revenue Service published final Treasury Regulations, §1.67-4, prescribing when costs incurred by estates or nongrantor trusts are subject to the 2-percent floor for miscellaneous itemized...more

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