[Federal Register Volume 68, Number 23 (Tuesday, February 4, 2003)]
[Notices]
[Pages 5648-5649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2489]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities: Proposed Collection; 
Comment Request

    In compliance with section 3506(c)(2)(A) of the Paperwork Reduction 
Act of 1995 concerning opportunity for public comment on proposed 
collections of information, the Substance Abuse and Mental Health 
Services Administration will publish periodic summaries of proposed 
projects. To request more information on the proposed projects or to 
obtain a copy of the information collection plans, call the SAMHSA 
Reports Clearance Officer on (301) 443-7978.
    Comments are invited on: (a) Whether the proposed collections of 
information are necessary for the proper performance of the functions 
of the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; and (d) ways 
to minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology.
    Proposed Project: 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 four 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)

[[Page 5649]]

the Council on Accreditation for Children and Family Services (COA), 
and (4) the State of Washington Department of Health and Human 
Services, Division of Alcohol and Substance 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 vesions 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 that have not 
yet undergone accreditation, 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 the course of 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 
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                        Total hour
              Form                  respondents     respondent       responses    Hours/response      burden
----------------------------------------------------------------------------------------------------------------
Self-administered pre-                       600               1             600               1             600
 accreditation questionnaire....
Self-administered post-                      700               1             700               1             700
 accreditation questionnaire....
Self-administered post-                      500               1             500               1             500
 accreditation-only
 questionnaire..................
Activity logs...................             240             312          74,880              .1           7,488
Activity summary worksheet......              60              26           1,560               1           1,560
Chart abstraction (OTP staff                  60               2             120               1             120
 spent pulling charts etc.).....
Patient questionnaire...........           6,000               1           6,000              .3           1,800
OTP/CBO staff interview.........             300               2             600              .7             420
                                 -----------------
    Total.......................           7,700  ..............          84,960  ..............          13,188
                                 =================
2-year Annual Average...........           3,850  ..............          42,480  ..............           6,594
----------------------------------------------------------------------------------------------------------------

    Send comments to Nancy Pearce, SAMHSA Reports Clearance Officer, 
Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. 
Written comments should be received within 60 days of this notice.

    Dated: January 28, 2003.
Richard Kopanda,
Executive Officer, Substance Abuse and Mental Health Services 
Administration.
[FR Doc. 03-2489 Filed 2-3-03; 8:45 am]
BILLING CODE 4162-20-P