[Federal Register Volume 68, Number 106 (Tuesday, June 3, 2003)]
[Notices]
[Pages 33172-33173]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-13789]


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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: Addiction Physician 
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 by DPT 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). Some of these specialists will be prescribing and distributing 
buprenorphine, while others not prescribing buprenorphine may or may 
not provide referrals or ancillary services to patients receiving 
buprenorphine treatment. The survey will provide early data about the 
availability, effectiveness, and public health consequences associated 
with the Waiver Program. Specifically, the survey will assess early 
perceptions of

[[Page 33173]]

physicians specializing in addiction medicine of whether buprenorphine 
as prescribed and distributed under the Waiver Program is a useful tool 
in the treatment of substance abuse, and whether there are any negative 
consequences associated with it. The survey will also assess whether 
there are early indications of limitations to the availability of the 
medication, related to factors such as geographic location, type of 
medical practice, patient population, or ability to pay. Physicians who 
do not respond after two mailings will receive a brief postcard to 
complete.
    Results from this survey will influence the focus and content of 
two additional proposed surveys to be fielded later in 2003. A second 
survey will focus on the clinical practice and perceived effectiveness 
of buprenorphine among physicians who are actively prescribing the 
medication. A third survey of patients who have received buprenorphine 
will assess its effectiveness and availability from the patients' point 
of view. A separate Federal Register notice will be published for each 
of these surveys. The estimated response burden for the first survey of 
physicians is summarized below.

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                                                     Number of      Responses/       Hours per      Total hour
              Addiction physicians                  respondents     respondent       response         burden
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Physician Survey................................             957               1             .33             316
Followup Postcard...............................             335               1            .017               6
    Total.......................................             957  ..............  ..............             322
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    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
Allison Herron Eydt, Human Resources and Housing Branch, Office of 
Management and Budget, New Executive Office Building, Room 10235, 
Washington, DC 20503; because of mail delays, it is recommended that 
comments be sent by fax to: (202) 395-6974.

    Dated: May 27, 2003.
Richard Kopanda,
Executive Officer, SAMHSA.
[FR Doc. 03-13789 Filed 6-2-03; 8:45 am]
BILLING CODE 4162-20-P