Request for Information on the HEALing Communities Study: Developing and Testing an Integrated Approach To Address the Opioid Crisis, 30756-30757 [2018-14031]
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Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
OUD. Opioids include prescription and
illicit opioids, such as heroin, illicitly
manufactured fentanyl, and related
National Institutes of Health
analogs. OUD refers to the clinical
diagnosis defined in the Diagnostic and
Request for Information on the
Statistical Manual of Mental Disorders,
HEALing Communities Study:
Fifth Edition (DSM–5).
Developing and Testing an Integrated
Problem Statement: Despite the
Approach To Address the Opioid
availability of multiple effective
Crisis
evidence-based interventions and
practices, most Americans at risk for or
AGENCY: National Institutes of Health;
suffering from an OUD do not receive
Substance Abuse and Mental Health
appropriate prevention and treatment
Services Administration, HHS.
services. Simultaneously, opioid
ACTION: Notice.
overdose rates continue to increase.
NIDA, in partnership with SAMHSA,
SUMMARY: This Request for Information
is exploring options for conducting a
(RFI) is intended to gather broad public
multi-site national research effort in up
input on the conduct of a multi-site
to three communities to develop and
national research effort to develop and
test approaches for the systematic
test approaches for the systematic
implementation and sustainability of an
implementation and sustainability of an
integrated set of evidence-based
integrated set of evidence-based
interventions across healthcare,
interventions across healthcare,
behavioral health, justice systems, state
behavioral health, justice systems, state
and local governments, and community
and local governments, and community
organizations to prevent and treat
organizations to prevent and treat
opioid misuse and OUD. The goals are
opioid misuse and Opioid Use Disorders
to decrease fatal and non-fatal
(OUD). The goals are to decrease fatal
overdoses, decrease the incidence of
and non-fatal overdoses, decrease the
OUD and related infectious diseases
incidence of OUD and related infectious
(e.g., Hepatitis C and HIV), increase the
diseases (e.g., Hepatitis C and HIV),
number of individuals receiving
increase the number of individuals
medication-assisted treatment (MAT),
receiving medication-assisted treatment
increase the proportion retained in
(MAT), increase the proportion retained
treatment beyond 6 months, and
in treatment beyond 6 months, and
increase the number of individuals
increase the number of individuals
receiving needed recovery support
receiving needed recovery support
services. This research would be a part
services.
of the NIH Helping to End Addiction
DATES: The RFI is open for public
Long-term (HEAL) Initiative (https://
comment for a period of 21 days.
www.nih.gov/research-training/medicalComments must be received by July 20,
research-initiatives/heal-initiative).
2018 to ensure consideration.
Information Requested: This RFI
solicits input from the extramural
ADDRESSES: Comments must be
research community and public
submitted electronically to the
stakeholders. NIDA and SAMHSA
following email address: OpioidRFI@
especially seek input on study elements
nida.nih.gov.
such as, but not limited to:
FOR FURTHER INFORMATION CONTACT:
Study Design:
Please direct all inquiries to Redonna K.
• How can ‘‘heavily affected
Chandler, Ph.D., National Institute on
communities’’ be defined, including
Drug Abuse; Phone: 301–443–1470;
geospatial/geopolitical definitions to
email: redonna.chandler@nih.gov.
provide consistent boundaries for a
SUPPLEMENTARY INFORMATION: This RFI is multi-site study?
for information and planning purposes
• What research designs might be
only, and should not be construed as a
appropriate to accomplish the overall
solicitation or an obligation on the part
goals of the study?
• How can effect size be estimated
of the federal government, the National
and what effect size might be expected
Institutes of Health (NIH), the National
in relation to candidate outcomes: Rates
Institute on Drug Abuse (NIDA), or the
of non-fatal and fatal overdose;
Substance Abuse and Mental Health
prevalence and incidence of opioid
Services Administration (SAMHSA).
misuse, OUD and Hepatitis C; percent of
NIH does not intend to make any
patients screened for opioid misuse and
awards based on responses to this RFI
OUD and who received a brief
or to otherwise pay for the preparation
intervention or were referred to
of any information submitted or for the
treatment; percent of patients initiated
government’s use of such information.
on MAT and retained in medication
Terminology: This RFI is focused on
treatment beyond 6 months; rates of
the use, misuse, abuse of opioids, and
sradovich on DSK3GMQ082PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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naloxone distribution and overdose
reversals; opioid analgesic and
benzodiazepine prescription rates; and
implementation of prevention
programs?
