[Federal Register Volume 66, Number 235 (Thursday, December 6, 2001)]
[Notices]
[Pages 63401-63402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-30234]


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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 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 Opioid Addiction Under 
21 U.S.C. 823(g)(2)

    --(New)--The Drug Addiction Treatment Act of 2000 (``DATA,'' Pub. 
L. 106-310 (21 U.S.C. 823(g)(2)) amended the Controlled Substances Act 
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 application 
process for physicians who seek waivers.
    To implement these new provisions, SAMHSA has developed a 
notification form to permit it to determine whether practitioners 
(i.e., individual physicians and physicians in group practices (as 
defined under section 1877(h)(4) of the Social Security Act, licensed 
to practice medicine) meet the qualifications for waivers set forth 
under the new law. The information entered on the form will assist 
SAMHSA in determining whether practitioners are eligible for a waiver. 
The Secretary will convey practitioner determination 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 will 
also use this notification form to renew their waivers at the time they 
renew their DEA practitioner registration--every three years.
    Practitioners will use the form for three types of notification: 
(a) New, (b) emergency, and (c) renewal. Under ``new'' notifications, 
practitioners will make their initial waiver requests to SAMHSA. 
``Emergency'' notifications will 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). ``Renewal'' notifications will be submitted to HHS to 
initiate review of an identification number already provided by DEA.
    The form will collect 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, emergency, or renewal); name of narcotic 
drugs or combinations for use under the notification; 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.
    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 future. 
Respondents will be able to submit the form electronically, through a 
dedicated Web page that SAMHSA will establish for the purpose, as well 
as via U.S. mail.

[[Page 63402]]

    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
Application for Renewal.........................           1,200               1            .083             100
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      Total.....................................           1,200                                             203
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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: November 29, 2001.
Richard Kopanda,
Executive Officer, Substance Abuse and Mental Health Services 
Administration.
[FR Doc. 01-30234 Filed 12-5-01; 8:45 am]
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