The Office of Management and Budget (OMB) recently issued an updated memorandum to the heads of executive departments and agencies entitled, “Guidance on Compliance with the Congressional Review Act” (2019 Memo). The 2019 Memo, effective on May 11th, “reinforces the obligations of Federal agencies” under the Congressional Review Act (CRA) to submit rules to Congress, and also clarifies when a rule is to be considered “major” by OMB’s Office of Information and Regulatory Affairs (OIRA). The criteria and process the 2019 Memo sets for triggering OIRA “major” designation are the more significant aspect of the document, as they have the potential to noticeably impact FDA issuance of guidance documents.