This week’s review is all about litigation updates: A new decision from the United States Court of Appeals for the Third Circuit struck down President Obama (POTUS)’s recess appointments to the National Labor Relations Board (NLRB) as unconstitutional. The ongoing authority feud surrounding the Food and Drug Administration (FDA) limitation of the emergency contraceptives for… Continue Reading
Tag Archives: DOJ
Monday Morning Regulatory Review – 5/13/13
Posted in Judicial Review & Remedies, Regulatory ProcessThis week a sprinkling of interesting events flavors administrative law. Recess appointments litigation may get closer to sweetening the United States Supreme Court (SCOTUS) calendar. A court decision on timing of electronic filing soured one agency’s day, and provides lessons for others. Another court fed a bitter pill to the Department of Justice (DOJ) in… Continue Reading
Teenagers and Plan B One Step: Appeal and Request for Stay of FDA Compliance with District Court Order
Posted in Agency Authority, Judicial Review & RemediesUPDATE (May 1, 2013 2015): In an unsurprising move, the Department of Justice (DOJ) is appealing the district court’s ruling in Tummino v. Hamburg II after the FDA announced yesterday a new approval for the sale of the Plan B One Step (or morning after pill) over the counter with proof of age of at… Continue Reading
Teenagers and Plan B One Step: FDA’s Compliance with a Court Order or Just a Different Decision
Posted in Judicial Review & Remedies, Regulatory ProcessThe Food and Drug Administration (FDA) approved an application by Teva Women’s Health, Inc. to market Plan B One-Step (levonorgestrel) for use without a prescription by teens 15 years of age and older. The approval of Teva’s application may or may not comply with the order the United States District Court for the Eastern District… Continue Reading
FDA’s Food Safety Regulations – Court Requires Timing Negotiation
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory ProcessThe United States District Court for the Northern District of California has found that the Food and Drug Administration (FDA) clearly exceeded the deadlines set by Congress for promulgating regulations under the Food Safety and Modernization Act of 2010 (FSMA). Rather than impose its own arbitrary deadline, the court sent the parties in Center for… Continue Reading
Homeland Security & Labor Issue H-2B Regulations: Authority Solved?
Posted in Agency Authority, Judicial Review & Remedies, Regulatory ProcessThe Department of Homeland Security (DHS) and the Department of Labor (DOL) moved quickly – perhaps too quickly – to resolve legal authority issues raised by recent court decisions vacating low-skilled worker visa (H-2B) regulations by adopting a “joint” interim final rules (IFR) that is available for public inspection and will be published in tomorrow’s… Continue Reading
Monday Morning Regulatory Review – 4/22/13
Posted in Judicial Review & Remedies, Regulatory ProcessThe Office of Management and Budget (OMB) rapidly completed review on a small step in response to President Obama (POTUS)’s agenda on gun violence with an advance notice of proposed rulemaking. The Department of Labor (DOL) submitted to OMB its response to at least one court decision on the H-2B conundrum and needed to explain… Continue Reading
Monday Morning Regulatory Review – 4/8/13
Posted in Judicial Review & Remedies, Regulatory ProcessFollow-up on previous events of interest is the focus of this morning’s review. The Environmental Protection Agency (EPA) has published its intentions on comments and hearings on new motor vehicle emission and fuel standards proposed rule, but has not published the proposed rule. Both the Department of Labor (DOL) and the Department of Homeland Security… Continue Reading
Court Requires FDA to Grant ‘Plan B’ OTC Status – Authority Issues
Posted in Agency Authority, Constitutional Issues in RegulationsA judge of the United States District Court for the Eastern District of New York has ordered the Department of Health and Human Services (HHS) Food and Drug Administration (FDA) to make “Plan B” – the post-intercourse, pre-fertilization contraceptive “morning after” pill – available over the counter (OTC) rather than by prescription to individuals under… Continue Reading
Monday Morning Regulatory Review – 4/1/13
Posted in Regulatory ProcessA busy last week leaves more to cover – particularly from the perspective of the Office of Management and Budget (OMB). While the OMB docket held relatively steady, OMB completed its long-term review of radiological incident guidance that probably involved substantial inter-agency discussion. Agencies submitted some interesting new proposed and final rules that are also… Continue Reading
More Alien Worker Wage Rules Vacated under APA: What H-2B Rules Apply?
Posted in Agency Authority, Judicial Review & Remedies, Regulatory ProcessWhile much attention in the immigration arena has focused on a new employment verification document, the potentially rapid filling of the professional employees (H-1B) temporary visa quota, and the apparent conflict over determining wage rates for foreign workers that may be stalling Senate negotiators, wage methodology for the unskilled workers temporary visa category (H-2B) is… Continue Reading
Monday Morning Regulatory Review – 3/25/13
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory ProcessThe interplay of regulations and litigation came to the fore in a very busy last week, not just in the United States Supreme Court (SCOTUS)’s recent Decker logging road culverts pollution permit decision and the for-profit colleges litigation, but five other matters: The Department of Justice (DOJ) called it quits in defending the Department of… Continue Reading
Administration’s Failing Grades 3: Educational Race to the Bottom?
