[Federal Register Volume 71, Number 166 (Monday, August 28, 2006)]
[Notices]
[Pages 50933-50934]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-14242]


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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 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.

Proposed Project: Opioid Drugs in Maintenance and Detoxification 
Treatment of Opioid Dependence--42 CFR part 8 (OMB No. 0930-0206)--
Revision

    This regulation establishes a certification program managed by 
SAMHSA's Center for Substance Abuse Treatment (CSAT). The regulation 
requires that Opioid Treatment Programs (OTPs) be certified. 
``Certification'' is the process by which SAMHSA determines that an OTP 
is qualified to provide opioid treatment under the Federal opioid 
treatment standards established by the Secretary of Health and Human 
Services. To become certified, an OTP must be accredited by a SAMHSA-
approved accreditation body. The regulation also provides standards for 
such services as individualized treatment planning, increased medical 
supervision, and assessment of patient outcomes. This submission seeks 
continued approval of the information collection requirements in the 
regulation and of the forms used in implementing the regulation.
    SAMHSA currently has approval for the Application for Certification 
to Use Opioid Drugs in a Treatment Program Under 42 CFR 8.11 (Form SMA-
162); the Application for Approval as Accreditation Body Under 42 CFR 
8.3(b) (Form SMA-163); and the Exception Request and Record of 
Justification Under 42 CFR 8.12 (Form SMA-168), which may be used on a 
voluntary basis by physicians when there is a patient care situation in 
which the physician must make a treatment decision that differs from 
the treatment regimen required by the regulation. Form SMA-162 is used 
as the initial application to request certification of an OTP, to 
request renewal of certification and to change existing information 
regarding the program's location, sponsor and medical director. This 
form collects information such as address, program name, contact 
information, sponsor name and address and medical director name and 
address. Attachments are required to complete this form regarding the 
OTPs accrediting status, organizational structure, and operating 
procedures. Form SMA-163 is used as an application to become a SAMHSA 
approved accrediting body. This form collects accrediting body name, 
address and contact information. Attachments are required to complete 
this form regarding the accrediting body's operating procedures and 
standards and their staff's education and experience. Form SMA-168 is a 
simplified, standardized form to facilitate the documentation, request, 
and approval process for exceptions. This form collects patient 
admission date, dosage amount, patient status, attendance schedule per 
week, dates of exception and justification.
    The tables that follow summarize the annual reporting burden 
associated with the regulation, including burden associated with the 
forms.

                     Estimated Annual Reporting Requirement Burden for Accreditation Bodies
----------------------------------------------------------------------------------------------------------------
                                                          Number of      Responses/     Hours/
         42 CFR citation                Purpose          respondents     respondent    response    Total hours
----------------------------------------------------------------------------------------------------------------
8.3(b)(1-11)....................  Initial approval                  1               1    6.0                 6
                                   (SMA-163).
8.3(c)..........................  Renewal of approval               2               1    1.0                 2
                                   (SMA-163).
8.3(e)..........................  Relinquishment                    1               1    0.5                 0.5
                                   notification.
8.3(f)(2).......................  Non-renewal                       1              90    0.1                 9
                                   notification to
                                   accredited OTPs.
8.4(b)(1)(ii)...................  Notification to                   2               2    1.0                 4
                                   SAMHSA for
                                   seriously
                                   noncompliant OTPs.
8.4(b)(1)(iii)..................  Notification to OTP               2              10    1.0                20
                                   for serious
                                   noncompliance.
8.4(d)(1).......................  General documents                 6               5    0.5                15
                                   and information to
                                   SAMHSA upon
                                   request.
8.4(d)(2).......................  Accreditation                     6              75   0.02                 9
                                   survey to SAMHSA
                                   upon request.
8.4(d)(3).......................  List of surveys,                  6               6    0.2                 7.2
                                   surveyors to
                                   SAMHSA upon
                                   request.
8.4(d)(4).......................  Report of less than               6               5    0.5                15
                                   full accreditation
                                   to SAMHSA.
8.4(d)(5).......................  Summaries of                      6              50    0.5               150
                                   Inspections.
8.4(e)..........................  Notifications of                  6               6    0.5                18
                                   Complaints.
8.6(a)(2) and (b)(3)............  Revocation                        1             185    0.3                55.5
                                   notification to
                                   Accredited OTPs.
8.6(b)..........................  Submission of 90-                 1               1     10                10.0
                                   day corrective
                                   plan to SAMHSA.
8.6(b)(1).......................  Notification to                   1             185    0.3                55.0
                                   accredited OTPs of
                                   Probationary
                                   Status.
                                                      ----------------------------------------------------------

[[Page 50934]]

 
    Total.......................  ...................               6  ..............  ........            376.2
----------------------------------------------------------------------------------------------------------------


                   Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
                                                  Number of      Responses/
       42 CFR citation            Purpose        respondents     respondent    Hours/response     Total Hours
----------------------------------------------------------------------------------------------------------------
8.11(b).....................  Renewal of                  370               1            0.30             111.00
                               approval (SMA-
                               162).
8.11(b).....................  Relocation of                35               1            1.17              40.95
                               Program (SMA-
                               162).
8.11(e)(1)..................  Application for              40               1            1                 40.00
                               provisional
                               certification.
8.11(e)(2)..................  Application for              30               1            0.25               7.50
                               extension of
                               provisional
                               certification.
8.11(f)(5)..................  Notification of              60               1            0.1                6.00
                               sponsor or
                               medical
                               director
                               change (SMA-
                               162).
8.11(g)(2)..................  Documentation                 1               1            1                  1.00
                               to SAMHSA for
                               interim
                               maintenance.
8.11(h).....................  Request to                 1150              30            0.07            2415.00
                               SAMHSA for
                               Exception from
                               8.11 and 8.12
                               (including SMA-
                               168).
8.11(i)(1)..................  Notification to              10               1            0.25               2.5
                               SAMHSA Before
                               Establishing
                               Medication
                               Units (SMA-
                               162).
8.12(j)(2)..................  Notification to               1              20            0.33               6.6
                               State Health
                               Officer When
                               Patient Begins
                               Interim
                               Maintenance.
8.24........................  Contents of                   2               1            0.25                .50
                               Appellant
                               Request for
                               Review of
                               Suspension.
8.25(a).....................  Informal Review               2               1            1.00               2.00
                               Request.
8.26(a).....................  Appellant's                   2               1            5.00              10.00
                               Review File
                               and Written
                               Statement.
8.28(a).....................  Appellant's                   2               1            1.00               2.00
                               Request for
                               Expedited
                               Review.
8.28(c).....................  Appellant                     2               1            5.00              10.00
                               Review File
                               and Written
                               Statement.
 
Total.......................  ...............           1,150  ..............  ..............            2655.05
----------------------------------------------------------------------------------------------------------------

    Written comments and recommendations concerning the proposed 
information collection should be sent by September 27, 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: August 18, 2006.
Anna Marsh,
Director, Office of Program Services.
[FR Doc. E6-14242 Filed 8-25-06; 8:45 am]
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