The 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
Category Archives: Regulatory Flexibility & Small Business
Subscribe to Regulatory Flexibility & Small Business RSS FeedOMB 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
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 – 11/19/12
Posted in Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessActivity at the Office of Management and Budget (OMB) has begun to pick up after the election – the Patient Protection and Affordable Care Act (ACA) regulations lead the way. On the other hand, another court ordered an exemption from the mandatory contraceptive coverage regulation ahead of Department of Health and Human Services (HHS) submitting… Continue Reading
Monday Morning Regulatory Review – 10/1/12
Posted in Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessSmall movements with potentially large impact over time occurred last week, but most did not see the light of day in the national or legal media. Key points: Department of Labor (DOL) extended the effective date of the H-2B Wage Methodology rule given another appropriation rider; Department of Homeland Security (DHS) continues to lag behind… Continue Reading
Monday Morning Regulatory Review – 9/24/12
Posted in Legislation, Regulatory Flexibility & Small BusinessA relatively quiet week allows us to catch up on some important odds and ends. The Small Business Administration (SBA) published three new small business size standards that affect large swaths of the economy and many future regulatory analyses. The Congress left town (they were here for a short period), but the House passed limitations… Continue Reading
Monday Morning Regulatory Review – 9/17/12
Posted in Regulatory Flexibility & Small Business, Regulatory ProcessA bevy of new rules and proposed rules were issued last week. Most notable contributions come from the Bureau of Consumer Financial Protection (CFPB), Securities and Exchange Commission (SEC), Commodities Futures Trading Commission (CFTC), Environmental Protection Agency (EPA), and Small Business Administration (SBA). On the management side, the Office of Management and Budget (OMB) has… 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
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
Monday Morning Regulatory Review – 8/6/12
Posted in Judicial Review & Remedies, Regulatory Flexibility & Small Business, UncategorizedLast week had a little of everything. The Environmental Protection Agency (EPA) noticed a reconsideration of some issues pending judicial review and backed out regulations determined to violate the Administrative Procedure Act (APA). The United States Court of Appeals for the Ninth Circuit found that Congress left a discrete authority in the Department of Justice… Continue Reading
Monday Morning Regulatory Review – 7/16/12
Posted in Regulatory Flexibility & Small Business, Regulatory ProcessSecurities Audit Trail: The Securities and Exchange Commission (SEC) approved a final rule under the Securities Exchange Act of 1934 to require national securities exchanges and associations to submit a national market system plan to create, implement, and maintain a consolidated audit trail for securities to capture customer and order event information across all markets,… Continue Reading
NLRB Union Representation Election Rule Struck Down for Lack of Quorum
Posted in Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory Process“According to Woody Allen, eighty percent of life is just showing up,” but for the National Labor Relations Board (NRLB), according to Judge James Boasberg, one hundred percent of its quorum is needed to vote. Chamber of Commerce v. NLRB. On that basis, Judge Boasberg struck down the NLRB’s Representation–Case Procedures rule based on the… Continue Reading
Monday Morning Regulatory Review – 4/30/12
Posted in Executive - OMB Review, Judicial Review & Remedies, Legislation, Regulatory Flexibility & Small BusinessRegulations: The Office of Management and Budget (OMB) began review on three more Small Business Administration (SBA) planned system of adjustments to the Small Business Size Standards, which generally increase the scope of regulatory flexibility analyses and the pool of businesses that are eligible for small business contracts. OMB completed review of SBA final rules… Continue Reading
Monday Morning Regulatory Review – 4/23/12
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessLast Week: Inadequate economic analysis at the Securities and Exchange Commission (SEC) and delay in rulemaking by the Occupational Safety and Health Administration (OSHA) were the focus of Congressional hearings. Meanwhile, the Environmental Protection Agency (EPA) issued new rules and proposals with both economic analysis and delay issues. This Week: United States District Court decisions… Continue Reading
Regulatory Right to Know: OMB Requests Comments on Draft Report
Posted in Executive - OMB Review, Regulatory Flexibility & Small Business, Regulatory ProcessThe Office of Management and Budget (OMB) requested public comments on its Draft 2012 Report to Congress on the Benefits and Costs of Federal Regulations and Unfunded Mandates on State, Local and Tribal Entities in today’s Federal Register. OMB’s draft report, required by the “Regulatory Right-to-Know Act,” presents OMB’s view of the benefits and costs… Continue Reading
New OMB Guidance on “Cumulative Regulatory Burden”
Posted in Executive - OMB Review, Regulatory Flexibility & Small Business, Regulatory ProcessThe Administration took another small step in the debate on the effect of regulations on small business and startups with new policy guidance. OMB / OIRA Administrator Cass Sunstein issued a Memorandum for the Heads of Executive Departments and Agencies advising that they “should take active steps to take account of the cumulative effects of… Continue Reading
Be Sued & Settle – Agencies Can’t Avoid Administrative Law
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessThe practice of suing and (immediately) settling litigation does not override the requirements of the Administrative Procedure Act (APA), the Regulatory Flexibility Act (RFA), and other statutory requirements, but it may limit the Administration’s discretion to review regulations under Executive Orders 12866 and 13653. Defenders of Wildlife v. Jackson illustrates this practice’s lack of transparency… Continue Reading
SBA Advocacy Releases New Database Tool for Regulatory Review
Posted in Regulatory Flexibility & Small Business, Regulatory ProcessThe SBA Office of Advocacy released a new document that may assist business (small and large), agencies, and others in evaluating the efficacy of regulations. Data on small business (or entities) is scattered; SBA has published a short list (with links) of government and private databases to simplify access to common data and ease review… Continue Reading
Size Matters: SBA Increasing Definitions of “Small” Business
Posted in Judicial Review & Remedies, Regulatory Flexibility & Small BusinessThe Small Business Administration (SBA) published a final rule on February 10, 2012, that generally increases the size definitions for Professional, Technical, and Scientific Services, and certain other services. This rule is important to business because it reflects a trend improve agency analysis required in Federal rulemaking and include more businesses. In short, increasing the… Continue Reading
Opinion: Regulatory Analysis, Public Comments, and Policy Decisions
Posted in Executive - OMB Review, Judicial Review & Remedies, Regulatory Flexibility & Small Business, Regulatory ProcessA crop of comments have sprung up recently on whether regulatory analyses in rulemaking – economic, scientific, and otherwise –support a specific point of view. At the same time, questions about whether public comments inherently bias a policy decision in a specific direction have arisen. At bottom, information is the currency of the regulatory process… Continue Reading
Jobs Council Recommends Regulatory Reforms: Old News?
Posted in Executive - OMB Review, Regulatory Flexibility & Small Business, Regulatory ProcessPresident Obama’s Jobs Council recommended regulatory reforms on January 17, 2012, with few surprises and little that is new. Some recommendations are welcome reiterations of good ideas, and some repeat past small steps already taken. A few are quite worthwhile. The Council now recommends: earlier public outreach through greater use of the existing Advance Notice… Continue Reading
House Passes Massive Administrative Law Reforms – President’s Advisors Recommend Veto – Future Uncertain
Posted in Legislation, Regulatory Flexibility & Small Business, Regulatory ProcessThe U.S. House of Representatives passed massive changes in the Administrative Procedure Act (APA), Regulatory Flexibility Act (RFA), and the Congressional Review Act (CRA) in late 2011. The President’s Senior Advisors indicated they would recommend that POTUS veto all of these bills if presented to him. Senate action, and thus enactment, is unlikely. The House… Continue Reading