DoD Breast Cancer, Clinical Research Extension Award

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate translation of scientific discoveries and engineering developments in imaging, data science and/or spectroscopic technologies into methods or tools that address contemporary problems in understanding the fundamental biology, potential risk of development, diagnosis, treatment, and/or disease status for cancer or other disease.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to stimulate efforts to translate scientific discoveries and engineering developments into methods or tools that address problems in basic research to understand disease, or in applied research to assess risk, detect, prevent, diagnose, treat, and/or manage disease. The rationale is to deliver new capabilities to meet evolving requirements for technologies and methods relevant to the advance of research and delivery of care in pre-clinical, clinical and non-clinical settings, domestic or foreign, for conditions and diseases within the missions of participating institutes.

This Funding Opportunity Announcement (FOA) invites applications for centers to support transdisciplinary teams of clinical and mental health services researchers, behavioral scientists, social scientists, health information and communications technologists, health systems engineers, decision scientists, and mental health stakeholders (e.g., service users, family members, clinicians, payers) to engage in high-impact studies that will significantly advance clinical practice and generate knowledge that will fuel transformation of mental health care in the United States. Advanced Laboratories for Accelerating the Reach and Impact of Treatments for Youth and Adults with Mental Illness (ALACRITY) Research Centers will support the rapid development, testing, and refinement of novel and integrative approaches for (1) optimizing the effectiveness of therapeutic or preventive interventions for mental disorders within well-defined target populations; (2) organizing and delivering optimized mental health services within real world treatment settings; and (3) continuously improving the quality, impact, and durability of optimized interventions and service delivery within diverse care systems. The ALACRITY Centers program is intended to support research that maximizes synergies across various components of the mental health research ecosystem, including new discoveries in clinical research, transformative health care technologies, advances in information science, and new federal and state mechanisms for organizing mental health care.

This Funding Opportunity Announcement (FOA) invites applications to the National Institute on Aging's (NIA) Small Business Technology Transfer Research (STTR) program. The aim of this FOA is to support research that may lead to the development of innovative products and/or services with the potential to advance progress in preventing and treating Alzheimer's disease (AD) and AD-related dementias (ADRD) and/or caring for and treating patients living with AD/ADRD.

This Funding Opportunity Announcement (FOA) invites applications to the National Institute on Aging's (NIA) Small Business Innovation Research (SBIR) program. The aim of this FOA is to support research that may lead to the development of innovative products and/or services that have the potential to advance progress in preventing and treating Alzheimer's disease (AD) and AD-related dementias (ADRD) and/or caring for and treating patients living with AD/ADRD.

The National Institute on Alcohol Abuse and Alcoholism solicits applications for an R01 Clinical Trial Optional mechanism focusing on alcohol health services. This NOFO will broadly focus on closing the treatment gap for individuals with alcohol use disorder (AUD); within this focus, there are five major areas of emphasis: (1) increasing access to treatment for AUD, (2) making treatment for AUD more appealing, (3) examining cost structures and insurance systems, (4) conducting studies on dissemination and implementation of existing evidence-based approaches to treating AUD, and (5) reducing health disparities as a means of addressing the treatment gap in AUD for health disparity populations.

The National Institute on Alcohol Abuse and Alcoholism solicits applications for an R01 Clinical Trial Required mechanism focusing on alcohol treatment and recovery research. This NOFO will focus broadly on topics relevant for treatment of and recovery from alcohol use disorder (AUD), including: medications development, precision medicine, behavioral therapies and mechanisms of behavioral change (MOBC), recovery, translational research, and innovative methods and technologies for AUD treatment and recovery.

This Funding Opportunity Announcement (FOA) invites applications from institutions proposing to develop, or renew, an Alzheimer's Disease Research Center (ADRC). The National Institute on Aging (NIA) funds ADRCs at major medical institutions across the United States. NIA-funded ADRCs serve as a national resource for research related to Alzheimers disease (AD) and AD-related dementias (ADRD). Additionally, ADRCs work to translate research advances into improved diagnosis and care, as well as find ways to treat, and possibly prevent, AD/ADRD. Lastly, ADRCs collaborate and coordinate their research efforts with other programs and investigators funded by the National Institutes of Health (NIH).

Summary: Supports clinical research or clinical trials that provides interventions, innovations, and solutions in critical areas for dementia care for individuals with Alzheimer's disease and Alzheimer's disease related dementias (AD/ADRD) and their care partner(s). Distinctive Features: This funding opportunity allows for multiple principal investigators (PIs) under the Career Initiation or Transition (CIT) Partnership Option. If utilizing this option, only the initiating PI will submit a pre-application, but each PI will need to submit a full application. Be advised, all associated applications for a research project may be withdrawn if the initiating or partnering application is rejected or administratively withdrawn. Community collaboration is required. Research should prioritize both the individual living with an AD/ADRD diagnosis and their care partner(s).

Summary: Supports solutions-oriented research seeking to improve diagnosis and prognosis of Alzheimer’s disease and/or Alzheimer's disease related dementias (AD/ADRD). Distinctive Features: This funding opportunity allows for multiple principal investigators (PIs) under the Career Initiation or Transition (CIT) Partnership Option. If utilizing this option, only the initiating PI will submit a pre-application, but each PI will need to submit a full application. Be advised, all associated applications for a research project may be withdrawn if the initiating or partnering application is rejected or administratively withdrawn. Community collaboration is required. Leveraging existing resources and cohorts, particularly those that address critical health challenges, is strongly encouraged.

Summary: Supports non-incremental research designed to reduce risk of or prevent the development of Alzheimer’s disease and/or Alzheimer's disease related dementias (AD/ADRD). Allowable research includes projects utilizing animal models as well as clinical research projects. Distinctive Features: This funding opportunity allows for multiple principal investigators (PIs) under the Career Initiation or Transition (CIT) Partnership Option. If utilizing this option, only the initiating PI will submit a pre-application, but each PI will need to submit a full application. Be advised, all associated applications for a research project may be withdrawn if the initiating or partnering application is rejected or administratively withdrawn. Community collaboration is required for projects proposing clinical research. Leveraging existing resources and cohorts, particularly those that address critical health challenges and facilitate applicability to military health, is strongly encouraged.

Sponsored by the National Science Foundation (NSF), America's Seed Fund offers up to $2 million for U.S.-based startups and small businesses developing innovative technology. Project pitches are accepted on a rolling basis, with official responses from NSF typically taking one month.

Avenir means future in French, and this award looks toward the future by supporting early stage investigators proposing highly innovative studies. The award will support those in an early stage of their career who may lack the preliminary data required for an R01 grant, but who propose high impact research and who show promise of being tomorrow's leaders in the field. NIDA has developed two Avenir Award Programs, one for HIV/AIDS research and the other for genetics or epigenetics studies.

A central goal of the BRAIN Initiative is to understand how electrical and chemical signals code information in neural circuits and give rise to sensations, thoughts, emotions and actions. While currently available technologies can provide some understanding, they may not be sufficient to accomplish this goal. For example, non-invasive technologies are low resolution and/or provide indirect measures such as blood flow, which are imprecise; invasive technologies can provide information at the level of single neurons producing the fundamental biophysical signals, but they can only be applied to tens or hundreds of neurons, out of a total number in the human brain estimated at 85 billion.Other BRAIN FOAs seek to develop novel technology (RFA-NS-17-003) or to optimize existing technology ready for in-vivo proof-of-concept testing and collection of preliminary data (RFA-NS-17-004) for recording or manipulating neural activity on a scale that is beyond what is currently possible. This FOA seeks applications for unique and innovative technologies that are in an even earlier stage of development than that sought in other FOAs, including new and untested ideas that are in the initial stages of conceptualization.In addition to experimental approaches, the support provided under this FOA might enable calculations, simulations, computational models, or other mathematical techniques for demonstrating that the signal sources and/or measurement technologies are theoretically capable of meeting the demands of large-scale recording or manipulation of circuit activity in humans or in animal models. The support might also be used for building and testing phantoms, prototypes, in-vitro or other bench-top models in order to validate underlying theoretical assumptions in preparation for future FOAs aimed at testing in animal models.

This notice of funding opportunity (NOFO) will support research towards understanding and mitigating the deleterious effects of acute exposure to Ultra-Potent Synthetic (UPS) opioids (e.g., fentanyl, carfentanil, nitazenes) and their combinations (fentanyl and xylazine). This NOFO will also support research on the persistent and/or delayed pathophysiological effects after acute exposure to such agents.

The Bioprocessing Research Infrastructure Program supports the growth of bioprocessing in Illinois by funding infrastructure and essential equipment to expand training and research. As the bioprocessing industry grows, this program will strengthen Illinois' position as a leader with investments in cutting-edge pilot-scale facilities, skilled technical staff, and accessible resources for both businesses and students.

