[Federal Register Volume 68, Number 180 (Wednesday, September 17, 2003)]
[Notices]
[Pages 54481-54483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-23678]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Submission for OMB 
Review; Comment Request

    Periodically, the Substance Abuse and Mental Health Services 
Administration (SAMHSA) will publish a summary of information 
collection requests under

[[Page 54482]]

OMB review, in compliance with the Paperwork Reduction Act (44 U.S.C. 
Chapter 35). To request a copy of these documents, call the SAMHSA 
Reports Clearance Officer on (301) 443-7978.
    Opioid Treatment Program Accreditation Evaluation--New--The 
Substance Abuse and Mental Health Services Administration (SAMHSA), 
Center for Substance Abuse Treatment (CSAT), Division of Pharmacologic 
Therapies (DPT), is evaluating the new system of opioid treatment 
program (OTP) regulation, which relies on accreditation by independent 
organizations approved by CSAT. This replaces the former system of 
regulation by the Food and Drug Administration (FDA). Effective May 18, 
2001, SAMHSA and CSAT, in conjunction with the FDA and other Federal 
agencies, issued ``final regulations for the use of narcotic drugs in 
maintenance and detoxification treatment of opioid addiction,'' 42 CFR 
part 8. To date, SAMHSA has approved five organizations to provide 
accreditation to or conduct accreditation surveys of programs that use 
methadone and other approved medications to treat opioid addiction: (1) 
The Commission on Accreditation of Rehabilitation Facilities (CARF), 
(2) the Joint Commission on Accreditation of Healthcare Organizations 
(JCAHO), (3) the Council on Accreditation for Children and Family 
Services (COA), (4) the State of Washington Department of Health and 
Human Services, Division of Alcohol and Substance Abuse, and (5) the 
Missouri Department of Mental Health, Division of Alcohol and Drug 
Abuse. The shift to an accreditation approach is expected to improve 
the quality of, and access to, OTPs.
    An earlier, related study, conducted prior to accreditation, 
examined the experience of a pilot group of OTPs undergoing the 
accreditation process with extensive technical assistance provided 
through CSAT. Now that accreditation has become mandatory, the current 
study will assess its impact on OTPs, and the field of substance abuse 
treatment at a critical beginning phase.
    The primary purposes of the proposed OTP Accreditation Evaluation 
are to assess the accreditation process and its cost and impact, and to 
provide input to CSAT concerning how the process might be improved. 
Specifically, the OTP Accreditation Evaluation will examine: (1) 
Processes, barriers, and costs associated with accreditation, (2) 
administrative and clinical impacts, (3) cost to the federal government 
for national implementation of the new regulations, and (4) potential 
policy changes affecting the accreditation-based oversight system.
    The evaluation will be accomplished by secondary analysis of 
existing data as well as by collecting data before and after 
accreditation, from different sources and using several different data 
collection methods. Given the great diversity of this relatively small 
body of programs, the first data collection effort involves 
administering a questionnaire to all OTPs. The questionnaire is 
intended to elicit information about the resources programs need to 
prepare for accreditation and undergo the accreditation survey; 
services provided; the costs of providing these services; and staff 
perceptions of the accreditation process. Three versions of the 
questionnaire will be used to accommodate OTPs' accreditation survey 
schedules: A pre-accreditation questionnaire, a post-accreditation 
questionnaire, and a post-only accreditation questionnaire. All OTPs 
will receive one or two questionnaires, depending on their 
accreditation survey status. OTPs that have not undergone an 
accreditation survey at the start of data collection will receive a 
pre-accreditation questionnaire. These OTPs will also receive a post-
accreditation questionnaire six months after their accreditation 
survey. OTPs that have been accredited for less than four months at the 
start of data collection will receive a post-only questionnaire and a 
post-accreditation questionnaire at six months after their 
accreditation survey. OTPs that have been accredited for more than four 
months at the start of data collection will receive a post-only 
questionnaire.
    In addition to the OTP survey, data will be obtained from existing 
sources including SAMHSA surveys such as the National Survey of 
Substance Abuse Treatment Services (N-SSATS) and the Treatment Episode 
Data Set (TEDS). These will provide an historical perspective on opioid 
treatment services and insight regarding the extent of opioid addiction 
service episodes. Information from the questionnaire administered to 
all OTPs will be supplemented and validated by more intensive data 
collection to be conducted with a small sample of OTPs, stratifying on 
factors determined by the earlier study to be related to OTPs' 
accreditation experience. Data will be collected from the smaller 
sample of OTPs through several means over a period up to one year per 
program (six months before and six months after an accreditation 
survey): (1) A questionnaire administered on-site to patients to obtain 
patient perceptions about accreditation and level of satisfaction, (2) 
chart abstraction by contractor staff of limited patient outcomes data, 
(3) activity logs to capture the amount of OTP staff time spent by OTP 
staff in various broad activities, and (4) interviews with OTP staff 
and related community organizations and with a sample of current 
patients concerning their perceptions and experience.
    The estimated response burden for the proposed OTP accreditation 
evaluation over a period of two years is summarized below.

----------------------------------------------------------------------------------------------------------------
                                    Number of       Responses/         Total          Hours/        Total hour
              Form                 respondents      respondent       responses       response         burden
----------------------------------------------------------------------------------------------------------------
Self-administered Pre-                      400              1               400            1.5              600
 Accreditation questionnaire*..
Self-administered Post-                     750              1               750            1.5             1125
 Accreditation questionnaire*..
Self-administered Post-                     700              1               700            1.5             1050
 Accreditation-Only
 questionnaire*................
Activity logs..................             420            213             89460             .1             8946
Activity summary worksheet.....              60             36              2160            1               2160
Service resource log...........              60              1.5              90           10                900
Chart abstraction (OTP staff                 60              1.5              90            1                 90
 time spent pulling charts,
 etc.).........................
Patient questionnaire..........            3600              1              3600             .25             900
OTP/community organization                  540              1.5             810             .75             608
 staff interview...............
SMA interview..................              48              1                48             .5               24
                                -----------------
    Total......................            6638  ...............           94508  ..............           16403
    2-year Annual Average......            3319  ...............           47524  ..............            8202
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[[Page 54483]]

    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
Lauren Wittenberg, Human Resources and Housing Branch, Office of 
Management and Budget, New Executive Office Building, Room 10235, 
Washington, DC 20503; due to potential delays in OMB's receipt and 
processing of mail sent through the U.S. Postal Service, respondents 
are encouraged to submit comments by fax to: 202-395-6974.

    Dated: September 10, 2003.
Anna Marsh,
Acting Executive Officer, SAMHSA.
[FR Doc. 03-23678 Filed 9-16-03; 8:45 am]
BILLING CODE 4162-20-P