[Federal Register: September 17, 2003 (Volume 68, Number 180)]
[Notices]
[Page 54481-54483]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17se03-94]
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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.
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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
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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