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DHHS Funding Opportunities

FUNDING OPPORTUNITIES from the Department of Health and Human Services (DHHS)

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Department of Health and Human Services – Administration for Community Living –  Disability and Rehabilitation Research Projects (DRRP) Program: Employment of Individuals with Disabilities (Development)

Proposal Due Date:                                                           March 29, 2021

Expected Number of Awards:                                        1

Estimated Total Program Funding:                              $500,000

Award Ceiling:                                                                    $500,000

Award Floor:                                                                       $495,000

Funding Opportunity Number:                                      HHS-2021-ACL-NIDILRR-DPEM-0053

Purpose: The purpose of  the National Institute on Disability, Independent Living and Rehabilitation (NIDILRR)’s Disability and Rehabilitation Research Projects (DRRP) which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).

Under this particular DRRP priority, applicants must propose a development project that is aimed at improving the employment outcomes of individuals with disabilities.  In carrying out a development activity under this program, a grantee must use knowledge and understanding gained from research to create materials, devices, systems, methods, measures, techniques, tools, prototypes, processes, or intervention protocols that are beneficial to the target population.    

Please note that this is the Funding Opportunity for field-initiated DRRP development projects in the employment domain. NIDILRR plans to make two field-initiated DRRP awards in the employment domain. NIDILRR’s two awards under this grant competition may include research projects, development projects, or both, depending on the ranking of applications provided by the peer review panel.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=330324

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Department of Health and Human Services – Administration for Community Living –  Disability and Rehabilitation Research Projects (DRRP) Program: Employment of Individuals with Disabilities (Research)

Proposal Due Date:                                                           March 29, 2021

Expected Number of Awards:                                        1

Estimated Total Program Funding:                              $500,000

Award Ceiling:                                                                    $500,000

Award Floor:                                                                       $495,000

Funding Opportunity Number:                                      HHS-2021-ACL-NIDILRR-DPEM-0052

Purpose: The purpose of  NIDILRR’s Disability and Rehabilitation Research Projects (DRRP) which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to plan and conduct research, demonstration projects, training, and related activities, including international activities, to develop methods, procedures, and rehabilitation technology that maximize the full inclusion and integration into society, employment, independent living, family support, and economic and social self-sufficiency of individuals with disabilities, especially individuals with the most severe disabilities, and to improve the effectiveness of services authorized under the Rehabilitation Act of 1973, as amended (Rehabilitation Act).

Under this particular DRRP priority, applicants must propose a research project that is aimed at improving the employment outcomes of individuals with disabilities.  In carrying out a research project under this program, a grantee must identify one or more hypotheses or research questions and, based on the hypotheses or research questions identified, perform an intensive, systematic study directed toward producing (1) new or full scientific knowledge, or (2) understanding of the subject or problem studied.

Please note that this is the Funding Opportunity for field-initiated DRRP research projects in the employment domain. NIDILRR plans to make two field-initiated DRRP awards in the employment domain. NIDILRR’s two awards under this grant competition may include research projects, development projects, or both, depending on the ranking of applications provided by the peer review panel.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=330323

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Department of Health and Human Services – Centers for Disease Control – National Center for Injury Prevention and Control (NCIPC)

Comprehensive Addiction and Recovery Act (CARA) Local Drug Crises Grants

Letter of Intent Due Date:                                              February 1, 2021

Proposal Due Date:                                                           April 1, 2021

Expected Number of Awards:                                        60

Estimated Total Program Funding:

Award Ceiling:                                                                    $50,000

Award Floor:

Funding Opportunity Number:                                      CDC-RFA-CE21-2103

Purpose: The Drug-Free Communities (DFC) Support Program was created by the Drug-Free Communities Act of 1997 (Public Law 105-20). The Executive Office of the President, Office of National Drug Control Policy (ONDCP), and the Department of Health and Human Services (HHS), Centers for Disease Control and Prevention (CDC), National Center for Injury Prevention and Control (NCIPC) are accepting applications for Fiscal Year (FY) 2021 Comprehensive Addiction and Recovery Act (CARA) Community-based Coalition Enhancement Grants to Address Local Drug Crises Grants (CARA Local Drug Crises Grants) as an enhancement to current or formerly funded Drug-Free Communities (DFC) Support Program recipients. The purpose of this program is to prevent and reduce the abuse of opioids or methamphetamines and the abuse of prescription drugs among youth ages 12-18 in communities throughout the United States.

All applicants applying to the FY 2021 CARA NOFO are encouraged to attend the CARA Applicant Workshop Training, which will take place on Friday, February 5 at 11:00 AM EST. Details on how to register and access the training are posted on the following website: https://tvworldwide.com/events/ondcp/2021/CARA/. The training will be recorded and

posted in mid-February. A link to the workshop training video can be found

at https://tvworldwide.com/events/ondcp/2021/CARA/.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=329980

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Department of Health and Human Services – National Institutes of Health – Limited Competition for the Continuation of Multisite Clinical Trial Data Coordinating Center (Collaborative U24 Clinical Trial Optional)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           March 15, 2021; May 28, 2021; September 28, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:                                                                    $500,000

Award Floor:

Funding Opportunity Number:                                      PAR-21-116

Purpose: This Funding Opportunity Announcement (FOA), utilizing the U24 grant funding mechanism, encourages applications for competing renewal of Data Coordinating Center (DCC) for ongoing clinical trials supported by NCCIH. Extension of an ongoing clinical trial will be supported when there is need for additional time to complete the trial or when an extended period of follow up is well justified to assess longer term outcomes. The DCC competing renewal application must propose a comprehensive plan for completion of the clinical trial data collection that provides overall project coordination and administrative; data management; and biostatistical support for the ongoing clinical trial. Both a DCC application and a corresponding Clinical Coordinating Center application can be submitted simultaneously for consideration by NCCIH if both are needed to complete the ongoing.  If clinical trial data collection and follow up can be completed centrally by the DCC and no study visits at clinical sites are needed, a single application for competing renewal for the DCC can be submitted. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact for the ongoing clinical trial for which they are planning a competing renewal application prior to submitting to this FOA.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-116.html

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Department of Health and Human Services – National Institutes of Health – Limited Competition for the Continuation or Revision of Multisite Clinical Trial Clinical Coordinating Center (Collaborative UH3 Clinical Trial Optional)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           March 15, 2021; May 28, 2021; September 28, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:                                                                    $500,000

Award Floor:

