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.
Evaluation of the Buprenorphine Waiver: Addiction 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 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 Start Printed Page 33173physicians 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. Physicians who do not respond after two mailings will receive a brief postcard to complete.
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 each of these surveys. The estimated response burden for the first survey of physicians is summarized below.
|Addiction physicians||Number of respondents||Responses/respondent||Hours per response|
Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: Allison Herron Eydt, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503; because of mail delays, it is recommended that comments be sent by fax to: (202) 395-6974.Start Signature
Dated: May 27, 2003.
Executive Officer, SAMHSA.
[FR Doc. 03-13789 Filed 6-2-03; 8:45 am]
BILLING CODE 4162-20-P