HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) - BEACON Center

HEAL Initiative: Integrative Management of Chronic Pain and OUD for Whole Recovery (IMPOWR) - BEACON Center is sponsored by NIH. Establishes centers to support integrated management of chronic pain and opioid use disorder.

Expired RFA-DA-21-029: HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Coordination and Dissemination Center (R24 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute on Drug Abuse ( NIDA ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Mental Health ( NIMH ) National Center for Complementary and Integrative Health ( NCCIH ) Funding Opportunity Title HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Coordination and Dissemination Center (R24 Clinical Trial Optional) R24 Resource-Related Research Projects January 13, 2021 - Notice of Pre-Application Information Webinar and Frequently Asked Questions (FAQs) for RFA-DA-21-029, RFA-DA-21-030, and RFA-MH-21-145.

See Notice NOT-DA-21-026 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity RFA-DA-21-030 - HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required) See Section III. 3.

Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 279, 93.

213, 93. 846, 93. 273, 93.

242 Funding Opportunity Purpose The National Institutes of Health (NIH) intends to establish an Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) network consisting of clinical research centers, which will be supported by a single Coordination and Dissemination center.

This network is intended to create multidisciplinary team science collaborations to develop effective interventions, best models of care for delivery of services, and sustainable implementation strategies for access to quality care for complex patients with chronic pain (CP) and opioid use disorder (OUD) or opioid misuse.

The network will be part of the NIH’s Helping to End Addiction Long-term (HEAL) SM Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management.

This FOA seeks applications for a single Coordination and Dissemination Center for the IMPOWR network.

Key responsibilities include coordination and communication to support the research centers within this network and other HEAL funded projects of relevance to CP and OUD/misuse, data harmonization on common data elements, providing educational infrastructure, stakeholder and patient engagement and information dissemination, and creating novel tool assessments.

This FOA runs in parallel with a companion FOA that seeks applications to develop collaborative research projects on approaches, models, delivery, and implementation of care for co-occurring chronic non-cancer pain and OUD/misuse ( RFA-DA-21-030 ). Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date All applications are due by 5:00 PM local time of applicant organization.

All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s). Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide ,except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV . When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV.

Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII.

Agency Contacts Section VIII. Other Information Part 2. Full Text of Announcement Section I.

Funding Opportunity Description The National Institutes of Health (NIH) intends to establish an Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) network consisting of clinical research centers, which will be supported by a single Coordination and Dissemination center.

This network is intended to create multidisciplinary team science collaborations to develop effective interventions, best models of care for delivery of services, and sustainable implementation strategies for access to quality care for complex patients with chronic pain (CP) and opioid use disorder (OUD) or opioid misuse.

The network will be part of the NIH’s Helping to End Addiction Long-term (HEAL) SM Initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis. The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment and prevention of opioid misuse and opioid use disorder and (2) enhance pain management.

Applicants interested in pursuing research examining comorbid OUD and other health conditions with or without suicide risk are encouraged to respond to NOT-MH-21-005 . This FOA seeks applications for a single Coordination and Dissemination Center for the IMPOWR network.

Key responsibilities include coordination and communication to support the research centers within this network and other HEAL funded projects of relevance to CP and OUD/misuse, data harmonization on common data elements, providing educational infrastructure, stakeholder and patient engagement and information dissemination, and creating novel tool assessments.

This FOA runs in parallel with a companion FOA that seeks applications to develop collaborative research projects on approaches, models, delivery, and implementation of care for co-occurring chronic non-cancer pain and OUD/misuse ( RFA-DA-21-030 ) . The ongoing opioid epidemic and the chronic pain (CP) crisis represent significant public health problems with unmet needs.

The opioid epidemic was fueled by three waves of opioid use: (1) the overprescribing of prescription opioids to manage pain; (2) the increased use of illicit opioids, such as heroin; and (3) the increased number of overdose deaths involving powerful synthetic opioids, like fentanyl.

As a result, an estimated 2 million individuals have an opioid use disorder (OUD), and to date, approximately 450,000 people have died from an overdose involving prescription or illicit opioids. In addition, nearly 10 million Americans misuse opioids, using them differently than prescribed or for the euphoric effects of the drug, which may elevate the risk for developing OUD.

