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Federal Regulations Advisor Insight and Commentary on U.S. Government Regulatory Affairs

Tag Archives: FDA

Monday Morning Regulatory Review – 5/8/17: Appropriations Impact on Regulations; Pending Disapproval; Legislation Repealing Regulation; WOTUS Reconsideration; Contraceptive Mandate Reconsideration; & Compliance Extension Good Cause

Posted in Agency Authority, Executive - OMB Review, Regulatory Process

Regulatory practice last week presented a number of different Congressional interventions – from the complexity of a Consolidated Appropriation for the remainder of the fiscal year, to disapproval of a regulation under the Congressional Review Act (CRA), to a direct legislative vitiation of a final rule.  The Administration took two different steps toward reconsideration of… Continue Reading

Monday Morning Regulatory Review – 5/1/17: Clean Power Plan & Mercury Holds; Litigation Choice & Appropriation Limitation; and Complicated Executive and Interagency Reviews

Posted in Executive - OMB Review, Judicial Process, Regulatory Process

Litigation over two more major rules was put on hold last week, leaving little actual litigation over past Administration rules proceeding – with small exceptions that may be short lived.  At the same time, one court of appeals recognized the reality of appropriations effectively limiting agency discretion – particularly when court orders have consumed limited… Continue Reading

Presidential Regulatory Transition: A Post-Election Monday Morning Review – 11/14/16

Posted in Agency Authority, Judicial Review & Remedies, Regulatory Process

Understanding the regulatory significance of the 2016 Presidential election focuses on both the authority of the current President of the United States (POTUS) and the President-elect of the United States.  The current POTUS, quite naturally, will seek to institutionalize his legacy while the incoming POTUS will seek to undo his predecessor’s regulatory actions that are… Continue Reading

Monday Morning Regulatory Review – 10/10/16: Fiduciary Litigation and Arbitration; Mandatory Labeling Speech & Nonacquiescence Regulation Petitions

Posted in Judicial Process, Judicial Review & Remedies

New grist for the regulatory litigation mill emerged in an additional but very different challenge to one aspect of a suite of highly litigated rules; a follow-on challenge to an agency’s lack of response to vacatur of prior statutorily required regulations; and a challenge to an agency policy guiding how it will respond to adverse… Continue Reading

Monday Morning Regulatory Review – 9/5/16: Guns, Drugs, and Guidelines; Nonacquiescence Not Arbitrary and Capricious; & Anti-Bacterial Soap and Passport Over-Regulation

Posted in Judicial Review & Remedies, Regulatory Process

Labor Day 2016 will be no holiday for regulatory experazzi, at least in this post.  Last week, a court of appeals affirmed dismissal of a host of constitutional claims that overshadowed an ineffectively plead Administrative Procedure Act (APA) claim – and the decision reprises the circuit law on when guidance becomes a rule only to… Continue Reading

Monday Morning Regulatory Review – 8/29/16: School Gender Identity Guidance Enjoined; Medicare Reconciliation Criteria; Food Rules Compliance Reality; Broadcast Ownership Again – Still & Heavy Speed Limiters

Posted in Agency Authority, Judicial Review & Remedies, Regulatory Process

Summer’s end (not Childhood’s End) brings the opening of schools across the country without the looming Administration guidance on gender identity.  More complex is the new overhang of Medicare hospital reimbursements that may not be recouped because of an agency failure to adopt criteria through notice and comment rulemaking.  On the other hand, in reality… Continue Reading

Monday Morning Regulatory Review – 8/22/16: Tobacco Products Guidance Vacatur; Waters Abeyance; Swaps Remand Response & Medium and Heavy Duty Emissions

Posted in Judicial Process, Judicial Review & Remedies, Regulatory Process

A hodgepodge of actions occurred in regulatory practice last week, including a district court decision vacating part of an agency guidance and a court of appeals decision to hold in abeyance litigation on regulatory efficacy to avoid possible conflicts with a sister circuit.  One agency published a final response to a remand that raises old… Continue Reading

Monday Morning Regulatory Review – 7/25/16: Immigration Rule or Non-Rule Rehearing; Contraceptives Information Request & Zubik Review; Distance Learning Accreditation & Payday Loans

Posted in Judicial Review & Remedies, Regulatory Process

Inter-convention, highlights from regulatory practice might be sparse, but both litigation and regulation provide some spice.  The Administration filed a petition for rehearing in the immigration policy case and a further response to the remand of a dozen decisions on the Administration’s contraceptive mandate application to religious organizations.  Two rules with regulatory process implications were… Continue Reading

