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

Tag Archives: Regulatory Flexibility Act

First FDA Food Safety Proposed Rules Released: A Long, Long Road Ahead

Posted in Executive - OMB Review, Regulatory Flexibility & Small Business, Regulatory Process

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

OMB Releases Fall 2012 Unified Agenda & Regulatory Plan: Meaning what?

Posted in Regulatory Flexibility & Small Business, Regulatory Process

The 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

Monday Morning Regulatory Review – 12/3/12

Posted in Regulatory Process

Rule 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

Monday Morning Regulatory Review – 11/19/12

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

Activity 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 – 11/5/12

Posted in Judicial Review & Remedies, Regulatory Process

The election is tomorrow and regulatory activity seems to be in the calm before the storm.  Congress further pressured the Administration on the lack of a Unified Agenda, but the Office of Management and Budget (OMB) did complete review on some very time-sensitive regulations, while the Environmental Protection Agency (EPA) announced at least some compliance… Continue Reading

Monday Morning Regulatory Review – 10/1/12

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

Small 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 Business

A 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 Process

A 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 Process

Food 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 Process

A 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 – 8/27/12

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

The Department of Health and Human Services (HHS) dominated last week.  The United States Court of Appeals for the District of Columbia Circuit affirmed the District Court in two cases of note:  upholding HHS’s revised embryonic stem cell research rules and striking down HHS’s tobacco packaging rules – which will be the subjects of future… Continue Reading

Conflicting Decisions on Delegated Rulemaking Authority: the Uncertain Fate of H-2B Regulations

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

A new decision in Louisiana Forestry Assn. v. Solis upheld the Department of Labor (DOL) Wage Methodology for the Temporary Non-agricultural Employment H-2B Program, adding another piece to a confusing jigsaw puzzle over the efficacy of the H-2B regulations.  District Court decisions upholding regulations normally do not garner major attention by this blog because there… Continue Reading

Monday Morning Regulatory Review – 8/20/12

Posted in Executive - OMB Review, Regulatory Flexibility & Small Business, Regulatory Process

It 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

Testing Paperwork Reduction Act Burdens: A Request for Public Information

Posted in Regulatory Process

Cass Sunstein, Administrator of the Office of Management and Budget (OMB)’s Office of Information and Regulatory Affairs (OIRA) instructed the executive departments and independent regulatory agencies on August 9, 2012, to test their information collection forms under the Paperwork Reduction Act before using them.  The instruction addresses a long-standing complaint that the burdens calculated by… Continue Reading

Monday Morning Regulatory Review – 8/6/12

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

Last 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 Process

Securities 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

Monday Morning Regulatory Review – 6/25/12

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

Regulations: 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

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 Business

Regulations:  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

Labor Enjoined from Regulating Temporary Worker Visas: No Statutory Delegated Authority

Posted in Judicial Process, Judicial Review & Remedies

The United States District Court for the Northern District of Florida has preliminarily enjoined the Department of Labor (DOL) from enforcing its Temporary Non-Agricultural Employment of H–2B Aliens in the United States rule published last February and that was scheduled to become effective today.  Bayou Lawn & Landscape Services v. Solis, N.D. Fla. No.  3:12-cv-00183-rv-CJK…. Continue Reading

Monday Morning Regulatory Review – 4/23/12

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

Last 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

NLRB Posting Rule II: Posting Rule Exceeded Authority under NLRA

Posted in Judicial Process, Judicial Review & Remedies

In a second blow to the National Labor Relations Board (NLRB) Posting Rule, the United States District Court for South Carolina has held that the NLRB violated the Administrative Procedure Act (APA) when it promulgated a rule without statutory authority requiring employers to display an NLRB-created poster.  Chamber of Commerce v. NLRB.  As previously discussed… Continue Reading