[Federal Register Volume 68, Number 148 (Friday, August 1, 2003)]
[Notices]
[Pages 45261-45262]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-19586]


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

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 (301) 443-7978.
    Opioid Drugs in Maintenance and Detoxification Treatment of Opioid 
Addiction--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 
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. Minor changes are being made to 
Form SMA-162 to account for newly approved opioid treatment drugs, to 
provide structures space on the form for required information and to 
make it more compatible with electronic submission.
    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  respondents    response     Total hours
----------------------------------------------------------------------------------------------------------------
8.3(b)(1-11)....................  Initial approval (SMA-              1            1          6.0            6.0
                                   163.
8.3(c)..........................  Renewal of approval (SMA-           2            1          1.0            2.0
                                   163).
8.3(e)..........................  Relinquishment                      1            1          0.5            0.5
                                   notification.
8.3(f)(2).......................  Non-renewal notification            1           90          0.1            9.0
                                   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 for             2           10          1.0           20.0
                                   serious noncompliance.
8.4(d)(1).......................  General documents and               6            5          0.5           15.0
                                   information to SAMHSA
                                   upon request.
8.4(d)(2).......................  Accreditation survey to             6           75          0.02           9.0
                                   SAMHSA upon request.
8.4(d)(3).......................  List of surveys,                    6            6          0.2            7.2
                                   surveyors to SAMHSA
                                   upon request.
8.4(d)(4).......................  Report of less than full            6            5          0.5           15.0
                                   accreditation to SAMHSA.
8.4(d)(5).......................  Summaries of Inspections            6           50          0.5          150.0
8.4(e)..........................  Notifications of                    6            6          0.5           18.0
                                   Complaints.
8.6(a)(2) and (b)(3)............  Revocation notification             1          185          0.3           55.5
                                   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          185          0.3           55.0
                                   accredited OTP's of
                                   Probationary Status.
=================================
----------------------------------------------------------------------------------------------------------------


                   Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
                                                             Number 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 (SMA-      370.00            1         1.00         370
                                   162).

[[Page 45262]]

 
8.11(b).........................  Relocation of Program              35            1         1.17          40.95
                                   (SMA-162).
8.11(d).........................  Application for                     0            0         0              0
                                   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 sponsor            60            1          .1            6.00
                                   or medical director
                                   change (SMA-162).
8.11(g)(2)......................  Documentation to SAMHSA             1            1         1              1.00
                                   for interim maintenance.
8.11(h).........................  Request to SAMHSA for           1,110            7          .152       1181.04
                                   Exemption from 8.11 and
                                   18.12 (SMA-168).
8.11(i)(1)......................  Notification to SAMHSA             10            1          .25           2.5
                                   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 Request.            2            1         1.00           2.00
8.26(a).........................  Appellant's Review File             2            1         5.00          10.00
                                   and Written Statement.
8.28(a).........................  Appellant's Request for             2            1         1.00           2.00
                                   Expedited Review.
8.28(c).........................  Appellant Review File               2            1         5.00          10.00
                                   and Written Statement.
=================================
----------------------------------------------------------------------------------------------------------------
* This is a one-time requirement that was 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 
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; due to potential delays in OMB's receipt and 
processing of mail sent through the U.S. Postal Service, respondents 
are encouraged to submit comments by fax to: 202-395-6974.

    Dated: July 25, 2003.
Anna Marsh,
Acting Executive Officer, SAMHSA.
[FR Doc. 03-19586 Filed 7-31-03; 8:45 am]
BILLING CODE 4162-20-P