(a) Though not legally binding, some agency guidance may result in a substantial economic impact. For example, the issuance of agency guidance may induce private parties to alter their conduct or conform to recommended standards of practices, thereby incurring costs beyond the costs of complying with existing statutes and regulations.

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(b) If there is a reasonable possibility the guidance may be considered “significant” within the meaning of § 813.7 or if the Agencies are uncertain whether the guidance may qualify as such, the Agencies must receive OMB’s Office of Information and Regulatory Affairs (OIRA) approval before issuance, unless the Agencies and OIRA agree that exigency, safety, health, or other compelling cause warrants an exemption from some or all requirements.

(c) When an agency is assessing or explaining whether it believes a guidance document is significant, it should, at a minimum, provide the same level of analysis that would be required for a major determination under the Congressional Review Act.1

1 See OMB Memorandum M-19-14, Guidance on Compliance with the Congressional Review Act (April 11, 2019).

(d) The following will apply to significant guidance documents:

(1) A period of public notice and comment of at least 30 days before the issuance of a final guidance document, and a public response from the Agencies to major concerns raised in comments. If the Agencies, for good cause, find that the notice and public comment are impracticable, unnecessary, or contrary to the public interest, then no period of public comment will be provided, with notification and consultation with OIRA;

(2) Approval by the respective Agency Director;

(3) Review by OIRA under Executive Order 12866 before issuance;

(4) Compliance with the applicable requirements for regulations or rules, including significant regulatory actions, set forth in E.O. 12866 (Regulatory Planning and Review), E.O. 13563 (Improving Regulation and Regulatory Review), E.O. 13609 (Promoting International Regulatory Cooperation), E.O. 13771 (Reducing Regulation and Controlling Regulatory Costs), and E.O. 13777 (Enforcing the Regulatory Reform Agenda).