[Federal Register Volume 77, Number 28 (Friday, February 10, 2012)]
[Notices]
[Pages 7169-7170]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-3141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


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 (SAMHSA) 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 (240) 276-1243.
    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

[[Page 7170]]

collection of information on respondents, including through the use of 
automated collection techniques or other forms of information 
technology.

Proposed 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)--Extension

    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; email address; name and 
address of group practice; group practice employer identification 
number; names and DEA registration numbers of group practitioners; 
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 25,000 notifications and 
has certified almost 27,000 physicians. Fifty-none percent of the 
notifications were submitted by mail or by facsimile, with 
approximately forty-one 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.
    There are no changes to the forms and burden hours.
    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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    Send comments to Summer King, SAMHSA Reports Clearance Officer, 
Room 8-1099, One Choke Cherry Road, Rockville, MD 20857 or email a copy 
to [email protected]. Written comments must be received before 
60 days after the date of the publication in the Federal Register.

Janine Denis Cook,
Chemist.
[FR Doc. 2012-3141 Filed 2-9-12; 8:45 am]
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