[Federal Register Volume 70, Number 243 (Tuesday, December 20, 2005)]
[Notices]
[Pages 75466-75467]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-7542]


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

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 information 
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 (240) 276-1243.

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.
    To implement these new 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 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 available on http://www.buprenorphine.samhsa.gov.
    Since July 2002, SAMHSA has received approximately 6,400 
notifications and has certified over 5,500 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 http://www.buprenorphine.samhsa.gov.
    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.

----------------------------------------------------------------------------------------------------------------
                                                                                    Burden per
              Purpose of submission                  Number of     Responses per     response      Total burden
                                                    respondents     respondent         (hr.)           (hrs)
----------------------------------------------------------------------------------------------------------------
Initial Application for Waiver..................           2,000               1            .066             132
Notification to Prescribe Immediately...........              50               1            .083               3
                                                 -----------------

[[Page 75467]]

 
    Total.......................................           2,050  ..............  ..............             135
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent by January 19, 2006 to: SAMHSA 
Desk Officer, Human Resources and Housing Branch, Office of Management 
and Budget, New Executive Office Building, Room 10235, Washington, DC 
20503; due to potential delays in OMB's receipt and processing of mail 
sent through the U.S. Postal Service, respondents are encouraged to 
submit comments by fax to: 202-395-6974.

    Dated: December 14, 2005.
Anna Marsh,
Director, Office of Program Services.
 [FR Doc. E5-7542 Filed 12-19-05; 8:45 am]
BILLING CODE 4162-20-P