Title 40

SECTION 2.506

2.506 Significant guidance document requirements and procedures.

§ 2.506 Significant guidance document requirements and procedures.

A significant guidance document will adhere to all the requirements described in § 2.505 and the requirements in this section.

(a) Draft for public comment. (1) The EPA will make publicly available a draft significant guidance document, including a significant guidance document that is being reinstated, or draft modification of a significant active guidance document, for public comment before finalizing any significant guidance document. The EPA will post appropriately labeled draft guidance and any supporting documents on the EPA's website.

(2) The EPA will publish a notice in the Federal Register announcing the availability of a draft significant guidance document, or draft modification of a significant active guidance document, to open the public comment period.

(b) Withdrawal of a significant guidance document. (1) The EPA will seek public comment on the Agency's intent to withdraw a significant active guidance document.

(2) The EPA will publish a notice in the Federal Register announcing the Agency's intent to withdraw a significant active guidance document to open the public comment period.

(c) Public comment process. (1) Except as provided in paragraph (d) of this section, a draft significant guidance document, or a draft modification or withdrawal of a significant active guidance document, will have a minimum of 30 days public notice and comment before issuance of a final significant guidance document or issuance of the final modified significant guidance document, or withdrawal of an active significant guidance document. Public comments shall be available to the public online, either in a docket or on the EPA website.

(2) The EPA shall respond to major concerns and comments in the final significant guidance document itself or in a companion document.

(d) Exceptions to comment process. The EPA will not seek or respond to public comment before the EPA implements a significant guidance document if at the sole discretion of the Administrator:

(1) Doing so is not feasible or appropriate because immediate issuance is required by a public health, safety, environmental, or other emergency requiring immediate issuance of the significant guidance document or a statutory requirement or court order that requires immediate issuance; or

(2) When the Agency for good cause finds (and incorporates such finding and a brief statement of reasons therefor into the significant guidance document) that notice and public comment thereon are impracticable, unnecessary, or contrary to the public interest.

(e) Additional notices. The EPA also will publish a notice in the Federal Register when it finalizes a significant guidance document, reinstates a significant guidance document, or finalizes a modification or withdrawal of a significant active guidance document.

(f) Approval. On a non-delegable basis, the EPA Administrator or other Presidentially-appointed EPA official, or an official who is serving in the acting capacity of either of the foregoing, will approve a significant guidance document prior to its issuance and posting in the EPA Guidance Portal website.

(g) Executive order compliance. A significant guidance document shall comply with the requirements of Executive Orders 12866, 13563, 13609, 13771, 13777, and 13891.

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