Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01 Clinical Trial Not Allowed)

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications for projects to expand, improve, or transform the utility of mammalian cancer and tumor models for translational research. With this NOFO, the NCI intends to encourage submission of projects devoted to demonstrating that mammalian models or their derivatives used for translational research are robust representations of human biology, are appropriate to test questions of clinical importance, and provide reliable information for patients' benefit. These practical goals contrast with the goals of many mechanistic, NCI-supported R01 projects that employ mammals, or develop and use mammalian cancer models, transplantation tumor models, or models derived from mammalian or human tissues or cells for hypothesis-testing, non-clinical research. Among many other possible endeavors, applicants in response to this FOA could propose demonstrations of how to overcome translational deficiencies of mammalian oncology models, define new uses of mammalian models or their genetics for unexplored translational challenges, advance standard practices for use of translational models, test approaches to validate and credential models, or challenge current practices for how models are used translationally

The NIH Research Education Program (R25) supports research education activities in the mission areas of the NIH. The overarching goal of this R25 program is to encourage individuals who have not had substantial biomedical research experience, or who have the potential to significantly benefit from additional biomedical research experience to pursue further studies or careers in research. To accomplish the stated over-arching goal, this NOFO will support educational activities with a primary focus on: (1) Research Experiences, (2) Curriculum or Methods Development and (3) Outreach. The NCI’s mission is to conduct and support research, training, health information dissemination, and other programs concerning cancer. This funding opportunity seeks to facilitate educational activities that encourage students to become knowledgeable about cancer and available to focus on cancer later in their careers. To promote broad interest in pursuing a career in biomedical research via early intervention strategies, the NCI Youth Enjoy Science (YES) Program will support efforts to create and maintain an institutional program to engage grades 6-12 and/or undergraduate students in cutting edge cancer research experiences. The proposed institutional programs may also provide research experiences for the grade 6-12 teachers and undergraduate faculty members. The goals are to inspire interest in biomedical sciences, help envision research as a career path, and strengthen practical research and career skills. In alignment with these goals, institutions may develop unique programs that capitalize on their research strengths and are responsive to their target populations.

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and validation of molecular/cellular/imaging markers (referred to as "markers" or "biomarkers") and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously. The UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays.

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.

