Agency Information Collection Activities: Submission for OMB Review; Comment Request, 40075-40077 [2019-17261]
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Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices
• A description of the
accomplishments resulting from such
activities;
• A description of systems to protect
and advocate the rights of individuals
with mental illness supported with
payments from PAIMI Program
allotments;
• A description of activities
conducted by States to protect and
advocate such rights;
• A description of mechanisms
established by residential facilities for
individuals with mental illness to
protect such rights;
• A description of the coordination
among such systems, activities and
mechanisms;
• Specification of the number of
public and nonprofit P&A systems
established with PAIMI Program
allotments; and
• Recommendations for activities and
services to improve the protection and
advocacy of the rights of individuals
with mental illness and a description of
the need for such activities and services
that were not met by the state P&A
systems established under the PAIMI
Act due to resource or annual program
priority limitations.
Each PAIMI grantee’s annual PPR
must include a separate section,
prepared by its PAIMI Advisory Council
(PAC), that describes the council’s
activities and its assessment of the state
P&A system’s operations per the PAIMI
Act at 42 U.S.C. 10805(7).
In 2017, SAMHSA included the
annual PAIMI PPR in the Web-based
Block Grant Application System
(WebBGAS). WebBGAS, SAMHSAs
electronic data system, is used to collect
grantee information for the following
reasons:
(1) To meet the OMB requirements for
data collection for mandatory (formula)
grant programs;
(2) To comply with the annual
program reporting requirements of the
PAIMI Act 42 U.S.C. 10801 et seq. and
the PAIMI Rules 42 CFR, Part 51;
(3) To simplify the submission of
PAIMI program data by the state P&A
systems;
(4) To meet the Government
Performance Results Act (GPRA)
requirements;
(5) To comply with the Government
Accountability Office (GAO) evaluation
recommendations that SAMHSA obtain
information that closely measures the
actual outcomes of the programs it
funds;
(6) To reduce the grantee data
collection burden by removing
information that did not facilitate
evaluation of a PAIMI grantee’s
programmatic and financial
management systems;
(7) To provide immediate access to
the PAIMI program data used to prepare
a section of the Secretary’s biennial
report to the President, Congress, and
National Council on Disability in
accordance with the Developmental
Disabilities Assistance Act of 2000 at 42
U.S.C. 15005. Reports of the Secretary;
(8) To improve SAMHSA’s ability to
create reports, analyze trends and
provide timely feedback to the P&A
grantees when PPR revisions are
needed.
On July 17, 2017, OMB approved
SAMHSA’s PPR and Advisory Council
Report (Control No. 0930–0169,
Expiration Date July 31, 2020). The
burden estimate for the annual State
P&A system reporting requirements for
these regulations is as follows:
42 CFR citation
Number of
respondents
Responses
per
respondent
Burden/
response
(hrs.)
Total hour
burden
51.8(a)(2) Program Performance Report 1 ......................................................
51.8(8)(a)(8) Advisory Council Report * ...........................................................
51.10 Remedial Actions: Corrective Action Plans & Implementation
Status Reports.
51.23(c) Reports, materials and fiscal data provided to the Advisory Council
51.25(b)(3) Grievance Procedure ....................................................................
51.43 Written denial of access by P&A system ** ...........................................
........................
........................
5
5
57
57
........................
........................
........................
2
3
1
1
........................
........................
........................
8
2
1
0.5
........................
........................
........................
80
30
57
28.5
........................
Total ..........................................................................................................
57
........................
11.5
195.5
jspears on DSK3GMQ082PROD with NOTICES
Note: Burden for the annual application [42 CFR 51.5(b–d)] is approved at a standard level per application under OMB control number 0920–
0428.
* Responses and burden hours associated with these reports are approved under OMB No. 0930–0169.
** There is no burden estimate associated with this program provision. State P&A systems report that when a facility denies a P&A system access to the facility, a client, or records, the P&A attempts to resolve the dispute through negotiation, conciliation, mediation, and other non-adversarial techniques. Only after exhausting the non-legal remedies provided under state and federal laws will a P&A system file a formal complaint
in the appropriate federal district court. See also, the PAIMI Act at 42 U.S.C. 10807(a)—Legal Actions and the PAIMI Final Rule at 42 CFR
51.32—Resolving Disputes.