• What baseline data should be
captured, what are potential existing
sources for this data, and what
challenges might exist with quality of
existing data?
• How long would an integrated set of
evidence-based interventions need to be
in place before expecting a meaningful
change in outcomes, and which
combination of interventions should be
implemented in communities with
different characteristics?
• What confounding variables need to
be considered?
• What are potential threats to
internal and external study validity and
what strategies could be deployed to
mitigate threats?
• Are there particular strategies that
can help the Coordinating Center
overcome barriers to the facilitation of
collaboration and coordination activities
across Research Centers with regard to
data harmonization, collection,
integration, cleaning, analyses, and
creating datasets for sharing with the
research community at large?
Outcomes:
• What target metrics would be
feasible for outcomes? Candidate
outcomes could include, but are not
limited to those listed above: Rates of
non-fatal and fatal overdose; prevalence
and incidence of opioid misuse, OUD
and Hepatitis C; percent of patients
screened for opioid misuse and OUD
and who received a brief intervention or
were referred to treatment; percent of
patients initiated on MAT and retained
in medication treatment beyond 6
months; rates of naloxone distribution
and overdose reversals; opioid analgesic
and benzodiazepine prescription rates;
and implementation of prevention
programs?
• What is the best way to gather
reliable data related to candidate
outcomes listed above?
• What are essential interventions for
an evidence-based integrated approach
to opioid prevention and treatment
services, including policies and
practices?
• How could ‘‘evidence-based or
evidence-informed’’ be defined?
• How can fidelity to an evidencebased integrated approach to opioid
prevention and treatment services,
including policies and practices be
measured?
• What strategies and resources
would be necessary, including training
and technical assistance, to have
meaningful penetration of the evidence-
E:\FR\FM\29JNN1.SGM
29JNN1
sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 126 / Friday, June 29, 2018 / Notices
based integrated approach to opioid
prevention and treatment services in a
single community?
Health Economics:
• What economic questions should be
included as part of the study to inform
systems and policy change?
Implementation Research:
• What implementation research
questions should be included to develop
best practices for replication in other
communities impacted by the opioid
crisis?
• What data should be collected to
help develop metrics for determining
the quality of an integrated approach to
opioid prevention and treatment
services, including policies and
practices?
• Are there examples of prior
implementation research studies that
highlight implementation tools that can
be used to replicate and scale up
integrated approaches?
Infrastructure, Partnerships,
Collaboration:
• What research, prevention, and
treatment infrastructure and
partnerships are needed to support a
community-based pragmatic trial
assessing the impact of an evidencebased integrated approach to opioid
prevention and treatment services?
• What is the best approach to
fostering collaboration and meaningful
participation between state, county, and
local governments; community
stakeholders; medical/clinical service
providers; and researchers?
• How do we construct a research
initiative with the highest likelihood of
having sustainable prevention and
treatment services?
• What data would be of most interest
to state and community partners?
Responses to this RFI are voluntary
and may be submitted anonymously.
Please do not include any personally
identifiable or other information that
you do not wish to make public.
Proprietary, classified, confidential, or
sensitive information should not be
included in responses. Comments
submitted will be compiled for
discussion and shared internally with
NIDA, SAMHSA, NIH program staff,
and participating leadership across the
Department of Health and Human
Services, as appropriate. Any personal
identifiers (personal names, email
addresses, etc.) will be removed when
responses are compiled.
This RFI is for informational and
planning purposes only and is not a
solicitation for applications or an
obligation on the part of the United
States Government to provide support
for any ideas identified in response to
it. Please note that the United States
VerDate Sep<11>2014
17:58 Jun 28, 2018
Jkt 244001
Government will not pay for the
preparation of any information
submitted or for use of that information.
Dated: June 25, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018–14031 Filed 6–28–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; T1D NIDDK Review.
Date: June 29, 2018.
Time: 9:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Elena Sanovich, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7351, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, 301–594–8886,
sanoviche@mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK–17–021:
HIRN Consortium on Beta Cell Death and
Survival Early T1D Biomarkers Discovery in
Human Pancreas.
Date: July 23, 2018.
Time: 11:00 a.m. to 4:00 p.m.
Agenda: To review and evaluate
cooperative agreement applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
PO 00000
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Contact Person: Najma S. Begum, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7349, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–8894,
begumn@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; T1D Clinical Trials
Testing Current and Novel Closed Loop
Systems (R01).
Date: July 24, 2018.
