On April 11, 2019 a memo was released from the Office of Management and Budget (OMB) stating that United States agencies, which include the Food and Drug Administration, rules and guidances must go to the OMB’s Office of Information and Regulatory Affairs for review beginning on May 11, 2019.
The OMB will be reviewing the agencies regulations and guidances to determine whether they are classified as “minor” or “major”. Previously, each agency was responsible for determining on its own whether the proposed new rule should be classified as major based on reviewing the CRA criteria, which is listed below.