The Biosensing program is part of the Engineering Biology and Health cluster, which also includes 1) the Biophotonics program; 2) the Cellular and Biochemical Engineering program; 3) the Disability and Rehabilitation Engineering program; and 4) the Engineering of Biomedical Systems program. The Biosensing program supports fundamental engineering research in the monitoring, identification and/or quantification of biological analytes and phenomena using innovations that exist at the intersection of engineering, life sciences, and information technology. Projects submitted to the program must advance both engineering and life sciences. The Biosensing program encourages proposals that, in addition to advancing biosensing technology, address critical sensor needs in biomedical research, public health, food safety, agriculture, forensics, environmental protection, and homeland security. Proposals are especially encouraged in areas of critical need: sensing technologies that can enable monitoring and surveillance of the environment and/or individuals for novel infectious agents; platform technologies that can readily be modified as soon as new agents are detected, sequenced, and/or otherwise characterized to enable rapid deployment of sensors in clinics and the environment; and adaptive and/or multiplex sensing technologies that can help the nation prevent the spread of the next global pandemic. Major areas of interest for the program include: -Novel signal transduction principles and mechanisms that enable sensitive and specific biosensors, suitable for measurements in multiple areas; -Design of novel biorecognition elements and appropriately designed transducing systems to enable adaptable and/or reconfigurable operating parameters in response to environmental changes or application needs at levels of device, system, or data analysis; -Development of adaptive and/or evolvable biosensing systems for detection of novel target analytes or analytes under novel conditions; -Novel synthetic biology approaches for the development of cell-free and cell-based biosensors; and -Combining biosensors with artificial intelligence (AI) methods to improve sensor specificity and response time.

This Funding Opportunity Announcement (FOA) invites applications for P30 Cancer Center Support Grants (CCSGs) to support NCI-designated Cancer Centers. CCSGs support three types of Cancer Centers: 1) Comprehensive Cancer Centers, which demonstrate reasonable depth and breadth of research activities in each of three major areas: basic laboratory; clinical; and prevention, control and population-based research, and which have substantial transdisciplinary research that bridges these scientific areas; and 2) Clinical Cancer Centers, which are primarily focused on basic laboratory; clinical; and prevention, cancer control, and population-based research; or some combination of these areas, and 3) Basic Cancer Centers, which focus on basic laboratory research. The purpose of all types of NCI-designated Cancer Centers is to capitalize on all institutional cancer research capabilities, integrating meritorious research into a single transdisciplinary research enterprise across all institutional boundaries. Cancer Centers supported through this FOA are expected to serve as major sources of discovery of the nature of cancer and of development of more effective approaches to prevention, diagnosis, and therapy; to contribute significantly to the development of Shared Resources that support research; to collaborate and coordinate their research efforts with other NCI-funded programs and investigators; and to disseminate research findings for the benefit of the community.

The goal of the NHLBI Catalyze Program is to provide a comprehensive suite of support and services to facilitate the transition of basic science discoveries into viable diagnostic and therapeutic candidates that have been cleared for human testing, and to develop translational researchers fluent in product development and entrepreneurship. This specific Catalyze Enabling Technologies and Transformative Platforms initiative will support needed to rigorously validate transformative, multi-use platforms or technologies that can enable. Well-suited applications must offer the potential to significantly accelerate and/or transform the areas of early detection and screening, model development, clinical diagnosis, treatment, control, behavior, prevention or epidemiology. Proposed platforms and technologies may have widespread applicability but must be able to improve the outlook for HLBS-related diseases and disorders.

Purpose: This grant allows Skilled Nursing Facilities (SNF) and associations on behalf of facilities to apply for funding for tablets and tablet-related accessories. The tablets will be used for virtual telehealth and family visits for SNF residents. Description: This grant opportunity allows Skilled Nursing Facilities to apply for funding to purchase tablets and tablet-related accessories. Facilities must attest the tablets will be used for facilitating virtual telehealth or family visits for residents. Facilities must be certified through the Centers of Medicare and Medicaid Services (CMS). Applicants may generally request up to $3,000.00 per facility, however requests beyond $3,000.00 per facility will be accepted and will require CDPH and CMS review.

Purpose: This grant allows Skilled Nursing Facilities (SNFs) and associations on behalf of facilities to apply for funding for in-person visitation support materials. Description: CMP In-Person Visitation grants provide funding for nursing homes to facilitate safer in-person visits through use of outdoor and indoor equipment such as tents, clear dividers, portable fans, and portable room air cleaners with high-efficiency particulate air (HEPA, H-13 or 14) filters in response to the COVID-19 pandemic. Replacement air filters are a prohibited expense under this program. Facilities must attest they meet the requirements to purchase the materials and facilitate in-person visitation for residents. Facilities must be certified through the Centers of Medicare and Medicaid Services (CMS). Applicants may request up to a maximum of $3,000.00 per facility.

The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare neurodegenerative diseases for children and adults. Through the support of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare neurodegenerative diseases and exert a broad and positive impact on rare disease drug development.

The National Institute on Drug Abuse (NIDA) Cutting-Edge Basic Research Award (CEBRA) is designed to foster highly innovative or conceptually creative research related to the etiology, pathophysiology, prevention, or treatment of substance use disorders (SUDs). It supports high-risk and potentially high-impact research that is sparse or not included in NIDA's current portfolio that has the potential to transform SUD research. The proposed research should: 1. develop, and/or adapt, revolutionary techniques or methods for addiction research or that show promising future applicability to SUD research; and /or 2. test an innovative and significant hypothesis for which there are scant precedent or preliminary data and which, if confirmed, would transform current thinking.

Data science is an important cross-cutting research approach in the 2022 - 2026 NIDA Strategic Plan and increasing the capacity of experts in addiction related data science is critical. The purpose of this Notice is to facilitate the entry of investigators to the area of addiction-related data science, including newly independent data scientists or established investigators seeking to incorporate novel and cutting-edge data science methodologies into their research programs for the first time. Through this opportunity, investigators will propose to apply emerging data science methods to answer critical questions requiring advanced data analytic strategies. Projects should be small in scale and answer specific research questions or provide preliminary data for a larger scale project. Applicants are encouraged to use existing datasets, follow FAIR principles, and, when applicable, attend to ethical concerns in the conduct of research involving human subjects. Ultimately, the aim is to expedite the development of robust research programs focused on the convergence of innovative data science techniques and addiction research, with initial projects serving as precursors for subsequent, more expansive research projects.

The Military Health System Research Program (MHSRP) provides research grants on topic areas directed by the Office of the Assistant Secretary of Defense for Health Affairs (OASD (HA)) and the Leadership of the Defense Health Agency (DHA). The intent of MHSRP is to improve the efficiency of healthcare delivery within Military Health System (MHS) and accelerate its mission to become a learning health system and to mature as an integrated health system focused on Ready Reliable Care that will improve outcomes for patients, staff, and the enterprise. The MHSRP funds innovative and groundbreaking research that examines factors that affect the military health enterprise in terms of economics/cost, quality, outcomes, variation, policies, and the impact to service member readiness. The goal is to identify and characterize factors that influence the efficiency and effectiveness of MHS care delivery, whether at the military treatment facilities, within the healthcare networks, and/or in the private sector. It is imperative that knowledge gained from this research will support evidence-based DoD policy and decision-making at the strategic and front-line levels. This Notice of Funding Opportunity (NOFO) seeks rigorous collaborative health system research that has the potential to innovate military and civilian health care.

Summary: The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Clinical Outcomes and Biomarkers Award (COBA) supports the development and/or validation of clinical outcomes and biomarkers to enrich clinical trials in Amyotrophic Lateral Sclerosis (ALS). Projects can be relevant to a specific therapy, a class of therapeutics, or to a specific ALS subtype (such as a particular genetic mutation) and do not have to broadly apply to all patients. To meet the intent of the funding opportunity, applications must address ONE or BOTH of the following focus areas: Clinical Biomarkers: Identification, development, and/or validation of promising biomarkers for ALS. Biomarkers may include, but are not limited to susceptibility/risk, diagnostic, monitoring/disease progression, prognostic, predictive, response, or safety biomarkers. Clinical Outcomes: Identification, development, and/or validation of clinician-, observer-, or patient-reported, and/or performance outcome measures for ALS. Projects may include optimization of current outcome measures already in use. Both focus areas are permitted to utilize digital health measures, including wearable devices, smart-phone sensors, video or voice recordings, imaging studies, or other devices which record disease-relevant physiological data and/or outcomes.

Summary: The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Pilot Clinical Trial Award supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of Amyotrophic Lateral Sclerosis (ALS). Projects may range from phase 1 to small-scale phase 2 trials. Applications must address one of the following focus areas: Biomarker-Driven Interventions: Disease-modifying interventions, with mechanism-specific biomarkers to predict which clinical trial participants are likely to respond, demonstrate target engagement, and effects on the intended biological pathway. Clinical Care: Improving aspects of clinical care and symptom management for ALS. Distinctive Features: Funding from this award mechanism must support a clinical trial. Projects proposing a therapeutic intervention (drug, biologic, and/or device) must incorporate biomarkers specific to the intervention into the trial design. All applications are required to incorporate a Community Collaboration Plan, as described in Attachment 8 to optimize research impact. The clinical trial should begin no later than 12 months after the award date or 18 months for FDA-regulated studies.

