§3.504. Hearings before an ALJ. — Inbound Citations

(6) Instructions for responding to the notice, including a statement of the respondent's right to a hearing, a statement that failure to request a hearing within 60 days permits the imposition of the proposed penalty without the right to a hearing under § 3.504 of this subpart or a right of appeal under § 3.548 of this subpart, and the address to which the hearing request must be sent.

If the respondent does not request a hearing within the time prescribed by § 3.504 of this subpart and the matter is not settled pursuant to § 3.416 of this subpart, the Secretary may impose the proposed penalty or any lesser penalty permitted by sections 921 through 926 of the Public Health Service Act, 42 U.S.C. 299b-21 through 299b-26. The Secretary will notify the respondent by certified mail, return receipt requested, of any penalty that has been imposed and of the means by which the respondent may satisfy the penalty, and the penalty is final on receipt of the notice. The respondent has no right to appeal a penalty under § 3.548 of this subpart with respect to which the respondent has not timely requested a hearing.

(c) Where a document has been served or issued by placing it in the mail, an additional 5 days must be added to the time permitted for any response. This paragraph does not apply to requests for hearing under § 3.504.

(ii) By the respondent, unless they are material and relevant to an admission, denial or explanation of a finding of fact in the notice of proposed determination under § 3.420 of this part, or to a specific circumstance or argument expressly stated in the request for hearing under § 3.504, including circumstances that may reduce penalties.