04-3049. 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 [phone].

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.

Respondents	Number of respondents	Responses per respondent	Hours per response	Total hour burden
All Physicians Who Have Submitted a Waiver	2,800	1	.05	140 hrs.
Sample of Prescribing Physicians	1,000	1	.50	500 hrs.
Total	3,800			640 hrs.

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: February 5, 2004.

Anna Marsh,

Acting Executive Officer, SAMHSA.