[Federal Register Volume 69, Number 136 (Friday, July 16, 2004)]
[Notices]
[Page 42760]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-16171]



[[Page 42760]]

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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.
    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, was 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 being conducted, 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, (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) and (3) perceive significance to its use, including 
clinical, financial, administrative, and logistic factors. The survey 
is also designed to identify issues related to treatment availability 
and possible adverse public health consequences associated with the 
drug.
    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              1,833                  1                .42                770
 Waiver.............................
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    Written comments and recommendations concerning the proposed 
information collection should be sent by August 16, 2004, 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: July 12, 2004.
Anna Marsh,
Executive Officer, SAMHSA.
[FR Doc. 04-16171 Filed 7-15-04; 8:45 am]
BILLING CODE 4162-20-P