Funding Opportunity Number:                                      PAR-21-117

Purpose: This Funding Opportunity Announcement (FOA) encourages applications for competing renewal of Clinical Coordinating Center (CCC) for ongoing clinical trials supported by NCCIH; or competitive revisions to support ancillary studies to ongoing NCCIH supported clinical trials. Extension of an ongoing clinical trial will be supported when there is need for additional time to complete the trial or when an extended period of follow up is well justified to assess longer term outcomes. Competitive revisions will be supported when there is compelling justification for the addition of an ancillary study to an ongoing clinical trial. The objective of the Clinical Coordinating Center is to provide the design scientific rationale and a comprehensive scientific and operational plan for the clinical trial. The Clinical Coordinating Center is expected to be responsible for project management, participant recruitment and retention strategies, performance milestones, scientific conduct, and dissemination of results. Both a DCC application and a corresponding Clinical Coordinating Center application should be submitted simultaneously for consideration by NCCIH if both are needed to complete the ongoing clinical trial.   Applicants are strongly encouraged to contact the appropriate Scientific/Research contact for the ongoing clinical trial for which they are planning a competing renewal application or competitive revision prior to submitting to this FOA.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-117.html

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Department of Health and Human Services – National Institutes of Health – Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Basic Experimental Studies with Humans Required)

Proposal Due Date:                                                           March 17, 2021

Expected Number of Awards:

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Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      PAR-21-144

Purpose: This funding opportunity announcement (FOA) invites research projects that seek to explain the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in human health, illness, recovery, and overall wellbeing. Types of projects submitted under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical and/or behavioral outcomes in humans to understand fundamental aspects of phenomena related to social connectedness and isolatedness. NIH considers such studies as prospective basic science studies involving human participants that meet the NIH definition of basic research and fall within the NIH definition of clinical trials (see, e.g., NOT-OD-19-024) Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-144.html

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Department of Health and Human Services – National Institutes of Health – Research on Biopsychosocial Factors of Social Connectedness and Isolation on Health, Wellbeing, Illness, and Recovery (R01 Clinical Trials Not Allowed)

Proposal Due Date:                                                           March 17, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      PAR-21-145

Purpose: This funding opportunity announcement (FOA) invites research projects that seek to model the underlying mechanisms, processes, and trajectories of social relationships and how these factors affect outcomes in health, illness, recovery, and overall wellbeing. Both animal and human subjects research projects are welcome. Researchers proposing basic science experimental studies involving human participants should consider this FOAs companion for basic experimental studies with humans.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-145.html

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Department of Health and Human Services – National Institutes of Health – NIA MSTEM: Advancing Diversity in Aging Research through Undergraduate Education (R25 – Independent Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              April 25, 2021

Proposal Due Date:                                                           May 25, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:                                                                    $375,000

Award Floor:

Funding Opportunity Number:                                      PAR-20-317

Purpose: The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH.  The overarching goal of this R25 program is to support educational activities that encourage individuals from diverse backgrounds, including those from groups underrepresented in the biomedical and behavioral sciences, to pursue further studies or careers in research.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=331122

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Department of Health and Human Services – National Institutes of Health – The Cellular Scale Connectome in Aging and Alzheimers Disease (U01 Clinical Trial Not Allowed)

Letter of Intent:                                                                  May 15, 2021

Proposal Due Date:                                                           June 15, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      RFA-AG-22-008

Purpose: This Funding Opportunity Announcement (FOA) invites applications that will: (1) promote the development of a comprehensive characterization of brain circuits susceptible to Alzheimers disease type pathology and/or neurodegeneration in mouse models of Alzheimer’s disease (AD), (2) share data on the cell connectome in the aging and AD brain in a common reference brain cell atlas that integrates both molecular and anatomical annotations, and (3) complement and extend research on vulnerable cell types to include the mapping of connectivity changes between cells in aging and AD and provide a greater understanding of the mechanisms underlying resilience and vulnerability in AD.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-22-008.html

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Department of Health and Human Services – National Institutes of Health – NIH Blueprint for Neuroscience Research: Tools and Technologies to Explore Nervous System Biomolecular Condensates (R21 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              August 15, 2021

Proposal Due Date:                                                           September 15, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:                                                                    $200,00

Award Floor:

Funding Opportunity Number:                                      RFA-DA-22-008

Purpose: To support the development of innovative tools and/or technologies to monitor or manipulate Biomolecular Condesates (BMCs) in vivo and enable investigators to adopt these tools to answer outstanding questions in basic neuroscience.  This research will transform our understanding of the mechanistic role of BMCs in human nervous system health and disease and may serve as the foundation for the development of novel BMC-based therapeutics.

https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-22-008.html

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Department of Health and Human Services – Administration for Community Living – Rehabilitation Research and Training Center (RRTC) on Employer Practices Leading to Successful Employment Outcomes Among People With Disabilities

Proposal Due Date:                                                           March 22, 2021

Expected Number of Awards:                                        1

Estimated Total Program Funding:                              $875,000

Award Ceiling:                                                                    $875,000

Award Floor:

Funding Opportunity Number:                                      HHS-2021-ACL-NIDILRR-RTEM-0027

Purpose: The purpose of the RRTCs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to achieve the goals of, and improve the effectiveness of, services authorized under the Rehabilitation Act through well-designed research, training, technical assistance, and dissemination activities in important topical areas as specified by NIDILRR. These activities are designed to benefit people with disabilities, family members, rehabilitation service providers, policymakers and other research stakeholders.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=330205

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Department of Health and Human Services – Food and Drug Administration – Advancing Conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies (U2F) Clinical Trials Not Allowed

Proposal Due Date:                                                           March 22, 2021

Expected Number of Awards:                                        1

Estimated Total Program Funding:

Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      RFA-FD-21-028

Purpose: The intended purpose of this FOA is to advance conformance with the Voluntary National Retail Food Regulatory Program Standards (VNRFRPS) by developing and implementing systems to administer financial assistance, assess training needs and facilitate training, and measure and track the extent of standardization of regulatory food safety inspection personnel in State, Local, Tribal, and Territorial (SLTT) Retail Food Regulatory Agencies.

https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-21-028.html

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Department of Health and Human Services – Health Resources and Services Administration – Bridging the Word Gap Research Network (BWG)

Proposal Due Date:                                                           April 22, 2021

Expected Number of Awards:                                        1

Estimated Total Program Funding:

Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      HRSA-21-040

Purpose: This notice announces the opportunity to apply for funding for the Bridging the Word Gap Research Network (BWG). Previous research has found that on average, by age three, children from low-income families knew less than half of the amount of words compared to children from more economically advantaged families (i.e., 500 words versus 1100 words).1 This word gap negatively impacts early language learning, educational attainment, health care-seeking, and socioeconomic outcomes in later years. The purpose of this program is to establish and maintain a national, multi-site, collaborative Research Network to develop, test, and promote effective interventions for supporting the enrichment of the early home learning environments of children from underserved2 families for whom there are limited interventions or existing interventions are ineffective.

