[Federal Register Volume 68, Number 249 (Tuesday, December 30, 2003)]
[Notices]
[Pages 75264-75265]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31976]


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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 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.
    Evaluation of the Buprenorphine Waiver: 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 (approved by OMB under control number 0930-0246) 
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.

[[Page 75265]]

    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. The Survey will collect 
longitudinal data from a cohort of about 420 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, and 
gives the patient a toll-free telephone number to call 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 30 days and 6 months later. 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.

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                                                               Number of    Responses/     Hours/     Total hour
                         Respondent                           respondents   respondent    response      burden
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Physicians..................................................          120           12          .08          116
Patient baseline interview..................................          420            1          .75          315
Patient 30-day followup interview...........................          420            1          .67          281
Patient 6-month followup interview..........................          420            1          .67          281
                                                             -------------                          ------------
    Total...................................................          540  ...........  ...........          993
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    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
SAMHSA Desk Officer, 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: December 18, 2003.
Anna Marsh,
Acting Executive Officer, SAMHSA.
[FR Doc. 03-31976 Filed 12-29-03; 8:45 am]
BILLING CODE 4162-20-P