The 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
Category Archives: Executive – OMB Review
Subscribe to Executive – OMB Review RSS FeedMonday 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 – 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 – 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 – 2/4/13
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
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
CFTC Pool Operator Rule Upheld – Broader Lessons Need Consideration
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessThe United States District Court for the District of Columbia granted the agency summary judgment in Investment Company Institute v. Commodity Futures Trading Commission (CFTC), leaving intact the Commodity Pool Operators and Commodity Trading Advisors: Compliance Obligations final rule (as corrected) (the “pool” rule). Plaintiffs claimed that the CFTC had violated the Administrative Procedure Act… 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 – 11/26/12
Posted in Executive - OMB Review, Judicial Review & RemediesThe week of Thanksgiving is traditionally a quiet one – dedicated rightly to giving thanks for what we have with a touch of jostling for more as Black Friday has blended backward into Thanksgiving Day. In addition to shopping, Black Friday traditionally is a quite time in the government – time to clean the office… Continue Reading
Monday Morning Regulatory Review – 11/12/12
Posted in Executive - OMB Review, Judicial Review & RemediesOn Election Night, the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) was reviewing 147 significant rules, proposed rules, and other notices. With the election over, the floodgates have now cracked. OMB’s docket has suddenly grown to 158, and we may expect to see many more rules – and perhaps… Continue Reading
Food Safety Statute & Delay: Litigating Congressional Deadlines
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessFood safety – what could be more important? The FDA Food Safety and Modernization Act (FSMA), signed into law on January 4, 2011, requires a significant regulatory shift by the Food and Drug Administration (FDA). FSMA imposed numerous deadlines for FDA to adopt regulations and those deadlines have passed into history without rules. Given those… Continue Reading
Monday Morning Regulatory Review – 9/3/12
Posted in Executive - OMB Review, Regulatory ProcessA rush to complete regulations may or may not be on, but the publication queue this week results in a long post and raises questions about whether a push is really under the radar. The Department of Health and Human Services (HHS) continues to dominate the field with Medicare, Medicaid, HITECH, and unique plan identifier… Continue Reading
Judicial Review & EO 12866 Regulatory Impact Analysis
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessA common but little understood Administrative Procedure Act (APA) issue arose from last Monday’s Regulatory Review: How does an aggrieved business acquire APA judicial review of a rulemaking under Executive Order 12886 – the executive and inter-agency review performed by the Office of Management and Budget (OMB) and its Office of Information and Regulatory Affairs… Continue Reading
Monday Morning Regulatory Review – 8/20/12
Posted in Executive - OMB Review, Regulatory Flexibility & Small Business, Regulatory ProcessIt may be vacation season, but this week agencies are steadily proposing and finalizing regulations – mortgages, settlements, electronic transfers, swaps, HAZMAT, Deepwater Horizon, and small business classification: The Bureau of Consumer Finance Protection (CFPB) proposed two mortgage rules and finalized its EFT rule, while the Commodities Futures Trading Commission (CFTC) and the Securities and… Continue Reading
Opinion: From EEOB to Langdell: A Change for Cass Sunstein
Posted in Executive - OMB ReviewThe White House and Harvard Law School announced the departure of Cass Sunstein from his role as Administrator of the Office of Management and Budget (OMB) Office of Information and Regulatory Affairs (OIRA) and his new position running a new law school Program on Behavioral Economics and Public Policy. Numerous press reports focused on dissatisfaction… Continue Reading
Administration’s Failing Grades: Education’s “For Profit” Debt Measure Rule Vacated
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory ProcessThe United States District Court for the District of Columbia vacated more Department of Education (DOE) “for-profit college” student loan funding rules on June 30. In this edition, the court accepted DOE’s interpretation of a statutory “gainful employment” requirement, but rejected DOE’s debt measure proxy and subsidiary reporting and approval rules. Association of Private Sector… Continue Reading
Monday Morning Regulatory Review – 7/23/12
Posted in Executive - OMB Review, Judicial Process, Judicial Review & RemediesThe Environmental Protection Agency (EPA) published its “portland cement” reconsideration and the Small Business Administration (SBA) published three more proposed size standard adjustments. The Department of Transportation (DOT) submitted a mammoth final 2017 model year passenger car and light truck mileage standard to the Office of Management and Budget (OMB). At the end of judicial… Continue Reading
Monday Morning Regulatory Review – 6/25/12
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory ProcessRegulations: DOJ Prison Rape: The Department of Justice (DOJ) published its final National Standards to Prevent, Detect, and Respond to Prison Rape final rule with a request for additional comments on June 20, 2012. This massive (it would have been ream-sized if double-spaced) rule may illustrate the need for careful evaluation of cumulative estimates and… Continue Reading
OMB Requests Paperwork Reduction Reporting, More Needed to Reduce Burden
Posted in Executive - OMB Review, Regulatory ProcessThe Office of Management and Budget (OMB) has followed up President Obama’s Executive Order 13610, Identifying and Reducing Regulatory Burdens, with specific examples of how agencies can reduce “paperwork” burdens on the “American people, including small businesses.” The OMB memo could have done more to ensure that agency reduce Paperwork Reduction Act (PRA) burdens but… Continue Reading
Monday Morning Regulatory Review – 5/14/12
Posted in Executive - OMB Review, Judicial Review & RemediesRegulations: Petroleum Refineries: The Office of Management and Budget (OMB) completed review of the Environmental Protection Agency (EPA)’s economically significant final rule to complete the Petroleum Refineries – New Source Performance Standards (NSPS)–Subparts J and Ja interim final rule. EPA has previously promulgated new source standards for refineries, then granted reconsideration of, and stayed, specific… Continue Reading
Obama Adds Three Requirements to Retroactive Review of Regulations
Posted in Executive - OMB ReviewPresident Barack Obama today added three new requirements to agency development of regulations and retrospective review of regulations in a new Executive Order: The new order supplements Executive Order 13563 by – Telling agencies to invite public suggestions and publicly releasing retrospective analyses of regulations and supporting data; Prioritizing initiatives that will produce significant quantifiable… Continue Reading