§ 89.6 - Procedures for significant guidance.

§ 89.6 Procedures for significant guidance.

In this section, requirements that apply to issuance of guidance also apply to modification or withdrawal of guidance.

(a) The Department must consult with OIRA to determine whether guidance is significant guidance, or qualifies as “major” guidance under the criteria in 5 U.S.C. 804(2), unless the guidance is otherwise exempted from such a determination by the Administrator of OIRA. Consultation with OIRA will consist of giving OIRA an opportunity to review each guidance document on a timeline reasonable for the size, complexity, and importance of the guidance document.

(b) For a significant guidance document, as determined by the Administrator of OIRA, unless the agency and the Administrator agree that exigency, safety, health, or other compelling cause warrants an exemption from some or all requirements of this paragraph, each significant guidance document must:

(1) Undergo a period of public notice and comment of at least 30 days before issuance of the final guidance document and be accompanied by a publicly posted response from the agency, made available either as part of the final guidance document or in a companion document, that addresses major concerns raised in timely submitted comments, except when the agency for good cause finds (and incorporates the finding and a brief statement of reasons for the finding into the guidance) that notice and public comment under this paragraph are impracticable, unnecessary, or contrary to the public interest;

(2) Before initial and final issuance, receive both approval and signature on a non-delegable basis by:

(i) The agency head;

(ii) An official who is serving in an acting capacity as the foregoing; or

(iii) The Secretary or the Deputy Secretary, as appropriate;

(3) Undergo review by OIRA under Executive Order 12866 before issuance; and,

(4) Comply with the applicable requirements that would otherwise apply to regulations or rules, including significant regulatory actions as set forth in Executive Orders 12866 (Regulatory Planning and Review), 13563 (Improving Regulation and Regulatory Review), 13609 (Promoting International Regulatory Cooperation), 13771 (Reducing Regulation and Controlling Regulatory Costs), and 13777 (Enforcing the Regulatory Reform Agenda).

(c) An agency must publish a notice in the Federal Register announcing the availability of each proposed and final significant guidance document and must make each proposed and final significant guidance document available on the website maintained under § 89.5.

(d) An agency must ensure that comments timely submitted in response to each proposed significant guidance document are published online or linked from the website maintained under § 89.5, before publishing the final significant guidance document.

(e) For each significant guidance document where the agency and the Administrator of OIRA agree that exigency, safety, health, or other compelling cause warrants an exemption from some or all requirements under paragraph (b) of this section, the agency must incorporate that finding and a brief statement of reasons for the finding into the guidance.

(f) For all significant guidance exempt from requirements under this section as permitted by paragraph (b) of this section, such significant guidance shall be treated as temporary and will be rescinded by operation of law 270 days after it is published. The agency may make the temporary significant guidance permanent before the automatic rescission by following the procedures outlined for all significant guidance not exempt under paragraph (b).

(g) This section does not apply to pre-enforcement rulings, defined in § 89.2(g), that are guidance under this rule.