Notice NOT-HL-17-559 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-18-427 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to encourage cooperative agreement applications to support early stage clinical trials of novel mechanism of action, investigational drugs or drug candidates for the treatment of psychiatric disorders in areas of unmet medical need. The FOA will support milestone-driven early stage trials in pediatric and adult populations. First in human (FIH) and Phase Ib studies of novel Agents must assess target engagement (brain exposure), pharmacological effects, safety, and tolerability to assess feasibility for Phase II/proof of concept (PoC) studies in psychiatric disorders. Phase II/PoC studies must evaluate the drugs impact on clinically relevant physiological systems (functional measures) and clinical indicators of effect. The FOA also supports FIH and early feasibility studies (EFS) of novel devices to evaluate target engagement, safety, tolerability, and efficacy. The overall objective is to facilitate rapid collection of data to "de-risk" novel mechanism of action investigational drugs, novel drugs for use in pediatric populations with psychiatric disorders, and devices or combination treatments in order to attract private funding for further clinical development as FDA-approved treatments. A key aspect of this FOA is the formation of collaborative partnerships between the biomedical researchers and biotechnology or industry researchers to facilitate psychiatric drug or device development.

Funding Opportunity PA-18-484 from the NIH Guide for Grants and Contracts. The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s). The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions. This Funding Opportunity Announcement does not accept clinical trials.

Funding Opportunity RFA-DA-18-020 from the NIH Guide for Grants and Contracts. The purpose of this award is to support outstanding basic and/or clinical researchers with the vision and expertise to translate research discoveries into medications for the treatment of Substance Use Disorders (SUDs) stemming from tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opiate use. Eligible applicants must demonstrate the ability to develop molecules with the potential to treat SUDs and advance them in the drug development continuum. The ultimate goal of this FOA is to bring molecules closer to FDA approval.

Funding Opportunity PAR-18-466 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) represents the continuation of an NCI program to facilitate the transition of investigators in mentored, non-independent cancer research positions to independent faculty cancer research positions. This goal is achieved by providing protected time through salary and research support for the initial 3 years of the first independent tenure-track faculty position, or its equivalent, beginning at the time when the candidate starts a tenure-track faculty position.

Funding Opportunity PAR-18-467 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) represents the continuation of an NCI program to facilitate the transition of investigators in mentored, non-independent cancer research positions to independent faculty cancer research positions. This goal is achieved by providing protected time through salary and research support for the initial 3 years of the first independent tenure-track faculty position, or its equivalent, beginning at the time when the candidate starts a tenure-track faculty position.

Funding Opportunity RFA-DA-18-019 from the NIH Guide for Grants and Contracts. The NIDA Avant-Garde Award Program for HIV/AIDS Research supports individual scientists of exceptional creativity who propose high-impact research that will open new areas of HIV/AIDS research relevant to drug abuse and/or lead to new avenues for prevention and treatment of HIV/AIDS among drug abusers. The term avant-garde is used to describe highly innovative approaches that have the potential to be transformative. The proposed research should reflect approaches and ideas that are substantially different from those already being pursued by the investigator or others and should support the NIH HIV/AIDS Research Priorities https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-137.html. The NIDA Avant-Garde award supports innovative, basic research that may lead to improved preventive interventions or therapies; creative, new strategies to prevent disease transmission; novel approaches to improve disease outcomes; and creative approaches to eradicating HIV or improving the lives of those living with HIV.

Funding Opportunity PA-18-465 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to support projects that will elucidate the therapeutic potential of the cannabinoids and endocannabinoid system in the development of mechanism-based therapies for pain.

Funding Opportunity RFA-NS-18-017 from the NIH Guide for Grants and Contracts. The purpose of this R34 FOA is to provide one year of support for planning activities necessary for initiating a Phase III clinical trial designed to treat patients with Lewy Body Dementias (LBD), which include Dementia with Lewy Bodies and Parkinson's Disease Dementia. Such activities may include identifying trial sites/collaborators, designing trial protocols and procedures, and addressing regulatory approvals.

Funding Opportunity PA-18-482 from the NIH Guide for Grants and Contracts. The NICHD Exploratory/Developmental Grant program supports exploratory and developmental research projects that fall within the NICHD mission by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research.

Funding Opportunity PA-18-480 from the NIH Guide for Grants and Contracts. The NICHD Research Project Grant (Clinical Trial Required) supports clinical trials that fall within the NICHD mission.

