[Federal Register Volume 80, Number 115 (Tuesday, June 16, 2015)]
[Notices]
[Pages 34448-34449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14727]
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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)--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
[[Page 34449]]
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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Burden per
Purpose of submission Number of Responses per response Total burden
respondents respondent (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 July 16, 2015 to the SAMHSA
Desk Officer at the Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB). To ensure timely receipt of
comments, and to avoid potential delays in OMB's receipt and processing
of mail sent through the U.S. Postal Service, commenters are encouraged
to submit their comments to OMB via email to:
[email protected]. Although commenters are encouraged to send
their comments via email, commenters may also fax their comments to:
202-395-7285. Commenters may also mail them to: Office of Management
and Budget, Office of Information and Regulatory Affairs, New Executive
Office Building, Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2015-14727 Filed 6-15-15; 8:45 am]
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