22 CFR §313.4

1. (a)A “significant guidance document” is a guidance document that will be disseminated to the general public and that may reasonably be anticipated:
   1. (1)To 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)To create serious inconsistency or otherwise interfere with an action taken or planned by another Federal agency;
   3. (3)To alter materially the budgetary impact of entitlements, grants, user fees, or loan programs or the rights and obligations of recipients thereof; or
   4. (4)To 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.
2. (b)The term “significant guidance document” does not include the categories of documents excluded by § 313.1(c) or any other category of guidance documents exempted by the Agency in consultation with the Office of Management and Budget, Office of Information and Regulatory Affairs (OMB/OIRA).
3. (c)Significant guidance documents must be reviewed by OMB/OIRA under E.O. 12866 before issuance; and must demonstrate 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.