More than 50 million Americans suffer from chronic pain, and approximately 20 million individuals have severe CP that interferes with life or work activities. CP treatment and loss of productivity are estimated to cost $635 billion annually in the United States. Both opioid over-prescribing and restrictions on opioid prescribing have led to unintended consequences for many who have CP.

People with pain may rely on opioids for pain relief in the absence of other effective treatments, and some turn to misuse or to illicit drug use for pain relief as health care professionals reduce or eliminate access to opioids for pain management. In addition, a subset of individuals with OUD may go on to develop acute or chronic pain. As a consequence, too many people suffer from both CP and OUD.

These complex patients often do not respond well to current treatments for pain or OUD, face challenges of stigma, and often have limited or no access to quality care. Evidence-based integrated treatments and models of care that are effective and accessible for patients with co-occurring conditions are urgently needed.

Care for patients who have co-occurring CP and OUD may be further complicated by additional comorbid mental health or substance use disorders. A significant number of individuals self-medicate for pain with alcohol and/or have Alcohol Use Disorder. Furthermore, the prevalence of General Anxiety Disorder and Major Depressive Disorder is high among individuals with co-occurring OUD and CP.

Patients who have co-occurring mental health or substance use diagnoses often have worse pain outcomes and may complicate effective management of comorbid CP and OUD. For this reason, the development of integrated treatments, integrated care delivery models, and implementation strategies should not ignore these comorbidities and opportunities may exist to attend to these psychiatric comorbidities in order to treat the whole patient.

Health care services for patients with both CP and OUD are fragmented in the United States. Providers in pain clinics and primary care clinics have evidence-based pain management treatments for patients with CP, such as opioid or non-opioid medications, interventional treatments, and non-pharmacological pain management strategies.

They also have tools to assess and monitor patient responses to opioid analgesics, compliance with treatment agreements to assure safe and effective opioid prescription use, and monitor behaviors indicative of misuse while managing their pain. However, if a patient exhibits opioid misuse, the patient may be discharged from a pain clinic or a primary care clinic and referred to substance use or OUD treatment programs.

While skilled at treating OUD, these programs often lack the expertise and resources to manage co-occurring CP. Healthcare providers lack tools and treatment guidelines and therefore, experience great difficulty treating patients with co-occurring CP and OUD. There is limited research on how to effectively and concurrently treat a patient’s CP and OUD.

For example, there is a lack of evidence regarding which medications and/or dosages can be used safely and effectively to treat these patients. There also is a lack of evidence about how best to integrate and dose pharmacotherapies with non-pharmacological behavioral approaches and complementary interventions to treat patients with CP and OUD.

The overall goal of these companion FOAs is to develop, evaluate, disseminate, and implement patient-centered and integrated treatments and models of care that are safe, effective, and accessible to complex patients with both CP and OUD. While challenging, strategies can be pursued to safely and effectively respond to the needs of this complex patient population.

Opportunities exist to leverage the effective treatment modalities targeting CP or OUD alone by integrating them to address the needs of individuals with both conditions. Medications for OUD (MOUDs; e.g. buprenorphine, methadone, and naltrexone) can effectively treat OUD and are often used in combination with behavioral approaches to improve treatment adherence and recovery outcomes.

Pharmacological treatments and complementary medicine approaches such as mindfulness, cognitive behavioral therapy, acupuncture, exercise, and physical therapy can be effective for treating CP. Despite scientific evidence for effectiveness of such approaches for OUD or pain, we have little knowledge of how best to leverage, integrate, and deliver these treatments for co-occurring CP and OUD/misuse.

Access to quality care for many, especially underserved populations, who have CP or OUD presents even greater challenges for care delivery to people with both conditions. Effort is needed to address the barriers that lead to fragmented health care delivery for CP and OUD. Best models for integrated care and best approaches to implementation need to be explored and evaluated to maximize sustained access to quality care.

Bringing together scientists, patients, and practitioners with the appropriate expertise to develop data-driven best practices to manage CP and OUD is an important part of the formula needed to improve the health of this population. This FOA seeks applications for a single Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR) Coordination and Dissemination Center.

