Litigation involving various aspects of Department of Health and Human Services (HHS) regulations and operations dominated the past week with quiet endings. The intense debate over the Food and Drug Administration (FDA) plans for emergency contraceptives Plan B and Plan B One Step fizzled with the government’s capitulation. The organ donor litigation that captured much… Continue Reading
Tag Archives: Department of Health and Human Services
Monday Morning Regulatory Review – 6/10/13
Posted in Agency Authority, Judicial Process, Regulatory ProcessUnrelated events of the past week in regulatory practice include the publication of Environmental Protection Agency (EPA)’s proposed new limitations on power plant water effluents – the result of cleaner air requirements – and wider dissemination of new “social cost of carbon” standards for regulatory impact analyses. The Department of Health and Human Services (HHS)… Continue Reading
Monday Morning Regulatory Review – 6/3/13
Posted in Regulatory ProcessThe Environmental Protection Agency (EPA) did not heed calls for extension of the public comment period on a massive rulemaking – granting a stingy extension that will cause more requests. The Consumer Financial Protection Bureau (CFPB), on the other hand, delayed the effective date on a major mortgage rule for seven months to try to… Continue Reading
Monday Morning Regulatory Review – 5/27/13
Posted in Agency Authority, Judicial Review & Remedies, Regulatory ProcessThis week, a little more movement toward the Supreme Court resolving the constitutionality of intrasession recess appointments – and the impact on a number of regulations approved by such recess appointees. A new study outlines to some extent the (environmental) agency practice of being sued by environmental supportive groups and settling on regulatory timing and… Continue Reading
Monday Morning Regulatory Review – 5/20/13
Posted in Agency Authority, Constitutional Issues in Regulations, Judicial Process, Judicial Review & RemediesThis 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
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: 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
Monday Morning Regulatory Review – 4/29/13
Posted in Agency Authority, Constitutional Issues in Regulations, Judicial Review & Remedies, Regulatory ProcessBusy and long today: The Department of Health and Human Services (HHS) submitted to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), a hospital disproportionate share payment reduction proposed rule. OIRA may have a new Administrator who may or may not have the opportunity to review the rule –… 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
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
Monday Morning Regulatory Review – 2/25/13
Posted in Constitutional Issues in Regulations, Judicial Review & RemediesLitigation over President Obama’s recess appointments took several additional steps last week and few significant rules were published. One rule worth noting is a Department of Health and Human Services (HHS) follow-up final rule establishing standards for essential health benefits under the Patient Protection and Affordable Care Act. Two Department of Labor cases also deserve… Continue Reading
Monday Morning Regulatory Review – 2/18/13
Posted in Constitutional Issues in Regulations, Executive - OMB Review, Regulatory ProcessThe Consumer Finance Protection Bureau (CFPB), along with some cohorts, published a flurry of four final rules last week that will give banking and mortgage attorneys plenty to read and absorb – and consider anew whether the CFPB can legitimately issue these rules. Adding a little fuel to the Noel Canning fire, a House of… Continue Reading
Monday Morning Regulatory Review – 2/11/13
Posted in Agency Authority, Judicial Review & Remedies, Regulatory ProcessA quiet week in regulations, punctuated by a few interesting events: The United States Court of Appeals for the District of Columbia Circuit vacated the entire definition of “Vented hearth heater” and remanded in part the Department of Energy (DOE)’s ubiquitous Energy Conservation Program rule. The Department of Health and Human Services (HHS) published their… Continue Reading
Monday Morning Regulatory Review – 2/4/13
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory ProcessRegulatory and judicial processes intersected last week to a greater extent than usual, with several departments addressing (or not) court decisions and ongoing litigation. Highlights: Department of Health and Human Services (HHS) proposing its promised rule on contraceptives and religious organizations that has been the subject of numerous cases, including direct challenges and injunctions; Environmental… 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
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
OMB Releases Fall 2012 Unified Agenda & Regulatory Plan: Meaning what?
Posted in Regulatory Flexibility & Small Business, Regulatory ProcessThe Obama Administration released a Unified Agenda and Regulatory Plan overnight December 22, 2012, after being missing in action for months and finally skipping the Spring 2012 version altogether, not releasing any instructions for the development of the Fall 2012 Unified Agenda, and with no announcement of the 2012 Fall Unified Agenda whatever. OMB’s lack… 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 – 12/10/12
Posted in Executive - OMB Review, Judicial Review & RemediesRegulatory activity continued to pick up speed last week, with the Environmental Protection Agency (EPA) submitting three rules for Office of Management and Budget (OMB) review, while OMB completed one time-sensitive review. The Department of Health and Human Services (HHS) published an economically significant Patient Protection and Affordable Care Act (ACA) proposed rule on benefit… Continue Reading
Monday Morning Regulatory Review – 12/3/12
Posted in Regulatory ProcessRule submission to and completions by the Office of Management and Budget (OMB) began to pick up speed last week. Most significant, OMB quickly completed review of a legally significant Environmental Protection Agency (EPA) logging road final rule – a subject of oral argument this morning at the Supreme Court and about which Congress has… Continue Reading