[Federal Register: December 4, 2002 (Volume 67, Number 233)]
[Notices]
[Page 72218-72219]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04de02-83]
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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