 BWG will:

 The recipient of the cooperative agreement should leverage existing work in the field, as appropriate, and extend the impact of HRSA’s existing programs and resources. The BWG research network should collaborate with researchers, health care practitioners, early childhood educators, policymakers, civic leaders and funders to advance a coordinated national research agenda to develop individual, community, and population-based interventions4 to support the enrichment of early home learning environments for  underserved children. Identification and dissemination of information on effective strategies allows parents and relevant professionals in the health and community sectors to create stronger early home learning environments and promote all children’s readiness for kindergarten.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=328461

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Department of Health and Human Services – National Institutes of Health – NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 5, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      PAR-21-114

Purpose: Some projects initiated with SBIR or STTR funding require considerable financing beyond the SBIR/STTR Phase II award to achieve commercialization. The development of medical biotechnology products is often impeded by a significant funding gap (known as the “Valley of Death”) between the end of the SBIR/STTR Phase II award and the commercialization stage. The goal of this FOA is to assist applicants in pursuing the next appropriate milestone(s) necessary to advance a product/technology that requires Federal regulatory approval or to bring a complex research tool to market. This opportunity aims to facilitate the transition of previously funded SBIR and STTR Phase II projects to the commercialization stage by promoting partnerships between NINDS SBIR or STTR awardees and third-party investors and/or strategic partners in the Phase IIB competing renewal. Applicants are strongly encouraged to secure independent third-party funding throughout the Phase IIB project period.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-114.html

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Department of Health and Human Services – National Institutes of Health – Nutrition for Precision Health, powered by the All of Us Research Program: Artificial Intelligence for Multimodal Data Modeling and Bioinformatics Center (U54 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 6, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

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Funding Opportunity Number:                                      RFA-RM-21-001

Purpose: The purpose of this FOA is to invite applications for the Artificial Intelligence for Multimodal Data Modeling and Bioinformatics (AIMDMB) Center to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). Awards made through this FOA will generate actively learning algorithms to predict human response to different foods, nutrients, food components, and dietary patterns as well as advance understanding, from the individual and population level, of longitudinal dynamics from multimodal data with advanced computer modeling tools (e.g., with in silico human dietary response replicates or user-tailored, high-fidelity models that incorporate demographic, environmental, behavioral, multi-omic, social, cultural, clinical or other data to predict health trajectories).The Center will support the development of robust and artificially intelligent informatics platforms of multimodal, metadata-complete, human data sets data from the Nutrition for Precision Health consortium. The proposed Center projects will develop a suite of computational tools to perform data integration, harmonization, analysis and visualization of the multi-modal and multi-fidelity data as well as incorporate an adaptive design for future data incorporation. The proposed Center will be a hub in communicating state of the art for AI-ready’ biomedical data to the Nutrition for Precision Health consortium. All Nutrition for Precision Health awardees must work collaboratively to plan and execute a large dietary intervention study to catalyze precision nutrition research in transforming the application of targeted dietary approaches to improve health and reduce chronic diseases. The end products of the Nutrition for Precision Health consortium will be a rich data resource for research use and algorithms to improve the precision of nutrition advice for individuals.

https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-21-001.html

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Department of Health and Human Services – National Institutes of Health – Nutrition for Precision Health, powered by the All of Us Research Program: Metabolomics and Clinical Assays Center (U24 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 6, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      RFA-RM-21-002

Purpose: The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for a Metabolomics and Clinical Assays Center (MCAC) to join the Nutrition for Precision Health Consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). The focus of this center is to (1) generate targeted and non-targeted metabolite profiles and (2) perform or facilitate clinical assays from blood, urine and stool biospecimens.

https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-21-002.html

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Department of Health and Human Services – National Institutes of Health – Nutrition for Precision Health, powered by the All of Us Research Program: Microbiome and Metagenomics Center (U24 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 6, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      RFA-RM-21-003

Purpose: The purpose of this FOA is to invite applications for Microbiome and Metagenomics Centers (MMC) to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). The overall goal of the Microbiome and Metagenomics Center (MMC) is to perform microbiome, metagenomics and metatranscriptomics analysis of stool specimens collected in the Nutrition for Precision Health study.

https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-21-003.html

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Department of Health and Human Services – National Institutes of Health – Nutrition for Precision Health, powered by the All of Us Research Program: Dietary Assessment Center (U24 Clinical Trial Optional)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 6, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

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Funding Opportunity Number:                                      RFA-RM-21-004

Purpose: The purpose of this Funding Opportunity Announcement (FOA) is to invite applications for the Dietary Assessment Center to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). The awards made through this FOA will support the side-by-side application of at least one innovative approach to assess dietary intake in addition to the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool using free-living and controlled feeding studies with a goal of improving these methodologies through validation, evaluation, and modeling efforts.   This FOA invites applications that will support a Dietary Assessment Center that will conduct innovative dietary assessment on all participants and develop innovative approaches to address dietary assessment challenges.

https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-21-004.html

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Department of Health and Human Services – National Institutes of Health – Nutrition for Precision Health, powered by the All of Us Research Program: Clinical Centers (UG1 Clinical Trial Required)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 6, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      RFA-RM-21-005

Purpose: The purpose of this FOA is to invite applications for Clinical Centers (CC)s to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). Awards made through this FOA will support CCs to recruit participants and implement complex, modular protocols for dietary interventions studies. The CCs selected will work collaboratively with each other and other participating components of the Nutrition for Precision Health consortium to develop and implement study protocols. It is anticipated that all participants enrolled by the CCs into the Nutrition for Precision Health dietary studies will be part of the All of Us Research Program, and all Nutrition for Precision Health data will be shared via the All of Us Researcher Workbench. The end products of the Nutrition for Precision Health consortium will be a rich data resource for research use and algorithms to improve the precision of nutrition advice for individuals.

https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-21-005.html

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Department of Health and Human Services – National Institutes of Health – Nutrition for Precision Health, powered by the All of Us Research Program: Research Coordinating Center (U24 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 6, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

Award Floor:

Funding Opportunity Number:                                      RFA-RM-21-006

Purpose: The purpose of this FOA is to invite applications for a Research Coordinating Center (RCC) to join the Nutrition for Precision Health consortium (https://commonfund.nih.gov/nutritionforprecisionhealth). The overall goals of the RCC are to provide administrative management and general coordination across the Nutrition for Precision Health consortium; facilitate the development and implementation of dietary intervention and assessment studies across the consortium; and manage relevant data. The RCC selected will work collaboratively, as part of the Nutrition for Precision Health consortium, to develop and implement research protocols and manage data sharing workflows. The RCC must also serve as a key partner with the All of Us Research Program, since it is anticipated that all participants enrolled in the Nutrition for Precision Health dietary studies will be participants in the All of Us Research Program, and all Nutrition for Precision Health data will be shared via the All of Us Researcher Workbench. The end products of the Nutrition for Precision Health consortium will be a rich data resource for research use and algorithms to improve the precision of nutrition advice for individuals.

https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-21-006.html

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Department of Health and Human Services – National Institutes of Health – Institutional Training Programs to Advance Translational Research on Alzheimer’s Disease (AD) and AD-Related Dementias (T32)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           May 25, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

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Funding Opportunity Number:                                      PAR-21-112

Purpose: This Funding Opportunity Announcement (FOA) seeks to enable the development of a diverse, translational research workforce capable of participating and/or leading cross-disciplinary team science programs focused on advancing therapy development for Alzheimer’s disease (AD) and AD-related dementias (ADRD). This FOA will support institutional training programs for predoctoral and postdoctoral level researchers with diverse educational backgrounds (i.e., basic biology, translational and clinical research, data science and behavioral research). The program invites eligible institutions to develop interdisciplinary training programs that will provide trainees with the knowledge and skills in data science, disease biology, and traditional and emerging drug discovery disciplines necessary to conduct rigorous and cutting-edge basic, translational, and clinical research for AD and AD-related dementias.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-112.html

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Department of Health and Human Services – National Institutes of Health – NIA Academic Leadership Career Award (K07 Independent Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 12, 2021

Expected Number of Awards:

Estimated Total Program Funding:

Award Ceiling:

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Funding Opportunity Number:                                      PAR-21-06

Purpose: The objective of the NIA Academic Leadership Career Award (K07) is to provide support for senior investigators who have the expertise and leadership skills to enhance aging and geriatric research capacity within their academic institution.

