Form SMA-163

DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION
CENTER FOR SUBSTANCE ABUSE TREATMENT
Application for Approval as Accreditation Body
Under 42 CFR § 8.3(b)

Form Approved: OMB Number 0930-0206
Expiration Date: 03/31/2013
See OMB Statement on Reverse
DATE OF SUBMISSION

Note: This form is required by 42 CFR § 8.3(b) pursuant to Sec. 303, Controlled Substances Act (21 USC 823) and the Drug Abuse Prevention and
Control Act of 1970 (42 USC 275 (a)). Failure to report may result in the suspension or revocation of the accreditation body approval.
1. NAME OF ACCREDITATION BODY

2. PURPOSE OF APPLICATION
New

3. ADDRESS OF ACCREDITATION BODY (Include ZIP Code)

□

Renewal

□

4. TELEPHONE NUMBER (Include Area Code)
5. FAX NUMBER (Include Area Code)
6. E-MAIL ADDRESS

7. NAME AND ADDRESS OF RESPONSIBLE OFFICIAL
(Include ZIP Code)

8. TELEPHONE NUMBER (Include Area Code)
9. FAX NUMBER (Include Area Code)
10. E-MAIL ADDRESS

11. Application

Center for Substance Abuse Treatment
Division of Pharmacologic Therapies
Substance Abuse and Mental Health Services Administration
Attention: OTP Certification Program
1 Choke Cherry Road, Suite 2-1086
Rockville, MD 20857
Overnight:
1 Choke Cherry Road, Suite 2-1086
Rockville, MD 20850
Dear Sir/Madam
As the official responsible for the accreditation body, I submit this
application in triplicate for approval to serve as an accreditation body under
42 CFR Part 8.
A. I have a copy of, or access to 42 CFR Part 8, Certification of Opioid
Treatment Programs, including 42 CFR § 8.4, Accreditation Body
Responsibilities. I have read, understand and will comply with these
regulations which address the accreditation of opioid treatment programs
(OTPs) that treat narcotic addiction with approved opioid drugs.
B. I have a copy of, or access to 42 CFR Part 2, Confidentiality of Alcohol
and Drug Abuse Patient Records. I have read and understand the
requirements to maintain the confidentiality of alcohol and drug abuse
treatment patient records. I agree to protect the identity of all patients in
accordance with the regulations and agree to maintain records of
accreditation activities for 5 years from the creation of the record.
C. Attached is evidence of the accreditation body’s nonprofit status (i.e.,
of fulfilling Internal Revenue Service requirements as a nonprofit
organization) if the accreditation body is not a State governmental entity or
political subdivision.
D. Attached is a set of accreditation elements and a detailed discussion
showing how the proposed accreditation elements will ensure that each OTP
surveyed by the accreditation body is qualified to meet or is meeting each of
the Federal opioid treatment standards set forth under 42 CFR § 8.12.

RESPONSIBLE OFFICIAL (Signature)

FORM SMA-163 (revised 2010) (FRONT) (Submit in triplicate)

E. Attached is a detailed description of the accreditation body’s
decision making process, including: procedures for initiating and
performing onsite accreditation surveys of OTPs, procedures for
assessing OTP personnel qualifications; copies of an application for
accreditation, guidelines, instructions, and other materials that the
accreditation body will send to OTPs during the accreditation process;
policies and procedures for notifying OTPs of deficiencies and for
suspending or revoking an OTP’s accreditation; policies and procedures
for ensuring the timely processing of accreditation applications, and a
description of the accreditation body’s appeals process to allow OTPs
to contest adverse accreditation decisions.
F. Attached are the policies and procedures established by the
accreditation body to avoid conflicts of interest, or the appearance of
conflicts of interest, by the accreditation body’s board members,
commissioners, professional personnel, consultants, administrative
personnel, and other representatives.
G. Attached is a description of the education, experience, and
training requirements for the accreditation body’s professional staff,
accreditation survey team membership, and the identification of at least
one licensed physician on the accreditation body’s staff, along with a
description of the accreditation body’s training policies and survey fee
schedules with supporting cost data.
H. Attached is an assurance that the accreditation body will comply
with the accreditation body responsibilities set forth under 42 CFR §
8.4, including a contingency plan for investigating complaints under
42 CFR § 8.4(e).
I. Attached are the policies and procedures that the accreditation
body has established to protect confidential information that the
accreditation body will collect or receive in its role as an accreditation
body.
As the responsible official, I certify that the information submitted in
this application is truthful and accurate.
DATE

Please send three copies of this form and all attachments to:
Center for Substance Abuse Treatment
Division of Pharmacologic Therapies
Substance Abuse and Mental Health Services Administration
Attention: OTP Certification Program
1 Choke Cherry Road, Suite 2-1086
Rockville, MD 20857
Overnight:
1 Choke Cherry Road, Suite 2-1086
Rockville, MD 20850
The preferred method for submitting this form to CSAT/DPT is online at the DPT Web site, http://dpt.samhsa.gov. The Web site contains
complete instructions for preparing and submitting your request. If you are unable to submit online, the form may be e-mailed as an attachment
to [email protected] or sent by traditional mail (include three copies of all attachments) to the mailing address above.
Paperwork Reduction Act Statement
Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing
instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for
reducing this burden to SAMHSA Reports Clearance Officer; Paperwork Reduction Project (0930-0206); Suite 7-1043, 1 Choke Cherry
Road, Rockville, MD 20857. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information
unless it displays a currently valid OMB control number. The OMB control number for this project is 0930-0206.
FORM SMA-163 (revised 2010) (BACK)