[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.
                                        ----------------                                ------------------------
    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]
BILLING CODE 4162-20-P