36 C.F.R. § 1213.2 – Definitions.

(a) Guidance or guidance document means any statement of agency policy or interpretation concerning a statute, regulation, or technical matter within our jurisdiction that we intend to have general applicability and future effect on the behavior of regulated parties, but which we do not intend to have the force or effect of law in its own right on non-Governmental regulated parties, and for which we are not otherwise required by statute to satisfy the rulemaking procedures in 5 U.S.C. 553 or 5 U.S.C. 556. The term is not confined to formal written documents; guidance may come in a variety of forms, including (but not limited to) letters, memoranda, circulars, bulletins, advisories, notices, handbooks and manuals, and may include video, audio, and web-based formats. See OMB Bulletin 07-02, Agency Good Guidance Practices, 72 FR 3432, 3434, 3439 (January 25, 2007) (“OMB Good Guidance Bulletin”).
(b) Significant guidance document means a guidance document that we reasonably anticipate will:
1. (1) Lead to an annual effect on the economy of $100 million or more or adversely affect in a material way the U.S. economy, a sector of the U.S. economy, productivity, competition, jobs, the environment, public health or safety, or state, local, or tribal governments or communities;
2. (2) Create serious inconsistency or otherwise interfere with an action another Federal agency takes or plans;
3. (3) Materially alter the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of those who receive them; or
4. (4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866, as further amended.