NEI Translational Research Program for Therapeutics (R61/R33 Clinical Trial Not Allowed)

The focus of this notice of funding opportunity (NOFO) is to produce insights into disease detection and prevention strategies, burden, severity, diagnostics, treatment, and outcomes of infectious diseases in international travelers. Timely surveillance and sentinel detection are essential for collecting actionable data. The research should:Address public health questions that improve the speed of outbreak detection.Help develop guidelines and recommendations to improve patient care.Enhance understanding of the natural history of disease.Optimize genomic surveillance as well as diagnostic and treatment strategies.Advance the global health security of the United States.This NOFO will have two components:Component A – Clinic-based sentinel network.Component B – Sentinel detection in international transportation hubs.You may apply for Component A, B, or both. If your application for both Component A and B is ranked top, Component B will be awarded.

The FY 2027 Health Center Program Service Area Competition (SAC) funding improves the health of medically underserved communities and populations by providing grants to support the delivery of comprehensive, high-quality preventive and primary health care services in the United States and its territories. For each SAC Notice of Funding Opportunity (NOFO), service areas available for competition are announced in the Service Area Announcement Table (SAAT). Throughout the year, we may announce additional service areas in a Service Area Competition-Additional Area (SAC-AA) if an awarded health center cannot continue to provide services in the funded service area.

NIOSH is encouraging the submission of an application from qualified organizations for a National Center for Construction Safety and Health Research and Translation. Applicants are encouraged to propose multidisciplinary approaches and coordination for impactful applied and intervention research, hazard identification, and controls; develop partnerships for implementing prevention and intervention activities; and serve as a leader in research translation and research-to-practice for the protection of construction workers in the U.S. The Center will accomplish these goals by integrating and advancing research, research translation, best practices, policy and guidance, and capacity building. Center work should consider the NIOSH strategic plan and NORA construction research objectives. Center structure should take advantage of diverse scientific resources and focus on national worker safety and health issues. Centers should emphasize the creation and implementation of evidence-based solutions that address important construction industry safety and health problems. Collaborations with other academic institutions, nonprofit organizations, and other occupational safety and health-focused groups are expected. Applicants must concisely describe the occupational health burden of important safety and health issues in the construction industry and discuss how focused research and outreach activities will help alleviate the burden and reduce numbers. Applicants should also clearly articulate the anticipated impacts of the Center’s proposed work, both during the project period and beyond.

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Technology Integration Center, which will enable the development of standards and best practices for applying new and emerging molecular methods in rare disease diagnosis. A major deliverable of the Center will be a multidimensional dataset that can be used for the development and benchmarking of novel tools and strategies that facilitate rare disease diagnosis.

The Office of Population Affairs (OPA) announces the anticipated availability of funds for Fiscal Year (FY) 2027 grants under the authority of Title X of the Public Health Service Act, Section 1001 (42 U.S.C. §300).This notice solicits applications for projects to provide Title X services throughout the 50 United States, District of Columbia, Guam, the Commonwealth of Puerto Rico, the Northern Mariana Islands, the U.S. Virgin Islands, American Samoa, the U.S. Outlaying Islands (Midway, Wake, et al.), the Republic of the Marshall Islands, the Federated State of Micronesia, and the Republic of Palau (hereafter, States). OPA intends to make available approximately up to $257 million for up to 90 grant awards for a period of up to five (5) years. The actual amount available will not be determined until enactment of the FY 2027 federal budget.OPA"s Title X Family Planning Program funds "voluntary family planning projects [that] offer a broad range of acceptable and effective family planning methods and services (including natural family planning methods, infertility services, and services for adolescents)." (Title X of the Public Health Service Act, 42 U.S.C. 300 et seq., available at https://opa.hhs.gov/sites/default/files/2020-07/title-x-statute-attachment-a_0.pdf). The Title X Program is implemented through competitively awarded grants to a diverse network of public and private nonprofit entities. The program helps millions of low-income and uninsured Americans develop health literacy and access family planning and related health services, empowering individuals and families to make informed decisions and navigate chronic health conditions and pregnancy with confidence. By offering counseling and education to improve individuals" optimal health outcomes, Title X promotes the level of health literacy necessary to support informed consent across the reproductive lifespan. For example, endometriosis often goes undiagnosed for years because symptoms such as severe menstrual pain or irregular bleeding are frequently normalized or minimized. Body literacy counseling helps patients recognize that these experiences are not "normal" features of womanhood, but potential indicators of an underlying condition, prompting earlier discussion with providers, timely diagnosis, appropriate treatment, and improved long-term reproductive and overall health outcomes.Likewise, foundational knowledge of reproductive physiology enables patients and couples to recognize early signs of dysfunction, seek timely evaluation, and participate meaningfully in care decisions. Persistent gaps in reproductive knowledge highlight the need for such education. For example, a survey conducted for OPA in 2020 found that only 50% of women and 38% of men know that a woman"s ovaries do not keep producing new eggs until menopause (https://opa.hhs.gov/sites/default/files/2021-01/fertility-knowledge-survey-findings-exec-summary-2020.pdf). By supporting body literacy education alongside evidence-based evaluation and treatment of chronic disease, Title X services can help patients move beyond symptom-focused care toward informed, preventive, and restorative approaches to reproductive health.These efforts align with HHS"s focus on addressing the root causes of chronic illnesses by targeting conditions that affect reproductive health and fertility. By promoting strategies that support education and counseling on reproductive health goals, reduce chronic disease, and assist individuals seeking to achieve healthy pregnancies, the Title X Program strengthens American families, individuals, and communities.This notice solicits applications from public and private nonprofit entities to establish and operate voluntary Title X projects. These projects include a broad range of effective and acceptable services, including pregnancy testing and counseling, basic infertility services, sexually transmitted infection (STI) services (such as HIV prevention education, counseling, testing, and referral), health literacy, reproductive goals counseling to increase optimal health outcomes, and other preconception health services. Title X services also help address and provide referrals for health conditions that affect fertility, including endometriosis, polycystic ovary syndrome (PCOS), and uterine fibroids in women, as well as low sperm count, low sperm motility, low testosterone, and erectile dysfunction in men. OPA seeks a broad competition for Title X grant awards and are interested in innovative strategies to address chronic disease; reduce overmedicalization by strengthening approaches focused on underlying behavioral and lifestyle factors of health and evidence-based practices such as fertility-awareness based methods; promote health and body literacy; advance reproductive goals counseling for all clients; and support family formation.All activities funded under this announcement must be in compliance with the requirements of the Title X statute, legislative mandates, and regulations. Copies of the Title X statute, regulations, and legislative mandates may be downloaded from the OPA website at https://opa.hhs.gov/grant-programs/title- x-service-grants/title-x-statutes-regulations-and-legislative-mandates.