This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by another investigator. 

https://grants.nih.gov/grants/guide/pa-files/PAR-21-106.html

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Department of Health and Human Services – Administration for Community Living – Disability and Rehabilitation Research Projects (DRRP) Program: Americans with Disabilities Act (ADA) National Network

Proposal Due Date:                                                           March 15, 2021

Expected Number of Awards:                                        10

Estimated Total Program Funding:                              $11,074,495

Award Ceiling:                                                                    $1,246,000

Award Floor:                                                                       $1,000,000

Funding Opportunity Number:                                      HHS-2021-ACL-NIDILRR-DPAD-0050

Purpose: The purpose of NIDILRR’s DRRPs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to improve the effectiveness of services authorized under the Rehabilitation Act by developing methods, procedures, and rehabilitation technologies that advance a wide range of independent living and employment outcomes for individuals with disabilities, especially individuals with the most significant disabilities. Under this priority, ten DRRPs, one within each of the 10 HHS regions, will be funded as part of the Americans with Disabilities Act (ADA) National Network. Applicants must propose a program of services and activities that lead to improved understanding among individuals and entities, of their rights and responsibilities under the ADA.  These services and activities include outreach, training, technical assistance, information dissemination, capacity building, and research.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=330314

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Department of Health and Human Services – Administration for Community Living – Disability and Rehabilitation Research Projects (DRRP) Program: Americans with Disabilities Act National Network Knowledge Translation Center

Proposal Due Date:                                                           March 15, 2021

Expected Number of Awards:                                        1

Estimated Total Program Funding:                              $850,000

Award Ceiling:                                                                    $850,000

Award Floor:                                                                       $845,000

Funding Opportunity Number:                                      HHS-2021-ACL-NIDILRR-DPAD-0051

Purpose: he purpose of NIDILRR’s DRRPs, which are funded through the Disability and Rehabilitation Research Projects and Centers Program, is to improve the effectiveness of services authorized under the Rehabilitation Act by developing methods, procedures, and rehabilitation technologies that advance a wide range of independent living and employment outcomes for individuals with disabilities, especially individuals with the most significant disabilities.

Under this particular opportunity, a DRRP must conduct knowledge translation and related activities in collaboration with the ADA National Network’s grantees. Specifically, among other requirements to be described in the funding opportunity announcement, the ADA KT Center must coordinate and support KT activities of the ADA National Network, conduct research aimed at improving knowledge translation on the ADA, manage and maintain the Outcome Measurement System (OMS) database, and organize and support an ADA research conference.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=330328

________________________________________________________

Department of Health and Human Services – Agency for Health Care Research and Quality – INTUIT-PC: Improving Nonsurgical Treatment of Urinary Incontinence among women in Primary Care: Dissemination and Implementation of PCOR Evidence (U18)

Letter of Intent Due Date:                                              February 24, 2021

Proposal Due Date:                                                           March 24, 2021

Expected Number of Awards:                                        5

Estimated Total Program Funding:                              $15,000,000

Award Ceiling:                                                                    $2,000,000

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-HS-21-001

Purpose: This initiative will fund up to 5 projects to use lessons learned from previous AHRQ primary care practice improvement initiatives to implement and test implementation strategies to address urinary incontinence in women, and to integrate it with specialty care. Projects may draw on community-based resources and/or include multilevel implementation strategies aligning improvement strategies between primary care practices and healthcare systems.

https://grants.nih.gov/grants/guide/rfa-files/RFA-HS-21-001.html

________________________________________________________

Department of Health and Human Services – Centers for Disease Control and Prevention – ERA – Rigorous Evaluation of Policies for their Impacts on the Primary Prevention of Multiple Forms of Violence

Proposal Due Date:                                                           April 5, 2021

Expected Number of Awards:                                        2

Estimated Total Program Funding:                              $2,100,000

Award Ceiling:                                                                    $350,000

Award Floor:                                                                       $200,000

Funding Opportunity Number:                                      RFA-CE-21-001

Purpose: The Centers for Disease Control and Prevention’s (CDC) National Center for Injury Prevention and Control (NCIPC) is soliciting research proposals to expand the evidence base for policy approaches for the primary prevention of multiple forms of violence experienced by children, youth, and adults. Policies that promote the social and economic well-being of populations and address community characteristics associated with violence have the potential to reduce rates of multiple forms of violence, including the four forms that are the focus of this announcement:  child abuse and neglect, youth violence, intimate partner violence, and sexual violence.  To advance NCIPC’s commitment to increasing health equity, the intent is to support applications that investigate policies that address social and structural conditions to reduce the disproportionate burden of violence experienced by some groups and communities.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=329352

________________________________________________________

Department of Health and Human Services – Centers for Disease Control – NCCDPHP – Improving Epilepsy Education, Systems of Care, and Health Outcomes through National and Community Partnerships

Proposal Due Date:                                                           April 12, 2021

Expected Number of Awards:                                        4

Estimated Total Program Funding:                              $20,000,00

Award Ceiling:                                                                    $4,400,000

Award Floor:                                                                       $100,000

Funding Opportunity Number:                                      CDC-RFA-DP21-2101

Purpose: The CDC Epilepsy Program is announcing a new, FY21 non-research NOFO designed to improve health and quality of life for people with epilepsy. Epilepsy is a chronic neurological condition characterized by recurrent seizures that can be caused by many different conditions that affect a person’s brain. In the US, about 3.4 million people have active epilepsy1 (physician-diagnosed epilepsy either currently under treatment or accompanied by 1 or more seizures in the past year).

