(a) Departmental overview. Except as provided in paragraph (c) of this section, prior to the Department taking any civil enforcement action with respect to a particular entity that has legal consequence for that entity, including by issuing to such a person a notice of noncompliance, or other similar notice that has immediate regulatory consequence, but excluding communications that have no immediate regulatory implications for the entity, such as those that serve as an interim step in the agency's compliance communications with the entity or that are intended to encourage voluntary compliance, the Department shall provide—

(1) Written notice to the affected entity of the initial legal and factual determinations underpinning the initial adverse determination;

(2) An opportunity for the affected entity to respond in writing and, if determined appropriate by the Department, orally; and

(3) A written response from the Department to the affected entity after receiving a timely request from the affected entity under paragraph (a)(2) of this section.

(b) Timing and content of written responses.

(1) The Department will select a meaningful amount of time in which the affected entity must submit a written response to the Department. This writing must be submitted within the time period specified by the Department, unless the Department concludes an extension is warranted, and state the reasons for the entity's disagreement with the Department's proposed action for purposes of requiring a response in accordance with paragraph (a)(3) of this section.

(2) The Department's written response must respond to the affected entity and articulate the basis for its final decision. This written response may be issued contemporaneous to the Department taking the action with legal consequence.

(c) Exceptions. The procedures in paragraphs (a) and (b) of this section do not apply where the Department, in its discretion, determines there is a serious threat to health, safety, or similar emergency, or where a statute specifically authorizes proceeding without a prior opportunity to be heard. In such event, HHS would still provide an affected entity with an opportunity to be heard and a written response as soon as practicable. The procedures in paragraphs (a) and (b) do not apply to settlement negotiations between agencies and regulated parties, to notices of a prospective legal action, to litigation before courts, or any action related to a criminal investigation or prosecution, including undercover operations that may be used in a criminal investigation or prosecution, or any civil enforcement action either related to an investigation by the Department of Justice, or referred to the Department of Justice.

[86 FR 3015, Jan. 14, 2021]