Monday Morning Regulatory Review – 7/11/16: A Regulatory Litigation Snapshot

Posted in Agency Authority, Judicial Process, Judicial Review & Remedies, Regulatory Process

The shortened holiday week generated few regulatory events and no real highlights, creating an opportunity to survey the major regulatory litigation as this Administration enters its final six months.  This post highlights major litigation over the Administration’s priorities – particularly those stayed or preliminarily enjoined, and those at risk.  The extent of this litigation risk… Continue Reading

Monday Morning Regulatory Review – 6/6/16: Warning Letter Finality; Untrusted Fiduciary Rule Tested; Great Lakes Pilotage Foundering; Oyster Illness Hazard Petition Grounding & Payday Loans Proposal Interest

Posted in Agency Authority, Constitutional Issues in Regulations, Judicial Review & Remedies, Regulatory Flexibility & Small Business

The United States Supreme Court (SCOTUS) decision in United States Army Corps of Engineers v. Hawkes Co. last Monday reverberated on Friday in United States Court of Appeals for the District of Columbia Circuit in dynamic Fair Labor Standards Act (FLSA) litigation.  In two different district courts, expected litigation challenged another Department of Labor (DOL)… Continue Reading

Monday Morning Regulatory Review – 5/23/16: Clean Power En Banc; FLSA Overtime & Exemptions; Food Labeling; E-Cigarettes Baggage & Unified Agenda

Posted in Executive - OMB Review, Judicial Process, Regulatory Process

More surprises after Spokeo and Zubik leavened last week’s regulatory practice, including an order by the United States Court of Appeals for the District of Columbia Circuit to hold en banc oral argument on the many challenges to the Administration’s environmental signature Clean Power Plan.  Major economically significant final rules to hit the street last… Continue Reading

Monday Morning Regulatory Review – 5/16/16: Deeming Rule & Litigation; Safety and Health Electronic Recordkeeping; Reconstructed or Modified Methane; Transgender Accommodations Guidance; & Conflicting Disability Compliance

Posted in Agency Authority, Constitutional Issues in Regulations, Executive - OMB Review, Judicial Process, Regulatory Flexibility & Small Business, Regulatory Process

Highlights with no surprises in regulatory practice last week focused on the rush to complete regulatory actions.  The Administration issued the controversial tobacco “deeming rule” and a vaping manufacturer immediately sued.  A new electronic reporting requirement must be challenged in affirmative pre-enforcement litigation because the underlying statute may bar challenges to the regulations in defensive… Continue Reading

Monday Morning Regulatory Review – 4/11/16: Corporate Inversions Ruled Out; Untrusted Fiduciary Rule; Sanitary Transport; Silica Suits & Agency Authority Constitutional Challenge

Posted in Agency Authority, Constitutional Issues in Regulations, Judicial Review & Remedies, Regulatory Process

The Administration fully engaged in institutionalizing its policies through promulgated rules with the Employee Benefits Security Administration (EBSA), the Internal Revenue Service (IRS), and the Food and Drug Administration (FDA) all publishing economically significant final rules this week.  Petitions for review challenged the Occupational Safety and Health Administration (OSHA)’s crystalline silica rule as expected.  In… Continue Reading

Monday Morning Regulatory Review – 12/28/15: A Regulatory Appropriation

Posted in Agency Authority, Legislation

This last column of the year takes a different approach to regulatory practice – a survey of some of the realities of Congressional “review” in the omnibus Consolidated Appropriations Act, 2016 (CAA16), signed into law December 18, 2015. This massive appropriation includes many different styles of Congressional oversight and intervention – from outright prohibition, to… Continue Reading

Monday Morning Regulatory Review – 11/16/15: Food Safety Rules Up; Energy Efficiency Removal; Conflict Minerals Review Denial; & WOTUS Forward

Posted in Executive - OMB Review, Judicial Process, Judicial Review & Remedies

The most significant agency action in regulatory practice last week may have been the release of three long-delayed Food Safety Modernization Act (FSMA) final rules. Courts took a number of small steps toward resolving challenges to Administration priority regulations, but no particular signal from these actions appears evident, except for the affirmance of the preliminary… Continue Reading

Monday Morning Regulatory Review – 9/14/15: Human Research; Food Safety Rules; Extraordinary Writs Declined; Finality Petition & Obamacare Coverage Regulation Enjoined

Posted in Judicial Process, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory Process

New food safety rules and a proposed common rule on protection of human subjects in research deserve attention in the regulatory process. An unsurprising denial of an extraordinary writ and an unsurprising petition for certiorari deserve as much attention as a surprising injunction against an insurance coverage regulation in the judicial process.

