[Federal Register Volume 74, Number 118 (Monday, June 22, 2009)]
[Notices]
[Pages 29487-29489]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-14554]


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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) and 
Opioid Treatment Programs (OTPs) Mortality Reporting Form--Revision

    42 CFR part 8 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-168 is a 
simplified, standardized form to facilitate the documentation, request, 
and approval process for exceptions.
    SAMHSA developed an OTP mortality report form to be utilized by 
OTPs in response to the increasing methadone associated mortality 
around the country. This form also assists SAMHSA with regulatory 
oversight of methadone for use in opioid addiction treatment because it 
is not clear whether and to what extent the increase in methadone-
associated deaths may be related to treatment in OTPs. A system within 
SAMHSA to gather information

[[Page 29488]]

directly relevant to the agency's mission of overseeing and ensuring 
safe and effective treatment for patients with opioid dependence 
provides an additional layer of oversight.
    SAMHSA currently has approval for the Opioid Treatment Programs 
(OTPs) Mortality Reporting Form. The data collected from the form is 
used by SAMHSA to increase understanding of the factors contributing to 
these deaths, identify preventable causes of deaths, and ultimately, 
take appropriate action to minimize risk and help improve the quality 
of care. SAMHSA recently received OMB approval for the voluntary 
collection of data regarding OTP mortality, which expires October 2011. 
The consolidation of the OMB packages for the mortality form with the 
regulatory forms SMA-162, SMA-163, and SMA-168 reduces agency and staff 
burden.
    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
----------------------------------------------------------------------------------------------------------------
                                                      No. 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                     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              12               6             0.5             3.6
                                 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  ..............  ..............          361.80
----------------------------------------------------------------------------------------------------------------


                   Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
                                                      No. of        Responses/        Hours/
        42 CFR citation              Purpose        respondents     respondent       response       Total hours
----------------------------------------------------------------------------------------------------------------
8.11(b).......................  Renewal of                   386               1            0.15            57.9
                                 approval (SMA-
                                 162).
8.11(b).......................  Relocation of                 35               1            1.17           40.95
                                 Program (SMA-
                                 162).
8.11(e)(1)....................  Application for               42               1               1           42.00
                                 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                 1,200              25             0.7          2135.0
                                 SAMHSA for
                                 Exemption 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.........................  ................           1,200  ..............  ..............         2323.95
----------------------------------------------------------------------------------------------------------------


[[Page 29489]]


                             Estimated Annual Reporting Requirement Burden for OTPs
----------------------------------------------------------------------------------------------------------------
                                                 Number of                          Burden/
                  Form name                      facilities     Responses per       response      Annual burden
                                                   (OTPs)          facility      (hours) to OTP  (hours) to OTPs
----------------------------------------------------------------------------------------------------------------
SAMHSA OTP Mortality Form...................           1,200       2 per year              0.5          1200.00
----------------------------------------------------------------------------------------------------------------


                     Estimated Annual Reporting Requirement Burden for Medical Examiner (ME)
----------------------------------------------------------------------------------------------------------------
                                                                                    Burden/
                  Form name                     Number of ME    Responses per       response      Annual burden
                                                 follow-ups           ME         (hours) for ME   (hours) for ME
----------------------------------------------------------------------------------------------------------------
SAMHSA OTP mortality form...................             230       1 per year              0.1              2.3
----------------------------------------------------------------------------------------------------------------

    SAMHSA believes that the recordkeeping requirements in the 
regulation are customary and usual practices within the medical and 
rehabilitative communities and has not calculated a response burden for 
them. The recordkeeping requirements set forth in 42 CFR 8.4, 8.11 and 
8.12 include maintenance of the following: 5-year retention by 
accreditation bodies of certain records pertaining to accreditation; 
documentation by an OTP of the following: a patient's medical 
examination when admitted to treatment, A patient's history, a 
treatment plan, any prenatal support provided the patient, 
justification of unusually large initial doses, changes in a patient's 
dosage schedule, justification of unusually large daily doses, the 
rationale for decreasing a patient's clinic attendance, and 
documentation of physiologic dependence.
    The rule also includes requirements that OTPs and accreditation 
organizations disclose information. For example, 42 CFR 8.12(e)(1) 
requires that a physician explain the facts concerning the use of 
opioid drug treatment to each patient. This type of disclosure is 
considered to be consistent with the common medical practice and is not 
considered an additional burden. Further, the rule requires, under Sec. 
8.4(i)(1) that accreditation organizations shall make public their fee 
structure; this type of disclosure is standard business practice and is 
not considered a burden.
    The information requested from OTPs on mortality report form should 
be readily available to any OTP that has met accreditation standards. 
The OTP should not find any need to otherwise analyze or synthesize new 
data in order to complete this form.
    Send comments to Summer King, SAMHSA Reports Clearance Officer, 
Room 7-1044, One Choke Cherry Road, Rockville, MD 20857 and e-mail her 
a copy at [email protected]. Written comments should be 
received within 60 days of this notice.

    Dated: June 15, 2009.
Elaine Parry,
Director, Office of Program Services.
[FR Doc. E9-14554 Filed 6-19-09; 8:45 am]
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