[Federal Register Volume 67, Number 146 (Tuesday, July 30, 2002)]
[Notices]
[Pages 49365-49367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-19167]


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

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 list 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 (301) 443-7978.

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, 
minor changes to Form SMA-162, and approval of a new form to be used in 
implementing the regulation.

[[Page 49366]]

    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) and the Application for Approval as Accreditation Body Under 42 
CFR 8.3(b) (Form SMA-163). SAMHSA also is seeking approval of a new 
form that has been developed at the request of the treatment field, 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. This is a simplified, standardized form to facilitate 
the documentation, request, and approval process for exceptions. 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  respondents    response     Total hours
----------------------------------------------------------------------------------------------------------------
8.3 (b)(1-11)......................  Initial approval (SMA-           2            1          3.0           6.0
                                      163).
8.3 (c)............................  Renewal of approval              2            1          1.0           2.0
                                      (SMA-163).
8.3 (e)............................  Relinquishment                   1            1          0.5           0.5
                                      notification.
8.3 (f)(2).........................  Non-renewal                      1           90          0.1           9.0
                                      notification to
                                      accredited OTP's.
8.4(d)(2) (b)(1)(ii)...............  Notification to                  2            2          1.0           4.0
                                      SAMHSA for seriously
                                      noncompliant
                                      programs.
8.4 (b)(1)(iii)....................  Notification to OTP              2            2          1.0           4.0
                                      for serious
                                      noncompliance.
8.4 (d)(1).........................  General documents and            7            4          0.5          14.0
                                      information to
                                      SAMHSA upon request.
8.4(d)(2)..........................  Accreditation survey             7           53          0.02          7.42
                                      to SAMHSA upon
                                      request.
8.4 (b)(3).........................  List of surveys,                 7            6          0.2           8.4
                                      surveyors to SAMHSA
                                      upon request.
8.4 (d)(4).........................  Report of less than              7          2.5          0.5           8.75
                                      full accreditation
                                      to SAMHSA.
8.4 (d)(5).........................  Summaries of                     7           50          0.5         175.0
                                      Inspections.
8.4(e).............................  Notifications of                 7            5          0.5          17.5
                                      Complaints.
8.6(a)(2) and (b)(3)...............  Revocation                       1           50          0.3          15.0
                                      notification and to
                                      Accredited OTP's.
8.6(b).............................  Submission of 90-day             1            1         10            10.0
                                      Corrective plan to
                                      SAMHSA.
8.6(b)(1)..........................  Notification to                  1           50          0.3          15.0
                                      accredited OTP's of
                                      Probationary Status.
    TOTAL..........................    ...................            7                                   297
----------------------------------------------------------------------------------------------------------------


                   Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
                                                               No. of     Responses/     Hours/
          42 CFR citation                   Purpose         respondents  respondents    response     Total hours
----------------------------------------------------------------------------------------------------------------
8.11(b)............................  New programs approval           75            1         1.50         112.50
                                      (SMA-162).
8.11(b)............................  Renewal of approval            350            1         1.00         350.00
                                      (SMA-162).
8.11(b)............................  Relocation of Program           35            1         1.17          40.95
                                      (SMA-162).
8.11(d)............................  Application for                  7            1         1.58          11.06
                                      transitional
                                      certification (SMA-
                                      162)*.
8.11(e)(1).........................  Application for                 75            1         1             75.00
                                      provisional
                                      certification.
8.11(e)(2).........................  Application for                 30            1          .25           7.50
                                      extension of
                                      provisional
                                      certification.
8.11(f)(5).........................  Notification of                 60            1          .2           12.00
                                      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 SAMHSA for        1,100            6          .152       1003.2
                                      Exemption from 8.11
                                      and 8.12 (SMA-168).
8.11(i)(1).........................  Notification to                 10            1          .25           2.5
                                      SAMHSA Before
                                      Establishing
                                      Medication Units
                                      (SMA-162).
8.12(j)(2).........................  Notification to State            1           20          .33           6.6
                                      Health Officer When
                                      Patient Begins
                                      Interim Maintenance.
8.24...............................  Contents of Appellant            2            1          .25            .50
                                      Request for Review
                                      of Suspension.
8.25(a)............................  Informal Review                  2            1         1.00           2.00
                                      Request.
8.26(a)............................  Appellant's Review               2            1         5.00          10.00
                                      File and Written
                                      Statement.
8.28(a)............................  Appellant's Request              2            1         1.00           2.00
                                      for Expedited Review.
8.28(c)............................  Appellant Review File            2            1         5.00          10.00
                                      and Written
                                      Statement.
    TOTAL..........................  .....................        1,100                                1,647
----------------------------------------------------------------------------------------------------------------
* This is a one-time requirement that will be fully met during the first three years of approval for the final
  rule.

    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

[[Page 49367]]

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.
    Written comments and recommendations concerning the proposed 
information collection should be sent within 30 days of this notice to: 
Allison Herron Eydt, Human Resources and Housing Branch, Office of 
Management and Budget, New Executive Office Building, Room 10235, 
Washington, DC 20503.

    Dated: July 23, 2002.
Richard Kopanda,
Executive Officer, SAMHSA.
[FR Doc. 02-19167 Filed 7-29-02; 8:45 am]
BILLING CODE 4162-20-P