[Federal Register Volume 68, Number 88 (Wednesday, May 7, 2003)]
[Notices]
[Pages 24495-24496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11263]


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

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: The Evaluation of the Buprenorphine Waiver 
Program: Longitudinal Patient Survey--New--The Substance Abuse and 
Mental Health Services Administration (SAMHSA), Center for Substance 
Abuse Treatment (CSAT), Division of Pharmacologic Therapies (DPT), is 
evaluating a program that permits office-based physicians to obtain 
Waivers from the requirements of the Narcotic Addict Treatment Act of 
1974 (21 U.S.C. 823 (g)). Under the Drug Addiction Treatment Act of 
2000 (21 U.S.C. 823 (g)(2)), the Waiver Program permits qualifying 
physicians to prescribe and dispense buprenorphine, a schedule III 
narcotic drug recently approved by the FDA for the treatment of opiate 
addiction. Furthermore, the Drug Abuse Treatment Act specifies that the 
Secretary of the Department of Health and Human Services make a 
determination of whether: (1) Treatments provided under the Waiver 
Program have been effective forms of maintenance treatment and 
detoxification treatment in clinical settings; (2) the Waiver Program 
has significantly increased (relative to the beginning of such period) 
the availability of maintenance treatment and detoxification treatment; 
and, (3) the Waiver Program has adverse consequences for the public 
health. In addition to the objectives above, the Evaluation of the 
Buprenorphine Waiver Program will examine other related objectives, 
including: (1) Describing the impact of the Waiver-based treatment on 
the existing treatment system; (2) providing information useful to 
guide and refine the processing/monitoring system being developed and 
maintained by CSAT/DPT; and (3) providing baseline data to inform 
future research and policy concerning the medicalization and 
mainstreaming of addiction treatment.
    The evaluation of the Buprenorphine Waiver Program will be 
accomplished using three survey efforts. The first of these is a mail 
survey of addiction physicians from the American Society of Addiction 
Medicine (ASAM) and/or the American Academy of Addiction Psychiatry 
(AAAP). That survey will assess early perceptions of physicians 
specializing in addiction medicine about whether buprenorphine, as it 
is prescribed and distributed under the Waiver, is a useful tool in the 
treatment of substance abuse, and whether they have encountered any 
negative consequences associated with it. Results from this survey will 
influence the focus and content of two additional proposed surveys to 
be fielded later in 2003.
    The Longitudinal Patient Survey will focus on patients who have 
received buprenorphine and will assess its availability and 
effectiveness from the patients' point of view. Beginning in October of 
2003, DPT plans to collect longitudinal data from a cohort of about 800 
buprenorphine patients to assess the effectiveness of buprenorphine 
therapy. Patients will be recruited through a sample of prescribing 
physicians' offices. Office staff will give each eligible buprenorphine 
patient a study brochure that explains the importance of the study, 
offers an incentive worth $50, and gives the

[[Page 24496]]

patient a toll-free telephone number to call at to complete the survey 
by telephone.
    Patients will be asked a series of questions that will provide 
baseline data for the evaluation. Follow-up data on the services 
received, satisfaction with the treatment, and outcomes will be 
collected at 30 days and 6 months intervals. Survey domains include the 
following: Patient demographics; Buprenorphine dose over time; Items 
from the short form of the Addiction Severity Index (ASI); Services 
being received in addition to medications; Needle-sharing and HIV 
status; Treatment and substance abuse history, in particular prior 
experience with medication-based treatment for opioid dependence; 
Experience, satisfaction with, and general knowledge of, buprenorphine.
    A third survey will be conducted later, focusing on the clinical 
practice and perceived effectiveness of buprenorphine among only those 
physicians who are actively prescribing the medication. A separate 
clearance request will be submitted for this physician survey.
    The estimated response burden for the longitudinal survey of 
buprenorphine patients over a period of one year is summarized below.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Number of        Responses/                                         Total hour
                                                                       respondents       respondent    Total responses   Hours/response       burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Buprenorphine patients.............................................             800                3            2,400              .50            1,200
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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: April 30, 2003.
Richard Kopanda,
Executive Officer, SAMHSA.
[FR Doc. 03-11263 Filed 5-6-03; 8:45 am]
BILLING CODE 4162-20-P