[Federal Register Volume 73, Number 95 (Thursday, May 15, 2008)]
[Notices]
[Pages 28126-28127]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10855]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


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 (240) 276-1243.

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

[[Page 28127]]

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
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                                                 Number of                          Burden/
                    Form                         facilities     Responses per      responses      Annual burden
                                                   (OTPs)          facility         (hours)          (hours)
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SAMHSA OTP Mortality Report.................           1,150                2              0.5            1,150
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    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.
 [FR Doc. E8-10855 Filed 5-14-08; 8:45 am]
BILLING CODE 4162-20-P