[Federal Register Volume 67, Number 77 (Monday, April 22, 2002)]
[Notices]
[Pages 19578-19580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-9725]


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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

[[Page 19579]]

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, 
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 will 
seek continued approval of the information collection requirements in 
the regulation and of three 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) and the Application for Approval as Accreditation Body Under 42 
CFR 8.3(b) (Form SMA-163). SAMHSA plans to also seek 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
----------------------------------------------------------------------------------------------------------------
                                                               Number of    Responses/     Hours/
           42 CFR citation                    Purpose         respondents   respondent    response   Total hours
----------------------------------------------------------------------------------------------------------------
8.3(b)(1-11)........................  Initial approval (SMA-            3            1          3.0          9.0
                                       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(b)(1)(ii).......................  Notification to SAMHSA            2            2          1.0          4.0
                                       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           50         0.02          7.0
                                       to SAMHSA upon
                                       request.
8.4(d)(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 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...........................  ......................           10  ...........  ...........          299
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                   Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
                                                               Number of    Responses/     Hours/
           42 CFR Citation                    Purpose         respondents   respondent    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           800            3         .417      1000.80
                                       Exemption from 8.11
                                       and 8.12 (SMA-168).
8.11(i)(1)..........................  Notification to SAMHSA            3            1          .25          .75
                                       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.

[[Page 19580]]

 
8.28 (c)............................  Appellant Review File             2            1         5.00        10.00
                                       and Written Statement.
                                                             ---------------------------------------------------
    Total...........................  ......................        1,100  ...........  ...........       1,643
----------------------------------------------------------------------------------------------------------------
* 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: April 16, 2002.
Richard Kopanda,
Executive Officer, Substance Abuse and Mental Health Services 
Administration.
[FR Doc. 02-9725 Filed 4-19-02; 8:45 am]
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