(a) General. Guidance documents deemed “significant” by OIRA must comply with the additional requirements specified in this section.

(b) Additional requirements. Significant guidance documents must:

(1) Satisfy the requirements in §1155.4, which are applicable to all guidance documents;

(2) Be approved by the Chair of the Board, on a non-delegable basis;

(3) Be accompanied by a regulatory impact analysis for proposed guidance that OIRA has determined to be economically significant;

(4) Be submitted to OIRA for coordinated review, along with, at minimum, a summary of the proposed guidance and documentation demonstrating compliance with applicable rulemaking requirements set forth in Executive Orders 12866, 13563, 13609, 13771, and 13777; and

(5) Comply with the notice-and-comment procedures prescribed in §1155.8, unless the General Counsel or his or her delegee issues a written determination that these informal rulemaking procedures would be impracticable, unnecessary, or contrary to the public interest.