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This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH) invites eligible United States small businesses to submit Small Business Technology Transfer (STTR) grant applications. United States small businesses that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH awarding components identified in this FOA are encouraged to submit STTR grant applications in response to identified topics (see PHS 2021-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA). This Parent Funding Opportunity Announcement does not accept clinical trials.

The National Institutes of Health (NIH) hereby notify recipient organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of recipient organization may be submitted to this FOA. This assumes such a change is programmatically permitted for the particular grant. Applications for change of recipient organization are considered prior approval requests (as described in Section 8.1.2.7 of the NIH Grants Policy Statement) and will be routed for consideration directly to the Grants Management Specialist named in the current award. Although requests for change of recipient organization may be submitted through this FOA, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission.

The participating Institutes and Centers (ICs) are inviting applications to expand existing awards that are not currently focused on Alzheimers disease and its related dementias--frontotemporal dementia, Lewy body dementia, vascular cognitive impairment with dementia, and multiple etiology dementias--to allow the research to develop such a focus.

This Funding Opportunity Announcement (FOA) aims to explore the role of adaptive immunity in Alzheimers disease and Alzheimers disease-related dementias (AD/ADRD). Specifically, the FOA seeks an understanding of brain immune surveillance, the generation of CNS-directed immune responses in neurodegenerative disorders, and the functional role of adaptive immunity in AD/ADRD onset and progression.

Reissue of RFA-NS-18-020: Understanding the dynamic activity of brain circuits is central to the NIH BRAIN Initiative. This FOA seeks applications for proof-of-concept testing and development of new technologies and novel approaches for recording and modulation (including various modalities for stimulation/activation, inhibition and manipulation) of cells (i.e., neuronal and non-neuronal) and networks to enable transformative understanding of dynamic signaling in the central nervous system (CNS). This FOA seeks exceptionally creative approaches to address major challenges associated with recording and modulating CNS activity, at or near cellular resolution, at multiple spatial and/or temporal scales, in any region and throughout the entire depth of the brain. It is expected that the proposed research may be high-risk, but if successful, could profoundly change the course of neuroscience research. Proposed technologies should be compatible with experiments in behaving animals, validated under in vivo experimental conditions, and capable of reducing major barriers to conducting neurobiological experiments and making new discoveries about the CNS. Technologies may engage diverse types of signaling beyond neuronal electrical activity such as optical, magnetic, acoustic and/or genetic recording/manipulation. Applications that seek to integrate multiple approaches are encouraged. If suitable, applications are expected to integrate appropriate domains of expertise, including biological, chemical and physical sciences, engineering, computational modeling and statistical analysis.

Reissue of RFA-NS-18-019: Understanding the dynamic activity of neural circuits is central to the NIH BRAIN Initiative. The invention, proof-of-concept investigation, and optimization of new technologies through iterative feedback from end users are key components of the BRAIN Initiative. This FOA seeks applications to optimize existing or emerging technologies through iterative testing with end users. The technologies and approaches should have potential to address major challenges associated with recording and modulation (including various modalities for stimulation/activation, inhibition and manipulation) of cells (i.e., neuronal and non-neuronal) and networks to enable transformative understanding of dynamic signaling in the central nervous system (CNS). These technologies and approaches should have previously demonstrated their transformative potential through initial proof-of-concept testing and are now ready for accelerated refinement. In conjunction, the manufacturing techniques should be scalable towards sustainable, broad dissemination and user-friendly incorporation into regular neuroscience research. Proposed technologies should be compatible with experiments in behaving animals, validated under in vivo experimental conditions, and capable of reducing major barriers to conducting neurobiological experiments and making new discoveries about the CNS. Technologies may engage diverse types of signaling beyond neuronal electrical activity such as optical, electrical, magnetic, acoustic or genetic recording/manipulation. Applications that seek to integrate multiple approaches are encouraged. If suitable, applications are expected to integrate appropriate domains of expertise, including biological, chemical and physical sciences, engineering, computational modeling and statistical analysis.

Reissue of RFA-NS-21-016: The goal of this funding opportunity announcement (FOA) is to solicit Initial Analgesic Development R61 applications that propose 2-year exploratory/planning awards that are expected to enable a future application for RFA-NS-21-015 HEAL Initiative: Team Research - for Initial Translational Efforts in Non-addictive Analgesic Development [Small Molecules and Biologics] (U19 Clinical Trial Not Allowed). Thus, the limited scope of aims and approach of these applications are expected to establish a strong research team, feasibility, validity, or other technically qualifying results that support, enable, and/or lay the groundwork for a subsequent Team Research U19 application. These R61 awards will support the building of a research team to collect initial data and recruit additional collaborators. The proposal must include a plan for developing a strong research team, as well as a strategy to collect preliminary data linking putative therapeutic targets to the proposed pain indication and supporting the hypothesis that altering target activity will produce desirable outcomes for the disease.