Posted in Judicial Process, Judicial Review & RemediesThe Department of Education (ED) took one step last week in its attempt to better regulate the “for profit” colleges, universities, and other schools: ED published a revision of a preamble to rules that the United States Court of Appeals for the District of Columbia Circuit remanded because the prior explanation was inadequate. Amending a… Continue Reading
SCOTUS Reverses 9th Circuit on Logging Road Culverts – New Rule Irrelevant
Posted in Judicial Review & Remedies, Regulatory ProcessThe Supreme Court of the United States (SCOTUS) today vacated the United States Court of Appeals for the Ninth Circuit decision in Decker v. Northwest Environmental Defense Center, holding that the Environmental Protection Agency (EPA)’s original interpretation of its original regulations warranted Auer deference, that a new EPA rule on the subject did not moot… Continue Reading
Monday Morning Regulatory Review – 3/18/13
Posted in Constitutional Issues in Regulations, Executive - OMB Review, Judicial Review & RemediesThe regulatory process thawed last week in the Executive and Judicial Branches. Among the highlights, the simmering Recess Appointments Clause issue facing the National Labor Relations Board (NLRB) will head to the United States Supreme Court (SCOTUS) while many enforcement cases are being held in abeyance and uncertainty surrounds many rules. The United States Court… Continue Reading
Monday Morning Regulatory Review – 3/11/13
Posted in Agency Authority, Regulatory ProcessForgive the absence – surprisingly little to report over the past two weeks. The Office of Management and Budget maintained a relatively stable docket with no truly significant rules being submitted or completed. One might attribute this lull to sequestration – fears and realities – but it remains a question. Congress may be tied up… Continue Reading
The Need to Know About Executive Orders: Much Ado About … Cybersecurity
Posted in Agency Authority, Constitutional Issues in Regulations“Executive Orders” will never be confused with Shakespeare, but they are often worth reading for political theater. The real question is not their literary or entertainment value, but what they really do. President Obama’s (aka POTUS) recent Executive Order 13,636: Improving Critical Infrastructure Cybersecurity provides a good example of what an executive order can and… Continue Reading
Monday Morning Regulatory Review – 1/28/13
Posted in Agency Authority, Executive - OMB Review, Judicial Review & RemediesA short week after the Inaugural Holiday (reaffirming that the Republic works) may have slowed publication of rules slightly, but the courts were in full swing. In addition to finding that the recess appointments to the National Labor Relations Board (NLRB) were unconstitutional and void, which drew the lion’s share of attention, the United States… Continue Reading
D.C. Circuit finds “Recess Appointments” Invalid: NLRB Lacked Quorum
Posted in Constitutional Issues in RegulationsThe United States Court of Appeals for the District of Columbia Circuit ruled today that the National Labor Relations Board (NLRB) lacked a quorum to act in Noel Canning v. NLRB because three Presidential “recess” appointments were invalid. The court found that the United States Senate was not in “the” recess contemplated by the United… Continue Reading
Monday Morning Regulatory Review – 1/21/13
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory ProcessThis past week saw the January thaw from the holidays in regulatory movement. The Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) completed review on a number of substantial (if not economically significant) regulations, from arms exports to domestic gun control, and health care privacy. The Consumer Finance Protection Bureau… Continue Reading
First FDA Food Safety Proposed Rules Released: A Long, Long Road Ahead
Posted in Executive - OMB Review, Regulatory Flexibility & Small Business, Regulatory ProcessThe Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) completed review of the first of the long-awaited major Department of Health and Human Services (HHS) Food and Drug Administration (FDA) Food Safety Modernization Act (FSMA) “first wave” proposed rules: Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls… Continue Reading
2012 Year End Review: Top 10 Most Read Posts & Thoughts for 2013
Posted in Judicial Review & Remedies, Regulatory ProcessA year of writing this blog – and 115 … now 116 posts – warrants a traditional end-of-year review and prospective for next year. For the Federal Regulations Advisor to be useful, it must be responsive to you, its readers. Top 10 Posts: Popularity is often fickle, skewed toward longevity and against recent posts, but… Continue Reading
Rules and Ripeness: Commitment to Changing Rules During Litigation
Posted in Judicial Process, Judicial Review & RemediesThe United States Court of Appeals for the District of Columbia, in a short order, has held the United States to its word that it will change the Patient Protection and Affordable Care Act rules requiring employers to provide contraceptive services at no cost. The order in Wheaton College v. Sebelius comes after oral argument… Continue Reading
Monday Morning Regulatory Review – 12/17/12
Posted in Executive - OMB Review“Review Lite.” The Office of Management and Budget (OMB) completed review on nine proposed or final rules last week, the most significant of which were the Environmental Protection Agency (EPA) particulate matter revision under court order and a reconsideration of the chemical manufacturing area sources by proposed rule. The Department of Transportation (DOT) National Highway… Continue Reading