Summary: The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Development Award (TDA) supports research ranging from preclinical validation of therapeutic leads through Food and Drug Administration (FDA) Investigational New Drug (IND)-enabling studies. The proposed studies are expected to be empirical in nature and product driven. Applicants with limited Amyotrophic Lateral Sclerosis (ALS) experience are strongly encouraged to include collaborators with substantial experience in the relevant ALS model systems, endpoints, and pathophysiology. Applications supported by this award must begin with lead compounds in hand and must already demonstrate proof-of-concept efficacy data in at least one appropriate preclinical model system of ALS, including whole animal and cellular model systems. Distinctive Features: Mechanism-specific, predictive/cohort-selective, target engagement, and pharmacodynamic biomarker development, in parallel to the main therapeutic effort, is a critical component of the FY25 ALSRP Therapeutic Development Award. If appropriate mechanism-specific biomarkers are already available or currently in development, how the existing biomarkers will improve trial design, patient selection, and efficiency or interpretation of the proposed ALS therapeutic approach must be apparent in the application. Development of biomarkers for the purposes of diagnosis, prognosis, or measurement of general disease progression without consideration of the therapeutic development process will not be supported. Therapeutic candidates which have already been granted an IND are not appropriate for this mechanism

Summary: The fiscal year 2025 (FY25) Amyotrophic Lateral Sclerosis Research Program (ALSRP) Therapeutic Idea Award (TIA) supports new, innovative, high-risk, high-gain ideas aimed at Amyotrophic Lateral Sclerosis (ALS) drug or therapy discovery. The studies supported by this award mechanism are expected to be hypothesis-driven and generate preliminary data for future avenues of therapeutic investigation. Distinctive Features: Applications may demonstrate the ability to achieve interpretable results in the absence of preliminary data supporting the hypothesis. While the inclusion of preliminary data is not prohibited, the strength of the application should rely on the approach.

Summary: The Ovarian Cancer Clinical Trial Academy (OCCTA) supports the next generation of Early-Career Investigators (ECIs) in clinical trial research to produce effective treatments and cures for ovarian cancer. The OCCTA, through its Leadership, provides for professional and leadership development of the ECIs to include skills and competencies needed to execute clinical trials, providing intensive mentoring, national networking, collaborations, and a peer group for junior clinical trialists. The OCCTA will bring together established investigators (the Academy Dean and Assistant Dean), established Career Guides (mentors), and a group of ECIs/Scholars to conduct successful, highly productive clinical trials in ovarian cancer. Distinctive Features: Research funded under this FY25 funding opportunity will support translational research and small-scale, early-phase clinical trials in ovarian cancer. Preliminary data are required, however, these data do not necessarily need to be derived from the ovarian cancer research field. ECI must be within 12 years of last postdoctoral research position (Ph.D.), clinical fellowship (M.D.), or equivalent at the time of full application submission deadline. Must commit no less than 25% effort to this award and/or OCCTA activities for the first 2 years. The Designated Mentor must be a clinical trialist with a strong record of mentoring and training early-career investigators.

Summary: The Ovarian Cancer Investigator-Initiated Research Award (OCRP) Investigator-Initiated Research Award is intended to support high-impact research that addresses a critical need and has the potential to make an important contribution to ovarian cancer or patient/survivor care. Distinctive Features: Application must contain strong research plan with sound scientific rational and logical reasoning. Preliminary data are required. Research projects may focus on any phase of research, from basic laboratory research through translational research, excluding clinical trials.

Summary: Supports research that expands or modifies current thinking about and/or approaches in ovarian cancer, exploring innovative concepts or theories in ovarian cancer that could ultimately lead to critical discoveries or major advancements that will drive the field forward. Distinctive Features: Innovation is key. Research projects that demonstrate exceptional scientific merit but lack innovation do not meet the intent of the mechanism. Preliminary data are not required but are allowed for this mechanism. Research projects may focus on any phase of research, from basic laboratory research through translational research, excluding clinical trials.

Summary: The fiscal year 2025 (FY25) Peer Reviewed Cancer Research Program (PRCRP) Clinical Trial Award (CTA) supports the rapid implementation of clinical trials with the potential to have a significant impact on the treatment or management of cancer within at least one of the FY25 PRCRP topic areas. Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies. Proposed projects may range from small proof-of-concept trials (e.g., pilot, first-in-human, phase 0) that evaluate the effects of interventions or inform the design of more advanced trials to large-scale trials (up to phase III) to determine efficacy in relevant patient populations. Distinctive Features: • Applications to this award mechanism must include a clinical trial. • Projects can range from phase 0 to phase III. • If an Investigational New Drug Application (IND) or an Investigational Device Exemption (IDE) is required, the application must be submitted to the FDA prior to the FY25 PRCRP Clinical Trial Award application submission deadline (this includes clinical trials requesting exception from informed consent under Code of Federal Regulations, Title 21, Part 50.24 (21 CFR 50.24). • Animal studies are NOT allowed under this award mechanism. All preclinical work must be completed prior to the award start date.

Summary: The fiscal year 2025 (FY25) Peer Reviewed Cancer Research Program (PRCRP) Idea Award (IA) supports innovative, untested, high-risk/potentially high-reward concepts, theories, paradigms, and/or basic cancer research. The advancement of knowledge in cancer research, patient care, and/or treatment options in the Military Health System (MHS) is critical to active-duty Service Members, Veterans, other military beneficiaries, and the American public. Distinctive Features: • The proposed project should demonstrate creative thinking and innovation. • Incremental advances, the next logical step, or switching a model system from one cancer to another cancer are not appropriate for this award. • Inclusion of preliminary data is not required; however, the project must be based on strong scientific rationale.

Summary: The fiscal year 2025 (FY25) Peer Reviewed Cancer Research Program (PRCRP) Impact Award supports mature research that will have a near-term impact on clinical cancer care in one of the congressionally directed FY25 PRCRP topic areas. Applicants must consider how the research project will lead to the advancement of knowledge in cancer research, patient care and/or treatment options in the Military Health System (MHS). Distinctive Features: • Applications must include preliminary data to support feasibility of the study. • Projects must have strong potential to result in a near-term impact in cancer • The funding mechanism allows clinical trials. • This funding mechanism allows for a single Principal Investigator (PI), or two partnering PIs referred to as the Initiating PI and the Partnering PI. Only the Initiating PI will submit a pre-application, but both PIs will need to submit full applications. The Partnering PI’s application is an abbreviated package specific to their distinct portion of the research project. Be advised, both applications for a research project may be withdrawn if the initiating or partnering application is rejected or administratively withdrawn.

This funding opportunity announcement (FOA) encourages the development and validation of animal models and human/animal tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological or neuromuscular disorder. The goal of this FOA is to promote a significant improvement in the translational relevance of animal models or ex vivo systems that will be utilized to facilitate future development of neurotherapeutics. Ideally, models proposed for this FOA would have the potential to provide feasible and meaningful assessments of efficacy following therapeutic intervention that would be applicable in both preclinical and clinical settings. This FOA is part of a suite of Innovation Grants to Nurture Initial Translational Efforts (IGNITE) Program focused on enabling the exploratory and early stages of drug discovery.

The INvestigation of Co-occurring conditions across the Lifespan to Understand Down syndromE (INCLUDE) Project encourages exploratory and innovative research to develop, characterize, or improve animal models and related biological materials for Down syndrome (DS) related research and to improve access to information about or from the use of animal models for DS research. The animal models and related biological materials developed must have utility in targeted or basic science studies in areas highly relevant to DS. With this funding opportunity announcement, the INCLUDE Project encourages, but is not limited to, projects focusing on development of various animal models, genetic resources, atlases at a single cell or subcellular level, advanced informatics technologies including artificial intelligence (AI) or machine learning (ML), and integration of multiple animal models and technology platforms for enhancing rigor and reproducibility of preclinical DS research.

The Disability and Rehabilitation Engineering program is part of the Engineering Biology and Health cluster, which also includes: 1) the Biophotonics program; 2) the Biosensing program; 3) the Cellular and Biochemical Engineering program; and 4) the Engineering of Biomedical Systems program. The Disability and Rehabilitation Engineering program supports fundamental engineering research that will improve the quality of life of persons with disabilities through the development of new theories, methodologies, technologies, or devices. Disabilities could be developmental, cognitive, hearing, mobility, visual, selfcare, independent living, or other. Proposed projects must advance knowledge regarding a specific human disability or pathological motion or understanding of injury mechanisms. Research may be supported that is directed toward the characterization, restoration, rehabilitation, and/or substitution of human functional ability or cognition, or to the interaction between persons with disabilities and their environment. Areas of particular interest are neuroengineering, rehabilitation robotics, brain-inspired assistive or rehabilitative systems, theoretical or computational methods, and novel models of functional recovery including the development and application of artificial physiological systems. Emphasis is placed on significant advancement of fundamental engineering knowledge that facilitates transformative outcomes. The DARE Program encourages high-risk/high-reward proposals that surpass incremental technological improvements. The DARE Program also encourages participatory design and the inclusion of trainees with disabilities as part of the proposed research or broader impacts. Innovative proposals outside of the above specific interest areas may be considered. NSF does not support clinical trials; however, feasibility studies involving human volunteers may be supported if appropriate to the project objectives. The development and application of artificial physiological systems that do not model functional recovery and instead improve fundamental understanding of physiological and pathophysiological processes would be appropriate for EBMS. Furthermore, the DARE program does not support proposals having as their central theme commercialization of a product. Small businesses seeking early stage R&D funding for product development are encouraged to contact the NSF SBIR/STTR program in the America's Seed Fund within the Directorate for Technology, Innovation and Partnerships (TIP).