This FOA runs in parallel with a companion FOA that seeks applications for multidisciplinary and collaborative research centers to develop, evaluate and implement effective patient-centered and integrated approaches to treat complex patients with CP can OUD and to evaluate best delivery models and implementation strategies for access to quality care (IMPOWR Research Centers: RFA-DA-21-030 ).

The Coordination and Dissemination Center is expected to develop a communication plan, enhance collaboration and coordinate activities across the network and with relevant NIH initiatives (e.g., NOT-MH-21-005 , and other HEAL programs on pain and OUD). The center will develop, evaluate and provide essential shared assessment tools and facilitate harmonization of data collected across the network.

It also will develop and support educational activities in support of the program goals. This initiative encourages innovative, multidisciplinary approaches. This FOA is part of the NIH’s Helping to End Addiction Long-term (HEAL) initiative to speed the development and implementation of scientific solutions to the national opioid public health crisis.

The NIH HEAL Initiative will bolster research across NIH to (1) improve treatment for opioid misuse and addiction and (2) enhance pain management. More information and periodic updates about the HEAL Initiative are available at: https://www. nih.

gov/research-training/medical-research-initiatives/heal-initiative. Network Structure and Objectives The network will support multidisciplinary research centers to develop and evaluate integrated interventions, models of care, and implementation strategies that will provide an evidence base for safe, effective, patient-centered treatments and facilitate access to quality care for individuals who have co-occurring CP and OUD.

To accomplish this objective, NIH intends to establish a network of investigators at multiple sites and with broad expertise in the areas of CP and OUD/misuse treatment and service delivery which are linked together through a central Coordination and Dissemination center that serves to promote collaboration and communication and to provide shared research resources across the network.

Multidisciplinary Research Centers : These programs will be comprised of RM1 centers conducting clinical research and adaptive clinical trials, which would include pragmatic clinical effectiveness, implementation and/or hybrid implementation-effectiveness studies .

In support of these clinical research efforts, research centers must maintain continuous engagement with persons with lived experience (PWLE) or representatives from patient organizations and key stakeholders relevant to the research projects.

Relevant stakeholders, in addition to PWLE, may include, but are not limited to payors, caretakers, health care providers from multiple disciplines, policymakers, advocacy groups, or professional organizations that create clinical care guidelines.

It is expected that awardees will interact extensively with the Coordination and Dissemination center to facilitate and accelerate sharing and dissemination of research resources, protocols, and findings across the network and to appropriate target audiences.

Coordination and Dissemination Center: A single Coordination and Dissemination Center will manage logistics, develop and maintain common data elements, disseminate findings and products generated from the research network to broader audiences, coordinate efforts across and between the network, support educational activities, develop novel tools, and identify areas of synergy and opportunities both within and external to the broader NIH HEAL Initiative, including Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk ( NOT-MH-21-005 ), Pragmatic and Implementation Studies for the Management of Pain to Reduce Opioid Prescribing ( PRISM ), Pain Management Effectiveness Research Network ( ERN ), Back Pain Consortium Research Program ( BACPAC ), and/or Behavioral Research to Improve Medication-Based Treatment ( BRIM ).

Applicants also are encouraged to review a related FOA that will optimize multi-component service delivery interventions for people with OUD and co-occurring conditions ( NOT-MH-21-005 ). Interaction is expected between the IMPOWR network and those from NOT-MH-21-005 and applicants should anticipate the potential for overlapping populations of interests across the studies.

The purpose of the related initiative is to support studies that will test (1) overall effectiveness of multi-component interventions for OUD and co-occurring conditions and (2) examine the relative contribution of constituent components to overall effectiveness. This research will streamline service packages so they only include components that drive clinical improvements for complex conditions.

Studies are to be highly pragmatic and practice relevant, with designs that balance rigor with time-to-practice urgency.

Projects will seek to a) identify constituent components that drive improvements in access, continuity, quality, value, and outcomes of care, for service delivery interventions with previously demonstrated effectiveness as a bundled package; and b) simultaneously test overall effectiveness of the package and its subcomponents, for widely implemented service delivery packages without previously demonstrated effectiveness.

Please review NOT-MH-21-005 for detailed information.

