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Focus on Regulation

Tag Archives: final rule

Certain Antiseptic Ingredients No Longer GRAS/GRAE, Says FDA

FDA announced a final rule today determining that certain common ingredients, most notably triclosan and triclocarban, in over-the-counter consumer antiseptic washes are not generally recognized as safe and effective (GRAS/GRAE), and thus, can no longer be provisionally marketed under the OTC Drug Review. The final rule affects the status of antibacterial soaps, hand washes, and

FDA Revises Its Drug Establishment Registration, Drug Listing, and National Drug Code (NDC) Regulations

Yesterday, the U.S. Food and Drug Administration (FDA) issued a final rule amending its regulations governing drug establishment registration and listing requirements for U.S. and foreign firms.  Also noteworthy is that the final rule expands FDA’s regulations governing National Drug Codes (NDCs).  The final rule is available at 81 Fed. Reg. 60170 (Aug. 31, 2016)

Department of Energy Issues Final Rule Amending its Nuclear Export Control Regulations

On 23 February 2015 the Department of Energy (DOE) published a Final Rule in the Federal Register (80 Fed. Reg. 9359) (Final Rule) to amend the Part 810 Regulations (10 C.F.R. Part 810), which govern the export and re-export of unclassified nuclear technology and assistance. Read more: Department of Energy Issues Final Rule Amending its

FAR Update Includes General Guidance to Acquisition Officials on COFC Bid Protests

On September 13, 2012, the Federal Acquisition Council published a final rule in the Federal Register updating FAR Part 33.* This part of the FAR provides guidance to Federal acquisition officials about the bid protest process, among other forms of contract litigation.  Before the update, Part 33 only provided guidance about agency-level protests and protests to