[Federal Register: August 1, 2003 (Volume 68, Number 148)]
[Notices]
[Page 45261-45262]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01au03-87]
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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 (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
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Number of Responses/ Hours/
42 CFR citation Purpose respondents respondents response Total hours
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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.
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Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
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Number of Responses/ Hours/
42 CFR citation Purpose respondents respondents response Total hours
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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.
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* 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]
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