Executive order “defunded”
This article was originally published in The Tan Sheet
Executive Summary
The House moves to block funding for Executive Order 13422, which would increase Office of Management and Budget oversight over all federal agencies, with legislation passed June 28. Among other things, the order states that OMB has the authority to require notice and review of agency guidance documents (1"The Tan Sheet" Jan. 29, 2007, In Brief). An amendment to an appropriations bill (HR 2829) passed by the House stipulates that "none of the funds made available by this act may be used to implement" the executive order. The bill provides funding for the Treasury Department, Executive Office and general government activities. The amendment was co-sponsored by Science Subcommittee on Oversight Chair Brad Miller, D-N.C., and Judiciary Subcommittee on Commercial and Administrative Law Chair Linda Sanchez, D-Cal., who each held hearings on the executive order in February (2"The Tan Sheet" March 12, 2007, p. 10). No similar action has been taken as yet in the Senate...
You may also be interested in...
Congress Urged To Address OMB’s Expanded Role In Regulations, Guidance
Government watchdog group OMB Watch is urging Congress to impede the implementation of an executive order that increases the administration's influence over regulations and guidance documents issued by FDA and other agencies
Guidances subject to new rules
Agencies are now required to conduct regulatory impact analyses for guidance documents, which fall under Executive Order 12866 following an amendment signed by President Bush Jan. 18. Previously the order affected only proposed and final rules. Additionally, agencies issuing "significant" guidance documents must now notify the Office of Management and Budget's Office of Information and Regulatory Affairs before publication of the guidance. The definition of "significant" guidance document includes those anticipated to have an annual effect of $100 mil. or more, create a major conflict between another agency's policies or raise novel legal or policy issues "arising out of legal mandates," the amendment states. The order also gives OIRA authority to request the full content of a significant guidance document as well as a "brief explanation" of its necessity and how it will meet that need. Additionally, OIRA "shall notify the agency when additional consultation will be required" prior to the issuance of the significant guidance document...
FDA’s New Dataset Aims To Assist Labs In Assessing Medical Device Biocompatibility
The US FDA’s device center has unveiled a new public dataset designed to assist chemistry laboratories in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices.