[Federal Register Volume 78, Number 95 (Thursday, May 16, 2013)]
[Notices]
[Pages 28865-28866]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-11637]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Request for Comment on the Federal Guidelines for Opioid 
Treatment

AGENCY: Substance Abuse and Mental Health Services Administration 
(SAMHSA), HHS.

ACTION: Request for comment.

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SUMMARY: This document is a request for comment on the revised draft of 
the Federal Guidelines for Opioid Treatment. These guidelines elaborate 
upon the Federal opioid treatment standards set forth under 42 CFR part 
8.

DATES: Comment Close Date: To be assured consideration, comments must 
be received at one of the addresses provided below, no later than 60 
calendar days from the date of publication in the Federal Register.

ADDRESSES: The draft guideline may be obtained directly from http://www.dpt.samhsa.gov or by contacting the Division of Pharmacologic 
Therapies. You may submit comments in one of four ways (please choose 
only one of the ways listed):
     Electronically. You may submit electronic comments to 
[email protected].
     By regular mail. You may mail written comments to the 
following address ONLY: Substance Abuse and Mental Health Services 
Administration, Attention: DPT Federal Register Representative, 
Division of Pharmacologic Therapies, 1 Choke Cherry Road, Room 7-1044, 
Rockville, MD 20857. Please allow sufficient time for mailed comments 
to be received before the close of the comment period.
     By express or overnight mail. You may send written 
comments to the following address ONLY: Substance Abuse and Mental 
Health Services Administration, Attention: DPT Federal Register 
Representative, Division of Pharmacologic Therapies, 1 Choke Cherry 
Road, Room 7-1044, Rockville, MD 20850.
     By hand or courier. Alternatively, you may deliver (by 
hand or courier) your written comments ONLY to the following address 
prior to the close of the comment period:
     For delivery in Rockville, MD: Substance Abuse and Mental 
Health Services Administration, Attention: DPT Federal Register 
Representative, Division of Pharmacologic Therapies, 1 Choke Cherry 
Road, Room 7-1044, Rockville, MD 20850. To deliver your comments to the 
Rockville address, call telephone number (240) 276-2700 in advance to 
schedule your delivery with one of our staff members.

FOR FURTHER INFORMATION CONTACT: Nichole Smith, Division of 
Pharmacologic Therapies, CSAT, SAMHSA, 1 Choke Cherry Road, Room 7-
1044, Rockville, Maryland 20857, (240) 276-2700 (phone) or email at 
[email protected].

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: All comments 
received before the close of the comment period are available for 
viewing by the public, including any personally identifiable or 
confidential business information that is included in a comment. 
Comments received by the deadline will be available for public 
inspection at the Substance Abuse and Mental Health Services 
Administration, Division of Pharmacologic Therapies, 1 Choke Cherry 
Road, Rockville, MD 20850, Monday through Friday of each week from 8:30 
a.m. to 4:00 p.m. To schedule an appointment to view public comments, 
phone (240) 276-2700.
    Background: 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

[[Page 28866]]

treatment in accordance with these standards as a basis for CSAT 
certification. These standards address patient admission requirements, 
medical 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 of the Federal opioid 
treatment standards. The Federal Guidelines for Opioid Treatment 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, the Federal Opioid Treatment Guidelines, 
originally titled Guidelines for the Accreditation of Opioid Treatment 
Programs, are being updated 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. All comments submitted no later 
than 60 calendar days from the date of publication in the Federal 
Register will be considered.

Summer King,
Statistician.
[FR Doc. 2013-11637 Filed 5-15-13; 8:45 am]
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