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

Monthly Archives: April 2013

Teenagers and Plan B One Step: FDA’s Compliance with a Court Order or Just a Different Decision

Posted in Judicial Review & Remedies, Regulatory Process

The 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 Process

Busy 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

FDA’s Food Safety Regulations – Court Requires Timing Negotiation

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

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

Homeland Security & Labor Issue H-2B Regulations: Authority Solved?

Posted in Agency Authority, Judicial Review & Remedies, Regulatory Process

The 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 – 4/15/13

Posted in Judicial Process, Regulatory Process

A confluence of external factors may have suppressed regulatory activity over the past week – the budget, sequestration, gun control, immigration, tax filing deadline, or what have you.  In any event, this morning’s review takes the opportunity to catch up on a few events and questions that might not otherwise garner attention: Environmental Protection Agency… Continue Reading

Monday Morning Regulatory Review – 4/8/13

Posted in Judicial Review & Remedies, Regulatory Process

Follow-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 Regulations

A 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

11th Circuit Holds Labor Department Has No Authority to Issue H-2B Rules

Posted in Agency Authority, Judicial Review & Remedies, Regulatory Process

Today the United States Court of Appeals for the Eleventh Circuit affirmed the decision of the United States District Court for the Northern District of Florida enjoining the Department of Labor (DOL) from enforcing its non-immigrant non-agricultural unskilled labor visa program (H-2B) in Bayou Lawn and Landscape Services v. Solis.  The court found that the… Continue Reading

Monday Morning Regulatory Review – 4/1/13

Posted in Regulatory Process

A 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