(a) Significant guidance documents. Significant guidance documents are guidance documents that may be reasonably anticipated to do one or more of the following:

(1) Lead to an annual effect on the economy of $100 million or more, or adversely and materially affect 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 a serious inconsistency or otherwise interfere with an action another agency has taken or planned.

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

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

(b) Significance determination. We will refer to the Administrator of the Office of Information and Regulatory Affairs within the Office of Management and Budget, or the Administrator's designee, the question of whether a guidance document is significant.

(c) Actions we will take before issuing significant guidance documents. For significant guidance documents, unless we and the Administrator of the Office of Information and Regulatory Affairs agree that exigency, safety, health, or other compelling cause warrants an exemption from some or all requirements, we will do the following:

(1) Submit the guidance document for review by the Office of Information and Regulatory Affairs under Executive Order 12866.

(2) Publish a document in the Federal Register announcing the availability of a significant guidance document and make the draft guidance document available on our website.

(3) Provide a public notice and comment period of at least 30 days before issuance of a final guidance document, and a public response to major concerns raised in comments, except when we for good cause find (and incorporate such finding and a brief statement of reasons therefor into the guidance document) that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest.

(4) Obtain approval on a non-delegable basis from the Commissioner of Social Security, or from a component head the President appoints (with or without confirmation by the Senate), or from an official who is serving in an acting capacity as either of the foregoing.

(5) Comply with the applicable requirements for regulations or rules, including significant regulatory actions, set forth in Executive Orders 12866 (Regulatory Planning and Review), 13563 (Improving Regulation and Regulatory Review), 13609 (Promoting International Regulatory Cooperation), 13771 (Reducing Regulation and Controlling Regulatory Costs), and 13777 (Enforcing the Regulatory Reform Agenda).