EPA publishes proposal to rescind and revise WOTUS rule
EPA and the Army Corps of Engineers officially published in the Federal Register a proposed rule to rescind the definition of "waters of the U.S." (WOTUS) established in a June 2015
. The proposal would re-codify the regulatory text that existed prior to the 2015 WOTUS rule to "reflect the current legal regime under which the agencies are operating" following a nationwide stay of the rule by the U.S. Court of Appeals for the Sixth Circuit.
EPA published a direct final rule and an accompanying proposed rule that would extend by one year the compliance date for EPA's national emission standards for hazardous air pollutants (NESHAP) for flame attenuation lines in the wool fiberglass manufacturing industry.
FDA is holding a public workshop on developing a framework for the use of real-world evidence (RWE) in FDA regulatory contexts. RWE includes clinical evidence derived from real-world data on the potential benefits or risks of a drug. FDA is seeking input on the use of RWE to support approval of a new indication for an already approved drug.