Time: 3:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Jason D. Hoffert, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7343, 6707 Democracy Boulevard,
Bethesda, MD 20817, 301–496–9010,
hoffertj@niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; RFA–DK–17–020:
Immune System Engineering for Targeted
Tolerance in Type 1 Diabetes (R01).
Date: July 25, 2018.
Time: 11:00 a.m. to 4:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Dianne Camp, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7013, 6707 Democracy Boulevard,
Bethesda, MD 20892–2542, 301–594–7682,
campd@extra.niddk.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; SBIR Phase II
Clinical Trials.
Date: July 26, 2018.
Time: 11:00 a.m. to 1:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Thomas A. Tatham, Ph.D.,
Scientific Review Officer, Review Branch,
DEA, NIDDK, National Institutes of Health,
Room 7021, 6707 Democracy Boulevard,
Bethesda, MD 20892–5452, (301) 594–3993,
tathamt@mail.nih.gov.
Name of Committee: National Institute of
Diabetes and Digestive and Kidney Diseases
Special Emphasis Panel; PAR–18–042:
NIDDK Ancillary Studies (R01).
Date: July 26, 2018.
Time: 11:30 a.m. to 1:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, Two
Democracy Plaza, 6707 Democracy
Boulevard, Bethesda, MD 20892 (Telephone
Conference Call).
Contact Person: Ann A. Jerkins, Ph.D.,
Scientific Review Officer, Review Branch,
E:\FR\FM\29JNN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 126 (Friday, June 29, 2018)]
[Notices]
[Pages 30756-30757]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-14031]
[[Page 30756]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Request for Information on the HEALing Communities Study:
Developing and Testing an Integrated Approach To Address the Opioid
Crisis
AGENCY: National Institutes of Health; Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This Request for Information (RFI) is intended to gather broad
public input on the conduct of a multi-site national research effort to
develop and test approaches for the systematic implementation and
sustainability of an integrated set of evidence-based interventions
across healthcare, behavioral health, justice systems, state and local
governments, and community organizations to prevent and treat opioid
misuse and Opioid Use Disorders (OUD). The goals are to decrease fatal
and non-fatal overdoses, decrease the incidence of OUD and related
infectious diseases (e.g., Hepatitis C and HIV), increase the number of
individuals receiving medication-assisted treatment (MAT), increase the
proportion retained in treatment beyond 6 months, and increase the
number of individuals receiving needed recovery support services.
DATES: The RFI is open for public comment for a period of 21 days.
Comments must be received by July 20, 2018 to ensure consideration.
ADDRESSES: Comments must be submitted electronically to the following
email address: [email protected].
FOR FURTHER INFORMATION CONTACT: Please direct all inquiries to Redonna
K. Chandler, Ph.D., National Institute on Drug Abuse; Phone: 301-443-
1470; email: [email protected].
SUPPLEMENTARY INFORMATION: This RFI is for information and planning
purposes only, and should not be construed as a solicitation or an
obligation on the part of the federal government, the National
Institutes of Health (NIH), the National Institute on Drug Abuse
(NIDA), or the Substance Abuse and Mental Health Services
Administration (SAMHSA). NIH does not intend to make any awards based
on responses to this RFI or to otherwise pay for the preparation of any
information submitted or for the government's use of such information.
Terminology: This RFI is focused on the use, misuse, abuse of
opioids, and OUD. Opioids include prescription and illicit opioids,
such as heroin, illicitly manufactured fentanyl, and related analogs.
OUD refers to the clinical diagnosis defined in the Diagnostic and
Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
Problem Statement: Despite the availability of multiple effective
evidence-based interventions and practices, most Americans at risk for
or suffering from an OUD do not receive appropriate prevention and
treatment services. Simultaneously, opioid overdose rates continue to
increase.
NIDA, in partnership with SAMHSA, is exploring options for
conducting a multi-site national research effort in up to three
communities to develop and test approaches for the systematic
implementation and sustainability of an integrated set of evidence-
based interventions across healthcare, behavioral health, justice
systems, state and local governments, and community organizations to
prevent and treat opioid misuse and OUD. The goals are to decrease
fatal and non-fatal overdoses, decrease the incidence of OUD and
related infectious diseases (e.g., Hepatitis C and HIV), increase the
number of individuals receiving medication-assisted treatment (MAT),
increase the proportion retained in treatment beyond 6 months, and
increase the number of individuals receiving needed recovery support
services. This research would be a part of the NIH Helping to End
Addiction Long-term (HEAL) Initiative (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative).