Written comments and
recommendations concerning the
proposed information collection should
be sent by September 12, 2019 to the
SAMHSA Desk Officer at the Office of
Information and Regulatory Affairs,
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:
OIRA_Submission@omb.eop.gov.
Although commenters are encouraged to
send their comments via email,
commenters may also fax their
VerDate Sep<11>2014
17:51 Aug 12, 2019
Jkt 247001
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. 2019–17263 Filed 8–12–19; 8:45 am]
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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
E:\FR\FM\13AUN1.SGM
13AUN1
40076
Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices
documents, call the SAMHSA Reports
Clearance Officer on (240) 276–1112.
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: 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 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.
The tables that follow summarize the
annual reporting burden associated with
the regulation, including burden
associated with the forms. There are no
changes being made to the forms.
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR ACCREDITATION BODIES
Purpose
8.3(b)(1–11) ........
8.3(c) ..................
8.3(e) ..................
8.3(f)(2) ...............
Initial approval (SMA–163) .................
Renewal of approval (SMA–163) ........
Relinquishment notification .................
Non-renewal notification to accredited
OTPs.
Notification to SAMHSA for seriously
noncompliant OTPs.
Notification to OTP for serious noncompliance.
General documents and information
to SAMHSA upon request.
Accreditation survey to SAMHSA
upon request.
List of surveys, surveyors to SAMHSA
upon request.
Report of less than full accreditation
to SAMHSA.
Summaries of Inspections ..................
Notifications of Complaints .................
Revocation notification to Accredited
OTPs.
Submission of 90-day corrective plan
to SAMHSA.
Notification to accredited OTPs of
Probationary Status.
8.4(b)(1)(ii) ..........
8.4(b)(1)(iii) .........
8.4(d)(1) ..............
8.4(d)(2) ..............
8.4(d)(3) ..............
8.4(d)(4) ..............
8.4(d)(5) ..............
8.4(e) ..................
8.6(a)(2) and
(b)(3).
8.6(b) ..................
8.6(b)(1) ..............
Subtotal .......
jspears on DSK3GMQ082PROD with NOTICES
Number of
respondents
42 CFR citation
.............................................................
Responses/
respondent
Total
responses
Hours/
response
Total
hours
1
2
1
1
1
1
1
90
1
2
1
90
6.0
1.0
0.5
0.1
6
2
0.5
9
2
2
4
1.0
4
2
10
20
1.0
20
6
5
30
0.5
15
6
75
450
0.02
9
6
6
36
0.2
7.2
6
5
30
0.5
15
6
12
1
50
6
185
300
72
185
0.5
0.5
0.3
150
36
55.5
1
1
1
10
10.0
1
185
185
0.3
55.0
54
........................
1,407
........................
394.20
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS
Number of
respondents
42 CFR citation
Purpose
8.11(b) ................
8.11(b) ................
Renewal of approval (SMA–162) ........
Relocation of Program (SMA–162) .....
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Responses/
respondent
386
35
Fmt 4703
Sfmt 4703
Total
responses
1
1
E:\FR\FM\13AUN1.SGM
386
35
13AUN1
Hours/
response
0.15
1.17
Total
hours
57.9
40.95
40077
Federal Register / Vol. 84, No. 156 / Tuesday, August 13, 2019 / Notices
ESTIMATED ANNUAL REPORTING REQUIREMENT BURDEN FOR OPIOID TREATMENT PROGRAMS—Continued
Purpose
8.11(e)(1) ............
8.11(e)(2) ............
Application for provisional certification
Application for extension of provisional certification.
Notification of sponsor or medical director change (SMA–162).
Documentation to SAMHSA for interim maintenance.
Request to SAMHSA for Exemption
from 8.11 and 8.12 (including
SMA–168).
Notification to SAMHSA Before Establishing Medication Units (SMA–162).
Notification to State Health Officer
When Patient Begins Interim Maintenance.
Contents of Appellant Request for Review of Suspension.
Informal Review Request ....................
Appellant’s Review File and Written
Statement.
Appellant’s Request for Expedited Review.
Appellant Review File and Written
Statement.
8.11(f)(5) .............
8.11(g)(2) ............
8.11(h) ................
8.11(i)(1) .............
8.12(j)(2) .............
8.24 .....................
8.25(a) ................
8.26(a) ................
8.28(a) ................
8.28(c) ................
