Agency Information Collection Activities: Proposed Collection; Comment Request, 41494 [2021-16402]
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41494
Federal Register / Vol. 86, No. 145 / Monday, August 2, 2021 / Notices
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 (SAMHSA)
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 (240) 276–
0361.
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) and
Opioid Treatment Programs (OTPs)—
Extension
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),
Number of
respondents
Form
Responses/
respondent
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: 5year 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 tables that follows summarizes
the annual reporting burden associated
with the regulation, including burden
associated with the forms. There are no
changes being made to the forms.
Total
responses
Hours/
response
Total hours
Estimated Annual Reporting Requirement Burden for Accreditation Bodies
SMA–163 .............................................................................
54
26.055
1,407
0.28
394
khammond on DSKJM1Z7X2PROD with NOTICES
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
SMA–162 .............................................................................
SMA–168 .............................................................................
651.33
1,302.67
17.976
17.977
11,708.91
23,418.09
Subtotal .........................................................................
1,954
17.977
35,127
0.08
2,902
Total .......................................................................
........................
........................
36,534
........................
3,296
Send comments to Carlos Graham,
SAMHSA Reports Clearance Officer,
Room 15–E57A, 5600 Fishers Lane,
Rockville, MD 20850 OR email him a
copy at carlos.graham@samhsa.hhs.gov.
Written comments should be received
within 60 days of this notice.
Carlos Graham,
Statistician.
[FR Doc. 2021–16402 Filed 7–30–21; 8:45 am]
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]]>Agencies
[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Page 41494]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-16402]
[[Page 41494]]
-----------------------------------------------------------------------
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 (SAMHSA) 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 (240) 276-0361.
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) and
Opioid Treatment Programs (OTPs)--Extension
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 attendance, and
documentation of physiologic dependence.
The tables that follows summarizes the annual reporting burden
associated with the regulation, including burden associated with the
forms. There are no changes being made to the forms.
----------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/
Form respondents respondent responses response Total hours
----------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Requirement Burden for Accreditation Bodies
----------------------------------------------------------------------------------------------------------------
SMA-163......................... 54 26.055 1,407 0.28 394
----------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
----------------------------------------------------------------------------------------------------------------
SMA-162......................... 651.33 17.976 11,708.91
SMA-168......................... 1,302.67 17.977 23,418.09
-------------------------------------------------------------------------------
Subtotal.................... 1,954 17.977 35,127 0.08 2,902
-------------------------------------------------------------------------------
Total................... .............. .............. 36,534 .............. 3,296
----------------------------------------------------------------------------------------------------------------
Send comments to Carlos Graham, SAMHSA Reports Clearance Officer,
Room 15-E57A, 5600 Fishers Lane, Rockville, MD 20850 OR email him a
copy at [email protected]. Written comments should be
received within 60 days of this notice.
Carlos Graham,
Statistician.
[FR Doc. 2021-16402 Filed 7-30-21; 8:45 am]
BILLING CODE 4162-20-P