A summary of the synergistic and distinct elements between these inter-related FOAs is provided below: HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Research Centers (RM1 Clinical Trial Required): RFA-DA-21-030 HEAL Initiative: Integrative Management of chronic Pain and OUD for Whole Recovery (IMPOWR): Coordination and Dissemination Center (R24 Clinical Trial Optional) HEAL Initiative: Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk (R01 Clinical Trials Optional): NOT-MH-21-005 Target Patient Population Patients must have CP and OUD/opioid misuse; may have AUD, GAD, MDD Patients must have CP and OUD/opioid misuse; may have AUD, GAD, MDD Patients must have OUD and Mental Health Disorders and/or Suicide; may have CP Identify targeted interventions for both CP and OUD/opioid misuse via: Effectiveness trials of integrated treatments Integrated Care delivery models Implementation strategies for integrating EBPs Provide support to the network, including: Coordination & Communication Stakeholder engagement and information dissemination Research education infrastructure Screening tool development Optimize existing multi-component, evidence based strategies to manage OUD + MH +/- suicide Value each component that drives clinical improvement Optimal sequence of each component IMPOWR research centers, the IMPOWR Coordination and Dissemination center and NOT-MH-21-005 awardees are expected to participate in shared executive committee meetings, which will meet quarterly and an annual in-person 2-day meeting throughout the life of the award.

These meetings provide a forum to discuss (1) research updates; (2) opportunities of synergy and collaboration (e.g., data harmonization, protocol modifications); (3) develop a bidirectional pipeline between the research projects to facilitate practice-based research and improve early identification, intervention effectiveness, service delivery, and optimal components that are driving integrated care delivery for CP and OUD.

It is also expected that IMPOWR research centers, the IMPOWR Coordination and Dissemination center and, NOT-MH-21-005 awardees will participate in workgroups that arise to support synergistic activities across these networks (e.g., publication policy, data policy, stakeholder and patient engagement, biostatistics, and subject recruitment).

Finally, IMPOWR research centers, the IMPOWR Coordination and Dissemination center and NOT-MH-21-005 awardees are expected to participate in break-out sessions with other HEAL programs of relevance to this initiative (e.g., PRISM, ERN, BACPAC, BRIM, etc) at the annual HEAL Investigator meeting.

IMPOWR Coordination and Dissemination Center: Scope of Activities and Purpose Applicants responding to this FOA must carefully review the companion FOA for IMPOWR research centers ( RFA-DA-21-030 ) and NOT-MH-21-005 to understand the full mission of this network. The Coordination and Dissemination center is expected to provide coordination, infrastructure and other supports for the network.

Key responsibilities for the Coordination and Dissemination center include: A. Administrative coordination and communication. Develop a communication strategy across the network and other NIH HEAL programs on pain and OUD, including awardees of Optimizing Multi-Component Service Delivery Interventions for People with Opioid Use Disorder, Co-Occurring Conditions, and/or Suicide Risk ( NOT-MH-21-005 ) .

The strategy should include a bidirectional pipeline between the research projects to facilitate practice-based research and improve early identification, intervention effectiveness, service delivery, and optimal components that will drive integrated care delivery for CP and OUD. Provide logistical support and hosting quarterly executive committee meetings and an annual in-person executive committee meeting throughout the grant award.

The executive committee is composed of research investigators, patient, and stakeholder representatives from each research center, the Coordination and Dissemination center, and awardees from NOT-MH-21-005. These meetings will provide a forum to discuss (1) research updates; (2) share research resources; (3) opportunities of synergy and collaboration (e.g., data harmonization, protocol modifications).

Coordinate trans-network workgroups that arise to support synergistic activities within this network (e.g., publication policy, data policy, biostatistics, and subject recruitment). It is expected that PWLE and stakeholders from each clinical research center will form a subcommittee, which is expected to meet every 6 months.

Provide NIH with quarterly reports on overall network progress related to participant recruitment, enrollment, findings from the clinical research centers within this network, and other progress metrics. Maintain awareness of emerging research findings of relevance to the network, including knowledge of other initiatives funded by the NIH HEAL initiative as well as broader programs supported by NIH/HHS.

The Coordination and Dissemination center should coordinate between research center PIs and investigators from other programs of relevance in the HEAL initiative, including NOT-MH-21-005 , BRIM , ERN , PRISM , and BACPAC .