This NOFO will implement strategies based on three CDC/National Center for Chronic Disease Prevention and Health Promotion domains (Environmental Approaches, Health Care Systems Interventions, and Community Programs Linked to Clinical Services) and will target social determinants of health in order to:

https://www.grants.gov/web/grants/view-opportunity.html?oppId=328415

________________________________________________________

Department of Health and Human Services – Health Resources and Services Administration – Evidence Based Telehealth Network Program

Proposal Due Date:                                                           April 2, 2021

Expected Number of Awards:                                        14

Estimated Total Program Funding:                              $4,900,000

Award Ceiling:                                                                    $350,000

Award Floor:                                                                      

Funding Opportunity Number:                                      HRSA-21-082

Purpose: This notice announces the opportunity to apply for funding under the Evidence Based Telehealth Network Program (EB THNP). The two-fold purpose of this award is (1) to demonstrate how health networks can increase access to health care services utilizing telehealth technologies and (2) to conduct evaluations of those efforts to establish an evidence base for assessing the effectiveness of telehealth care for patients, providers, and payers.

 The implementation of telehealth technology is rapidly expanding into health systems.1 HRSA defines telehealth as the use of electronic information and telecommunication technologies to support and promote long-distance clinical health care, patient and professional health-related education, public health and health administration. Telehealth modalities that support clinical treatment may include video conferencing, the internet, store-and-forward imaging, streaming media, and terrestrial and wireless communications. Rising evidence supports that many health conditions can be addressed with a virtual in home visit from a doctor to his or her patient.2 In 2015, the American College of Physicians declared their position and support for Direct-to-Consumer (DTC) considering the patient has an established relationship with the providers, and the care meets in person standards of quality.3

 For this NOFO, applicants must propose to provide DTC telehealth services to patients within established telehealth networks. This can be accomplished, in part, by identifying and partnering with local established health care facilities (especially primary care facilities) within the target service area, elevating the trusted patient-provider relationship, access, and quality of care directly to the patient via telehealth. Also, this service will allow for the expansion of access to care in Medically Underserved Areas (MUA) and primary care or mental health defined Health Professional Shortage areas (HPSA). The EB THNP program presents the opportunity for network sites that are currently or have previously utilized telehealth as defined above to efficiently and effectively pilot and/or expand DTC telehealth care. Applicants for this EB THNP Program must utilize synchronous (real-time virtual visits) audio-visual technology and may include remote patient monitoring (RPM) to provide DTC telehealth care to patients (see Appendix). This EB THNP program will expand access to health services in three clinical primary focus areas: (1) Primary Care, (2) Acute Care, and (3) Behavioral Health Care (see Appendix). In addition, applicants have the option to address one of the following secondary focus areas: Maternal Care, Substance Use Disorder, or Chronic Care Management.

 Changes to reimbursement policies related to in-home telehealth services and RPM in recent years, particularly in the Medicare program, have laid the framework to enable providers to feasibly integrate these technologies into their practices. For example, even prior to COVID-19, Medicare began to allow beneficiaries to receive telehealth services at home for a limited set of services/conditions including home dialysis and the treatment of a substance use disorder or a co-occurring mental health disorder.4 Home health is also an example of how the Medicare program has expanded the ability of home health agencies (HHAs) to use RPM technologies to augment the health care of the patients they serve. Recently, Medicare explicitly allowed HHAs to provide RPM services to their patients to help foster the adoption of emerging technologies by HHAs and result in more effective care planning.5,6 Such approaches, to the extent that they strengthen rather than supplant existing patterns and systems of care, reinforce the objectives of this funding opportunity. Namely, a key objective of this program is to demonstrate how providers can use DTC telehealth services in a way that enhances the existing health care infrastructure, as opposed to incentivizing care delivery that circumvents and disadvantages providers in local communities, including rural areas.

 Applicants are encouraged to include populations that have historically suffered from poorer health outcomes, health disparities, and other inequities, as compared to the rest of the rural population, when addressing health care needs via telehealth. Examples of these populations include, but are not limited to, racial and ethnic minorities, person/persons experiencing homelessness, pregnant women, disabled individuals, youth and adolescents, etc.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=329771

________________________________________________________

Department of Health and Human Services – Health Resources and Services Administration – Autism Secondary Data Analysis Research Program

Proposal Due Date:                                                           April 12, 2021

Expected Number of Awards:                                        4

Estimated Total Program Funding:                              $400,000

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      HRSA-21-052

Purpose: This notice announces the opportunity to apply for funding under the Autism Secondary Data Analysis Research (SDAR) Program. This program supports applied Maternal and Child Health (MCH) research that exclusively utilizes the secondary analysis of existing national databases and/or administrative records to determine the evidence-based practices for interventions to improve the physical and behavioral health of children and adolescents with Autism Spectrum Disorder (ASD) and other Developmental Disabilities (DD), Programs should address ASD/DD across the lifespan, with a focus on addressing the needs of underserved populations for whom there is limited evidence of the effectiveness of interventions, and limited access to screening, diagnosis, and treatment for ASD/DD.2   

https://www.grants.gov/web/grants/view-opportunity.html?oppId=330896

________________________________________________________

Department of Health and Human Services – Health Resources and Services Administration – Autism Field-Initiated Innovative Research Studies Program (Autism-FIRST)

Proposal Due Date:                                                           April 15, 2021

Expected Number of Awards:                                        2

Estimated Total Program Funding:                              $600,000

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      HRSA-21-053

Purpose: Bureau (MCHB)’s Office of Epidemiology and Research is accepting applications for the fiscal year (FY) 2021 Autism Field-Initiated Innovative Research Studies (Autism-FIRST) Program. The purpose of this program is to support empirical research that advances the evidence base on interventions designed to improve the health of children, adolescents, and young adults with autism spectrum disorders and other developmental disabilities (ASD/DD) across the lifespan. Because racial and ethnic disparities exist in the early screening and diagnosis of ASD/DD, the Autism-FIRST Program has a special focus on addressing the needs of underserved populations, such as low-income, racial/ethnic minorities, individuals living in rural areas and, in the case of ASD/DD populations, girls and young women, who are often under identified with regard to ASD, particularly at the higher functioning end.1 The Autism-FIRST program supports research studies that address critical issues surrounding the health and well-being of underserved children, adolescents, and young adults with ASD/DD up to the age of 26, and their families, recognizing that the first 25 years of life help lay the foundation for health and well-being across the lifespan.

