[Federal Register Volume 67, Number 181 (Wednesday, September 18, 2002)]
[Notices]
[Pages 58816-58817]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-23682]


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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 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 (301) 443-7978.
    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,'' Public Law 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

[[Page 58817]]

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 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 or immediate); 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 these 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 has 
established 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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                                                                                Responses  Burden per    Total
                      Purpose of submission                        Number of       per      response     burden
                                                                  respondents  respondent     (Hr.)      (Hrs.)
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Initial Application for Waiver..................................       1,200            1        .083        100
Notification to Prescribe Immediately...........................          33            1        .083          3
                                                                 --------------
    Total.......................................................       1,200   ..........  ..........        103
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    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
Allison Herron Eydt, Human Resources and Housing Branch, Office of 
Management and Budget, New Executive Office Building, Room 10235, 
Washington, DC 20503.

    Dated: September 12, 2002.
Richard Kopanda,
Executive Officer, SAMHSA.
[FR Doc. 02-23682 Filed 9-17-02; 8:45 am]
BILLING CODE 4162-20-P