Summary: Supports promising research that has high potential to lead to or make breakthroughs in breast cancer. All applications must address at least one of the fiscal year 2025 (FY25) Breast Cancer Research Program (BCRP) overarching challenges, unless adequate justification for exception is provided. Applications must address the challenge in a way that can lead to or make a breakthrough and have major impact. The FY25 Breakthrough Award mechanism contains three different funding levels designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. The current program announcement discusses the Breakthrough Award Level 3. Distinctive Features: - For this funding mechanism, small-scale clinical trials are allowed but not required. Applications proposing projects with a clinical trial should be submitted under the Clinical Trial option. - The research team must include two or more breast cancer consumer advocates. - This funding mechanism allows for a single Principal Investigator (PI), or two partnering PIs referred to as the Initiating PI and the Partnering PI. For the Partnering PI Option (PPIO), only the Initiating PI will submit a pre-application, but both PIs will need to submit at the full application stage. Be advised, applications may be withdrawn if both the initiating and partnering applications are not submitted by the full application deadline or if the initiating or partnering application is administratively withdrawn.

Summary: Supports promising research that has high potential to lead to or make breakthroughs in breast cancer. All applications must address at least one of the fiscal year 2025 (FY25) Breast Cancer Research Program (BCRP) overarching challenges, unless adequate justification for exception is provided. Applications must address the challenge in a way that can lead to or make a breakthrough and have major impact. The FY25 Breakthrough Award mechanism contains three different funding levels designed to support major (but not all) stages of research that will lead to clinical application. Each level has a defined research scope. The current program announcement discusses the Breakthrough Award Levels 1 and 2. Distinctive Features: · This funding mechanism allows for applications submitted under Funding Level 1 or Funding Level 2. Funding Level 2 also includes a Population Science and Prevention Studies option. With compelling justification, population science and prevention studies may request higher levels of funding and an additional year in the period of performance. · This funding mechanism allows for a single Principal Investigator (PI), or two partnering PIs referred to as the Initiating PI and the Partnering PI. For the Partnering PI Option (PPIO), only the Initiating PI will submit a pre-application, but both PIs will need to submit at the full application stage.

Summary: Supports a multidisciplinary research program of at least two, but not more than three, distinct but complementary research projects addressing an overarching question relevant to rare melanomas. Distinctive Features: *New for FY25* This funding mechanism is a partnering mechanism, requiring an Initiating Principal Investigator (PI) and at least one, but not more than two, Partnering PIs, see Figure 1. - Each named PI is expected to be a Project Leader for one of the proposed research projects. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). *New for FY25* After submitting the required pre-application, investigators must receive an invitation to submit a full application. - Only the Initiating PI will submit a pre-application. All PIs will need to submit full applications. The Partnering PI(s)’s application is an abbreviated package specific to their proposed research project. - Clinical trials are allowed. - Investigators are encouraged, but not required, to form collaborative relationships with the rare melanoma consumer community to maximize the impact and translatability of the research for the benefit of the intended community(ies).

Summary: Addresses the relatively new and underfunded area of melanoma-specific survivorship by supporting a broad range of innovative and impactful research that has the intended outcome of improving the health and well-being of melanoma survivors, their families, and/or their caregivers. Proposed studies focusing exclusively on animal models or considering survival only without consideration of quality of life, overall health, and/or function are not responsive to this funding opportunity. Distinctive Features: · The application must include at least one melanoma consumer collaborator, defined as a melanoma survivor, family member, and/or caregiver who can provide lived experience expertise to the research project team, or a melanoma-community supporting organization who will be integral to the planning, execution and implementation of the proposed research. · Clinical trials are allowed.

Summary: Supports a broad range of hypothesis-driven, multidisciplinary studies that have a short-term goal of advancing the state of the science in melanoma research and/or patient care. Team science is a synergistic effort that harnesses techniques, approaches, and perspectives from multiple disciplines and/or therapeutic areas to address complex, multi-dimensional problems that will impact patient outcomes. Distinctive Features: - This funding mechanism requires multiple Principal Investigators (PIs). At least two and up to three PIs should partner to jointly design and execute a single research project; multi- institutional partnerships are encouraged. If recommended for funding, each PI will be named on separate awards to the recipient organization(s). - *New for FY25* After submitting the required pre-application, investigators must receive an invitation to submit a full application. - Only the Initiating PI will submit a pre-application. All PIs will need to submit full applications. The Partnering PI(s)’s application is an abbreviated package specific to their proposed effort. - Investigators are encouraged, but not required, to form collaborative relationships with the melanoma consumer community to maximize the impact and translatability of the research for the benefit of the intended community(ies).

Summary: The fiscal year 2025 (FY25) Military Burn Research Program (MBRP) Discovery Award (DA) Supports innovative, untested, groundbreaking research that provides new insights and explores early concepts in combat-relevant burn care that provides the foundation for future translational and/or clinical research. The proposed project may be exploratory, hypothesis-driven, or hypothesis-generating research but must be novel and must be based on a strong scientific rationale and a well-developed study design. Distinctive Features: The focus of this award mechanism is innovation. Proposed research should lay the groundwork for future avenues of scientific investigation or product development in the area of combat-relevant burn care. The outcome of research supported by this award should be the generation of robust preliminary data that can be used as a foundation for groundbreaking future research projects.

Summary: Despite significant research investment in combat-relevant burn care, a disparity exists between newly discovered knowledge in burn care and its implementation into clinical practice in the distributed operational battlespace. The fiscal year 2025 (FY25) Military Burn Research Program (MBRP) Patient-Centered Research Award (PCRA) seeks to bridge the gap between research, practice, and policy by developing a knowledge base that provides clinically useful findings about how interventions, clinical practices, guidelines, tools, and policies can be deployed to burn patients in an austere, resource-limited, distributed operational environment at the point of need. Distinctive Features: Funding from this award mechanism must support clinical research or clinical trials but cannot support preclinical or animal research. Applications may propose prospective or retrospective research involving human subjects or human subject data.

Summary: The fiscal year 2025 (FY25) Military Burn Research Program (MBRP) Technology/Therapeutic Development Award (TTDA) is a burn-focused, product-driven award mechanism intended to provide support for the translation of promising preclinical findings into burn products for clinical application in an austere, resource-limited, distributed operational environment. Distinctive Features: The technology or therapeutic product(s) to be developed must be product-oriented (e.g., medical device, drug, or clinical practice guidelines involving a therapeutic or technology). The product(s) to be developed may be tangible or knowledge supporting the development of a tangible product and must address one or more of the FY25 MBRP TTDA focus areas. Knowledge products are allowable, provided that the knowledge is applicable to a technology or therapeutic under development. (A “knowledge product” is a non-tangible, non-materiel product that results from research with the potential to improve individual or public health.)

Summary: The fiscal year 2025 (FY25) Prostate Cancer Research Program (PCRP) Clinical Consortium Award (CCA) provides support to develop, maintain, and enhance the necessary collaborations and resources to rapidly execute phase 2 and/or phase 2-linked phase 1 (phase1/2) prostate cancer clinical trials. The primary intent of the PCRP Clinical Consortium Award is to combine the efforts of leading investigators across multiple institutions to expedite the clinical advancement of novel therapeutic interventions in prostate cancer to decrease the impact of the disease. Distinctive Features: · This award mechanism does not support the development of clinical protocols. · Coordinating Center: This award mechanism supports one coordinating center, which will be responsible for development and maintenance of the consortium organizational structure, and also function as a Clinical Research Site. · Clinical Research Sites: This award mechanism supports multiple clinical research sites, which will be responsible for clinical trial introduction and selection, patient accrual for consortium studies, data collection and timely submissions, meeting attendance, and adherence to the consortium’s operating procedures.

Summary: The fiscal year 2025 (FY25) Prostate Cancer Research Program (PCRP) Idea Development Award (IDA) supports new ideas that represent innovative approaches to prostate cancer research and have the potential to make an important contribution to the PCRP mission. All applications are required to address one or more of the FY25 PCRP Overarching Challenges. Distinctive Features: New Investigator Category: In addition to Established Investigators, the FY25 PCRP Idea Development Award encourages research ideas from investigators in the early stages of their careers (i.e., within 10 years after completion of their terminal degree). Qualified New Investigators must identify a collaborator(s) experienced in prostate cancer research.

Summary: The fiscal year 2025 (FY25) Rare Cancers Research Program (RCRP) Concept Award (CA) supports highly innovative, untested, potentially groundbreaking novel concepts in rare cancers. This award mechanism supports high-risk studies that have the potential to reveal entirely new avenues for investigation in rare cancers. Applications must describe how the new idea will be innovative and present as a novel course of investigation in the field of rare cancers.