Funding Opportunity PAR-18-431 from the NIH Guide for Grants and Contracts. NIMH seeks applications for pilot effectiveness projects to evaluate the preliminary effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden. In this pilot phase of effectiveness research, the trial should be designed to evaluate the feasibility, tolerability, acceptability, safety, and potential effectiveness of the approach; to address whether the intervention engages the target(s)/mechanisms(s) that is/are presumed to underlie the intervention effects; and to obtain preliminary data needed as a pre-requisite to a larger-scale effectiveness trial (e.g., comparative effectiveness study, practical trial) designed to definitely test the effectiveness of interventions to improve post-acute outcomes. This FOA supports pilot effectiveness research to evaluate the feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches and inform the design of definitive effectiveness trials. Support for fully-powered, definitive effectiveness studies focused on post-acute phase interventions is provided via the R01 in PAR-18-423.

Funding Opportunity PAR-18-430 from the NIH Guide for Grants and Contracts. NIMH seeks applications for research projects to evaluate the effectiveness of therapeutic and service delivery interventions for the post-acute management of mental health conditions affecting youth, adults, and older adults. This FOA encourages clinical trials to establish the effectiveness and test hypotheses regarding moderators, mediators, and mechanisms of action of post-acute phase therapeutic and services interventions that are matched to the stage of illness in terms of both their focus (e.g., consolidating and maintaining gains from initial treatment, managing residual symptoms/impairment, preventing relapse, promoting adherence and appropriate service use) and intensity/burden for promoting optimal longer-term outcomes. This FOA is intended to support effectiveness trials testing post-acute phase interventions that are statistically powered to provide a definitive answer regarding the study intervention's effectiveness. Support for pilot effectiveness trials to evaluate the initial feasibility, tolerability, acceptability, safety and preliminary indications of effectiveness of post-acute phase intervention approaches is provided via the R34 in PAR-18-422 .

Notice NOT-HL-17-567 from the NIH Guide for Grants and Contracts

Funding Opportunity PA-18-489 from the NIH Guide for Grants and Contracts. The NIH Exploratory/Developmental Grant supports exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. This Funding Opportunity Announcement does not accept clinical trials.

Funding Opportunity PA-18-488 from the NIH Guide for Grants and Contracts. The NIH Small Research Grant Program supports small research projects that can be carried out in a short period of time with limited resources. This program supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. This Funding Opportunity Announcement does not accept clinical trials.

Funding Opportunity PA-18-426 from the NIH Guide for Grants and Contracts. The purpose of this administrative supplement is to facilitate collaboration by supporting multidisciplinary research teams comprised of quantitative researchers and clinician-scientists from active CTSA institutions (PAR-15-304). This supplement will support translational team research projects by providing salary and research support to a quantitative researcher, contingent upon his/her collaborating with a clinician-scientist KL2 scholar. The collaborative KL2 clinician-scientist will be supported independently of this supplement through the parent KL2 award throughout the duration of the proposed supplement. Both team members will be selected by the KL2 PI. The KL2 PI will assist the quantitative researcher and clinician-scientist in developing a translational research project aligned with NIBIBs research mission under the guidance of their identified basic and clinical science mentors. Based on this, the KL2 PI will submit a supplement request under this FOA.

Notice NOT-AT-18-002 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-18-464 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity announcement (FOA) is to invite applications to participate in the Clinical and Translational Science Award (CTSA) program which supports high quality translational and clinical research locally, regionally and nationally and fosters innovation in research methods, training, and career development.

Funding Opportunity PAR-18-429 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to encourage research applications to develop and pilot test the effectiveness and implementation of family navigator models designed to promote early access, engagement and coordination of mental health treatment and services for children and adolescents who are experiencing early symptoms of mental health problems. For the purposes of this FOA, NIMH defines a family navigator model as a health care professional or paraprofessional whose role is to deploy a set of strategies designed to rapidly engage youth and families in needed treatment and services, work closely with the family and other involved treatment and service providers to optimize care and monitor the trajectory of mental health symptoms and outcomes over time. Applicants are encouraged to develop and pilot test the navigator models ability to promote early access, engagement and coordination of mental health treatment and services for children and adolescents as soon as symptoms are detected. Of interest are navigator models that coordinate needed care strategies, determine the personalized match to the level of needed service amount, frequency and intensity, and harness novel technologies to track and monitor the trajectory of clinical, functional and behavioral progress toward achieving intended services outcomes. This FOA is published in parallel to a companion FOA, PAR-18-428 which uses the R01 funding mechanism.