 A focus on underserved populations is consistent with HRSA’s mission as an agency that promotes access to equitable and coordinated health and health care delivery services. A focus on children, adolescents, and young adults up to the age of 26 is consistent with the mission of the Maternal and Child Health Bureau (MCHB) and the populations it serves. The Autism-FIRST’s program’s goals and objectives are to:

 o Improve access to supports and services among underserved populations of children, adolescents, and young adults with ASD/DD and their families;

 o Effectively tailor services, supports, and interventions to individual and family strengths, needs, and challenges, recognizing the heterogeneity with which ASD/DD manifests itself across children, adolescents, and young adults with ASD/DD and their families;

 o Facilitate the transition into adulthood, including continuity in health care and other supports and services associated with optimal transitions and laying the foundation for improved health and well-being across the lifespan;

 o Improve the coordination of care across different aspects of the medical home, and/or across multiple sectors (e.g., health, school) that affect the lives of children, adolescents, and young adults with ASD/DD and their families; and

 o Identify services and supports that mediate or moderate relations between family stresses and outcomes for children, adolescents, and young adults with ASD/DD.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=330982

________________________________________________________

Department of Health and Human Services – Health Resources and Services Administration – Behavioral Health Workforce Education and Training (BHWET) Program for Paraprofessionals

Proposal Due Date:                                                           April 12, 2021

Expected Number of Awards:                                        43

Estimated Total Program Funding:                              $24,300,000

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      HRSA-21-090

Purpose: The purpose of the BHWET Program for Paraprofessionals is to develop and expand community-based experiential training to increase the supply of students preparing to become peer support specialists and other behavioral health-related paraprofessionals while also improving distribution of a quality behavioral health workforce. A special focus is placed on the knowledge and understanding of the specific concerns of children, adolescents, and transitional-aged youth in high need and high demand areas at risk for behavioral health disorders.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=328445

________________________________________________________

Department of Health and Human Services – Health Resources and Services Administration – Vision Screening in Young Children Program

Proposal Due Date:                                                           April 12, 2021

Expected Number of Awards:                                        1

Estimated Total Program Funding:                              $300,000

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      HRSA-21-033

Purpose: This notice announces the opportunity to apply for funding under the Vision Screening in Young Children Program. The purpose of the program is to improve children’s vision and eye health through early detection, follow-up, treatment, and surveillance at the national, state, and community levels for children under 5 years of age, including traditionally underserved populations,1 and those residing in medically underserved areas.2 The recipient will be expected to: 1) Serve as a national resource at the national, state, and community-levels on children’s vision and eye health; and 2) Convene an advisory committee to provide guidance to the Vision Screening in Young Children Program on achieving improved children’s vision and eye health.

https://www.grants.gov/web/grants/view-opportunity.html?oppId=329948

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Infectious Etiology of Alzheimer’s Disease (R01 Clinical Trial Optional)

Letter of Intent Due Date:                                              February 28, 2021

Proposal Due Date:                                                           March 31, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AG-21-034

Purpose: This Funding Opportunity Announcement (FOA) will support applications aimed at: (1) determining whether microbial pathogens represent a causal component of Alzheimer’s disease (AD), (2) establishing mechanisms by which microbial pathogens impact neurodegenerative processes in AD, and (3) informing aspects of future translational studies in AD, including the discovery of candidate therapeutics aimed at regulating pathogen-associated networks and molecules in AD.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-21-034.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required)

Letter of Intent Due Date:                                              March 13, 2021

Proposal Due Date:                                                           April 13, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-TR-21-010

Purpose: The purpose of this Funding Opportunity Announcement (FOA) is to support basket clinical trials of drugs targeting shared molecular etiologies in more than one rare disease. To facilitate clinical trial start up, and leverage existing datasets, preference will be given to applications focusing on diseases that are under study by the Rare Disease Clinical Research Network (RDCRN), and that involve collaborations with RDCRN clinical investigators.

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-21-010.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Multi-disciplinary Machine-assisted, Genomic Analysis and Clinical Approaches to Shortening the Rare Diseases Diagnostic Odyssey (UG3/UH3 Clinical Trial Optional)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 19, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-TR-21-008

Purpose: This Funding Opportunity Announcement (FOA) invites researchers to submit applications for multi-disciplinary diagnostic strategies for rare diseases that combine machine-assistance, genomic analysis, and clinical consultation. Of particular importance, these strategies must be able to be adopted and performed at the primary or secondary care levels by front-line healthcare providers and be readily integrated into their clinical care workflow.

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-21-008.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – BRAIN Initiative: New Concepts and Early-Stage Research for Recording and Modulation in the Nervous System (R21) (Clinical Trial Not Allowed)

Proposal Due Date:                                                           May 3, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-EY-21-001

Purpose: This FOA seeks applications for unique and innovative recording and/or modulation technologies that are in the earliest stage of development, including new and untested ideas that are in the initial stages of conceptualization. Some projects may aim to increase recording or modulation capabilities by many orders of magnitude, while others may aim to improve the precision and selectivity of recording or modulation (also referred to as stimulation, perturbation, or manipulation). A wide range of modalities are appropriate including acoustic, chemical, electrical, magnetic, optical and chemical, as well as the use of genetic tools.

Invasive or non-invasive approaches are sought that will enable large-scale recording and/or precise manipulation of neural activity, and that would ultimately be compatible with experiments in humans or behaving animals. Applications are encouraged from any qualified individuals, including physicists, engineers, theoreticians, and scientists, especially those not typically involved with neuroscience research.

https://grants.nih.gov/grants/guide/rfa-files/RFA-EY-21-001.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Letter of Intent Due Date:                                              April 14, 2021

Proposal Due Date:                                                           May 14, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-083

Purpose: This Funding Opportunity Announcement (FOA) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.

Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role).

Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-083.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

Letter of Intent Due Date:                                              April 14, 2021

Proposal Due Date:                                                           May 14, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-082

Purpose: This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-082.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Immune Development in Early Life (IDEaL) (U01 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                    $500,000

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AI-20-077

Purpose: The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or non-pathogenic microbes or vaccination against infectious diseases, allergens or environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-077.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Immune Development in Early Life (IDEaL) (U19 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                    $1,000,000

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AI-20-078

Purpose: The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development, and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or non-pathogenic microbes or vaccination against infectious diseases, allergens, and environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-078.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-119

Purpose: The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.

Applicants applying for funding under this FOA should be ready to initiate the clinical trial within the first quarter of the project period.  Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award.  If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion FOA, PAR-21-119, which utilizes an R61/R33 phased approach.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-119.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-118

Purpose: The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.

Applicants applying for funding under this FOA should be ready to initiate the clinical trial within the first quarter of the project period.  Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award.  If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion FOA, PAR-21-119, which utilizes an R61/R33 phased approach.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-118.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Infectious Etiology of Alzheimer’s Disease (R01 Clinical Trial Optional)

Letter of Intent Due Date:                                              February 28, 2021

Proposal Due Date:                                                           March 31, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AG-21-034

Purpose: This Funding Opportunity Announcement (FOA) will support applications aimed at: (1) determining whether microbial pathogens represent a causal component of Alzheimer’s disease (AD), (2) establishing mechanisms by which microbial pathogens impact neurodegenerative processes in AD, and (3) informing aspects of future translational studies in AD, including the discovery of candidate therapeutics aimed at regulating pathogen-associated networks and molecules in AD.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-21-034.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required)

Letter of Intent Due Date:                                              March 13, 2021

Proposal Due Date:                                                           April 13, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-TR-21-010

Purpose: The purpose of this Funding Opportunity Announcement (FOA) is to support basket clinical trials of drugs targeting shared molecular etiologies in more than one rare disease. To facilitate clinical trial start up, and leverage existing datasets, preference will be given to applications focusing on diseases that are under study by the Rare Disease Clinical Research Network (RDCRN), and that involve collaborations with RDCRN clinical investigators.