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

The Genomics Research to Elucidate the Genetics of Rare Diseases:innovation (GREGoRi) initiative seeks to accelerate a paradigm shift in rare disease diagnosis by reimagining the tools, molecular technologies and analytical approaches used to identify the causal gene(s) and/or variant(s) underlying rare genetic disorders. The purpose of this Notice of Funding Opportunity is to establish the GREGoRi Data Coordination and Outreach Center. The Data Coordination and Outreach Center will act as the central point of coordination for the GREGoRi Research Program, and will be responsible for ensuring that the protocols, data, metadata, computational tools and other resources developed as part of GREGoRi are made available to the broader research community.

This funding opportunity announcement (FOA) encourages applications for institutional research career development (K12) programs that propose to support intensive supervised research training and career development experiences for clinician scientists (Scholars) leading to research independence in the area of substance use and substance use disorder research.

The overarching goal of this notice of funding opportunity (NOFO) and its companion opportunities is to establish the Precision Medicine with AI: Integrating Imaging with Multimodal Data (PRIMED-AI) Program to support development of innovative, reliable, cost-effective, and sustainable multimodal AI-based clinical decision support (CDS) tools. PRIMED-AI CDS tools are based on the integration of clinical imaging with other types of multimodal health data to enhance care for patients with a wide range of health conditions. The PRIMED-AI Program seeks to catalyze the adoption of AI-based CDS tools into clinical workflows to enable novel personalized medicine strategies that address significant health challenges. The purpose of this NOFO is to solicit applications for the creation of a Validation Center to serve as a dedicated hub for the comprehensive evaluation and characterization of AI-enabled, image-based, multimodal CDS tools developed by the PRIMED-AI Consortium, to ensure these tools are reliable, reproducible, and generalizable. The Validation Center will focus on verification, validation, interoperability, and uncertainty quantification to comprehensively characterize performance of the CDS tools developed by the program. The core functions of the Validation Center will involve the systematic validation of PRIMED-AI Consortium deliverables, including those emerging from award recipients under the Playbook, Data-to-Model Academic-Industrial Partnerships, and Model-to-Clinic NOFOs.

This Notice of Funding Opportunity (NOFO) invites a single cooperative agreement application for the Resource Center for the Cardiovascular Repository for Type 1 Diabetes (CaRe-T1D). The purpose of CaRe-T1D is to support innovative, discovery and mechanistic research through the study of human cardiovascular (CV) tissue. This research seeks to better understand cardiovascular disease (CVD) in type 1 diabetes, highlight differences compared to type 2 diabetes, and ultimately guide the development of therapies to treat this major cause of morbidity and mortality for individuals with type 1 diabetes. To achieve these goals, the Resource Center will expand the CaRe-T1D biorepository of human CV tissue, further develop the data commons for data sharing and for artificial intelligence (AI) tools, coordinate the research activities of the investigative teams in the CaRe-T1D consortium, and make CaRe-T1D resources accessible to the broader research community. This NOFO is associated with the Special Diabetes Program (https://www.niddk.nih.gov/about-niddk/research-areas/diabetes/type-1-diabetes-special-statutory-funding-program/about-special-diabetes-program) which funds research on the prevention, treatment, and cure of type 1 diabetes and its complications, including unique, innovative, and collaborative research consortia and clinical trials networks.This is a Notice of Funding Opportunity (NOFO) for a Single Source that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding.