[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40075-40077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17261]


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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

[[Page 40076]]

documents, call the SAMHSA Reports Clearance Officer on (240) 276-1112.

Project: Opioid Drugs in Maintenance and Detoxification Treatment of 
Opioid Dependence--42 CFR Part 8 (OMB No. 0930-0206) and Opioid 
Treatment Programs (OTPs)--Extension

    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 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 tables that follow summarize the annual reporting burden 
associated with the regulation, including burden associated with the 
forms. There are no changes being made to the forms.

                                         Estimated Annual Reporting Requirement Burden for Accreditation Bodies
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of      Responses/         Total          Hours/
            42 CFR citation                          Purpose                respondents     respondent       responses       response      Total  hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.3(b)(1-11)..........................  Initial approval (SMA-163)......               1               1               1             6.0               6
8.3(c)................................  Renewal of approval (SMA-163)...               2               1               2             1.0               2
8.3(e)................................  Relinquishment notification.....               1               1               1             0.5             0.5
8.3(f)(2).............................  Non-renewal notification to                    1              90              90             0.1               9
                                         accredited OTPs.
8.4(b)(1)(ii).........................  Notification to SAMHSA for                     2               2               4             1.0               4
                                         seriously noncompliant OTPs.
8.4(b)(1)(iii)........................  Notification to OTP for serious                2              10              20             1.0              20
                                         noncompliance.
8.4(d)(1).............................  General documents and                          6               5              30             0.5              15
                                         information to SAMHSA upon
                                         request.
8.4(d)(2).............................  Accreditation survey to SAMHSA                 6              75             450            0.02               9
                                         upon request.
8.4(d)(3).............................  List of surveys, surveyors to                  6               6              36             0.2             7.2
                                         SAMHSA upon request.
8.4(d)(4).............................  Report of less than full                       6               5              30             0.5              15
                                         accreditation to SAMHSA.
8.4(d)(5).............................  Summaries of Inspections........               6              50             300             0.5             150
8.4(e)................................  Notifications of Complaints.....              12               6              72             0.5              36
8.6(a)(2) and (b)(3)..................  Revocation notification to                     1             185             185             0.3            55.5
                                         Accredited OTPs.
8.6(b)................................  Submission of 90-day corrective                1               1               1              10            10.0
                                         plan to SAMHSA.
8.6(b)(1).............................  Notification to accredited OTPs                1             185             185             0.3            55.0
                                         of Probationary Status.
                                                                         -------------------------------------------------------------------------------
    Subtotal..........................  ................................              54  ..............           1,407  ..............          394.20
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                                       Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                             Number of      Responses/         Total          Hours/
            42 CFR citation                          Purpose                respondents     respondent       responses       response      Total  hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
8.11(b)...............................  Renewal of approval (SMA-162)...             386               1             386            0.15            57.9
8.11(b)...............................  Relocation of Program (SMA-162).              35               1              35            1.17           40.95

[[Page 40077]]

 
8.11(e)(1)............................  Application for provisional                   42               1              42               1           42.00
                                         certification.
8.11(e)(2)............................  Application for extension of                  30               1              30            0.25            7.50
                                         provisional certification.
8.11(f)(5)............................  Notification of sponsor or                    60               1              60             0.1            6.00
                                         medical director change (SMA-
                                         162).
8.11(g)(2)............................  Documentation to SAMHSA for                    1               1               1               1            1.00
                                         interim maintenance.
8.11(h)...............................  Request to SAMHSA for Exemption            1,200              20          24,000            0.07           1,680
                                         from 8.11 and 8.12 (including
                                         SMA-168).
8.11(i)(1)............................  Notification to SAMHSA Before                 10               1              10            0.25             2.5
                                         Establishing Medication Units
                                         (SMA-162).
8.12(j)(2)............................  Notification to State Health                   1              20              20            0.33             6.6
                                         Officer When Patient Begins
                                         Interim Maintenance.
8.24..................................  Contents of Appellant Request                  2               1               2            0.25             .50
                                         for Review of Suspension.
8.25(a)...............................  Informal Review Request.........               2               1               2            1.00            2.00
8.26(a)...............................  Appellant's Review File and                    2               1               2            5.00           10.00
                                         Written Statement.
8.28(a)...............................  Appellant's Request for                        2               1               2            1.00            2.00
                                         Expedited Review.
8.28(c)...............................  Appellant Review File and                      2               1               2            5.00           10.00
                                         Written Statement.
                                                                         -------------------------------------------------------------------------------
    Subtotal..........................  ................................           1,775  ..............          24,594  ..............        1,868.95
                                                                         -------------------------------------------------------------------------------
        Total.........................  ................................           1,829  ..............          26,001  ..............        2,263.15
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    Written comments and recommendations concerning the proposed 
information collection should be sent by September 12, 2019 to the 
SAMHSA Desk Officer at the Office of Information and Regulatory 
Affairs, Office of Management and Budget (OMB). To ensure timely 
receipt of comments, and to avoid potential delays in OMB's receipt and 
processing of mail sent through the U.S. Postal Service, commenters are 
encouraged to submit their comments to OMB via email to: 
[email protected]. Although commenters are encouraged to send 
their comments via email, commenters may also fax their comments to: 
202-395-7285. Commenters may also mail them to: Office of Management 
and Budget, Office of Information and Regulatory Affairs, New Executive 
Office Building, Room 10102, Washington, DC 20503.

Summer King,
Statistician.
[FR Doc. 2019-17261 Filed 8-12-19; 8:45 am]
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