As used in this part:

Administrator means the Administrator of the Office of Management and Budget's Office of Information and Regulatory Affairs (OIRA).

Department means the Department of Commerce including any of its component bureaus and agencies.

Guidance document means a Department statement of general applicability, intended to have future effect on the behavior of regulated parties, that sets forth a policy on a statutory, regulatory, or technical issue, or an interpretation of a statute or regulation, but does not include the following:

(1) Rules promulgated pursuant to notice and comment under 5 U.S.C. 553,or;

(2) Rules exempt from rulemaking requirements under 5 U.S.C. 553(a);

(3) Rules of Department organization, procedure, or practice;

(4) Decisions of Department adjudications under 5 U.S.C. 554,or;

(5) Internal guidance directed to the Department that is not intended to have substantial future effect on the behavior of regulated parties; or

(6) Internal executive legal advice or legal opinions addressed to executive branch officials.

Pre-enforcement ruling means a formal written communication by the Department in response to an inquiry from a person concerning compliance with legal requirements that interprets the law or applies the law to a specific set of facts supplied by the person. The term includes informal guidance under section 213 of the Small Business Regulatory Enforcement Fairness Act of 1996, Public Law 104-121 (Title II), as amended, letter rulings, advisory opinions, and no-action letters.

Secretary means the Secretary of Commerce.

Significant guidance document means a guidance document deemed to be significant by OIRA because it may reasonably be anticipated to:

(1) Lead to an annual effect on the economy of $100 million or more or adversely affect in a material way the economy, a sector of the economy, productivity, competition, jobs, the environment, public health or safety, or State, local, or tribal governments or communities;

(2) Create serious inconsistency or otherwise interfere with an action taken or planned by another agency;

(3) Materially alter the budgetary impact of entitlements, grants, user fees, loan programs, or the rights and obligations of recipients thereof; or

(4) Raise novel legal or policy issues arising out of legal mandates, the President's priorities, or the principles of Executive Order 12866.