NIH Weekly Funding Opportunities and Policy Notices
Funding Opportunity RFA-NS-19-016 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress. This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination The Common Funds Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding, MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research. In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data.
Funding Opportunity RFA-DA-19-034 from the NIH Guide for Grants and Contracts. The purpose of this FOA is to fund a single coordinating center to formalize and centralize support for the HEAL Preventing Opioid Misuse and Opioid Use Disorder in Older Adolescents and Young Adults (ages 16-30) initiative administered by NIDA. The coordinating center will provide administrative and scientific, technical, and logistical support for coordination of common data elements, data harmonization, data sharing across projects; methodological and statistical support in the areas of study design, complex statistical analyses, economic analyses, implementation research; coordination of stakeholder and partnership engagement activities; developing and coordinating a HEAL prevention initiative publication and dissemination plan, providing logistical support for in-person meetings, conference calls, and webinars that include HEAL prevention grantees, funders and stakeholders. In addition, the coordinating center also will assist with collecting data on prevalence, incidence, risk and protective factors, and contextual factors in the identified populations and settings that will inform HEAL prevention research projects.
Funding Opportunity RFA-AT-19-006 from the NIH Guide for Grants and Contracts. The purpose of this FOA is to solicit applications to examine the impact of behavioral and social interventions designed to improve adherence to Medication Assisted Treatment (MAT) for persons with Opioid Use Disorders (OUD). Applications may address MAT initiation, implementation, and/or persistence by OUD patients. Descriptive and intervention research that address adherence determinants at more than one level levels of ecologic influence (including the patient, caregiver/family, providers and/or healthcare system, and community levels) are of higher priority. Attention to scientific rigor in all applications is paramount, with emphasis on appropriate sample sizes and valid outcome measures.
Funding Opportunity RFA-HL-19-028 from the NIH Guide for Grants and Contracts. This FOA aims to elucidate basic sleep and circadian mechanisms contributing to the risk of opiate use disorder (OUD), the pathobiology of opiate withdrawal, and that influence the response to medication-assisted treatment (MAT). Studies are needed to apply advances in understanding sleep and circadian biology to improving our understanding of OUD, the directionality of sleep and OUD interactions, and the opportunities to improve therapy and outcome. Multi-disciplinary, multiple-investigator teams combining expertise in sleep and circadian neurobiology with the neurobiology OUD and pharmacology of MAT are strongly encouraged. This FOA is only open to the study of OUD relevant mechanisms and pathobiology. The study of other drugs of abuse will not be responsive.
Notice NOT-TR-18-031 from the NIH Guide for Grants and Contracts
Funding Opportunity RFA-DK-18-030 from the NIH Guide for Grants and Contracts. Pain is a common problem in Medicare End-Stage Renal Disease (ESRD) Hemodialysis (HD) patients, but its prevalence varies widely by geography, dialysis unit, and possibly, ethnicity. Pain has been linked to decreased quality of life, lack of social support, depressed mood and other mental health disorders. Chronic opioid prescription has been identified in approximately 20% of US ESRD HD patients, far higher than in Medicare comparison populations. Opioid doses prescribed to HD patients exceed Centers for Disease Control and Prevention (CDC) recommendations. Prescription and dose level have been associated with increased hospitalizations and mortality in this population. Interventions including behavioral modification techniques such as Cognitive Behavioral/Group Therapy and social media platforms for sharing information and enhancing social support have not been employed to reduce perception of pain and the rate of opioid prescription, dose and opioid use, as well as addressing comorbid related issues such as depression, and anxiety in the HD population.Medical interventions such as use of naloxone and buprenorphine have not been evaluated by randomized controlled trials in HD patients who use opioids. The ESRD population, because of its continuous longitudinal participation in monitored treatment and the availability of data resources is an ideal population in which to launch and monitor interventions. The Hemodialysis Opioid Prescription Effort (HOPE) consortium composed of 5 or 6 Clinical Centers (CCs)and a Scientific and Data Research Center (SDRC) will develop an intervention to simultaneously address the problem of pain and opioid use in US HD populations by a) initiating multipronged pain treatment tailored individually to each patient, without opioids, and b) using buprenorphine and other novel agents to reduce dependence on opioids in affected patients.
