[Federal Register Volume 67, Number 110 (Friday, June 7, 2002)]
[Notices]
[Pages 39413-39414]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-14325]
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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 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 (301) 443-7978.
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
[[Page 39414]]
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.
To implement these new provisions, SAMHSA has 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 and
physicians in group practices (as defined under section 1877(h)(4) of
the Social Security Act) 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 two types of notification: (a)
New, and (b) immediate. 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).
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 Substance Abuse
Treatment Facility Locator.
At present, there are no narcotic drugs or combinations for use
under notifications; however, SAMHSA believes that it is appropriate to
develop a notification system to implement DATA in anticipation of
narcotic treatment medications becoming available in the very near
future. Therefore, SAMHSA recently obtained emergency OMB approval of
form SMA 167 so that physicians will have it available to use if they
wish to be assured that all required information is provided on their
waiver submission and so that the review of submissions may be
facilitated by use of a standard format for provision of the required
information. 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.................. 1,200 1 .083 100
Notification to Prescribe Immediately........... 33 1 .083 3
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Total....................................... 1,200 .............. .............. 103
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Send comments to Nancy Pearce, SAMHSA Reports Clearance Officer,
Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857.
Written comments should be received within 60 days of this notice.
Dated: May 31, 2002.
Richard Kopanda,
Executive Officer, SAMHSA.
[FR Doc. 02-14325 Filed 6-6-02; 8:45 am]
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