Since these programs are already in the field, the bidirectional communication between the research centers and these programs is intended to keep abreast of emerging findings, related challenges, actionable solutions, and inform data standards in the field.

It is expected that this center will identify opportunities for synergy and coordinate collaborative efforts accordingly, which may result in regular meetings between PIs funded within this network and PIs from these HEAL programs. Facilitate harmonizing common data elements and any data collection procedures across the research centers within this network and NOT-MH-21-005 , and align with other NIH/HHS initiatives as appropriate.

The network will be required to use the HEAL Pain Core common data elements (CDEs; CP Core CDEs ) and to select from coded HEAL Pain Supplemental CDEs. This effort will begin with a data harmonization meeting in Fall 2021, prior to individual protocol launch for each awarded research center. Facilitate data sharing agreements that align with HEAL data sharing requirements.

C. Patient and stakeholder engagement and information dissemination. Each research center within this network must include PWLE/patient organizations and key stakeholders relevant to their research projects.

Relevant stakeholders, in addition to PWLE/patient organizations, may include, but are not limited to payors, care takers, health care providers from multiple disciplines, policymakers, advocacy groups, or professional organizations that create clinical care guidelines. The Coordination and Dissemination center is expected to translate broader network findings into resources of interest to external stakeholders.

Responsibilities include: Facilitate bidirectional communication and translation between network investigators and external stakeholders. Engage stakeholder communities not formally involved in the network and identifying strategies for assisting those communities in applying insights that emerge from research supported by the awarded research centers within this network.

It is expected that research centers and the Coordination and Dissemination center will interact collaboratively to accomplish this goal. Disseminate protocols, resources, products and information generated by the research centers, including research educational content generated by the Coordination and Dissemination center. Applicants may opt to execute small pilot studies on effective dissemination strategies to meet this goal.

D. Research education infrastructure. Applicants should propose a robust infrastructure of educational activities designed to enhance treatment of concurrent CP and OUD.

User-friendly, and audience-appropriate, educational activities and materials include, but are not limited to: a workshop series on diverse topics of interest relevant to CP, OUD, and attendant psychiatric comorbidities (e.g., AUD, MDD, GAD) aimed at key stakeholders, advanced seminars on methodology, web resources, pocket guidelines, any other products that bridge OUD and CP expertise, or short term educational opportunities (intensive workshops, summer institutes, or visiting scholar programs, etc.).

Educational content on reducing stigma and health disparities in OUD and CP is required. Applicants are encouraged to be thoughtful about competency assessments of the educational content generated by this center. Resources that educate a wide range of audiences are encouraged and are expected to be facilitated by the stakeholder engagement and information dissemination efforts developed in the Coordination and Dissemination center.

If excellent research education resources currently exist that address CP and OUD and/or stigma associated with this population, but do not have educational accreditation, considerable thought should be given towards professional training accreditation and include a plan to address this issue.

Of note, if applicants have identified existing meritorious resources that address the training and education needs specified in this FOA, applicants may propose a multi-pronged approach to disseminate existing resources as appropriate and develop new activities to address any remainingresearch education gaps . Applicants are encouraged to be thoughtful about competency assessments of the exiting educational content.

The Coordination and Dissemination center should plan to track educational metrics throughout the life of the grant award (e.g., quantity of educational content generated, quantity of medical professionals, patients, and stakeholders engaged, competency evaluations, etc.). E. Create innovative research resources appropriate to co-occurring CP and OUD, composite outcomes measures, and screening tools for both OUD and CP.

Currently, health care providers must use separate assessment and screening tools and outcomes measures for CP and OUD. Applicants must propose to develop a single composite outcomes measure tool for both CP and OUD to be used across the network. An option to include AUD, MDD, and GAD could be considered.

In addition, the Coordination and Dissemination should create other assessment tools of high priority as a research and potential clinical resource for this population. Examples of these tools include, but are not limited to: ONE composite outcome measure tool for both conditions that is patient-centered, defined, and valued and includes function/behavior and well-being, and patient goals that can be aggregated to populations.

This tool is expected to be used across the network and should be developed with network participation. Applicants have the option to create a separate composite outcomes measure tool for CP and opioid misuse.

