E8-10855. 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 [phone].

Project: Opioid Treatment Programs (OTPs) Mortality Reporting Form—NEW

The Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT), has developed a voluntary reporting form for Opioid Treatment Programs (OTPs) to report mortality data on patients who at the time of death, were enrolled in the Programs that were certified to operate by SAMHSA.

Methadone is a Schedule II controlled substance approved by the Food and Drug Administration for the treatment of opioid dependence and pain. Although it has been proven safe and effective, it must be carefully administered and for that reason, treatment of opioid dependence with methadone is provided only through specialized and Federally regulated and accredited clinics, the OTPs. Buprenorphine, a Schedule III controlled substance, is also used in the treatment of opioid addiction by OTPs and office-based physicians.

In recent years, methadone has been associated with an increasing number of deaths around the country. Simultaneously, the use of methadone for pain has increased significantly over the last 5 to 10 years. While the Food and Drug Administration (FDA) maintains oversight of methadone for use in pain, SAMHSA provides oversight of methadone for use in opioid addiction treatment. Currently, there is no national database that tracks mortality among patients receiving methadone in OTPs and as a result, it is not clear whether and to what extent the increase in methadone-associated deaths may be related to treatment in OTPs. MedWatch, a voluntary reporting system maintained by FDA, provides information relevant to its role in its more general oversight of medication and device safety. A similar system is needed within SAMHSA to gather information directly relevant to the agency's mission of overseeing and ensuring safe and effective treatment for patients with opioid dependence.

In order to more accurately understand potential methadone-associated deaths at the OTP level, it is necessary to examine all patient deaths, including those related to buprenorphine. Understanding the actual cause of death of patients enrolled in OTPs can be a challenging task for many reasons, including inconsistencies in methods of reporting causes of deaths across different localities and officials; patients' use of other drugs, including illicit, over-the-counter, and prescription products; and other aspects of the patient's physical and mental condition. The standardized terminology to be used for reporting in the proposed system will contribute to a more precise and relevant analysis of individual cases and higher-level trends. The data will be used by SAMHSA to increase understanding of the factors contributing to these deaths, identify preventable causes of deaths, and ultimately, take appropriate action to minimize risk and help improve the quality of care. Importantly, better data will enable the agency to more proactively manage the oversight of treatment.

The information requested from OTPs should be readily available to any OTP that has met accreditation standards. The OTP should not find any need to otherwise analyze or synthesize new data in order to complete this form.

Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs

Form	Number of facilities (OTPs)	Responses per facility	Burden/responses (hours)	Annual burden (hours)
SAMHSA OTP Mortality Report	1,150	2	0.5	1,150

Written comments and recommendations concerning the proposed information collection should be sent by June 16, 2008 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: May 6, 2008.

Elaine Parry,

Acting Director, Office of Program Services.