Title 22

SECTION 212.32

212.32 Definitions of “significant guidance document” and guidance documents that are “otherwise of importance to the Agency's interests.”

§ 212.32 Definitions of “significant guidance document” and guidance documents that are “otherwise of importance to the Agency's interests.”

(a) The term “significant guidance document” means a guidance document USAID will disseminate to regulated entities or the general public and that might reasonably be anticipated:

(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.

(b) The term “significant guidance document” does not include the categories of documents excluded by § 212.26 or any other category of guidance documents exempted in writing by OMB/OIRA.

(c) OMB/OIRA must review significant and economically significant guidance documents under E.O. 12866 before issuance, and they 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.

(d) Even if not “significant,” USAID will consider a guidance document of regulatory impact as “otherwise of importance to the Agency's interests” within the meaning of this paragraph if it might reasonably be anticipated:

(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.

(e) As noted in paragraphs (a) through (d) of this section, “guidance documents” for the purposes of this rule, including this subpart, do not include those documents identified in this subpart O.

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