Information Requested: This RFI solicits input from the extramural
research community and public stakeholders. NIDA and SAMHSA especially
seek input on study elements such as, but not limited to:
Study Design:
How can ``heavily affected communities'' be defined,
including geospatial/geopolitical definitions to provide consistent
boundaries for a multi-site study?
What research designs might be appropriate to accomplish
the overall goals of the study?
How can effect size be estimated and what effect size
might be expected in relation to candidate outcomes: Rates of non-fatal
and fatal overdose; prevalence and incidence of opioid misuse, OUD and
Hepatitis C; percent of patients screened for opioid misuse and OUD and
who received a brief intervention or were referred to treatment;
percent of patients initiated on MAT and retained in medication
treatment beyond 6 months; rates of naloxone distribution and overdose
reversals; opioid analgesic and benzodiazepine prescription rates; and
implementation of prevention programs?
What baseline data should be captured, what are potential
existing sources for this data, and what challenges might exist with
quality of existing data?
How long would an integrated set of evidence-based
interventions need to be in place before expecting a meaningful change
in outcomes, and which combination of interventions should be
implemented in communities with different characteristics?
What confounding variables need to be considered?
What are potential threats to internal and external study
validity and what strategies could be deployed to mitigate threats?
Are there particular strategies that can help the
Coordinating Center overcome barriers to the facilitation of
collaboration and coordination activities across Research Centers with
regard to data harmonization, collection, integration, cleaning,
analyses, and creating datasets for sharing with the research community
at large?
Outcomes:
What target metrics would be feasible for outcomes?
Candidate outcomes could include, but are not limited to those listed
above: Rates of non-fatal and fatal overdose; prevalence and incidence
of opioid misuse, OUD and Hepatitis C; percent of patients screened for
opioid misuse and OUD and who received a brief intervention or were
referred to treatment; percent of patients initiated on MAT and
retained in medication treatment beyond 6 months; rates of naloxone
distribution and overdose reversals; opioid analgesic and
benzodiazepine prescription rates; and implementation of prevention
programs?
What is the best way to gather reliable data related to
candidate outcomes listed above?
What are essential interventions for an evidence-based
integrated approach to opioid prevention and treatment services,
including policies and practices?
How could ``evidence-based or evidence-informed'' be
defined?
How can fidelity to an evidence-based integrated approach
to opioid prevention and treatment services, including policies and
practices be measured?
What strategies and resources would be necessary,
including training and technical assistance, to have meaningful
penetration of the evidence-
[[Page 30757]]
based integrated approach to opioid prevention and treatment services
in a single community?
Health Economics:
What economic questions should be included as part of the
study to inform systems and policy change?
Implementation Research:
What implementation research questions should be included
to develop best practices for replication in other communities impacted
by the opioid crisis?
What data should be collected to help develop metrics for
determining the quality of an integrated approach to opioid prevention
and treatment services, including policies and practices?
Are there examples of prior implementation research
studies that highlight implementation tools that can be used to
replicate and scale up integrated approaches?
Infrastructure, Partnerships, Collaboration:
What research, prevention, and treatment infrastructure
and partnerships are needed to support a community-based pragmatic
trial assessing the impact of an evidence-based integrated approach to
opioid prevention and treatment services?
What is the best approach to fostering collaboration and
meaningful participation between state, county, and local governments;
community stakeholders; medical/clinical service providers; and
researchers?
How do we construct a research initiative with the highest
likelihood of having sustainable prevention and treatment services?
What data would be of most interest to state and community
partners?
Responses to this RFI are voluntary and may be submitted
anonymously. Please do not include any personally identifiable or other
information that you do not wish to make public. Proprietary,
classified, confidential, or sensitive information should not be
included in responses. Comments submitted will be compiled for
discussion and shared internally with NIDA, SAMHSA, NIH program staff,
and participating leadership across the Department of Health and Human
Services, as appropriate. Any personal identifiers (personal names,
email addresses, etc.) will be removed when responses are compiled.
This RFI is for informational and planning purposes only and is not
a solicitation for applications or an obligation on the part of the
United States Government to provide support for any ideas identified in
response to it. Please note that the United States Government will not
pay for the preparation of any information submitted or for use of that
information.
Dated: June 25, 2018.
Lawrence A. Tabak,
Deputy Director, National Institutes of Health.
[FR Doc. 2018-14031 Filed 6-28-18; 8:45 am]
BILLING CODE 4140-01-P
