(a) Good faith cost estimates. Even though not legally binding on the public, some agency guidance may result in a substantial economic impact on the public. For example, the guidance's existence may induce private parties to alter their conduct to conform to recommended standards or practices, thereby incurring costs beyond the costs of complying with existing statutes, regulations, and other authorities. While it may be difficult to predict with precision the economic impact of voluntary guidance on the public, we, to the extent practicable, make a good faith effort to estimate the likely economic cost impact on the public, to determine whether the document might be significant.

(b) Regulatory impact analyses. When we, or OIRA, determine that a guidance document will have an economically significant impact on the public, we conduct and publish a regulatory impact analysis of the sort that would accompany an economically significant rulemaking, to the extent reasonably possible.

(c) Excluded guidance. Significant guidance documents do not include the categories of documents excluded by §1213.1(b) or any other category of guidance documents the regulatory office exempts in writing in consultation with OIRA.

(d) OIRA review of significant guidance. If OIRA designates a guidance document as significant or economically significant, we submit it to OIRA for review under E.O. 12866 before we issue it, as with regulations; and we process significant guidance in compliance with the applicable requirements for regulations or rules, including significant regulatory actions, set forth in E.O. 12866, E.O. 13563, E.O. 13609, E.O. 13771, and E.O. 13777.

(e) Signature or approval. The Archivist of the United States or a senior executive designee signs or approves significant guidance.

(f) Informal notice-and-comment procedures. Except as outlined in paragraph (g) of this section, we subject all proposed guidance documents OIRA determines to be significant to the following informal notice-and-comment procedures. We publish a notice in the Federal Register announcing that a draft of the proposed guidance document is publicly available and where, either post the draft guidance document on our guidance portal or on regulations.gov in a docket with the notice (depending on the nature, size, and scope of the guidance), invite public comment on the draft document for a minimum of 30 days, and prepare and post a public response to major concerns raised in the comments, as appropriate, on our guidance portal or in the docket on regulations.gov (whichever location we used to post the draft guidance), either before or when we issue the guidance document.

(g) Exceptions to notice-and-comment procedures. The requirements of paragraph (f) of this section do not apply to any significant guidance document or categories of significant guidance documents for which we find, in consultation with OIRA, good cause that notice and public comments are impracticable, unnecessary, or contrary to the public interest (and we will incorporate the finding of good cause and a brief statement of reasons in the guidance).