§ 8.14 - Suspension or revocation of certification.

§ 8.14 Suspension or revocation of certification.

(a) Revocation. Except as provided in paragraph (b) of this section, SAMHSA the Secretary may revoke the certification of an OTP if SAMHSA the Secretary finds, after providing the program sponsor with notice and an opportunity for a hearing in accordance with this subpart C of this part, that the program sponsor, or any employee of the OTP:

(1) Has been found guilty of to have engaged in misrepresentation in obtaining the certification;

(2) Has failed to comply with the Federal opioid Opioid Use Disorder treatment standards in any respect;

(3) Has failed to comply with reasonable requests from SAMHSA the Secretary or from an accreditation body Accreditation Body for records, information, reports, or materials that are necessary to determine the continued eligibility of the OTP for certification or continued compliance with the Federal opioid Opioid Use Disorder treatment standards; or

(4) Has refused a reasonable request of a duly designated SAMHSA inspector, Drug Enforcement Administration (DEA) Inspector, State Inspector, or accreditation body Accreditation Body representative for permission to inspect the program or the program's operations or its records.

(b) Suspension. Whenever SAMHSA the Secretary has reason to believe that revocation may be required and that immediate action is necessary to protect public health or safety, SAMHSA the Secretary may immediately suspend the certification of an OTP, and notify the Attorney General that the OTP's registration should be suspended, before holding a hearing under this subpart C of this part. SAMHSA . The Secretary may immediately suspend as well as propose revocation of the certification of an OTP before holding a hearing under this subpart C of this part if SAMHSA if the Secretary makes a finding described in paragraph (a) of this section and also determines that:

(1) The failure to comply with the Federal opioid Opioid Use Disorder treatment standards presents an imminent danger to the public health or safety;

(2) The refusal to permit inspection makes immediate suspension necessary; or

(3) There is reason to believe that the failure to comply with the Federal opioid Opioid Use Disorder treatment standards was intentional or was associated with fraud.

(c) Written notification. In the event that SAMHSA the Secretary suspends the certification of an OTP in accordance with paragraph (b) of this section or proposes to revoke the certification of an OTP in accordance with paragraph (a) of this section, SAMHSA the Secretary shall promptly provide the sponsor of the OTP with written notice of the suspension or proposed revocation by facsimile transmission, personal service, commercial overnight delivery service, or certified mail, return receipt requested. Such notice shall state the reasons for the action and shall , state that the OTP may seek review of the action in accordance with the procedures in subpart C of this partthis subpart, and identify the reviewing official to whom a written request for review may be submitted.

(d) Procedure.

(1) If SAMHSA the Secretary suspends certification in accordance with paragraph (b) of this section:

(i) SAMHSA The Secretary will immediately notify DEA that the OTP's registration should be suspended under 21 U.S.C. 824(d); and

(ii) SAMHSA the Secretary will provide an opportunity for a hearing under this subpart C of this part.

(2) Suspension of certification under paragraph (b) of this section shall remain in effect until the agency determines that:

(i) The basis for the suspension cannot be substantiated;

(ii) Violations of required standards have been corrected to the agency's satisfaction; or

(iii) The OTP's certification shall be revoked.