[Federal Register Volume 69, Number 29 (Thursday, February 12, 2004)]
[Notices]
[Pages 7006-7007]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3049]
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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.
Proposed Project: The Evaluation of the Buprenorphine Waiver
Program--Survey of Physicians with Waivers--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 qualified
physicians to dispense or prescribe schedule III, IV, and V narcotic
drugs or combinations of such drugs approved by the Food and Drug
Administration (FDA) for the treatment of addiction to opiates. Subutex
and Suboxone, two formulations of buprenorphine, a schedule III
narcotic drug, were approved by the FDA in October, 2002, for the
treatment of opiate addiction and are now being used under the Waiver
Program. The Drug Abuse Treatment Act (DATA) also specifies that the
Secretary of the Department of Health and Human Services may make
determinations concerning 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. This Evaluation will provide data to: inform the determinations
listed in DATA; describe the impact of the Waiver-based treatment on
the existing treatment system; guide and refine the processing/
monitoring system being developed and maintained by CSAT/DPT; and
inform future research and policy concerning the mainstreaming of
addiction treatment.
The evaluation by SAMHSA/CSAT of the Buprenorphine Waiver Program
will be accomplished using three survey efforts. The first survey, now
completed, is a mail survey of addiction-specialist physicians from the
American Society of Addiction Medicine (ASAM), the American Academy of
Addiction Psychiatry (AAAP), and the American Osteopathic Academy of
Addiction Medicine (AOAAM). The survey provided early data about the
availability, effectiveness, and public health consequences associated
with buprenorphine treatment under the Waiver Program. A second
longitudinal telephone study, now in review by the Office of Management
and Budget, focuses on patient responses to buprenorphine, including
its effectiveness and availability.
The third survey, the subject of this Federal Register Notice,
focuses on the clinical experience of waivered physicians who are
currently prescribing buprenorphine and who represent a range of
medical specialties. The survey is designed to identify broad clinical
issues in providing buprenorphine treatment, particularly whether
physicians (1) perceive it to be an effective treatment and (2) are
aware of important moderators of treatment effectiveness, such as
specific clinical subpopulations or particular clinical practices (e.g.
detoxification appearing to be more effective than long-term
maintenance). The survey is also designed to identify issues related to
treatment availability and possible adverse public health consequences
associated with the drug.
All Waivered physicians will first be screened using a postcard
mailing to determine what individuals are actually prescribing the
medication. The screening card will be sent to all physicians who have
submitted a notification for a Waiver, estimated at about 2,800
individuals. The full survey instrument will then be sent to a sample
of 1,000 individuals that are known to be prescribing or whose
prescribing status is unknown (due to nonresponse on the screening
card).
The estimated response burden over a period of one year is
summarized below.
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Number of Responses per Hours per
Respondents respondents respondent response Total hour burden
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All Physicians Who Have Submitted a 2,800 1 .05 140 hrs.
Waiver.
Sample of Prescribing Physicians....... 1,000 1 .50 500 hrs.
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Total.............................. 3,800 .............. .............. 640 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.
[[Page 7007]]
Dated: February 5, 2004.
Anna Marsh,
Acting Executive Officer, SAMHSA.
[FR Doc. 04-3049 Filed 2-11-04; 8:45 am]
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