[Federal Register Volume 67, Number 233 (Wednesday, December 4, 2002)]
[Notices]
[Pages 72218-72219]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-30684]


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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.

[[Page 72219]]

    Proposed Project: Evaluation of the Buprenorphine Waiver Program--
Baseline 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, in the 
first year of the evaluation, 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 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.
    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 these 
surveys.
    The estimated response burden for the first survey of physicians 
over a period of one year is summarized below.

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                                                            Number of
           Addiction physicians               Number of    responses/   Total number      Hrs./      Total hour
                                             respondents   respondent   of responses    response       burden
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Physician survey..........................        1,000             1         1,000            .5      500 hrs.
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    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: November 26, 2002.
Richard Kopanda,
Executive Officer, SAMHSA.
[FR Doc. 02-30684 Filed 12-3-02; 8:45 am]
BILLING CODE 4162-20-P