Summary: The fiscal year 2025 (FY25) Rare Cancers Research Program (RCRP) Idea Development Award (IDA) promotes new ideas that are still in the early stages of development and have the potential to yield impactful data and new avenues of investigation. Distinctive Features: - Applications are encouraged to include an exploratory aim or sub-aim to support any necessary discovery-driven research. - Preliminary data with disease-specific rationale are required. However, these data do not necessarily need to be derived from studies of the proposed rare cancer type(s)/subtype(s) under study. - Research should have high potential impact on rare cancers and the patient community.

Summary: The fiscal year 2025 (FY25) Rare Cancers Research Program (RCRP) Resource and Community Development Award (RCDA) supports the development of research resources and clinical or preclinical data sets that will advance the field of rare cancers research and ultimately improve outcomes for individuals with rare cancers. Major gaps to be filled by this funding opportunity include: - Lack of research and clinical resources, including patient tissues, cell, and tumor models. - Lack of communication and dissemination strategies within scientific and patient communities for sharing rare cancers research and clinical findings. - Lack of infrastructure for sharing data and other resources. - Lack of therapeutics and mechanistic research to inform treatment development. Distinctive Features: - Engagement and partnerships with Patient Advocates must be integrated into the project from development of the research question through the execution of the study. - Community building and enhancement are key components. - Dissemination and sustainability of the platform for scientific and/or clinical, and patient community must be described. - Preliminary data not required but may be included to address feasibility.

Summary: The intent of the FY25 Toxic Exposures Research Program (TERP) Clinical Trial Partnership Award (CTPA) is to support new or existing collaborative partnerships that will rapidly implement clinical trials with the potential to have a significant impact on the prevention, treatment or management of symptoms, diseases, or conditions associated with or resulting from military-related toxic exposures. Proposed projects may range from small proof-of-concept clinical trials (e.g., pilot, first-in-human, phase 0) designed to demonstrate the feasibility or inform the design of more advanced trials through large-scale trials (including pragmatic clinical trials) to determine efficacy in relevant patient populations. Distinctive Features: To encourage applications that include meaningful and productive collaborations between investigators, the FY25 TERP CTPA requires partnership of the Initiating Principal Investigator (PI) with at least one, and up to two, other collaborating PIs for the completion of one overarching study.

The FY25 Toxic Exposures Research Program (TERP) Investigator-Initiated Research Award (IIRA) is intended to support studies that will make an important contribution toward research and/or patient care for diseases or conditions associated with military-related toxic exposures. Research projects may focus on any phase of research from basic laboratory research through translational research, including preclinical studies in animal models and human subjects, as well as correlative studies associated with an existing clinical trial. New Approach Methodologies may also be used.

Summary: The intent of the FY25 Toxic Exposures Research Program (TERP) Translational Research Partnership Award (TRPA) is to support new or existing collaborative partnerships to pursue translational research that will accelerate the movement of promising ideas in military-related toxic exposure research into clinical applications, including health care products, interventions, technologies, and/or clinical practice guidelines. Translational research may be defined as an integration of basic science and clinical observations. New Approach Methodologies may also be used. Applications should provide evidence for the reciprocal transfer of information between basic and clinical science or vice versa in developing and implementing the research plan. Distinctive Features: To encourage applications that include meaningful and productive collaborations between investigators, the FY25 TERP TRPA requires partnership of the Initiating Principal Investigator (PI) with at least one, and up to two, other collaborating PIs for the completion of one overarching study. The intent is to support interdisciplinary partnerships, such as those between clinicians and research scientists that will accelerate the movement of promising ideas into clinical applications.

The purpose of this Notice of Funding Opportunity (NOFO) is tofurther elucidate the mechanisms of early immune development in utero, during the early post-natal period and during early childhood in neonates, infants, and children and adolescents with or without in-utero exposure to HIV or Anti-Retroviral Therapeutics (ART).This initiative aims to understand intricate mechanisms of immune cells at the maternal-fetal interface, T and B cell development and maturation in offspring, and local immune responses and the role of systemic immunity.

This Funding Opportunity Announcement (FOA) supports the development of early-stage or new data repositories and knowledge bases as distinct and separate resources that could be valuable for the biomedical research community.

The purpose of this Notice of Funding Opportunity (NOFO) is to invite Small Research Grant (R21) applications that propose to study the ethical, legal, and social implications (ELSI) of human genetics and genomics. Applications may propose studies using either single or mixed methods. Direct involvement of key stakeholders where appropriate is encouraged. These applications should be for small research projects, such as those that involve single investigators. Of particular interest are projects that propose normative or conceptual analyses, including focused legal, economic, philosophical, anthropological, or historical analyses of new or emerging issues. This mechanism can also be used for the collection of preliminary data and the secondary analysis of existing data.

This Notice of Funding Opportunity (NOFO) invites applications that propose to use mouse models to conduct rigorous preclinical testing of drugs or drug combinations currently used for other conditions, as well as investigational drugs at various stages of clinical development, predicted to be efficacious in AD/ADRD. This initiative will also support preclinical testing of repurposable or investigational drug candidates in combination with non-pharmacologic interventions leading to robust translational outcomes. The central goal is to establish robust proof of concept that will enable rational drug repurposing and combination therapy development for the treatment and prevention of AD/ADRD.

The purpose of this initiative are to accelerate research leading to improved understanding and treatments for Guillain Barre Syndrome (GBS) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). Responsive applications would propose studies of immunological mechanisms of nerve damage/dysfunction, contributing genetic/epigenetic factors, novel animal/cellular model systems, discovery of novel diagnostic or treatment response biomarkers, novel treatments or mechanisms of action of existing treatments.

The purpose of the FDA (R13) Scientific Conference Grant Program is to facilitate the provision of federal financial assistance in support of high-quality conferences and scientific meetings designed to research and investigate a topic clearly aligned with the FDA mission. The FDA recognizes the value of supporting high quality conferences and scientific meetings relevant to its mission and to the public health. A conference or scientific meeting is defined as a symposium, seminar, workshop, or any formal meeting, whether conducted face-to-face or virtually to exchange information and explore a defined subject, issue, or area of concern impacting the public's health within the scope of the FDA's mission. Permission to submit a conference grant application does not assure funding or funding at the level requested. FDA will not issue a conference grant award unless it can be issued before the conference start date.

The purpose of this Funding Opportunity Announcement (FOA) is to facilitate the transition of previously funded SBIR and STTR Phase II and Phase IIB projects in pain management to the commercialization stage by providing additional assistance for private partnering activities through the Commercialization Readiness Pilot (CRP) program. Specifically, this FOA supports the addition of entrepreneurial expertise into small business leadership teams along with supporting partnering activities to aid in commercialization through private third-party funding or partnership with industry.

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for pilot projects to identify new druggable targets for pain within the understudied druggable proteome. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s) listed in this NOFO. This NOFO is intended to jumpstart research on understudied proteins within the context of pain and pain management and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins to identify new druggable targets for pain. This NOFO is part of the NIH Helping to End Addiction Long Term (HEAL) initiative to accelerate the development of novel medications to treat all aspects of the opioid addiction cycle, including progression to chronic use, withdrawal symptoms, craving, relapse, and overdose.

This funding opportunity is part of a suite of NOFOs within the NIH HEAL Initiative to support the development of safe, effective, and non-addictive therapeutics to treat pain. The goal is to encourage initial translational efforts that will support a drug discovery program and advance projects to the point where they meet the entry criteria for the Pain Therapeutics Development Program. The scope will therefore be focused on development of assays to support a distinct testing funnel, screening efforts to identify hits, and initial characterization of hits and potential therapeutic agents (including small molecules, biologics, and natural products).

The Illinois Department of Commerce and Economic Opportunity is issuing this Notice of Funding Opportunity (“NOFO”) to implement a capital grant program to support reproductive health care facilities in Illinois that are experiencing increased demand for their services. Following the Supreme Court decision to overturn Roe v Wade in 2022, Illinois clinics have seen an influx of out-of-state patients, resulting in limited capacity and stress to reproductive health care service providers. To address the need to maintain and expand access to care, the Illinois Reproductive Health Facilities Capital Grant Program will help abortion providers in Illinois address their needs for capital investment. Grant funds may be used to invest in facility construction or durable equipment.

This Notice of Funding Opportunity Announcement (NOFO) is designed to encourage and facilitate the entry of investigators to the area of brain imaging research. This NOFO will support both newly independent investigators and established investigators who are seeking to develop and adopt neuroimaging tools and methodologies in their research programs and conduct small "proof-of-concept" studies relevant to substance use disorders and addiction. This NOFO is intended to support Small Research Grant (R03) projects that can be carried out in a short period of time with limited resources.

