Code of Federal Regulations Title 22. Foreign Relations § 22.212.32 Definitions of “significant guidance document” and guidance documents that are “otherwise of importance to the Agency's interests.”

(1) To lead to an annual effect on the U.S. 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) To create serious inconsistency or otherwise interfere with an action taken or planned by another Federal Department or Agency;

(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) To raise novel legal or policy issues that arise out of legal mandates, the President's priorities, or the principles set forth in E.O. 12866, as further amended.

(1) To relate to a major program, policy, or activity of the Agency or a high-profile issue that is pending for decision before the Agency;

(2) To involve one of the Administrator's top policy priorities;

(3) To garner significant press or Congressional attention;  or

(4) To raise significant questions or concerns from constituencies of importance to the Agency, such as Committees of Congress, States or Indian tribes, the White House or other Departments and Agencies of the Executive Branch, courts, consumer or public-interest groups, or leading representatives of industry.