Rulemaking Process

News & Analysis as of

FDA Hardens Its Stance on Intended Use and Off-Label Use and Industry Responds

From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more

Tennessee Health Services and Facilities Report: February 2017 Newsletter

The Tennessee Health Services and Development Agency (“HSDA”) is responsible for regulating the health care industry in Tennessee through the Certificate of Need Program. A Certificate of Need (“CON”) is a permit for the...more

New York Pay Card Regulations Revoked, March 7, 2017 Implementation Halted

New regulations governing the use of payroll debit cards (also known as “pay cards”) in New York will not go into effect as planned on March 7, 2017. Yesterday, the New York Industrial Board of Appeals granted the petition of...more

House Financial Services Committee Chairman Hensarling Proposes Changes to the CHOICE Act.

On Monday, Chairman Hensarling circulated a memorandum to the House Financial Service Committee Leadership Team suggesting key revisions to the CHOICE Act. It only addresses proposed changes to the CHOICE Act; several key...more

OIRA guidance confirms executive order to reduce regulations does not apply to independent agencies

Interim Guidance issued by the Office of Information and Regulatory Affairs (OIRA) to implement President Trump’s executive order entitled “Reducing Regulation and Controlling Regulatory Costs” confirms that the order does...more

Breaking: FCC Seeks Comment on Petition Asking it to Overturn Presumed Prior Express Consent Rule for Informational Calls

The Commission announced today that it is soliciting comments on a petition for rulemaking and declaratory ruling filed by Craig Moskowitz and Craig Cunningham. The Petitioners request that the Commission initiate a...more

WPI Insider Briefing: New President, New Congress, New Direction in Workplace Policy

President Donald J. Trump was sworn into office on January 20, 2017, ushering in a new balance of power in Washington and what is expected to be a dramatically different era of workplace policy. On his first day in office,...more

President Trump Orders Review of DOL Fiduciary Rule and Addresses Financial Industry in Latest Actions

On February 3, 2017, President Trump took actions aimed at alleviating some of the regulatory burdens on the financial services industry. Through a Presidential Memorandum, President Trump ordered the DOL to “examine the...more

EEOC’s Enforcement Guidance Urges Employers To Be Proactive in Preventing, Addressing Workplace Harassment

In its Proposed Enforcement Guidance on Unlawful Harassment issued on January 10, 2017, the U.S. Equal Employment Opportunity Commission (EEOC) emphasizes that employers should take a proactive role in preventing harassment,...more

SAMHSA Finalizes Its Changes to the Confidentiality of Substance Use Disorder Patient Records Regulations

Executive Summary - The Substance Abuse and Mental Health Services Administration (“SAMHSA”), an agency within the U.S. Department of Health and Human Services (“HHS”), recently finalized its changes to the...more

Final FEHC Criminal History Regulations Approved, Move One Step Closer to Implementation

On January 10th, the California Fair Employment and Housing Council (FEHC) approved proposed regulations related to employer use of criminal history information. The regulations will be filed with the Office of...more

Maine DEP Marches Toward Rulemaking on its Wind Energy Standards Rule

Expecting to initiate a formal rulemaking in March of this year, the Maine Department of Environmental Protection (DEP) invited final public comment on its pre-rulemaking draft Wind Energy Standards rule at a workshop held on...more

Trump Administration’s Freeze on New Federal Regulations Will Impact Furniture Industry, EPA’s Formaldehyde Rule

The Trump Administration wasted no time getting started, as the new President issued a number of new executive branch directives in his first few days in office....more

Director Cordray’s Wall Street Journal interview today

Here are the highlights from Richard Cordray’s interview earlier today with the Wall Street Journal. He refused to respond to the question of whether or not the memo issued on January 20 on behalf of President Trump by...more

House Acts to Place Additional Limitations on SEC Rulemaking

With its passage of the SEC Regulatory Accountability Act last week, the U.S. House of Representatives has taken action to place additional constraints on future rulemaking by the Securities and Exchange Commission; however,...more

Proposed reform measure passed by House would result in seismic change in congressional review procedure for “major rules”

We have previously written about the Congressional Review Act (“CRA”), which was enacted as part of the Contract with America Advancement Act of 1996. The CRA created a fast-track legislative process for Congress to nullify...more

[Webinar] 2017 MSHA Enforcement Initiatives and Rulemaking Outlook - Jan. 26th, 1:00pm EST

As we begin a new calendar year and look ahead to a new administration, industry should continue to stay informed as to MSHA’s regulatory agenda and enforcement initiatives. While MSHA will soon have new decision makers in...more

Gaming Commission Requests Public Comment on Table Game Rules

On January 5, at the Massachusetts Gaming Commission’s first meeting of 2017, the Commission posed a series of questions related to the Commission’s promulgation of regulations governing “table game” rules. As resort casinos...more

House passes proposed Congressional Review Act amendments authorizing en bloc consideration in resolutions of disapproval for...

We have previously written about the Congressional Review Act (“CRA”), a law enacted in 1996 that establishes a procedure by which Congress can nullify a covered rule adopted by a federal agency. According to a Congressional...more

The Regulatory Transition: How the Trump Administration is Likely to Try to Block and Undo Obama Administration Regulations

The incoming Trump Administration is expected to break the mold in many ways, but in one respect it is likely to follow recent precedent fairly closely, author Jonathan G. Cedarbaum of WilmerHale writes: President Trump is...more

SuperVision Today - December 2016

Notes from the Chair and Executive Editor - Welcome to the final edition of SuperVision Today for 2016. The topic that has consumed the time and interest of many human resource professionals in recent days has been the...more

There’s Still Time For Congress To Void The SEC’s Resource Extraction Rule

Last June, the Securities and Exchange Commission belatedly adopted a rule requiring disclosure of resource extraction payments by issuers. As I wrote at the time...more

Proposed Rule for Prevention of Workplace Violence in Healthcare and Social Assistance Industries

Seyfarth Synopsis: OSHA Publishes RFI on Proposed Rule Concerning Workplace Violence in Healthcare and Social Assistance Industries. Federal OSHA currently enforces workplace violence under the General Duty Clause, under...more

Federal Court Enjoins CMS Regulation Banning Arbitration of Nursing Home Disputes

The United States District Court for the Northern District of Mississippi issued a preliminary injunction barring the scheduled November 28, 2016, implementation of a Center for Medicare and Medicaid Services (“CMS”)...more

EPA Announces Opportunity To Comment On Changing The RFS Point Of Obligation

On November 22, 2016, the U.S. Environmental Protection Agency (EPA) issued a notice in the Federal Register of an opportunity to comment on petitions requesting EPA initiate a rulemaking process to reconsider its regulations...more

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