[Federal Register Volume 68, Number 60 (Friday, March 28, 2003)]
[Notices]
[Pages 15215-15216]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7458]


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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 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 (301) 443-7978.
    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, no change)--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 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.
    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 (SMA-163).............               2               1             3.0             6.0
8.3(c).........................................  Renewal of approval (SMA-163)..........               2               1             1.0             2.0
8.3(e).........................................  Relinquishment notification............               1               1             0.5             0.5
8.3(f)(2)......................................  Non-renewal notification to accredited                1              90             0.1             9.0
                                                  OTP's.
8.4(b)(1)(ii)..................................  Notification to SAMHSA for seriously                  2               2             1.0             4.0
                                                  noncompliant programs.
8.4 (b)(1)(iii)................................  Notification to OTP for serious                       2               2             1.0             4.0
                                                  noncompliance.
8.4(d)(1)......................................  General documents and information to                  7               4             0.5            14.0
                                                  SAMHSA upon request.
8.4(d)(2)......................................  Accreditation survey to SAMHSA upon                   7              53            0.02            7.42
                                                  request.
8.4(d)(3)......................................  List of surveys, surveyors to SAMHSA                  7               6             0.2             8.4
                                                  upon request.
8.4(d)(4)......................................  Report of less than full accreditation                7             2.5             0.5            8.75
                                                  to SAMHSA.
8.4(d)(5)......................................  Summaries of Inspections...............               7              50             0.5           175.0
8.4(e).........................................  Notifications of Complaints............               7               5             0.5            17.5
8.6(a)(2) and (b)(3)...........................  Revocation notification to Accredited                 1              50             0.3            15.0
                                                  OTP's.

[[Page 15216]]

 
8.6(b).........................................  Submission of 90-day Corrective plan to               1               1              10            10.0
                                                  SAMHSA.
8.6(b)(1)......................................  Notification to accredited OTP's of                   1              50             0.3            15.0
                                                  Probationary Status.
    Total......................................  .......................................               7  ..............  ..............             297
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                                       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)........................................  New programs approval (SMA-162)........              75               1            1.50          112.50
8.11(b)........................................  Renewal of approval (SMA-162)..........             350               1            1.00          350.00
8.11(b)........................................  Relocation of Program (SMA-162)........              35               1            1.17           40.95
8.11(d)........................................  Application for transitional                          7               1            1.58           11.06
                                                  certification (SMA-162) *.
8.11(e)(1).....................................  Application for provisional                          75               1               1           75.00
                                                  certification.
8.11(e)(2).....................................  Application for extension of                         30               1             .25            7.50
                                                  provisional certification.
8.11(f)(5).....................................  Notification of sponsor or medical                   60               1              .2           12.00
                                                  director change (SMA-162).
8.11(g)(2).....................................  Documentation to SAMHSA for interim                   1               1               1            1.00
                                                  maintenance.
8.11(h)........................................  Request to SAMHSA for Exemption from              1,100               6            .152          1003.2
                                                  8.11 and 8.12 (SMA-168).
8.11(i)(1).....................................  Notification to SAMHSA Before                        10               1             .25             2.5
                                                  Establishing Medication Units (SMA-
                                                  162).
8.12(j)(2).....................................  Notification to State Health Officer                  1              20             .33             6.6
                                                  When Patient Begins Interim
                                                  Maintenance.
8.24...........................................  Contents of Appellant Request for                     2               1             .25             .50
                                                  Review of Suspension.
8.25(a)........................................  Informal Review Request................               2               1            1.00            2.00
8.26(a)........................................  Appellant's Review File and Written                   2               1            5.00           10.00
                                                  Statement.
8.28(a)........................................  Appellant's Request for Expedited                     2               1            1.00            2.00
                                                  Review.
8.28(c)........................................  Appellant Review File and Written                     2               1            5.00           10.00
                                                  Statement.
    Total......................................  .......................................           1,100  ..............  ..............           1,647
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* 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 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.
    Send comments to Nancy Pearce, SAMHSA Reports Clearance Officer, 
Room 16-105, Parklawn Building, 5600 Fishers Lane, Rockville, MD 20857. 
Written comments should be received within 60 days of this notice.

    Dated: March 24, 2003.
Richard Kopanda,
Executive Officer, Substance Abuse and Mental Health Services 
Administration.
[FR Doc. 03-7458 Filed 3-27-03; 8:45 am]
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