This funding opportunity aims to support the development of in vivo high-resolution structural and functional imaging technologies for the living human inner ear. Proposed projects should focus on improving the resolution of current imaging techniques or developing new imaging techniques that can visualize inner ear structures in vivo with significantly greater detail and accuracy than currently possible. Both structural and functional aspects, including visualizing dynamic elements are important to development of new and improved techniques. Projects may also focus on developing new imaging probes or contrast agents that can enhance visualization of the inner ear structures. Ultimately, research supported in response to this RFA is to encourage technologies that allow, for example, structures such as hair cells, otoliths, membranes, ions, and vasculature to be viewed in detail in awake patients in a clinical setting using non-invasive techniques. To achieve this goal, a multi-disciplinary team approach that takes advantage of the expertise of each team member is highly encouraged. Studies in humans and intermediate studies in animals, but not non-mammalian species, may be proposed to develop or advance the needed technology. Any intermediate studies must articulate a clear path of the proposed methodology to application in awake humans or define the limitations and the usefulness in anesthetized humans.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits grant applications proposing exploratory research projects focused on the early-stage development of highly innovative technologies offering novel molecular or cellular analysis capabilities for basic or clinical cancer research. The emphasis of this NOFO is on supporting the development of novel capabilities involving a high degree of technical innovation for targeting, probing, or assessing molecular and cellular features of cancer biology. Technologies proposed for development may be intended to have widespread applicability but must be focused on improving molecular and/or cellular characterizations of cancer biology. Well-suited applications must offer the potential to accelerate and/or enhance research in the areas of cancer biology, early detection and screening, clinical diagnosis, treatment, control, or epidemiology, and/or address issues associated with cancer health disparities. This funding opportunity is part of a broader NCI-sponsored Innovative Molecular Analysis Technologies (IMAT) Program.

The purpose of this Notice of Funding Announcement (NOFO) is to encourage pilot research that is not an immediate precursor to testing a service intervention but is consistent with NIMH priorities for services research. While NIMH now requires use of an experimental therapeutics model for all intervention studies, there is recognition that some mission-relevant areas of services research do not involve clinical trials.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) encourages applications promoting transformative discoveries in cancer biology and/or oncology through the use of nanotechnology. Proposed projects should address major barriers in cancer biology and/or oncology using nanotechnology and should emphasize mechanistic studies toward fundamental understanding of nanomaterial and/or nanodevice interactions with biological systems. These studies should be performed in context of research concerning the delivery of nanoparticles and/or nano-devices to desired and intended cancer targets in vivo and/or characterization of detection and diagnostic devices in vitro. IRCN awards are expected to produce fundamental knowledge to aid future and more informed development of nanotechnology-based cancer interventions. The clinical translation of these interventions is outside of the scope of this NOFO.

This FOA encourages research relevant to the development of novel screening approaches and/or therapeutic interventions for potentially fatal or disabling conditions that have been identified through newborn screening, as well as for "high priority" genetic conditions where screening may be possible in the near future.Having an accurate screening test, as well as demonstrating the benefits of early intervention or treatment, are important criteria for including a condition on a newborn screening panel. This FOA defines a "high priority" condition as one where screening is not currently recommended, but infants with the condition would significantly benefit from early identification and treatment.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) seeks research project (R01) grant applications describing projects that integrate imaging and fluid-based tumor monitoring (liquid biopsy) assays during cancer therapy in patients to determine the optimal use of those modalities in the characterization of therapy response and/or emergence of resistance.

This Notice of Funding Opportunity (NOFO) is issued by the Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), and solicits Research Project (R01) grant applications from institutions or organizations that propose to develop or support the development of designated new animal drugs intended for minor uses in major species or for use in minor species (MUMS). The FDA is authorized to provide grants to assist in defraying the costs of qualified safety and effectiveness testing that could be used to satisfy the requirements for FDA approval of MUMS-designated drugs. Only entities developing drugs for veterinary use or parties working as research partners with such entities are eligible for grants. The organization (or applicant) seeking approval of the new animal drug under investigation must have opened an Investigational New Animal Drug (INAD) file with FDA/CVM and must hold a minor use or minor species "designation" granted by FDA/CVM's Office of Minor Use and Minor Species Animal Drug Development (OMUMS) for that drug for a specified intended use, in accordance with the provisions of section 573 of the Food, Drug and Cosmetic Act (21 U.S.C. 360ccc-2) and 21 CFR part 516.

The purpose of this Notice of Funding Opportunity (NOFO) is to invite research grant applications (R01) for the development and use of current and emerging molecular imaging methods to gain fundamental insights into cancer inflammation in vivo. The motivation for this initiative is that much of current imaging research into the role of inflammation in cancer is largely based on in vitro and ex vivo methods with limited utilization of imaging approaches that could lead to significant new insights relevant to dynamic cancer and inflammation interactions. Utilization of molecular imaging probes in pre-clinical and clinical investigations for precise temporal resolution at the molecular and cellular level are valuable approaches for identification and characterization of in vivo inflammatory cellular physiology in cancers and of molecular changes in response to treatment. This FOA encourages applications that focus on developing integrated imaging approaches to interrogate the role of inflammation in cancer through strong cross-field collaboration between cancer basic science researchers and imaging scientists. These collaborations are expected to advance science and understanding of cancer inflammation interactions.

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to 3 years support for studies to replicate the impact of the natural product on target engagement when used by humans, and assess whether there is an association between the degree of the impact on target engagement and functional or clinical outcomes in a patient population. Applications are encouraged to design studies to determine how to optimize the impact of the natural product on target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to engage the same target; or study the impact of the natural product in a target population that is more responsive. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This R33 funding mechanism is intended to accelerate the translation of emerging basic science findings about natural products into early-stage clinical testing to determine whether continued clinical research is warranted. This NOFO will not support efficacy or effectiveness trials, nor will

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated, early phase, clinical trials of natural products (i.e., botanicals, probiotics, and products marketed as dietary supplements), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. Under this NOFO, trials must be designed so that results, whether positive or negative, will provide information of high scientific utility and will support decisions about further development or testing of the natural product. This NOFO will provide up to three years (R61 phase) of support for milestone-driven testing of pharmacokinetics, bioavailability, and assessment of the natural products effect (i.e., measure of mechanism of action) when used by humans on a specified target measure. If milestones in the R61 phase are achieved, up to 3 years of additional support (R33 phase) may be awarded to replicate the impact of the natural product on target engagement(s) when used by humans and assess whether there is an association between the degree of the impact on the target engagement and clinical outcomes in a participant population. Applications are encouraged to design R33 studies to determine how to optimize the impact of the natural product on the target engagement by optimizing the delivery of the natural product through examination of different doses or formulations. In addition, applications can be designed to combine the natural product with another treatment approach that is known to impact the same target engagement measure; or study the impact of the natural product in a population that is more responsive,

This Notice of Funding Opportunity (NOFO) encourages applications for investigator-initiated mid-phase clinical trials of natural products(i.e., botanicals, dietary supplements, and probiotics), which have a strong scientific premise to justify further clinical testing. For this NOFO, natural products include promising nutritional regimens that standardize the amount of a specific naturally occurring nutritional compound (e.g., omega-3 fatty acids, anthocyanidins, or polyphenols) and have compelling preliminary evidence. All applications submitted under this NOFO must be supported by sufficient preliminary data demonstrating bioavailability (if applicable) and documentation that the natural product produces a reproducible and measurable impact on target engagement (i.e., measure of the mechanism of action). Only in cases when it is not possible/practical to measure target engagement in the patient population of interest or when there is a fundamental understanding of the products mechanism of action will this preliminary data requirement be waived. Applications submitted to this NOFO should propose a mid-phase clinical trial to do the following: determine the optimal dose or formulation of a given natural product for use in a future multi-site efficacy trial; or determine which patient phenotypes will be responders versus non-responders to the natural product to inform inclusion/exclusion criteria of a future efficacy trial. Clinical trials submitted under this NOFO are expected to be hypothesis based, milestone-driven, and directly related to the research priorities and mission of NCCIH. This NOFO will not support single-site or multi-site efficacy or effectiveness trials, nor will it support trials to test natural products for the treatment or prevention of cancer. Applicants are encouraged to contact the appropriate NCCIH Scientific/Research contact for the area of science for which they are planning to develop an application prior to submitting to this NO

The National Cancer Institute (NCI) intends to supports the development of new exploratory research in cancer diagnosis, treatment, imaging, symptom/toxicity, and prevention clinical trials; correlative studies associated with clinical trials; novel cancer therapeutic, symptom/toxicity, and preventive agent development, radiotherapy development activities, and mechanism-driven combinations; and innovative preclinical studies--including the use of new clinically-relevant models and imaging technologies--which could lead to first-in-human clinical trials. The R21 mechanism is intended to encourage exploratory and developmental research projects by providing support for the early and conceptual stages of these projects. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of cancer research (pre-clinical or clinical).

This notice of funding opportunity (NOFO) supports small research projects on cancer that can be carried out in a short period of time with limited resources. The R03 grant mechanism supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology.

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 NOFO 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 NOFO which utilizes an R61/R33 phased approach.

The NICHD Small Research Grant Program (R03Basic Experimental Studies with HumansRequired) supports clinical trials that fall within the NICHD mission and also meet the criteria for basic science experimental studies involving humans (BESH), referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this NOFO 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.

