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NOTICE: NOTICES

SUBJECT CATEGORY: Agency Information Collection Activities: Submission for OMB Review; Comment Request

DOCUMENT SUMMARY:

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) 4437978.

Evaluation of the Buprenorphine Waiver: Longitudinal Patient SurveyNewThe 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 officebased 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 Waiverbased 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 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). That survey (approved by OMB under control number 09300246) will assess early perceptions of physicians specializing in addiction medicine about whether buprenorphine, as it is prescribed and distributed under the Waiver, is a useful tool in the treatment of substance abuse, and whether they have encountered any negative consequences associated with it.

[[Page 75265]]

The Longitudinal Patient Survey will focus on patients who have received buprenorphine and will assess its availability and effectiveness from the patients' point of view. The Survey will collect longitudinal data from a cohort of about 420 buprenorphine patients to assess the effectiveness of buprenorphine therapy. Patients will be recruited through a sample of prescribing physicians' offices. Office staff will give each eligible buprenorphine patient a study brochure that explains the importance of the study, offers an incentive, and gives the patient a tollfree telephone number to call to complete the survey by telephone.

Patients will be asked a series of questions that will provide baseline data for the evaluation. Followup data on the services received, satisfaction with the treatment, and outcomes will be collected 30 days and 6 months later. Survey domains include the following: Patient demographics; Buprenorphine dose over time; Items from the short form of the Addiction Severity Index (ASI); Services being received in addition to medications; Needlesharing and HIV status; Treatment and substance abuse history, in particular prior experience with medicationbased treatment for opioid dependence; Experience, satisfaction with, and general knowledge of, buprenorphine.

A third survey will be conducted later, focusing on the clinical practice and perceived effectiveness of buprenorphine among only those physicians who are actively prescribing the medication. A separate clearance request will be submitted for this physician survey.

The estimated response burden for the longitudinal survey of buprenorphine patients over a period of one year is summarized below. Number of Responses/ Hours/ Total hour Respondent respondents respondent response burden Physicians.................................................. 120 12 .08 116 Patient baseline interview.................................. 420 1 .75 315 Patient 30day followup interview........................... 420 1 .67 281 Patient 6month followup interview.......................... 420 1 .67 281

Total................................................... 540 ........... ........... 993

Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice 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) 3956974.

Dated: December 18, 2003.
Anna Marsh,
Acting Executive Officer, SAMHSA.
[FR Doc. 0331976 Filed 122903; 8:45 am]
BILLING CODE 416220P

SUMMARY: Agency information collection activities; proposals, submissions, and approvals,

DOCUMENT BODY 2:

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) 4437978.

Evaluation of the Buprenorphine Waiver: Longitudinal Patient SurveyNewThe 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 officebased 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 Waiverbased 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 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). That survey (approved by OMB under control number 09300246) will assess early perceptions of physicians specializing in addiction medicine about whether buprenorphine, as it is prescribed and distributed under the Waiver, is a useful tool in the treatment of substance abuse, and whether they have encountered any negative consequences associated with it.

[[Page 75265]]

The Longitudinal Patient Survey will focus on patients who have received buprenorphine and will assess its availability and effectiveness from the patients' point of view. The Survey will collect longitudinal data from a cohort of about 420 buprenorphine patients to assess the effectiveness of buprenorphine therapy. Patients will be recruited through a sample of prescribing physicians' offices. Office staff will give each eligible buprenorphine patient a study brochure that explains the importance of the study, offers an incentive, and gives the patient a tollfree telephone number to call to complete the survey by telephone.

Patients will be asked a series of questions that will provide baseline data for the evaluation. Followup data on the services received, satisfaction with the treatment, and outcomes will be collected 30 days and 6 months later. Survey domains include the following: Patient demographics; Buprenorphine dose over time; Items from the short form of the Addiction Severity Index (ASI); Services being received in addition to medications; Needlesharing and HIV status; Treatment and substance abuse history, in particular prior experience with medicationbased treatment for opioid dependence; Experience, satisfaction with, and general knowledge of, buprenorphine.

A third survey will be conducted later, focusing on the clinical practice and perceived effectiveness of buprenorphine among only those physicians who are actively prescribing the medication. A separate clearance request will be submitted for this physician survey.

The estimated response burden for the longitudinal survey of buprenorphine patients over a period of one year is summarized below. Number of Responses/ Hours/ Total hour Respondent respondents respondent response burden Physicians.................................................. 120 12 .08 116 Patient baseline interview.................................. 420 1 .75 315 Patient 30day followup interview........................... 420 1 .67 281 Patient 6month followup interview.......................... 420 1 .67 281

Total................................................... 540 ........... ........... 993

Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice 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) 3956974.

Dated: December 18, 2003.
Anna Marsh,
Acting Executive Officer, SAMHSA.
[FR Doc. 0331976 Filed 122903; 8:45 am]
BILLING CODE 416220P