Title 45

SECTION 1.4

1.4 Guidance repository.

§ 1.4 Guidance repository.

(a) Existing guidance. By January 6, 2021, the Department shall maintain a guidance repository on its website at www.hhs.gov/guidance.

(1) The guidance repository shall be fully text searchable and contain or link to all guidance documents in effect that have been issued by any component of the Department.

(2) If the Department does not include a guidance document in the guidance repository by January 6, 2021, the guidance document shall be considered rescinded.

(3) Any web page in the guidance repository that contains or links to guidance documents must state:

(i) That the guidance documents contained therein:

(A) “Lack the force and effect of law, except as authorized by law or as specifically incorporated into a contract.”; and

(B) “The Department may not cite, use, or rely on any guidance that is not posted on the guidance repository, except to establish historical facts.”

(ii) That any guidance document previously issued by the Department is no longer in effect, and will be considered rescinded, if it is not included in the guidance repository.

(4) If the Department wishes to reinstate a rescinded guidance document, the Department may do so only by complying with all of the requirements applicable to guidance documents issued after January 6, 2021.

(b) Guidance issued after January 6, 2021. (1) For all guidance documents issued after January 6, 2021, the Department must post each guidance document to the Department's guidance repository within three business days of the date on which that guidance document was issued.

(2) For significant guidance documents issued after January 6, 2021, the Department shall post proposed new significant guidance to the guidance repository as part of the notice-and-comment process.

(i) The posting shall clearly indicate the end of each significant guidance document's comment period and provide a means for members of the public to submit comments.

(ii) The Department shall also post online all responses to major public comments.

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