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-21-010.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Multi-disciplinary Machine-assisted, Genomic Analysis and Clinical Approaches to Shortening the Rare Diseases Diagnostic Odyssey (UG3/UH3 Clinical Trial Optional)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 19, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-TR-21-008

Purpose: This Funding Opportunity Announcement (FOA) invites researchers to submit applications for multi-disciplinary diagnostic strategies for rare diseases that combine machine-assistance, genomic analysis, and clinical consultation. Of particular importance, these strategies must be able to be adopted and performed at the primary or secondary care levels by front-line healthcare providers and be readily integrated into their clinical care workflow.

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-21-008.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – BRAIN Initiative: New Concepts and Early-Stage Research for Recording and Modulation in the Nervous System (R21) (Clinical Trial Not Allowed)

Proposal Due Date:                                                           May 3, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-EY-21-001

Purpose: This FOA seeks applications for unique and innovative recording and/or modulation technologies that are in the earliest stage of development, including new and untested ideas that are in the initial stages of conceptualization. Some projects may aim to increase recording or modulation capabilities by many orders of magnitude, while others may aim to improve the precision and selectivity of recording or modulation (also referred to as stimulation, perturbation, or manipulation). A wide range of modalities are appropriate including acoustic, chemical, electrical, magnetic, optical and chemical, as well as the use of genetic tools.

Invasive or non-invasive approaches are sought that will enable large-scale recording and/or precise manipulation of neural activity, and that would ultimately be compatible with experiments in humans or behaving animals. Applications are encouraged from any qualified individuals, including physicists, engineers, theoreticians, and scientists, especially those not typically involved with neuroscience research.

https://grants.nih.gov/grants/guide/rfa-files/RFA-EY-21-001.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Letter of Intent Due Date:                                              April 14, 2021

Proposal Due Date:                                                           May 14, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-083

Purpose: This Funding Opportunity Announcement (FOA) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.

Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role).

Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-083.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

Letter of Intent Due Date:                                              April 14, 2021

Proposal Due Date:                                                           May 14, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-082

Purpose: This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-082.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Immune Development in Early Life (IDEaL) (U01 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                    $500,000

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AI-20-077

Purpose: The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or non-pathogenic microbes or vaccination against infectious diseases, allergens or environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-077.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Immune Development in Early Life (IDEaL) (U19 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                    $1,000,000

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AI-20-078

Purpose: The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development, and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or non-pathogenic microbes or vaccination against infectious diseases, allergens, and environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-078.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-119

Purpose: The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.

Applicants applying for funding under this FOA should be ready to initiate the clinical trial within the first quarter of the project period.  Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award.  If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion FOA, PAR-21-119, which utilizes an R61/R33 phased approach.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-119.html

Department of Health and Human Services – National Institutes of Health – NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-118

Purpose: The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.

Applicants applying for funding under this FOA should be ready to initiate the clinical trial within the first quarter of the project period.  Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award.  If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion FOA, PAR-21-119, which utilizes an R61/R33 phased approach.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-118.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Infectious Etiology of Alzheimer’s Disease (R01 Clinical Trial Optional)

Letter of Intent Due Date:                                              February 28, 2021

Proposal Due Date:                                                           March 31, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AG-21-034

Purpose: This Funding Opportunity Announcement (FOA) will support applications aimed at: (1) determining whether microbial pathogens represent a causal component of Alzheimer’s disease (AD), (2) establishing mechanisms by which microbial pathogens impact neurodegenerative processes in AD, and (3) informing aspects of future translational studies in AD, including the discovery of candidate therapeutics aimed at regulating pathogen-associated networks and molecules in AD.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-21-034.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required)

Letter of Intent Due Date:                                              March 13, 2021

Proposal Due Date:                                                           April 13, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-TR-21-010

Purpose: The purpose of this Funding Opportunity Announcement (FOA) is to support basket clinical trials of drugs targeting shared molecular etiologies in more than one rare disease. To facilitate clinical trial start up, and leverage existing datasets, preference will be given to applications focusing on diseases that are under study by the Rare Disease Clinical Research Network (RDCRN), and that involve collaborations with RDCRN clinical investigators.

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-21-010.html

 

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Multi-disciplinary Machine-assisted, Genomic Analysis and Clinical Approaches to Shortening the Rare Diseases Diagnostic Odyssey (UG3/UH3 Clinical Trial Optional)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 19, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-TR-21-008

Purpose: This Funding Opportunity Announcement (FOA) invites researchers to submit applications for multi-disciplinary diagnostic strategies for rare diseases that combine machine-assistance, genomic analysis, and clinical consultation. Of particular importance, these strategies must be able to be adopted and performed at the primary or secondary care levels by front-line healthcare providers and be readily integrated into their clinical care workflow.

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-21-008.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – BRAIN Initiative: New Concepts and Early-Stage Research for Recording and Modulation in the Nervous System (R21) (Clinical Trial Not Allowed)

Proposal Due Date:                                                           May 3, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-EY-21-001

Purpose: This FOA seeks applications for unique and innovative recording and/or modulation technologies that are in the earliest stage of development, including new and untested ideas that are in the initial stages of conceptualization. Some projects may aim to increase recording or modulation capabilities by many orders of magnitude, while others may aim to improve the precision and selectivity of recording or modulation (also referred to as stimulation, perturbation, or manipulation). A wide range of modalities are appropriate including acoustic, chemical, electrical, magnetic, optical and chemical, as well as the use of genetic tools.

Invasive or non-invasive approaches are sought that will enable large-scale recording and/or precise manipulation of neural activity, and that would ultimately be compatible with experiments in humans or behaving animals. Applications are encouraged from any qualified individuals, including physicists, engineers, theoreticians, and scientists, especially those not typically involved with neuroscience research.

https://grants.nih.gov/grants/guide/rfa-files/RFA-EY-21-001.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Letter of Intent Due Date:                                              April 14, 2021

Proposal Due Date:                                                           May 14, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-083

Purpose: This Funding Opportunity Announcement (FOA) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.

Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role).

Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-083.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

Letter of Intent Due Date:                                              April 14, 2021

Proposal Due Date:                                                           May 14, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-082

Purpose: This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-082.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Immune Development in Early Life (IDEaL) (U01 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                    $500,000

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AI-20-077

Purpose: The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or non-pathogenic microbes or vaccination against infectious diseases, allergens or environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-077.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Immune Development in Early Life (IDEaL) (U19 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                    $1,000,000

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AI-20-078

Purpose: The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development, and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or non-pathogenic microbes or vaccination against infectious diseases, allergens, and environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-078.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-119

Purpose: The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.

Applicants applying for funding under this FOA should be ready to initiate the clinical trial within the first quarter of the project period.  Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award.  If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion FOA, PAR-21-119, which utilizes an R61/R33 phased approach.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-119.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-118

Purpose: The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.