The NIDA Avant-Garde Award Program for HIV/AIDS Research supports individual scientists of exceptional creativity who propose high-impact research that will open new areas of HIV/AIDS research relevant to drug abuse and/or lead to new avenues for prevention and treatment of HIV/AIDS among drug abusers. The term avant-garde is used to describe highly innovative approaches that have the potential to be transformative. The proposed research should reflect approaches and ideas that are substantially different from those already being pursued by the investigator or others and should support the NIH HIV/AIDS Research Priorities https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-018.html. The NIDA Avant-Garde award supports innovative, basic research that may lead to improved preventive interventions or therapies; creative, new strategies to prevent disease transmission; novel approaches to improve disease outcomes; and creative approaches to eradicating HIV or improving the lives of those living with HIV.

This Funding Opportunity Announcement (FOA) is intended to provide an avenue for basic scientists, clinicians and clinical scientists to jointly initiate and conduct translational research projects which translate basic research findings into clinical tools for better human health. The scope of this FOA includes a range of activities to encourage translation of basic research findings which will impact the diagnosis, treatment and prevention of communication disorders. Connection to the clinical condition must be clearly established and the outcomes of the grant must have practical clinical impact.

This announcement invites applications for basic research projects on chemical warfare agents, toxic industrial chemicals, and pesticides that have primary or secondary effects on the nervous system. Chemical threats are toxic compounds that could be used in a terrorist attack or accidentally released from industrial production, storage, or shipping. Projects supported by this NOFO are expected to generate data that elucidate mechanisms of toxicity of these agents, possible new manifestations of toxic exposures, and potential new targets for therapeutic development.

The NIH Directors New Innovator Award Program supports early stage investigators of exceptional creativity who propose bold and highly innovative research projects with the potential to produce a major impact on broad, important areas relevant to the mission of NIH. For the program to support the best possible researchers and research, applications are sought which reflect the full diversity of the research workforce. To support innovative and novel research across the vast NIH mission, individuals from diverse backgrounds (including those from underrepresented groups; see Notice of NIHs Interest in Diversity) and from the full spectrum of eligible institutions in all geographic locations are encouraged to apply to this Notice of Funding Opportunity. Applications in all topics relevant to the broad mission of NIH are welcome, including, but not limited to, behavioral, social, biomedical, applied, and formal sciences and topics that may involve basic, translational, or clinical research. The NIH Director's New Innovator Award Program complements other ongoing efforts by NIH and its Institutes and Centers to fund early stage investigators.

The NIH Directors Pioneer Award Program supports individual scientists of exceptional creativity who propose bold and highly innovative research projects with the potential to produce a major impact on broad, important areas relevant to the mission of NIH. To support innovative and novel research across the vast NIH mission, individuals from diverse backgrounds (including those from underrepresented groups; see Notice of NIHs Interest in Diversity) and from the full spectrum of eligible institutions in all geographic locations are encouraged to apply to this Notice of Funding Opportunity. Applications in all topics relevant to the broad mission of NIH are welcome, including, but not limited to, topics in the behavioral, social, biomedical, applied, and formal sciences and topics that may involve basic, translational, or clinical research.

The NIH Small Research Grant Program supports small research projects that can be carried out in a short period of time with limited resources. This program supports different types of projects including pilot and feasibility studies; secondary analysis of existing data; small, self-contained research projects; development of research methodology; and development of new research technology. This Notice of Funding Opportunity does not accept applications proposing clinical trial(s).

The purpose of this grant program is to develop an understanding of the risks and conditions associated with occupational diseases and injuries, to explore methods for reducing risks and preventing or minimizing exposure to hazardous conditions in the workplace, and to translate significant scientific findings into prevention practices and products that will effectively reduce work-related illnesses and injuries. NIOSH sponsors exploratory and developmental research projects by providing support for the early and conceptual stages of projects. Applicants must concisely describe the occupational health burden(s) being addressed in their proposal while also linking the need for the proposed research activities to planned outputs that will help address or alleviate this burden. Applicants should clearly articulate the anticipated impacts of the proposed research, both during the project period and beyond.

The purpose of this grant program is to develop an understanding of the risks and conditions associated with occupational diseases and injuries, to explore methods for reducing risks and preventing or minimizing exposure to hazardous conditions in the workplace, and to translate significant scientific findings into prevention practices and products that will effectively reduce work-related illnesses and injuries. The NIOSH R03 grant mechanism supports small occupational safety and health research projects that can be carried out with limited resources such as pilot and feasibility studies, secondary data analysis or development of research methods.

The National Library of Medicine (NLM) supports innovative research and development in biomedical informatics and data science. This funding opportunity focuses on biomedical discovery and data-powered health, integrating streams of complex and interconnected research outputs that can be translated into scientific insights, clinical care, public health practices, and personal wellness to ensure the research is scalable, reproducible, and generalizable. The scope of NLM's interest in these research domains is broad, with emphasis on new and innovative methods and approaches to foster data driven discovery in the biomedical and clinical health sciences as well as domain-independent, scalable, and reusable approaches to discovery, curation, analysis, organization, and management of health-related data and digital objects.

The National Library of Medicine (NLM) supports innovative research and development in biomedical informatics and data science. This funding opportunity focuses on biomedical discovery and data-powered health, integrating streams of complex and interconnected research outputs that can be translated into scientific insights, clinical care, public health practices, and personal wellness to ensure the research is scalable, reproducible, and generalizable. The scope of NLM's interest in these research domains is broad, with emphasis on new and innovative methods and approaches to foster data driven discovery in the biomedical and clinical health sciences as well as domain-independent, scalable, and reusable approaches to discovery, curation, analysis, organization, and management of health-related data and digital objects.

Through this Notice of Funding Opportunity, the National Cancer Institute (NCI) seeks research projects that implement early phase (Phase 0, I, and II) investigator-initiated clinical trials focused on cancer-targeted diagnostic and therapeutic interventions of direct relevance to the research mission of DCTD and OHAM. The proposed project must involve at least 1 clinical trial related to the scientific interests of one or more of the following research programs: Cancer Therapy Evaluation Program, Cancer Imaging Program, Cancer Diagnosis Program, Radiation Research Program, Complementary and Alternative Medicine Program and/or the HIV and AIDS Malignancies Research Programs. Applicants may propose to conduct an early phase trial by itself, or in combination with another research aim(s) as appropriate.

The New Investigator Gateway Award in T1D Research is designed to supporta robust pipeline of innovative projects and talented new investigators in T1D research. In addition to providing support for preliminary research, the Gateway program provides an opportunity for new Program Directors/Principal Investigators (PD/PIs) to pursue their studies within the intellectual environment of a select number of large, ongoing collaborative research programs. Embedding awardees within an established scientific framework in each of these consortia will provide unique opportunities for New andEarly Stage Investigators to increase their understanding of key questions in the field, to network, and to establish unique and potentially long-lasting collaborations that will propel their careers forward. Bringing New and Early Stage Investigators into existing collaborative research networks will also benefit the networks by providing new ideas and perspectives.

The purpose of the R01 grant program is (1) to develop an understanding of the risks and conditions associated with occupational diseases and injuries, (2) to explore methods for reducing risks and preventing or minimizing exposure to hazardous conditions in the workplace, and (3) to translate significant scientific findings into prevention practices and products that will effectively reduce work-related illnesses and injuries. The Research Project Grant (R01) supports a discrete, specified, circumscribed project in scientific areas that represent the investigators specific interests and competencies and that fall within the mission of NIOSH.

The purpose of this Notice of Funding Opportunity (NOFO) is to advance the development of novel informatics and data science approaches that can help individuals understand and improve their health through actionable insights. NLM seeks applications that further the science of personal health informatics by providing meaningful and actionable insights to individuals through innovative personal health data collection, integration, analysis, and personalized risk assessments and interpretation. Applications seeking to advance the understanding of how informatics tools, systems, and platforms can best present the results, interpretation, and limitations of personalized assessments for the benefit of individuals are encouraged. Applications should include end user engaged approaches and real-world evaluation to inform the design of generalizable, reusable, and scalable personal health informatics tools, systems, and platforms for the benefit of individuals in understanding and improving their health.

The purpose of this notice of funding opportunity (NOFO) is to solicit applications for pilot projects to elucidate a role for understudied proteins in rare disease. Awards will support generation of preliminary data and/or tools around eligible understudied protein(s). A list of eligible proteins is provided and are members of druggable protein families that have a known association with a rare disease. This NOFO is intended to jumpstart research on understudied proteins that are associated with rare diseases and provide applicants with sufficient funding to perform basic biochemical and/or biological work to further the characterization of understudied proteins within the context of rare disease.

The purpose of this Notice of Funding Opportunity (NOFO) is to support the development of a comprehensive and well-defined product development strategy for next-generation treatments for HIV and HIV-associated comorbidities, coinfections and complication and preventive strategies for HIV, as well as facilitating the translation of research findings into drug products that enables submission of an Investigational New Drug (IND) application to the FDA.

Awarded activities will facilitate the translation of novel recording and modulation technologies that can be used to treat and/or diagnose central nervous system (CNS) diseases and disorders and to better understand the human CNS, from proof of concept up to the stage of readiness for first in human (FIH) studies. Technologies may incorporate any signal modality (e.g., electrical, optical, magnetic, acoustic) or a combination thereof. Diverse team-based applications that integrate appropriate domains of expertise are encouraged.

