[Federal Register Volume 67, Number 76 (Friday, April 19, 2002)]
[Notices]
[Pages 19443-19444]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9799]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Substance Abuse and Mental Health Services Administration


Agency Information Collection Activities Under Emergency Review 
by the Office of Management and Budget

    The Substance Abuse and Mental Health Services Administration

[[Page 19444]]

(SAMHSA) has submitted the following request (see below) for emergency 
OMB review under the Paperwork Reduction Act (44 U.S.C. chapter 35). 
OMB approval has been requested by May 1. A copy of the information 
collection plans may be obtained by calling the SAMHSA Reports 
Clearance Officer on (301) 443-7978.
    Title: 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 Number: 0930-New.
    Frequency: On-occasion.
    Affected public: Business or other for-profit.
    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 will facilitate the submission and 
review of notifications. The form will provide 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 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) immediate, and (c) renewal. Under ``new'' notifications, 
practitioners will make their initial waiver requests to SAMHSA. 
``Immediate'' 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 existing waiver.
    The form will collect data on the following items: Pactitioner 
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 will also notify 
practitioners of Privacy Act considerations, and permit 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 is requesting 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 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.
    The following table summarizes the estimated annual burden for the 
use of this form.

----------------------------------------------------------------------------------------------------------------
                                                   Number of     Responses per      Burden per     Total burden
             Purpose of Submission                respondents      respondent     response (Hr.)      (Hrs.)
----------------------------------------------------------------------------------------------------------------
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
                                               -----------------------------------------------------------------
      Total...................................           1,200  ...............  ...............             203
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent by April 30, 2002 to: Lauren 
Wittenberg, Human Resources and Housing Branch, Office of Management 
and Budget, New Executive Office Building, Room 10235, Washington, DC 
20503.

    Dated: April 4, 2002.
Richard Kopanda,
Executive Officer, SAMHSA.
[FR Doc. 02-9799 Filed 4-18-02; 8:45 am]
BILLING CODE 4162-20-P