45 CFR § 1.3
Requirements for Department issuance and use of guidance documents
April 14, 2021

(a) Guidance documents.

(1) Under the Administrative Procedure Act, the Department may not issue any guidance document that establishes a legal obligation that is not reflected in a duly enacted statute or in a regulation lawfully promulgated under a statute.

(2) The Department may not use any guidance document for purposes of requiring a person or entity outside the Department to take any action, or refrain from taking any action, beyond what is required by the terms of an applicable statute or regulation.

(3) Each guidance document issued by the Department must:

(i) Identify itself as “guidance” (by using the term “guidance”) and include the following language, unless the guidance is authorized by law to be binding: “The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract. This document is intended only to provide clarity to the public regarding existing requirements under the law.”;

(ii) Not direct parties outside the Federal Government to take or refrain from taking action, except when restating—with citations to statutes, regulations, or binding judicial precedent—clear mandates contained in a statute or regulation; and

(iii) Include the following information:

(A) The activities to which and the persons to whom the document applies;

(B) The date of issuance;

(C) Unique agency identifier;

(D) Whether the guidance document replaces or revises a previously issued guidance document and, if so, identify the guidance document that it replaces or revises;

(E) Citation to the statutory provision(s) and/or regulation(s) (in Code of Federal Regulations format) that the guidance document is interpreting or applying; and

(F) A short summary of the subject matter covered in the guidance document.

(4) The Secretary must approve, on a non-delegable basis, all non-significant guidance documents that the Secretary determines will either

(i) Implicate, including potentially impede, any policy matter of priority to the Secretary, or

(ii) Potentially create a serious inconsistency, or otherwise interfere, with an action taken or planned by another operating division or the Office of the Secretary.

(b) Significant guidance documents.

(1) Before the Department issues any significant guidance document, it must be approved, on a non-delegable basis, by the Secretary.

(2) Before issuing any significant guidance document, the Department must:

(i) Submit the significant guidance document to OIRA for review under Executive Order 12866 prior to issuance.

(ii) Provide at least a 30-day public notice and comment period on the proposed significant guidance document, unless the Department for good cause finds (and incorporates such finding and a brief statement of reasons therefor into the guidance document) that notice and public comment are impracticable, unnecessary, or contrary to the public interest. If no such good cause exists, the public notice (which must be published in the Federal Register and posted in the guidance repository) shall include all of the following information:

(A) Information as to where the public may access a copy of the proposed significant guidance document;

(B) Information as to where written comments may be sent, and an internet website where those comments may be reviewed by the public; and

(C) The time period during which comments will be accepted.

(iii) Publish a public response to the major concerns raised during the comment period.

(3) Significant guidance documents must comply with applicable requirements for significant regulatory actions, as set forth in Executive Orders, except that only economically significant guidance documents require a separate Regulatory Impact Analysis.

(4) A significant guidance document may be exempted from any requirement otherwise applicable to significant guidance documents if the Secretary and the Administrator of OIRA agree that exigency, safety, health, or other compelling cause warrants the exemption. The Secretary must make this finding, and the significant guidance document must incorporate the finding and a brief statement of reasons in support.

(5) The Department shall seek from OIRA, as appropriate, categorical determinations that classes of guidance presumptively do not qualify as significant. Any guidance satisfying such a categorical exemption presumptively need not comply with the requirements of this paragraph (b) but must comply with all other requirements applicable to guidance documents. OIRA may determine that a particular guidance document within a categorical exemption is nonetheless significant.

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