[Federal Register: March 28, 2003 (Volume 68, Number 60)]
[Notices]
[Page 15215-15216]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28mr03-91]
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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
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Number of Responses/
42 CFR citation Purpose respondents respondent Hours/response Total hours
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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
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Number of Responses/
42 CFR citation Purpose respondents respondent Hours/response Total hours
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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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