The shock and kill strategy is one of the commonly used approaches for targeting latent reservoirs in hopes to cure HIV-1. It is based on the concept of purposely inducing reactivation of latent reservoirs in ART (antiretroviral therapy)-treated individuals by using stimulatory agents. However, it has become increasingly evident that attempts at elimination of HIV-1 reservoirs through latency reactivating agents (LRA) -mediated reactivation alone may not be sufficient. Novel strategies such as immunotherapy and gene excision therapies to optimize the recognition and elimination of reservoir cells such are being conceptualized and researched. Immunotherapy strategies like therapeutic vaccines to enhance HIV-1-specific CTL (cytotoxic T-cell) response, Chimeric Antigen Receptor T-cells (CAR-T cells) therapies, broadly neutralizing antibodies, dual-affinity retargeting antibodies that not only bind to HIV-1 viral envelope antigen but also activate the CTL response, and immune modulators, such as anti-PD1 (programmed cell death protein-1) or anti-CTL4 antibodies, to correct the immune exhaustion noticed in ART-treated individuals are being developed. In addition to immunotherapy strategies, Recombinant TALEN or CRISPR/Cas9 gene editing molecules delivered to latently infected cells designed to induce cleavage at highly conserved regions of the integrated HIV provirus genome are being researched. However, majority of immunotherapy-based and gene editing based HIV eradication strategies are focused on the periphery. The brain presents a unique challenge where access is difficult and innovative strategies are needed to overcome the blood brain barrier. It is also important to understand the potential CNS toxicity of immunotherapy-based and gene-editing based approaches currently being tested in clinical trials

This funding opportunity announcement (FOA) encourages applications for the Chronic, Non-Communicable Diseases and Disorders Across the Lifespan: Fogarty International Research Training Award (NCD-LIFESPAN) D43 program for institutional research training programs in low-and middle-income countries (LMICs, as defined by the World Bank classification system). Applications may be for collaborations between institutions in the U.S and an eligible LMIC or may involve just LMIC institutions if there is a previous track record of externally funded research and/or research training programs by the lead LMIC institution. The proposed institutional research training program is expected to sustainably strengthen the NCD research capacity of the LMIC institutions, and to train in-country experts to develop and conduct research on NCDs across the lifespan, with the long-range goal of developing and implementing evidence-based interventions relevant to their countries. The main focus of research training covered in the application must be relevant to the interests of at least one of the participating NIH ICs as stated by each in this FOA. Other NCD topics may be included as secondary and complementary focus areas. This Funding Opportunity Announcement (FOA) allows support of trainees as the lead investigator of an independent clinical trial; or a separate ancillary study to an existing trial; or to gain research experience in a clinical trial led by another investigator, as part of their research and career development.

Companion to R01 (RFA-MH-21-225). The shock and kill strategy is one of the commonly used approaches for targeting latent reservoirs in hopes to cure HIV-1. It is based on the concept of purposely inducing reactivation of latent reservoirs in ART (antiretroviral therapy)-treated individuals by using stimulatory agents. However, it has become increasingly evident that attempts at elimination of HIV-1 reservoirs through latency reactivating agents (LRA) -mediated reactivation alone may not be sufficient. Novel strategies such as immunotherapy and gene excision therapies to optimize the recognition and elimination of reservoir cells such are being conceptualized and researched. Immunotherapy strategies like therapeutic vaccines to enhance HIV-1-specific CTL (cytotoxic T-cell) response, Chimeric Antigen Receptor T-cells (CAR-T cells) therapies, broadly neutralizing antibodies, dual-affinity retargeting antibodies that not only bind to HIV-1 viral envelope antigen but also activate the CTL response, and immune modulators, such as anti-PD1 (programmed cell death protein-1) or anti-CTL4 antibodies, to correct the immune exhaustion noticed in ART-treated individuals are being developed. In addition to immunotherapy strategies, Recombinant TALEN or CRISPR/Cas9 gene editing molecules delivered to latently infected cells designed to induce cleavage at highly conserved regions of the integrated HIV provirus genome are being researched. However, majority of immunotherapy-based and gene editing based HIV eradication strategies are focused on the periphery. The brain presents a unique challenge where access is difficult and innovative strategies are needed to overcome the blood brain barrier. It is also important to understand the potential CNS toxicity of immunotherapy-based and gene-editing based approaches currently being tested in clinical trials.