Purpose: Passed in March 2024, Proposition 1 includes Behavioral Health Services Act (SB 326) and the Behavioral Health Infrastructure Bond Act of 2024 (BHIBA) (AB 531). BHIBA is a $6.38B general obligation bond to develop behavioral health treatment facilities and supportive housing for individuals experiencing mental health and substance use disorders. Of the total amount, DHCS will award up to $4.4 billion in bond funding for BHCIP competitive grants. Description: Bond BHCIP Round 2: Unmet Needs grant funding of over $800 million will be available to construct, acquire, and rehabilitate real estate assets to expand the continuum of behavioral health treatment and service resources for Californians in this round of Bond BHCIP funding. Bond BHCIP Round 2: Unmet Needs funds are not intended to preserve existing service capacity. Bond BHCIP Round 2: Unmet Needs grantees must commit to serving Medi-Cal members and vulnerable populations, including unhoused people, veterans, older adults, adults with disabilities, and children and youth. For purposes of Bond BHCIP Round 2: Unmet Needs funding, DHCS will focus on the remaining gaps in the statewide behavioral health continuum and prioritize mental health community residential beds and crisis settings. DHCS also aims to distribute grant funds to rural/remote areas with outstanding behavioral health needs or insufficient behavioral health infrastructure, and geographic areas with no prior BHCIP infrastructure projects. In addition, DHCS is prioritizing regional models aimed at constructing, renovating, and/or expanding community-based services.

This Notice of Funding Opportunity Announcement (NOFO) solicits resource grant applications for projects that will provide accurate, useful, usable, and understandable health information to populations that experience health disparities and their health care providers. This NOFO supports the development of resources that can be used to improve health and well-being and that lead to reductions in health disparities. Access to accurate, useful, usable, and understandable health information is an important factor when managing health and health care. Proposed projects should harness the capabilities of information technology and medical or health libraries to disseminate clear, evidence-based health-related information in formats used by individuals and their health care providers. Proposed projects should emphasize the development and deployment of new information resources or services, or expand and improve an existing resource or service, to meet the needs of populations experiencing health disparities and to promote health access for all.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) along with other participating Institutes encourages submission of applications proposing to conduct secondary data analysis and integration of existing datasets and database resources, with the ultimate aim to elucidate cancer risk and related outcomes (e.g., risk prediction or reduction, survival, or response to treatment, etc.). The goal of this initiative is to address key scientific questions relevant to cancer by supporting the analysis of existing clinical, environmental, surveillance, health services, vital statistics, behavioral, lifestyle, genomic, and molecular profiles data. Applicants are encouraged to leverage and perform innovative analyses of the existing data. Applications may include new research aims that are being addressed with existing data, new or advanced methods of analyses, or novel combinations and integration of datasets that allow the exploration of important scientific questions in cancer research.

The goal of this funding opportunity is to stimulate the use of existing human datasets for well-focused secondary analyses to investigate novel scientific ideas or new models, systems, tools, methods, or technologies that have the potential for significant impact on biomedical or biobehavioral research in areas relevant to the NHLBI mission.

The purpose of this funding opportunity is to support applications from small business concerns (SBCs) to develop technologies for commercialization to address health-related social needs that impact substance use disorders (SUD), excluding alcohol use disorder.

The purpose of this funding opportunity is to support applications from small business concerns (SBCs) to develop technologies for commercialization to address health-related social needs that impact substance use disorders (SUD), excluding alcohol use disorder.

This Notice of Funding Announcement (NOFO) encourages the submission ofpilot and feasibilityclinical trialsconducted in humans that will lay the foundation for larger clinical trials related to the prevention and/or treatment of diseases and conditions within the mission of NIDDK. The program will support small, short-term proof-of-concept clinical trials in humans to acquire preliminary data regarding the effects of the intervention, as well as feasibility data related to recruitment and retention, and study conduct. Applications for clinical trials submitted under this NOFO should have clearly described aims and objectives and have a high likelihood that the trial findings will lead to more definitive, hypothesis-driven trials to improve understanding, diagnosis, prevention or treatment of the diseases studied and have the potential to impact clinical practice and/or public health.Preliminary data regarding intervention efficacy are not required.

This Small Research Grant (R03) will support meritorious projects to provide needed scientific insight to improve the prevention, diagnosis, treatment, and/or care for individuals with Alzheimer's disease and Alzheimer's disease-related dementias (AD/ADRD). Specifically, this NOFO will support projects covering a wide range of topics related to AD/ADRD. The overall goal of this NOFO is (i) to encourage the next generation of researchers to pursue research and academic careers in AD/ADRD research; and (ii) to stimulate established researchers who have not had a major award in AD/ADRD research to perform pilot studies to develop new, innovative AD/ADRD research programs that leverage and build upon their existing expertise.

Purpose: The Song-Brown program funds institutions that train primary care health professionals to provide healthcare in California’s medically underserved areas. Description: This grant opportunity will result in funding organizations to train primary carenurse practitioners and physician assistant trainees to work in underservedcommunities. Such strategies shall incorporate the following elements: 1. Establishing procedures to identify, recruit and admit primary care nursepractitioner and physician assistant trainees who possess characteristicswhich would suggest a predisposition to practice in areas of unmet need, andwho express a commitment to serve in areas of unmet need. 2. Implementing counseling and placement program to encourage trainingprogram graduates to enter practice in areas of unmet need. 3. Providing a preceptorship experience in an area of unmet need to enhancethe potential of training program graduates to practice in such an area.

Purpose: The Song-Brown Program funds institutions that train primary care doctors to provide health care in California’s medically underserved areas. Description: This grant opportunity will result in funding organizations to educate and train primary care (family medicine, internal medicine, OB/GYN, and pediatric) residents to work in underserved communities. All residency programs shall incorporate the following strategies into their programs: 1. Providing training sites in medically underserved multi-cultural communities, lower socioeconomic neighborhoods, or rural communities, and preparing primary care physicians for service in such neighborhoods and communities. 2. Establishing procedures to identify, recruit, and match primary care residents who possess characteristics which would suggest a predisposition to practice in areas of unmet need, and who express a commitment to serve in areas of unmet need. 3. Implementing counseling and placement programs to encourage training program graduates to enter practice in areas of unmet need. 4. Providing preceptorship experiences in an area of unmet need to enhance the potential of training program graduates to practice in such an area. Keywords: funding, graduate medical education funding, residency funding, family medicine, internal medicine, obstetrics and gynecology, pediatric

Purpose: The Song-Brown program funds institutions that train primary care health professionals to provide healthcare in California’s medically underserved areas. Description: This grant opportunity will result in funding organizations to train certified nurse midwifery students to work in underserved communities. Such strategies shall incorporate the following elements: 1. Establishing procedures to identify, recruit, and admit certified nurse midwifery students who possess characteristics which would suggest a predisposition to practice in areas of unmet need, and who express a commitment to serve in areas of unmet need. 2. Implementing counseling and placement programs to encourage training program graduates to enter practice in areas of unmet need. 3. Providing a preceptorship experience in an area of unmet need to enhance the potential of training program graduates to practice in such an area.

This Notice of Funding Opportunity (NOFO) is intended to support novel environmental health research in which an unpredictable event or policy change provides a limited window of opportunity to collect human biological samples or environmental exposure data. The primary motivation of the NOFO is to understand the consequences of natural and human-made disasters, emerging environmental public health threats, and policy changes in the U.S. and abroad. A distinguishing feature of an appropriate study is the need for rapid review and funding, substantially shorter than the typical NIH grant review/award cycle, for the research question to be addressed and swiftly implemented. The shortened timeframe will be achieved by more frequent application due dates and expediting peer review, council concurrence and award issuance. The entire cycle, from submission to award, is expected to be within 4-6 months.

This Notice of Funding Opportunity (NOFO) aims to support new biomedical, behavioral, and social science investigators who are in the early stages of establishing independent careers in tobacco regulatory research. The R03 grant mechanism supports different types of projects, including pilot and feasibility studies, secondary analysis of existing data, small, self-contained research projects, development of research methodology, and development of new research technology. Applicants are encouraged to conduct projects that ultimately have the potential to inform regulations on tobacco product manufacturing, distribution, and marketing. Research projects must address one or more High-Priority Research Topic(s) related to the regulatory authority of the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as mandated by the Family Smoking Prevention and Tobacco Control Act (FSPTCA), Public Law 111-31. The awards under this NOFO will be administered by NIH using funds made available through FDA CTP and the FSPTCA. Research results from this NOFO are expected to generate findings and data directly relevant to informing the FDA's regulation of the manufacture, distribution, and marketing of tobacco products to protect public health.

This Funding Opportunity Announcement (FOA) solicits Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that translate technology and therapeutic innovations from academic and other non-profit research sectors to the marketplace to advance the development of diagnostic and prevention tools or treatments for musculoskeletal, rheumatic, or skin diseases. It supports late-stage pre-clinical research and development, such as moving products towards regulatory approval for clinical testing or making the new lab technologies more practical to use in a clinical setting. It requires close collaboration between the original developers of these technologies and the SBCs.