[Code of Federal Regulations]
[Title 42, Volume 1]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR8.14]

[Page 70]
 
                         TITLE 42--PUBLIC HEALTH
 
    CHAPTER I--PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN 
                                SERVICES
 
PART 8--CERTIFICATION OF OPIOID TREATMENT PROGRAMS--Table of Contents
 
            Subpart B--Certification and Treatment Standards
 
Sec. 8.14  Suspension or revocation of certification.

    (a) Revocation. Except as provided in paragraph (b) of this section, 
SAMHSA may revoke the certification of an OTP if SAMHSA finds, after 
providing the program sponsor with notice and an opportunity for a 
hearing in accordance with subpart C of this part, that the program 
sponsor, or any employee of the OTP:
    (1) Has been found guilty of misrepresentation in obtaining the 
certification;
    (2) Has failed to comply with the Federal opioid treatment standards 
in any respect;
    (3) Has failed to comply with reasonable requests from SAMHSA or 
from an 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 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 representative for permission to 
inspect the program or the program's operations or its records.
    (b) Suspension. Whenever SAMHSA has reason to believe that 
revocation may be required and that immediate action is necessary to 
protect public health or safety, SAMHSA may immediately suspend the 
certification of an OTP before holding a hearing under subpart C of this 
part. SAMHSA may immediately suspend as well as propose revocation of 
the certification of an OTP before holding a hearing under subpart C of 
this part if SAMHSA makes a finding described in paragraph (a) of this 
section and also determines that:
    (1) The failure to comply with the Federal opioid 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 treatment standards was intentional or was associated 
with fraud.
    (c) Written notification. In the event that SAMHSA 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 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 part.
    (d)(1) If SAMHSA suspends certification in accordance with paragraph 
(b) of this section:
    (i) SAMHSA will immediately notify DEA that the OTP's registration 
should be suspended under 21 U.S.C. 824(d); and
    (ii) SAMHSA will provide an opportunity for a hearing under 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.

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