Funding Opportunity RFA-DK-18-031 from the NIH Guide for Grants and Contracts. Pain is a common problem in Medicare End-Stage Renal Disease (ESRD) Hemodialysis (HD) patients, but its prevalence varies widely by geography, dialysis unit, and possibly, ethnicity. Perception of pain has been linked to decreased quality of life, lack of social support, depressed mood and other mental health disorders. Chronic opioid prescription has been identified in approximately 20% of US ESRD HD patients, far higher than the rate in Medicare comparison populations. Opioid doses prescribed to HD patients exceed Centers for Disease Control and Prevention (CDC) recommendations. Prescription and dose level have been associated with increased hospitalizations and mortality in this population. Interventions including behavioral modification techniques such as Cognitive Behavioral/Group Therapy and social media platforms for sharing information and enhancing social support have not been employed to reduce the rate of opioid prescription and opioid use, as well as addressing comorbid related issues such as depression, anxiety and pain in the HD population.Medical interventions such as use of naloxone and buprenorphine have not been evaluated by randomized controlled trials in HD patients who use opioids. The ESRD HD population, because of its continuous longitudinal participation in monitored treatment and the availability of data resources is an ideal population in which to launch and monitor interventions. The Hemodialysis Opioid Prescription Effort (HOPE) Consortium, composed of a Scientific and Data Research Center (SDRC) and 5 or 6 Clinical Centers (CCs) will develop an intervention to simultaneously address the problem of pain and opioid use in US HD populations a) by initiating multipronged pain treatment tailored individually to each patient, without opioids, and b) by using buprenorphine and other novel agents to reduce dependence on opioids in affected patients.
Funding Opportunity RFA-DA-19-025 from the NIH Guide for Grants and Contracts. The intersection of justice and community-based health systems is a critical target for addressing the opioid crisis. The National Institute on Drug Abuse intends to establish the Justice Community Opioid Innovation Network (JCOIN) using the cooperative agreement mechanism. The purpose of the network is to establish a national consortium of investigators examining promising interventions and other approaches that can improve the capacity of the justice system to effectively respond to the opioid epidemic. The structure of the network shall consist of three highly integrated components - (1) Clinical Research Centers (each center will propose a study to be executed in at least 5 research performance sites), (2) a single, central Coordination and Translation Center, and (3) a single, central Methodology and Advanced Analytics Resource Center. This FOA solicits applications for Clinical Research Centers. This FOA runs in parallel with companion FOAs that seek applications for a single Coordination and Translation Center (RFA-DA-19-024), and a single Methodology and Advanced Analytics Resource Center (RFA-DA-19-023).
Funding Opportunity RFA-DA-19-024 from the NIH Guide for Grants and Contracts. The intersection of justice and community-based health systems is a critical target for addressing the opioid crisis. The National Institute on Drug Abuse intends to establish the Justice Community Opioid Innovation Network (JCOIN) using the cooperative agreement mechanism. The purpose of the network is to establish a national consortium of investigators examining promising interventions and other approaches that can improve the capacity of the justice system to effectively respond to the opioid epidemic.
Funding Opportunity RFA-DA-19-023 from the NIH Guide for Grants and Contracts. The intersection of justice and community-based health systems is a critical target for addressing the opioid crisis. The National Institute on Drug Abuse intends to establish the Justice Community Opioid Innovation Network (JCOIN) using the cooperative agreement mechanism. The purpose of the network is to establish a national consortium of investigators examining promising interventions and other approaches that can improve the capacity of the justice system to effectively respond to the opioid epidemic. The structure of the network shall consist of three highly integrated components - (1) Clinical Research Centers (each center will propose a study to be executed in at least 5 research performance sites); (2) a single, central Coordination and Translation Center; and (3) a single, central Methodology and Advanced Analytics Resource Center. This FOA solicits applications for a Methodology and Advanced Analytics Resource Center. This FOA runs in parallel with companion FOAs that seek applications for Clinical Research Centers (RFA-DA-19-025), and a single Coordination and Translation Center (RFA-DA-19-024).
Funding Opportunity RFA-HL-19-029 from the NIH Guide for Grants and Contracts. This FOA invites clinical studies to elucidate sleep and circadian mechanisms that contribute to the risk of opiate use disorder (OUD), the pathobiology of opiate withdrawal, and that influence the response to medication-assisted treatment (MAT). Studies are needed to apply advances in understanding sleep and circadian biology to improving our understanding of OUD, the directionality of sleep and OUD interactions, and the opportunities to improve therapy and outcome. Multi-disciplinary, multiple-investigator teams combining expertise in clinical research, mechanisms of sleep and circadian rhythms, neurobiology of OUD, and neuropharmacology of MAT are strongly encouraged. This FOA is only open to the study of OUD relevant mechanisms and pathobiology. Evaluating the efficacy of one or more interventions without a rigorous mechanistic study design should not be proposed.
