[Federal Register Volume 74, Number 37 (Thursday, February 26, 2009)]
[Notices]
[Pages 8803-8804]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-4089]


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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: Notification of Intent To Use Schedule III, IV, or V Opioid 
Drugs for the Maintenance and Detoxification Treatment of Opiate 
Addiction Under 21 U.S.C. 823(g)(2) (OMB No. 0930-0234)--Revision

    The Drug Addiction Treatment Act of 2000 (``DATA,'' Pub. L. 106-
310) amended the Controlled Substances Act (21 U.S.C. 823(g)(2)) to 
permit practitioners (physicians) to seek and obtain waivers to 
prescribe certain approved narcotic treatment drugs for the treatment 
of opiate addiction. The legislation sets eligibility requirements and 
certification requirements as well as an interagency notification 
review process for physicians who seek waivers. The legislation was 
amended in 2005 to eliminate the patient limit for physicians in group 
practices, and in 2006, to permit certain physicians to treat up to 100 
patients.
    To implement these provisions, SAMHSA developed a notification form 
(SMA-167) that facilitates the submission and review of notifications. 
The form provides the information necessary to determine whether 
practitioners (i.e., independent physicians) meet the qualifications 
for waivers set forth under the new law. Use of this form will enable 
physicians to know they have provided all information needed to 
determine whether practitioners are eligible for a waiver.
    However, there is no prohibition on use of other means to provide 
requisite information. The Secretary will convey notification 
information and determinations to the Drug Enforcement Administration 
(DEA), which will assign an identification number to qualifying 
practitioners; this number will be included in the practitioner's 
registration under 21 U.S.C. 823(f).
    Practitioners may use the form for three types of notification: (a) 
New, (b) immediate, and (c) to notify of their intent to treat up to 
100 patients. Under ``new'' notifications, practitioners may make their 
initial waiver requests to SAMHSA. ``Immediate'' notifications inform 
SAMHSA and the Attorney General of a practitioner's intent to prescribe 
immediately to facilitate the treatment of an individual (one) patient 
under 21 U.S.C. 823(g)(2)(E)(ii). Finally, the form may be used by 
physicians with waivers to certify their need and intent to treat up to 
100 patients.
    The form collects data on the following items: Practitioner name; 
State medical license number and DEA registration number; address of 
primary location, telephone and fax numbers; e-mail address; purpose of 
notification new, immediate, or renewal; certification of qualifying 
criteria for treatment and management of opiate dependent patients; 
certification of capacity to refer patients for appropriate counseling 
and other appropriate ancillary services; certification of maximum 
patient load, certification to use only those drug products that meet 
the criteria in the law. The form also notifies practitioners of 
Privacy Act considerations, and permits practitioners to expressly 
consent to disclose limited information to the SAMHSA Buprenorphine 
Physician Locator.
    Since July 2002, SAMHSA has received over 17,000 notifications and 
has certified almost 16,000 physicians. Eighty-one percent of the 
notifications were submitted by mail or by facsimile, with 
approximately twenty percent submitted through the Web based online 
system. Approximately 60 percent of the certified physicians have 
consented to disclosure on the SAMHSA Buprenorphine Physician Locator.
    Respondents may submit the form electronically, through a dedicated 
Web page that SAMHSA will establish for the purpose, as well as via 
U.S. mail.
    The following table summarizes the estimated annual burden for the 
use of this form.

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                                                     Number of     Responses per    Burden per     Total burden
              Purpose of submission                 respondents     respondent    response (hr.)       (hrs)
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Initial Application for Waiver..................           1,500               1            .083             125
Notification to Prescribe Immediately...........              50               1            .083               4
Notice to Treat up to 100 patients..............             500               1            .040              20
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    Total.......................................           2,050  ..............  ..............             149
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    Written comments and recommendations concerning the proposed 
information collection should be sent by March 30, 2009 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.


[[Page 8804]]


    Dated: February 20, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-4089 Filed 2-25-09; 8:45 am]
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