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Notice of Availability of Draft Guideline; Comment Request

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Information about this document as published in the Federal Register.

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Center for Substance Abuse Treatment, Substance Abuse and Mental Health Services Administration (SAMHSA), Department of Health and Human Services.


Availability of Guideline—Opportunity for Comment.


The Center for Substance Abuse Treatment is seeking public comments on the revised draft Guidelines for the Accreditation of Opioid Treatment Programs. These guidelines elaborate upon the Federal opioid treatment standards set forth under 42 CFR part 8.


Comments should be submitted by July 14, 2006.


The draft guideline may be obtained directly from, or by contacting the Division of Pharmacologic Therapy with the information provided below. Comments should be submitted to the Division of Pharmacologic Therapy, Center for Substance Abuse Treatment, 1 Choke Cherry Road, Room 2-1080, Rockville, MD, 20857; Attention: DPT Federal Register Representative. Comments may also be faxed to 240-276-2710 or e-mailed to Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday.

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Sarah Crowley, Center for Substance Abuse Treatment (CSAT), Division of Pharmacologic Therapy, 1 Choke Cherry Road, Room 2-1080, Rockville, MD 20857, (240-276-2704, e-mail:

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Federal Regulations codified under 42 CFR part 8 set forth requirements for opioid treatment programs (“OTPs”), also known as methadone treatment programs. The regulations, which were the subject of a Final Rule published in the Federal Register on January 17, 2001, (“Final Rule” 66 FR 4075-4102, January 17, 2001) include standards for opioid treatment. OTPs are required to provide treatment in accordance with these standards as a basis for CSAT certification. These standards address patient admission requirements, Start Printed Page 28044medical and counseling services, drug testing, and other requirements.

The final rule also established an accreditation requirement. Each OTP is required to obtain and maintain accreditation from an accreditation organization approved by SAMHSA under 42 CFR part 8. Accreditation organizations that provide OTP accreditation under the final rule are required to apply for and obtain SAMHSA approval. Under 42 CFR 8.3(a)(3), each accreditation organization must develop a set of accreditation elements or standards together with a detailed discussion of how these elements will assure that each OTP surveyed by the accreditation organization is meeting each for the Federal opioid treatment standards.

The Guidelines for the Accreditation of Opioid Treatment Programs, are intended to guide accreditation organizations in preparing their accreditation standards. In addition, the Guidelines provide useful elaborations on the regulatory standards set forth under 42 CFR part 8. As such, the updated guidelines will assist both accreditation organizations and OTPs in complying with regulatory requirements.

Prepared initially in 1997, Guidelines for the Accreditation of Opioid Treatment Programs are being updated now to reflect new information and research in the field of opioid assisted treatment. CSAT convened an expert panel to provide the draft guideline now being circulated for comment. CSAT is soliciting comments on the guideline from the public, and expects comments from OTPs, accreditation organizations, patients, the medical community and other interested parties.

CSAT will consider all comments submitted by July 16, 2006; in order to publish a revised guideline; however, CSAT will continuously accept and consider comments for future consideration.

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Dated: May 8, 2006.

Anna Marsh,

Director of OPS, SAMHSA.

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[FR Doc. 06-4498 Filed 5-12-06; 8:45 am]