Responses/
respondent
Total
responses
Hours/
response
Total
hours
42
30
1
1
42
30
1
0.25
42.00
7.50
60
1
60
0.1
6.00
1
1
1
1
1.00
1,200
20
24,000
0.07
1,680
10
1
10
0.25
2.5
1
20
20
0.33
6.6
2
1
2
0.25
.50
2
2
1
1
2
2
1.00
5.00
2.00
10.00
2
1
2
1.00
2.00
2
1
2
5.00
10.00
Subtotal .......
.............................................................
1,775
........................
24,594
........................
1,868.95
Total .....
.............................................................
1,829
........................
26,001
........................
2,263.15
Written comments and
recommendations concerning the
proposed information collection should
be sent by September 12, 2019 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:
OIRA_Submission@omb.eop.gov.
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.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
establish policy, direct program
activities, and better allocate resources.
Substance Abuse and Mental Health
Services Administration
2020 NSDUH Main Study
Summer King,
Statistician.
The National Survey on Drug Use and
Health (NSDUH) is a survey of the U.S.
civilian, non-institutionalized
population aged 12 years old or older.
The data are used to determine the
prevalence of use of tobacco products,
alcohol, illicit substances, and illicit use
of prescription drugs. The results are
used by SAMHSA, the Office of
National Drug Control Policy (ONDCP),
federal government agencies, and other
organizations and researchers to
[FR Doc. 2019–17261 Filed 8–12–19; 8:45 am]
BILLING CODE 4162–20–P
jspears on DSK3GMQ082PROD with NOTICES
Number of
respondents
42 CFR citation
VerDate Sep<11>2014
17:51 Aug 12, 2019
Jkt 247001
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) 276–1112.
Project: 2020 National Survey on Drug
Use and Health, Clinical Validation
Study and Redesign Field Test (OMB
No. 0930–0110)—Revision to 2019
NSDUH Collection
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
NSDUH must be updated periodically
to reflect changing substance use and
mental health issues and to continue
producing current data. For the 2020
NSDUH main study the following
changes from 2019 are planned: (1) The
addition of lifetime and recency
questions about vaping anything and
vaping nicotine or tobacco; the addition
of lifetime and recency questions on
synthetic marijuana and synthetic
stimulants; (2) the addition of questions
in concordance with the Diagnostic and
Statistical Manual of Mental Disorders
(DSM), fifth edition criteria (DSM–5) to
measure the occurrence of marijuana
withdrawal symptoms, occurrence of
prescription tranquilizer misuse
withdrawal symptoms and occurrence
of craving for all substances; (3) minor
revisions to the marijuana marketplace
module; and (4) other minor wording
changes to improve the flow of the
interview, increase respondent
comprehension or to be consistent with
text in other questions.
By including these new questions in
NSDUH, estimates may be generated on
the use of these substances among the
general population and allow SAMHSA
to provide national-level estimates
among adults and adolescents on the
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]]>Agencies
[Federal Register Volume 84, Number 156 (Tuesday, August 13, 2019)]
[Notices]
[Pages 40075-40077]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-17261]
-----------------------------------------------------------------------
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
[[Page 40076]]
documents, call the SAMHSA Reports Clearance Officer on (240) 276-1112.
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 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.
The tables that follow summarize the annual reporting burden
associated with the regulation, including burden associated with the
forms. There are no changes being made to the forms.
Estimated Annual Reporting Requirement Burden for Accreditation Bodies
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/
42 CFR citation Purpose respondents respondent responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 6 5 30 0.5 15
information 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.
-------------------------------------------------------------------------------
Subtotal.......................... ................................ 54 .............. 1,407 .............. 394.20
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Requirement Burden for Opioid Treatment Programs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours/
42 CFR citation Purpose respondents respondent responses response Total hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
[[Page 40077]]
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 1,680
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 2 1 2 0.25 .50
for 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 2 1 2 1.00 2.00
Expedited Review.
8.28(c)............................... Appellant Review File and 2 1 2 5.00 10.00
Written Statement.
-------------------------------------------------------------------------------
Subtotal.......................... ................................ 1,775 .............. 24,594 .............. 1,868.95
-------------------------------------------------------------------------------
Total......................... ................................ 1,829 .............. 26,001 .............. 2,263.15
--------------------------------------------------------------------------------------------------------------------------------------------------------
Written comments and recommendations concerning the proposed
information collection should be sent by September 12, 2019 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. 2019-17261 Filed 8-12-19; 8:45 am]
BILLING CODE 4162-20-P
