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Burr & Forman

ADEM Proposes Revisions to its Recycling Rules – 15 Years in the Making

Burr & Forman on

After 15 years without significant revisions, the Alabama Department of Environmental Management (ADEM) is proposing an overhaul of its recycling rules.  The proposed regulations, which ADEM released for public notice and...more

J.S. Held

PFAS Monitoring Requirements and Stormwater Pollution Prevention Under the 2026 NPDES Permit

J.S. Held on

On December 13, 2024, the United States Environmental Protection Agency (EPA) published a request for public comment for the 2026 National Pollutant Discharge Elimination System (NPDES) general permit for stormwater...more

Bergeson & Campbell, P.C.

EPA Reopens Comment Period on Proposed Risk Management Rule for PV29

On March 4, 2025, the U.S. Environmental Protection Agency (EPA) announced that it is reopening the comment period for the January 2025 proposed rule to address the unreasonable risk of injury to human health presented by...more

Skadden, Arps, Slate, Meagher & Flom LLP

FDA Proposes Amendments to Medical Device Quality System Regulation

On February 22, 2022, the Food and Drug Administration (FDA) proposed a long-awaited rule to amend its Quality System Regulation (QSR), which is codified at 21 CFR Part 820 and sets forth current good manufacturing practice...more

Kilpatrick

TSCA’s Information Grab – Manufacturers and Importers Subject to Proposed Expansive Ten-Year “Look Back” PFAS Reporting...

Kilpatrick on

Did you manufacture or import a water repellant t-shirt or a nonstick cooking pan or high performance mountain wear in the past ten years? If so, you could be required to provide ten years of past data and details regarding...more

Ogletree, Deakins, Nash, Smoak & Stewart,...

OSHA Issues Proposed Rule to Update Its Hazard Communication Standard

Employers have been on the lookout for a temporary emergency standard for COVID-19 from the federal Occupational Safety and Health Administration (OSHA), but what they have thus far received is a proposed rule to update the...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

MarkIt to Market® - July 2020: Made in the USA: The Federal Trade Commission Proposes a New Rule to Protect U.S. Manufacturers and...

On June 22, 2020, the Federal Trade Commission (FTC) announced a Notice of Proposed Rulemaking pertaining to “Made in USA” claims, which applies to labels and marketing that fraudulently asserts that products are made in the...more

Akin Gump Strauss Hauer & Feld LLP

CMS Issues Proposed Revisions to Open Payments/Sunshine Act Reporting Requirements

• On July 29, 2019, CMS released its proposed 2020 Physician Fee Schedule rule, which includes the much anticipated proposed regulatory changes to the Sunshine Act/Open Payments program (“Open Payments”). The proposed...more

Wilson Sonsini Goodrich & Rosati

HHS Releases Proposed Rule That Could Significantly Impact Drug Manufacturers, PBMs, and Other Stakeholders

The pharmaceutical industry invests billions in research and development. And as a result, the pharmaceutical industry has brought—and continues to bring—beneficial, life-saving, life-prolonging, life-enhancing, and...more

Perkins Coie

FAA Updates Small UAS Rules

Perkins Coie on

The Federal Aviation Administration (FAA) published proposed rules on the Operation of Small Unmanned Aircraft Over People on February 13, 2019. The proposed rules would amend the FAA’s Part 107 rules to allow for commercial...more

Sheppard Mullin Richter & Hampton LLP

HHS Proposes Rule to Eliminate Safe Harbor for PBM Drug Rebates

On February 6, 2019, the Office of the Inspector General of the U.S. Department of Health and Human Services (the “OIG”) published in the Federal Register a proposed rule (the “Proposed Rule”) that, if made final in its...more

Skadden, Arps, Slate, Meagher & Flom LLP

Sweeping Changes Proposed to Safe Harbors for Drug Discounts to Health Plans

The Department of Health and Human Services (HHS) has published a proposed rule that would make sweeping changes to the discount and rebate arrangements between drug manufacturers on the one hand and Medicare Part D plans and...more

Bass, Berry & Sims PLC

OIG Proposed Rule Seeks to Address Drug Pricing Concerns – But Will It?

In an effort to respond to prescription drug pricing concerns, on January 31, 2019, the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services (HHS) released a highly anticipated, 123-page...more

Holland & Knight LLP

Administration Proposes Changes to the Drug Rebate Program

Holland & Knight LLP on

On Jan. 31, 2019, the Department of Health and Human Services' (HHS) Office of the Inspector General (OIG) issued a long-awaited proposed rule that would, if finalized, remove the existing legal "safe harbor" that protects...more

King & Spalding

HHS Proposes Rule Challenging Drug Manufacturer Rebates to PBMs and Payors

King & Spalding on

The Proposed Rule Would Make Clear that the Anti-Kickback Statute’s Discount Safe Harbor Does Not Protect Manufacturer Rebates to PBMs or Payors, But Would Create New Safe Harbors for Rebates Passed Through to the...more

Foley & Lardner LLP

NHTSA Considers Changes to Longstanding Headlight Standards

Foley & Lardner LLP on

After a multi-year push from automakers, NHTSA recently proposed changes to the long standing federal laws governing headlights. For years, NHTSA only permitted high beams and low beams in headlights. Although some automakers...more

Mintz - Health Care Viewpoints

Trump Administration Proposes Requiring Disclosure of Drug Prices in TV Ads

The Trump Administration is moving full speed ahead with its proposals under the Blueprint to Lower Drug Prices (the “Blueprint”). Earlier this week, the Centers for Medicare & Medicaid Services (“CMS”) released a proposed...more

Akin Gump Strauss Hauer & Feld LLP

What's New In Washington - September 2018

Following a truncated August recess, the House and the Senate returned to Washington after Labor Day with a full plate of legislative items to address prior to the end of the fiscal year on September 30. That list includes...more

Mintz

Proposal for FCC Rules for UAS Command and Control Spectrum

Mintz on

The Federal Communications Commission (FCC) is seeking public comment on a proposal by the Aerospace Industries Association (AIA) to adopt service rules for the use of 5030-5091 MHz by small Unmanned Aircraft Systems (sUAS). ...more

Schwabe, Williamson & Wyatt PC

Public Hearing Set for Amended Overtime Statutes

Manufacturers who will be affected by the new changes to the overtime rules may be interested in attending a public hearing and/or providing public comment on the development of the Oregon Administrative Rules that BOLI will...more

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