Title 36

SECTION 1155.7

1155.7 Additional requirements applicable to significant guidance documents.

§ 1155.7 Additional requirements applicable to significant guidance documents.

(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.

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