Applicants applying for funding under this FOA should be ready to initiate the clinical trial within the first quarter of the project period.  Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award.  If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion FOA, PAR-21-119, which utilizes an R61/R33 phased approach.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-118.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Infectious Etiology of Alzheimer’s Disease (R01 Clinical Trial Optional)

Letter of Intent Due Date:                                              February 28, 2021

Proposal Due Date:                                                           March 31, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AG-21-034

Purpose: This Funding Opportunity Announcement (FOA) will support applications aimed at: (1) determining whether microbial pathogens represent a causal component of Alzheimer’s disease (AD), (2) establishing mechanisms by which microbial pathogens impact neurodegenerative processes in AD, and (3) informing aspects of future translational studies in AD, including the discovery of candidate therapeutics aimed at regulating pathogen-associated networks and molecules in AD.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AG-21-034.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (U44 Clinical Trial Required)

Letter of Intent Due Date:                                              March 13, 2021

Proposal Due Date:                                                           April 13, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-TR-21-010

Purpose: The purpose of this Funding Opportunity Announcement (FOA) is to support basket clinical trials of drugs targeting shared molecular etiologies in more than one rare disease. To facilitate clinical trial start up, and leverage existing datasets, preference will be given to applications focusing on diseases that are under study by the Rare Disease Clinical Research Network (RDCRN), and that involve collaborations with RDCRN clinical investigators.

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-21-010.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Multi-disciplinary Machine-assisted, Genomic Analysis and Clinical Approaches to Shortening the Rare Diseases Diagnostic Odyssey (UG3/UH3 Clinical Trial Optional)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           April 19, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-TR-21-008

Purpose: This Funding Opportunity Announcement (FOA) invites researchers to submit applications for multi-disciplinary diagnostic strategies for rare diseases that combine machine-assistance, genomic analysis, and clinical consultation. Of particular importance, these strategies must be able to be adopted and performed at the primary or secondary care levels by front-line healthcare providers and be readily integrated into their clinical care workflow.

https://grants.nih.gov/grants/guide/rfa-files/RFA-TR-21-008.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – BRAIN Initiative: New Concepts and Early-Stage Research for Recording and Modulation in the Nervous System (R21) (Clinical Trial Not Allowed)

Proposal Due Date:                                                           May 3, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-EY-21-001

Purpose: This FOA seeks applications for unique and innovative recording and/or modulation technologies that are in the earliest stage of development, including new and untested ideas that are in the initial stages of conceptualization. Some projects may aim to increase recording or modulation capabilities by many orders of magnitude, while others may aim to improve the precision and selectivity of recording or modulation (also referred to as stimulation, perturbation, or manipulation). A wide range of modalities are appropriate including acoustic, chemical, electrical, magnetic, optical and chemical, as well as the use of genetic tools.

Invasive or non-invasive approaches are sought that will enable large-scale recording and/or precise manipulation of neural activity, and that would ultimately be compatible with experiments in humans or behaving animals. Applications are encouraged from any qualified individuals, including physicists, engineers, theoreticians, and scientists, especially those not typically involved with neuroscience research.

https://grants.nih.gov/grants/guide/rfa-files/RFA-EY-21-001.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NIAID Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required)

Letter of Intent Due Date:                                              April 14, 2021

Proposal Due Date:                                                           May 14, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-083

Purpose: This Funding Opportunity Announcement (FOA) encourages cooperative agreement applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Mechanistic work in clinical trials may be of great value because it promotes the understanding of human diseases and the development of future therapeutic modalities.

Investigators are encouraged to visit the NIAID website for additional information about the research mission and high-priority research areas of the NIAID (https://www.niaid.nih.gov/research/role).

Only one clinical trial may be proposed in each NIAID Clinical Trial Implementation Cooperative Agreement (U01) application.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-083.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44 Clinical Trial Required)

Letter of Intent Due Date:                                              April 14, 2021

Proposal Due Date:                                                           May 14, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-082

Purpose: This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose to implement investigator-initiated clinical trials related to the research mission of the NIAID. This program provides support for hypothesis-driven, milestone-driven clinical trials. Although clinical trials not considered high-risk may be proposed, this program encourages high-risk clinical studies. High-risk does not imply human subject or patient risk, but rather defines a study that contains one or more of the following unique features: involves non-routine interventions, administration of an unlicensed product, or administration of a licensed product for an unapproved indication. Mechanistic studies are also encouraged and can be proposed under this program.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-082.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Immune Development in Early Life (IDEaL) (U01 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                    $500,000

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AI-20-077

Purpose: The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or non-pathogenic microbes or vaccination against infectious diseases, allergens or environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-077.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – Immune Development in Early Life (IDEaL) (U19 Clinical Trial Not Allowed)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                    $1,000,000

Award Floor:                                                                      

Funding Opportunity Number:                                      RFA-AI-20-078

Purpose: The purpose of this Funding Opportunity Announcement is to support research to define the mechanisms regulating the establishment, development, and maintenance of immunity throughout childhood (from birth to less than 18 years of age), including the impact of pathogenic or non-pathogenic microbes or vaccination against infectious diseases, allergens, and environmental pollutants on immune ontogeny and function. This program will establish collaborations among immunologists, neonatologists, pediatricians, systems biologists, and microbiologists to expand our knowledge of the developing immune system. Knowledge obtained through this program may be applied to the design of improved vaccines and immunotherapies to combat infections or treat/prevent immune-mediated diseases in this vulnerable population.

https://grants.nih.gov/grants/guide/rfa-files/RFA-AI-20-078.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R61/R33 Clinical Trial Required)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-119

Purpose: The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.

Applicants applying for funding under this FOA should be ready to initiate the clinical trial within the first quarter of the project period.  Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award.  If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion FOA, PAR-21-119, which utilizes an R61/R33 phased approach.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-119.html

________________________________________________________

Department of Health and Human Services – National Institutes of Health – NHLBI Early Phase Clinical Trials for Therapeutics and/or Diagnostics (R33 Clinical Trial Required)

Letter of Intent Due Date:                                              30 days prior to application due date

Proposal Due Date:                                                           June 4, 2021

Expected Number of Awards:                                       

Estimated Total Program Funding:                             

Award Ceiling:                                                                   

Award Floor:                                                                      

Funding Opportunity Number:                                      PAR-21-118

Purpose: The objective of this funding opportunity is to support investigator-initiated, phase I clinical trials for diagnostic and therapeutic interventions for heart, lung, blood, and sleep (HLBS) disorders in adults and children. The proposed trial can be single or multisite.

Applicants applying for funding under this FOA should be ready to initiate the clinical trial within the first quarter of the project period.  Discussion, submission, and attainment of applicable regulatory (FDA, DSMB, IRB) approvals, and establishment of drug (and placebo, if applicable) supplies, and any necessary third-party agreements should be established by the time of award.  If time and support for these and other pre-clinical and/or trial readiness activities are desired, applicants should consider the companion FOA, PAR-21-119, which utilizes an R61/R33 phased approach.

https://grants.nih.gov/grants/guide/pa-files/PAR-21-118.html