[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Notices]
[Pages 16516-16518]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-06029]
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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 (240) 276-1243.
Project: Opioid Drugs in Maintenance and Detoxification Treatment of
Opioid Dependence--42 CFR Part 8 and Opioid Treatment Programs (OTPs)
(OMB No. 0930-0206)--Revision
42 CFR part 8 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.
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
[[Page 16517]]
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.
There are no changes being made to the forms. The reason for the
reduction in burden hours is due to more respondents submitting
information through an online function. The forms are available online
with a unique feature for both the SMA-162 and SMA-168 that pre-
populates certain information within the form. This in turn reduces the
program's time spent filling out the forms as well as the staff time
spent on processing it. Also, a final rule effective January 7, 2013,
(77 FR 72752, Federal Register December 6, 2012) eliminated dispensing
restrictions for buprenorphine products used in OTPs. As a result there
OTPs will complete and submit fewer SMA-168 forms, therefore reducing
burden hours.
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/ Total Hours/ Total
42 CFR citation Purpose respondents respondent responses response hours
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8.3(b)(1-11).................................. Initial approval (SMA-163)....... 1 1 1 6.0 6
8.3(c)........................................ Renewal of approval (SMA-163).... 2 1 2 1.0 2
8.3(e)........................................ Relinquishment notification...... 1 1 1 0.5 0.5
8.3(f)(2)..................................... Non-renewal notification to 1 90 90 0.1 9
accredited OTPs.
8.4(b)(1)(ii)................................. Notification to SAMHSA for 2 2 4 1.0 4
seriously noncompliant OTPs.
8.4(b)(1)(iii)................................ Notification to OTP for serious 2 10 20 1.0 20
noncompliance.
8.4(d)(1)..................................... General documents and information 6 5 30 0.5 15
to SAMHSA upon request.
8.4(d)(2)..................................... Accreditation survey to SAMHSA 6 75 450 0.02 9
upon request.
8.4(d)(3)..................................... List of surveys, surveyors to 6 6 36 0.2 7.2
SAMHSA upon request.
8.4(d)(4)..................................... Report of less than full 6 5 30 0.5 15
accreditation to SAMHSA.
8.4(d)(5)..................................... Summaries of Inspections......... 6 50 300 0.5 150
8.4(e)........................................ Notifications of Complaints...... 12 6 72 0.5 36
8.6(a)(2) and (b)(3).......................... Revocation notification to 1 185 185 0.3 55.5
Accredited OTPs.
8.6(b)........................................ Submission of 90-day corrective 1 1 1 10 10.0
plan to SAMHSA.
8.6(b)(1)..................................... Notification to accredited OTPs 1 185 185 0.3 55.0
of Probationary Status.
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Sub Total................................. ................................. 54 .............. 1,407 ........... 394.20
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Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
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Number of Responses/ Total Hours/
42 CFR citation Purpose respondents respondent responses response Total hours
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8.11(b)....................................... Renewal of approval (SMA-162).... 386 1 386 0.15 57.9
8.11(b)....................................... Relocation of Program (SMA-162).. 35 1 35 1.17 40.95
8.11(e)(1).................................... Application for provisional 42 1 42 1 42.00
certification.
8.11(e)(2).................................... Application for extension of 30 1 30 0.25 7.50
provisional certification.
8.11(f)(5).................................... Notification of sponsor or 60 1 60 0.1 6.00
medical director change (SMA-
162).
8.11(g)(2).................................... Documentation to SAMHSA for 1 1 1 1 1.00
interim maintenance.
8.11(h)....................................... Request to SAMHSA for Exemption 1,200 20 24,000 0.07 1680
from 8.11 and 8.12 (including
SMA-168).
8.11(i)(1).................................... Notification to SAMHSA Before 10 1 10 0.25 2.5
Establishing Medication Units
(SMA-162).
8.12(j)(2).................................... Notification to State Health 1 20 20 0.33 6.6
Officer When Patient Begins
Interim Maintenance.
8.24.......................................... Contents of Appellant Request for 2 1 2 0.25 .50
Review of Suspension.
8.25(a)....................................... Informal Review Request.......... 2 1 2 1.00 2.00
8.26(a)....................................... Appellant's Review File and 2 1 2 5.00 10.00
Written Statement.
8.28(a)....................................... Appellant's Request for Expedited 2 1 2 1.00 2.00
Review.
8.28(c)....................................... Appellant Review File and Written 2 1 2 5.00 10.00
Statement.
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Sub Total................................. ................................. 1,775 .............. 24,594 ........... 1868.95
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Total................................. ................................. 1,829 .............. 26,001 ........... 2,263.15
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[[Page 16518]]
Written comments and recommendations concerning the proposed
information collection should be sent by April 15, 2013 to the SAMHSA
Desk Officer at the Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB). To ensure timely receipt of
comments, and to avoid potential delays in OMB's receipt and processing
of mail sent through the U.S. Postal Service, commenters are encouraged
to submit their comments to OMB via email to: [email protected]. Although commenters are encouraged to send
their comments via email, commenters may also fax their comments to:
202-395-7285. Commenters may also mail them to: Office of Management
and Budget, Office of Information and Regulatory Affairs, New Executive
Office Building, Room 10102, Washington, DC 20503.
Summer King,
Statistician.
[FR Doc. 2013-06029 Filed 3-14-13; 8:45 am]
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