Public Comment

News & Analysis as of

Massachusetts Hospital Licensing Regulations Proposed Amendments – Key Take-Aways

The Massachusetts Department of Public Health (DPH) has released for public comment proposed amendments to DPH’s Hospital Licensure Regulations (105 CMR 130.00) (the “regulations”). The proposed amendments are designed to...more

Comments Due November 1, 2016 on Proposed Update to Framework for Biotechnology Regulation

On September 18, 2016, the Obama Administration issued two major documents in connection with its ongoing efforts to modernize the federal Coordinated Framework for the Regulation of Biotechnology. The first document, a...more

Estate Planning Valuation Discounts Under Section 2704: An Update

For about a generation, families have taken minority discounts when valuing interest in closely-held businesses for estate, gift and generation-skipping transfer tax purposes. This popular estate planning technique is often...more

NHTSA Releases Highly Anticipated Federal Automated Vehicles Policy

60-Day Comment Period Provides Important Chance to Have Local Voices Heard - With the goal of creating a path for the safe testing and deployment of autonomous vehicles on public roads nationwide, the U.S. Department of...more

“Full Employment for CISOs in New York”: New York Proposes the Nation’s First Cybersecurity Regulation

If you’re a CISO living in New York get ready for the phone calls!!! On September 13, 2016, Governor Andrew M. Cuomo proposed the nation’s first cybersecurity regulation. Starting on September 28, 2016 there is a limited 45...more

Update: Antitrust-Intellectual Property Licensing Guidelines

The Antitrust Division of the Department of Justice (DOJ) and the Federal Trade Commission (FTC) announced, on August 12, 2016, they are seeking public comments on the first update to the Antitrust Guidelines for the...more

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

After launching with an ambitious agenda fourteen months ago, last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks. The Working Group has proposed an Update to...more

New York DFS Proposes New Cybersecurity Regulations

Earlier this month, the New York State Department of Financial Services (“DFS”) announced proposed cybersecurity regulations for financial institutions. This proposal is, according to Governor Cuomo, a “new...more

Another Step Closer to Direct Potable Reuse: California Releases Draft Report on the Feasibility of Developing Regulations for...

The California State Water Board released its Draft Report on the Feasibility of Developing Regulations for Direct Potable Reuse (the “Draft Report”). California Water Code Section 13561 defines “direct potable reuse” as...more

U.S. Fish and Wildlife Service Proposes Threatened Status for San Fernando Valley Spineflower

On September 15, 2016, the U.S. Fish and Wildlife Service (USFWS) proposed to list as threatened the San Fernando Valley spineflower (Chorizanthe parryi var. fernandina), a plant species native to Southern California, under...more

NHTSA Issues Guidance for Manufacturers of Highly Automated Vehicles

The Department of Transportation (DOT) and the National Highway Traffic Safety Administration (NHTSA) has provided much-anticipated guidance to manufactures of automated vehicles with the release of the new Federal Automated...more

Financial Institutions Going First? New York Proposes Mandatory Minimum Cybersecurity Compliance Standards

Just as it promised a year ago, New York State proposed new proscriptive, minimum cybersecurity requirements for regulated financial services institutions. The regulations go final after a 45-day notice and public comment...more

FDA Announces Upcoming Public Meeting on Its Recommendations for Reauthorizing the Biosimilar User Fee Act

Today FDA announced that it will hold a public meeting on October 20, 2016 to discuss its proposed recommendations for the reauthorization of the Biosimilar User Fee Act, which permits FDA to collect fees and use them for the...more

FDA Will Hold Hearing on Communications Regarding Unapproved Uses

The Food and Drug Administration has issued a notice announcing a public hearing on November 9 & 10, 2016 to gather input relating to companies’ communications about their medical products, with a particular focus on...more

FTC Weighs-in on Telehealth, Comments on Delaware’s Occupational Therapy Practice Rule

On August 3, 2016, the Federal Trade Commission (FTC) staff submitted public comments regarding the Delaware Board of Occupational Therapy Practice’s proposed regulation for the provision of occupational therapy services via...more

A Proposed New York State Regulation Requires First-Of-Their-Kind Cybersecurity Requirements for Financial Services Companies

On September 13, 2016, New York Governor Andrew Cuomo announced that a first-of-its kind cybersecurity regulation has been proposed by the New York State Department of Financial Services (DFS) to further protect New York...more

Draft 2016 NNI Strategic Plan Available for Public Comment

On September 13, 2016, the National Nanotechnology Initiative (NNI) announced in the Federal Register the availability of the draft 2016 NNI Strategic Plan for public comment. The NNI Strategic Plan represents a consensus...more

Canada Consultation on Prioritization for Nanoscale Forms of DSL Substances

A consultation period for a proposed prioritization approach for nanoscale forms of Domestic Substance List (DSL) substances was initiated by Environment and Climate Change Canada (ECCC) and Health Canada (HC) on July 27,...more

CFTC Seeks Public Comment on Proposed Whistleblower Rule Amendments

On September 1, 2016, the U.S. Commodity Futures Trading Commission (“CFTC”) announced that it is “requesting public comment on proposed amendments to the Whistleblower Rules found in Part 165 of the CFTC’s regulations.” The...more

Lawsuit Challenges OSHA’s “Union Walk Around Rule”

On September 8, the National Federation of Independent Business (NFIB) filed a federal court complaint in Dallas, seeking to strike down what has become known as the U.S. Occupational Safety and Health Administration’s (OSHA)...more

Cybersecurity News and Notes - September 2016

In Case You Missed It: The Federal Trade Commission has opened a public comment period to evaluate its Safeguards Rule (16. C.F.R. § 314.3). Under the Gramm-Leach-Bililey Act (GLBA), which regulates financial institutions,...more

Oregon OSHA's Proposed Silica Rules Comment Period Comes to a Close

On September 16, 2016, the period for public comment on Oregon OSHA’s proposed rules for respirable crystalline silica closes, and Oregon OSHA is expected to adopt the proposed rules by September 25, 2016. The proposed rules...more

EPA Announces Public Meeting On Algae And TSCA

On September 1, 2016, the Algae Biomass Organization (ABO) announced that the U.S. Environmental Protection Agency (EPA) will be hosting an "Opportunity for Public Comment on Algae Guidance for The Preparation of [Toxic...more

Manatt on Health Reform: Weekly Highlights - September 2016

The national uninsurance rate hits a record low; Georgia’s Chamber of Commerce outlines three Medicaid expansion proposals; and California legislation targets surprise medical bills. FEDERAL AND STATE MARKETPLACE...more

The New Rule 23 Is Available for Public Comment

In August, while we were all on vacation, beating the heat, or recovering from a busy first half of 2016, the Advisory Committee published the new proposed Rule 23 for public comment. The proposed changes here fall into...more

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