[Federal Register: November 4, 2008 (Volume 73, Number 214)]
[Notices]
[Page 65611-65612]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04no08-70]
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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 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)--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
[[Page 65612]]
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; 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 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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Send comments to Summer King, SAMHSA Reports Clearance Officer,
Room 7-1044, One Choke Cherry Road, Rockville, MD 20857 and e-mail her
a copy at summer.king@samhsa.hhs.gov. Written comments should be
received within 60 days of this notice.
Dated: October 28, 2008.
Elaine Parry,
Acting Director, Office of Program Services.
[FR Doc. E8-26247 Filed 11-3-08; 8:45 am]
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