Funding Opportunity RFA-AT-19-004 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct efficient, large-scale pragmatic trial or implementation science study designs to improve pain management and reduce the use of opioid medications. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. The overall goal of this initiative is to identify effective methods to improve the management of pain and reduce the need for opioid medications at the health care system level. This FOA requires that the intervention under study be embedded into health care delivery system, real world settings. Studies can propose to integrate interventions that have demonstrated efficacy into health care system; or implement health care system changes to improve adherence to evidence-based guidelines. Trials must be conducted across two or more health care systems (HCS) and must be conducted as part of the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory). The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. After awards are made by NIH, the CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) and the NIH will work with successful awardees from this FOA to facilitate the planning and rapid execution of high impact trials that conduct research studies in partnerships with health care delivery systems.
Notice NOT-NS-19-014 from the NIH Guide for Grants and Contracts
Notice NOT-DA-19-003 from the NIH Guide for Grants and Contracts
Funding Opportunity RFA-DA-19-019 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA), issued by the National Institutes on Drug Abuse (NIDA), invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications to develop technologies to provide science- and research-based solutions to the national opioid crisis and offer new hope for individuals, families, and communities affected by this devastating crisis. United States SBCs that have the research capabilities and technological expertise to contribute to NIDA R and D mission identified in this FOA are encouraged to submit SBIR grant applications in response to the FOA topics.
Funding Opportunity RFA-DA-19-020 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA), issued by the National Institutes on Drug Abuse (NIDA), invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) grant applications to develop technologies to provide science- and research-based solutions to the national opioid emergency and offer new hope for individuals, families, and communities affected by this devastating crisis. United States SBCs that have the research capabilities and technological expertise to contribute to NIDA R and D mission identified in this FOA are encouraged to submit STTR grant applications in response to the FOA topics.
Funding Opportunity RFA-AT-19-005 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) encourages UG3/UH3 phased cooperative research applications to conduct an efficient, large-scale pragmatic trial or implementation science study to evaluate the impact of and how best to implement acupuncture treatment for chronic low back pain into health care delivery. Awards made under this FOA will initially support a one-year milestone-driven planning phase (UG3), with possible transition to an implementation phase (UH3). UG3 projects that have met the scientific milestone and feasibility requirements may transition to the UH3 phase. The UG3/UH3 application must be submitted as a single application, following the instructions described in this FOA. Trials must be conducted across two or more health care systems (HCS) and must be conducted as part of the NIH HCS Research Collaboratory supported through the NIH Common Fund. (See https://commonfund.nih.gov/hcscollaboratory). The NIH HCS Research Collaboratory Program has established a Collaboratory Coordinating Center (CCC) that is providing national leadership and technical expertise in all aspects of research with HCS. After awards are made by NIH, the CCC (http://rethinkingclinicaltrials.org/about-nih-collaboratory/) and the NIH will work with successful awardees from this FOA to facilitate the planning and rapid execution of high impact trials that conduct research studies in partnerships with health care delivery systems.
Funding Opportunity RFA-AT-19-007 from the NIH Guide for Grants and Contracts. The purpose of this FOA is to solicit applications to expand research activities funded under RFA-AT-18-002 and RFA-DA-18-005 on the impact of interventions designed to improve adherence to Medication Assisted Treatment (MAT) or linking individuals with Opioid Use Disorders (OUD) who receive naloxone for the reversal of overdose to MAT within the context of states use of the SAMHSA Opioid STR grant funds authorized under the 21st Century Cures Act. Expansion of research activities should increase the generalizability of findings to allow for more rapid dissemination and implementation of successful interventions. Examples of additional activities include but are not limited to adding recruitment/study sites, increasing the overall sample size, targeting under-represented populations, and adjusting for longer follow-up.
Funding Opportunity RFA-HD-19-025 from the NIH Guide for Grants and Contracts. The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) invites applications from investigators willing to participate with the NICHD + others for an observational clinical study of infants born to mothers who are exposed to prenatal opioids. The public health opioid epidemic has a significant effect on infants who were exposed prenatally to opioids. This funding opportunity announcement (FOA) is intended to support multi-site clinical research devoted to investigating the impact of prenatal opioid exposure on infant outcomes as well as neuroimaging in opioid exposed versus unexposed newborns. The objective of this program is to advance scientific research that facilitates knowledge and care for infants exposed in utero to opioids. This program benefits the public: infants and families with opioid exposure and their health care providers. This FOA supports trials that require participation of two or more collaborative sites for completion of the study. Accordingly, the collaborating sites develop a specific protocol across the sites and are organized to increase sample size, accelerate recruitment, or increase sample diversity and representation. Each site has its own Program Director/Principal Investigator (PD/PI) and each consortium includes a mechanism for coordination, implementation and monitoring of the protocol across sites, quality control, database management, statistical analysis, and reporting. Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed on March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.
Funding Opportunity RFA-NS-19-018 from the NIH Guide for Grants and Contracts. HEAL Initiative: This is a HEAL Initiative UH3 FOA that will solicit device applications to treat pain.