Monday Morning Regulatory Review – 7/13/15: Nutrition Labeling Extended; Housing Grants; Contraceptive Mandate Update; Truck Emissions & Immigration Executive Action Again

Posted in Judicial Review & Remedies, Regulatory Process

Summer in Washington and the regulatory agenda is not on vacation, but small sauntering through large items. For example, one agency has extended by a year the compliance date for a major rule, another agency created a public relations controversy while releasing a much narrower rule, a third agency released only a fact sheet on… Continue Reading

Monday Morning Regulatory Review – 6/15/15: Final Rules, not Proposed; Open Internet Unstayed & Effective; Complete Agency Rulemaking Records; Aircraft Engine Endangerment; & Food Safety Returns

Posted in Agency Authority, Judicial Process, Regulatory Process

Federal courts reminded by agencies and litigators of lessons they should have previously learned last week, while agencies banked more fuel for future regulatory fires. The United States Court of Appeals for the District of Columbia Circuit reiterated that only final rules, not proposed rules, are subject to judicial review, and it also denied a… Continue Reading

Monday Morning Regulatory Review – 12/1/14: Electric Generating Hazardous Emissions & Costs; Quintennial Ozone Standard; Calorie Counting; and Election Financing Disclosure

Posted in Executive - OMB Review, Judicial Process, Judicial Review & Remedies, Regulatory Process

The very short Thanksgiving workweek was punctuated by a significant new United States Supreme Court (SCOTUS) grant of review of requirements for the Environmental Protection Agency (EPA) in regulating hazardous air pollutants – this time by electric utilities.  The day before Thanksgiving has traditionally been a day for rolling out controversial actions to reduce adverse… Continue Reading

Monday Morning Regulatory Review – 9/22/14: CFTC Extraterritorial Application; Food Safety Rules; & OMB Reviews

Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Process

Summer is clearly over and the regulatory machinery is back up to full speed.  The United States District Court for the District of Columbia remanded without vacatur more than half a dozen Commodities Futures Trading Commission (CFTC) rules for failure to adequately explain the costs and benefits of extraterritorial application of those rules.  Within the… Continue Reading

Monday Morning Regulatory Review – 7/28/14: Contraception Regulations Revision; Advisory Committee Appointments; Orphan Drugs; and Oil & Ethanol Rail Cars

Posted in Agency Authority, Executive - OMB Review, Judicial Review & Remedies, Regulatory Process

A number of volatile issues made ripples in regulatory practice last week that will not be found in the general media.  The saga of the religious exemption from the contraceptives mandate in Obamacare (Patient Protection and Affordable Care Act or PPACA) added an introduction to a new chapter last week when the Department of Justice… Continue Reading

Monday Morning Regulatory Review – 6/2/14: Health & Food Regulations; Expected Electricity Carbon Rule; Waters of the United States; & Acid Rain Litigation

Posted in Judicial Process, Regulatory Flexibility & Small Business, Regulatory Process

The short holiday workweek produced few hard regulatory events although soft indications continue of the federal government’s intent to regulate the minutiae of daily life.  The Department of Health and Human Services (HHS) published its final rule on long-term Obamacare exchange and insurance market standards and extended the comment period on several food labeling proposals. … Continue Reading

Monday Morning Regulatory Review – 4/28/14: Net Neutrality II; Coal Dust; Tier 3 Vehicle Emissions Standards; Beer & Grain Retreat; & Drones Won’t Fly

Posted in Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory Process

A crowded week of regulatory events means that some highlights must be left behind.  Highlights of the week in review (and the litigation to come) include the Federal Communications Commission (FCC) reboot of its vacated net neutrality rules, the Department of Labor (DOL) Federal Mine Safety and Health Administration (FMSHA) release of its new coal… Continue Reading

Monday Morning Regulatory Review – 4/21/14: EPA Electricity Generating Units; Beer, Grain & Cattle; Tax Exempt Organizations & Politics; Waters of the United States; & Helicopter Ambulances

Posted in Agency Authority, Judicial Review & Remedies, Regulatory Process

Regulatory practice was illustrated by several specific actions in the past week, some of which have subtle implications.  The United States Court of Appeals for the District of Columbia Circuit opined on the efficacy of the Environmental Protection Agency (EPA)’s 2012 air pollution regulation of electric generating units, but with several deep divisions.  In the… Continue Reading