[Federal Register Volume 81, Number 119 (Tuesday, June 21, 2016)]
[Notices]
[Pages 40335-40337]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14586]


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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.

Project: Opioid Drugs in Maintenance and Detoxification Treatment of 
Opioid Dependence--42 CFR Part 8 (OMB No. 0930-0206) and Opioid 
Treatment Programs (OTPs)--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 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, 
and 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 to 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 
section 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.
    A number of changes have been made to the forms. Forms have been 
reworded for clarification, updated with current SAMHSA mailing and 
web-submission information, and a few additional fields have been 
provided for clarity and for providers to best explain their services 
(e.g., expanding the former global patient census in the SMA-162 to 
request patient census by drug type--methadone, buprenorphine, 
naltrexone, or other) and the needs of their patients (e.g., including 
urinalysis results on the SMA-168 and adding ``weather crisis'' as a 
standard option for physician justification of the requested 
exception). Amendments also include the removal of information 
pertaining to faxing the forms to SAMHSA, as this is no longer an 
acceptable form of submission. The burden hours have increased slightly 
(by 28% or approximately 639 hours) due to an increase in the number of 
facilities accredited and certified by SAMHSA since the previous 
submissions of these forms. The forms are available online with a 
unique feature for both the SMA-162 and SMA-168 that pre-populates 
certain information within the form. This in turn reduces the program's 
time spent

[[Page 40336]]

filling out the forms as well as the staff time spent on processing it.
    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
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                                                                             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            6.00            6.00
8.3(c)................................  Renewal of approval (SMA-163)...               2               1               2            1.00            2.00
8.3(e)................................  Relinquishment notification.....               1               1               1            0.50            0.50
8.3(f)(2).............................  Non-renewal notification to                    1              90              90            0.10            9.00
                                         accredited OTPs.
8.4(b)(1)(ii).........................  Notification to SAMHSA for                     2               2               4            1.00            4.00
                                         seriously noncompliant OTPs.
8.4(b)(1)(iii)........................  Notification to OTP for serious                2              10              20            1.00           20.00
                                         noncompliance.
8.4(d)(1).............................  General documents and                          6               5              30            0.50           15.00
                                         information to SAMHSA upon
                                         request.
8.4(d)(2).............................  Accreditation survey to SAMHSA                 6              75             450            0.02            9.00
                                         upon request.
8.4(d)(3).............................  List of surveys, surveyors to                  6               6              36            0.20            7.20
                                         SAMHSA upon request.
8.4(d)(4).............................  Report of less than full                       6               5              30            0.50           15.00
                                         accreditation to SAMHSA.
8.4(d)(5).............................  Summaries of Inspections........               6              50             300            0.50          150.00
8.4(e)................................  Notifications of Complaints.....              12               6              72            0.50           36.00
8.6(a)(2) and (b)(3)..................  Revocation notification to                     1             185             185            0.30           55.50
                                         Accredited OTPs.
8.6(b)................................  Submission of 90-day corrective                1               1               1           10.00           10.00
                                         plan to SAMHSA.
8.6(b)(1).............................  Notification to accredited OTPs                1             185             185            0.30           55.50
                                         of Probationary Status.
                                                                         -------------------------------------------------------------------------------
    Subtotal..........................  ................................              54  ..............           1,407  ..............          394.70
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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           57.90
8.11(b)...............................  Relocation of Program (SMA-162).              35               1              35            1.17           40.95
8.11(e)(1)............................  Application for provisional                   42               1              42            1.00           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            0.10            6.00
                                         medical director change (SMA-
                                         162).
8.11(g)(2)............................  Documentation to SAMHSA for                    1               1               1            1.00            1.00
                                         interim maintenance.
8.11(h)...............................  Request to SAMHSA for Exemption            1,325              25          33,125            0.07        2,318.75
                                         from 8.11 and 8.12 (including
                                         SMA-168).
8.11(i)(1)............................  Notification to SAMHSA Before                 10               1              10            0.25            2.50
                                         Establishing Medication Units
                                         (SMA-162).
8.12(j)(2)............................  Notification to State Health                   1              20              20            0.33            6.60
                                         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..........................  ................................           1,900  ..............          33,719  ..............        2,507.70
                                                                         -------------------------------------------------------------------------------
        Total.........................  ................................           1,954  ..............          35,126  ..............        2,902.40
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[[Page 40337]]

    Written comments and recommendations concerning the proposed 
information collection should be sent by July 21, 2016 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. 2016-14586 Filed 6-20-16; 8:45 am]
 BILLING CODE 4162-20-P