[Federal Register Volume 71, Number 73 (Monday, April 17, 2006)]
[Notices]
[Pages 19738-19740]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-5644]


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

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 (SAMHSA) 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 (240) 276-1243.
    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: Opioid Drugs in Maintenance and Detoxification 
Treatment of Opioid Dependence--42 CFR part 8 (OMB No. 0930-0206)--
Extension

    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

[[Page 19739]]

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/
        42 CFR citation              Purpose        respondents     respondent    Hours/response    Total hours
----------------------------------------------------------------------------------------------------------------
8.3(b)(1-11)..................  Initial approval               1               1             6.0               6
                                 (SMA-163).
8.3(c)........................  Renewal of                     2               1             1.0               2
                                 approval (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                2              10             1.0              20
                                 OTP for serious
                                 noncompliance.
8.4(d)(1).....................  General                        6               5             0.5              15
                                 documents 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                 6               5             0.5              15
                                 than 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.
                               ---------------------------------------------------------------------------------
    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 to               1               1               1            1.00
                                 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 Review               2               1            5.00           10.00
                                 File and
                                 Written
                                 Statement.
                               ---------------------------------------------------------------------------------
    Total.....................  ................           1,150  ..............  ..............         2655.05
----------------------------------------------------------------------------------------------------------------


[[Page 19740]]

    Send comments to Summer King, SAMHSA Reports Clearance Officer, 
Room 7-1044, One Choke Cherry Road, Rockville, MD 20857. Written 
comments should be received within 60 days of this notice.

    Dated: April 10, 2006.
Anna Marsh,
Director, Office of Program Services.
[FR Doc. E6-5644 Filed 4-14-06; 8:45 am]
BILLING CODE 4162-20-P