“…Fortunately, in November 2009, while working at the White House Office of management and Budget, I was able to convene representatives of HHS and other departments to develop reforms to enhance participant protections and make the oversight process more efficient.  Those meetings led to an Advance Notice of Proposed Rulemaking in 2011 and release of a Notice of Proposed Rulemaking (NRPM) this September.  The end of this process is now in sight.”  (The New England Journal of Medicine)