Measuring opioid craving in patients with comorbid CP and OUD Screening tools to distinguish subgroups of responders to assist in developing tailored integrated treatment Tools to characterize phenotypes presenting as a spectrum of chronic pain and misuse/severity of OUD (mild, moderate, severe) Holistic screening tool (e.g., comorbidities, demographics, condition severity, duration, function, wellbeing) Characterizing the patient journey in care and recovery to evaluate outcomes on treatment engagement, retention and follow-up care The Coordination and Dissemination center should include plans for psychometrically validating these tools, if needed, and include plans for disseminating the tools for use in awarded research centers within this network and to the broader research field/clinical community.

These plans should consider approaches to facilitate integration into multiple digital platforms (e.g., REDcap, qualtrics, etc.) to increase uptake. Points to Consider Regarding Racial Diversity in Multidisciplinary Team Science: Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams.

Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health.

Fostering diversity by addressing underrepresentation in the scientific research workforce and health care system is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific workforce.

Therefore, applicants are strongly encouraged to include as research and healthcare staff, and key contributors, individuals who are underrepresented in biomedical research including individuals of diverse racial/ethnic, gender, rural and low-income backgrounds.

Points to Consider Regarding Early Stage Investigators: Pain treatment in individuals with OUD and other co-occurring substance use and psychiatric conditions is identified as an under-resourced medical need and has received limited research attention.

To assure a sustained workforce and effort toward identifying and developing effective pain treatment for these vulnerable populations in the future, applicants are strongly encouraged to indicate how they will include early stage investigators in this funding opportunity.

Applications with the following specifics will be considered non-responsive and will not be reviewed: Applications that do not commit to collaborating in efforts across the network , including executive meeting and workgroup participation, data harmonization, and other activities of synergy Applications that do not include a plan for supporting engagement with diverse stakeholders and PWLE or representatives from patient organizations relevant to this RFA Applications that do not include innovative tool development, including developing a single composite outcomes measure tool for CP and OUD Applications that do not include an education infrastructure plan targeting CP and OUD, including addressing stigma and health disparities in this patient population Applications with activities outside the US and its territories PIs who do not devote at least 2.

0 person months of effort to the application per year for the life of the award On June 1-2, 2020, NIH held a workshop on Managing Chronic Pain in Individuals with Co-occurring OUD, and Other Psychiatric Conditions. A recording and summary of this meeting's proceedings are available at https://apps1. seiservices.

com/HEALPainOUDWorkshop/Default. aspx . NIH issued a Notice of Intent to Publish a Funding Opportunity Announcement for the Coordination and Dissemination center ( NOT-DA-20-077 ).

Applicants are encouraged to participate in a future technical assistance webinar related to the FOA, which is anticipated to occur December 2020/January 2021. The date for this webinar will be published in a Notice associated with this RFA.

Points to Consider Regarding Tobacco Industry Funding of NIDA Applicants: The National Advisory Council on Drug Abuse (NACDA) encourages NIDA and its grantees to consider the points it has set forth with regard to existing or prospective sponsored research agreements with tobacco companies or their related entities and the impact of acceptance of tobacco industry funding on NIDA's credibility and reputation within the scientific community.

Please see (http://ww2. drugabuse. gov/about/organization/nacda/points-to-consider.

html) for details.

Data Harmonization for Substance Abuse and Addiction via the PhenX Toolkit: NIDA strongly encourages investigators involved in human-subjects studies to employ a common set of tools and resources that will promote the collection of comparable data across studies and to do so by incorporating the measures from the Core and Specialty collections, which are available in the Substance Abuse and Addiction Collection of the PhenX Toolkit (www.

phenxtoolkit. org). Please see NOT-DA-12-008 (http://grants.

nih. gov/grants/guide/notice-files/NOT-DA-12-008. html) for further details See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Optional: Accepting applications that either propose or do not propose clinical trial(s) Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The HEAL Initiative intends to commit $575,000 direct costs in FY 2021 to fund 1 award. Application budgets are limited to $575,000 per year in direct costs. Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation.

The maximum project period is 5 years. NIH grants policies as described in the NIH Grants Policy Statement will