A.   ELIGIBILITY 1.  Eligible Applicants The following organizations are eligible to apply: ●       Not-for-profit organizations, including think tanks and civil society/non-governmental organizations ●        Public and private educational institutions ●        Public International Organizations and Governmental institutions For-profit entities, even those that may fall into the categories listed above, are not eligible to apply for this NOFO. Organizations may sub-contract with other entities, but only one, non-profit, non-governmental entity can be the prime recipient of the award. When sub-contracting with other entities, the responsibilities of each entity must be clearly defined in the proposal. For more information on the difference between sub-contract and sub-recipient, please refer to 2 CFR 200.331 . 2.  Cost Sharing or Matching Cost sharing or matching is encouraged, but not required for this funding opportunity.  3.  Other Eligibility Requirements All organizations must have a Unique Entity Identifier (UEI) issued via SAM.gov as well as a valid registration in SAM.gov. Please see Section E.3 for more information. Individuals are not required to have a UEI or be registered in SAM.gov. Optional: Applicants are only allowed to submit one proposal per organization. If more than one proposal is submitted from an organization, all proposals from that institution will be considered ineligible for funding under this funding opportunity. 4.    This opportunity will not support: ●       Projects relating to partisan political activity; ●       Charitable or development activities; including direct social services such as medical, psychological, and/or humanitarian support ●       Construction projects; ●       Projects that support specific religious activities; ●       Fund-raising campaigns; ●       Lobbying for specific legislation or programs ●       Scientific research or surveys; ●       Commercial projects; ●       Projects intended primarily for the growth or institutional development of the organization; ●       Projects that duplicate existing projects; ●       Illegal activities B.   PROGRAM DESCRIPTION 1.  Project Background, Goals, and Objectives Algeria presents a significant opportunity for U.S. technological engagement at a pivotal moment. With nearly two-thirds of its population under age 30, the country's shift to English-medium instruction and ambitious University 4.0 initiative create unprecedented openings for American collaboration in the technology sector. As Algeria modernizes its digital infrastructure and educational systems, there is strong interest in partnering with leading technology providers to ensure access to cutting-edge tools and internationally recognized standards. Algeria's next generation of technology leaders—students, educators, entrepreneurs, and community leaders—currently have limited access to training in U.S. artificial intelligence tools, international standards, and best practices in AI governance. Providing access to American AI methodologies and best practices will help ensure that Algerian professionals have diverse options and can make informed choices about the technological ecosystems that best serve their needs and reflect democratic values of transparency, user-centered design, and ethical AI development. This Freedom250 initiative addresses these opportunities by leveraging the five American Spaces across Algeria to deliver practical, hands-on AI training to at least 150 strategic participants who will serve as multipliers within their communities. The program advances U.S. priorities in technological excellence and international partnerships by introducing American AI methodologies in Algeria's technology landscape. Through a modular curriculum spanning AI fundamentals, evaluation frameworks, hands-on labs, and localized application development, participants progress from conceptual understanding to practical proficiency, becoming advocates who can independently apply American frameworks in their professional contexts. This initiative builds directly on Mission Algeria's proven track record in technology and education programming. A 2026 program featuring a Freedom250 AI Envoy engaged Algeria's Ministry of Youth, establishing productive government relationships and demonstrating official interest in U.S. AI collaboration. Additionally, the Mission's 2025 collaboration with the Ministries of Higher Education and Vocational Training—including the country's largest English teaching conference—revealed that 70% of participating teachers expressed greater interest in learning about American AI tools, validating significant demand for practical AI training. The Public Diplomacy Section seeks to implement a transformative program that strengthens U.S.-Algeria partnership in artificial intelligence and emerging technology. At least 150 participants across five cities will complete the program with measurable gains, producing tangible artifacts like prompt libraries and localized AI applications. A cohort of trained local facilitators will later independently deliver the curriculum, enabling the American Spaces to continue programming beyond initial funding and exponentially expand reach. The alumni will serve as advocates for American AI frameworks, with educators integrating U.S. tools into teaching, entrepreneurs building ventures on American platforms, and community leaders promoting informed discourse about ethical technology development using learned frameworks. The ideal implementing partner will demonstrate sustainability-first design through clear training-of-trainers strategies, capacity to deliver quality programming across all five cities, rigorous monitoring and evaluation frameworks, emphasis on practical application over theory, concrete alumni engagement plans, and flexibility to adapt to changing circumstances including virtual delivery. This program represents an important opportunity to strengthen bilateral cooperation. The successful implementer will share the Mission's vision of promoting American technological excellence and ensuring democratic values shape the digital future of the region. Project Audience(s): The primary beneficiaries of this program are the minimum of 150 participants across five Algerian cities who will receive direct training in U.S.-aligned AI tools, standards, and governance frameworks. The program targets university students (ages 18-30) pursuing degrees in technology, engineering, business, and education—a particularly strategic demographic given that nearly two-thirds of Algeria's population is under 30. These young professionals represent the future workforce and are eager to acquire cutting-edge skills that enhance their employability in the global technology marketplace. Educators including teachers, professors, and instructional designers serve as critical multipliers who can integrate American AI tools into their curricula, potentially reaching hundreds of additional students over their careers. They are positioned to normalize U.S. technological frameworks within Algeria's educational system and shape how the next generation understands and applies AI technologies. The program also targets entrepreneurs and small business owners developing technology-based ventures or seeking to integrate AI solutions into existing businesses. This audience is motivated by practical applications that improve efficiency and create competitive advantages. Finally, community leaders and civil society representatives working in non-governmental organizations and youth programs influence public discourse about technology adoption and are positioned to promote ethical AI development and democratic governance frameworks that align with American values. These audiences share key characteristics: they have capacity to train others and are at career stages where exposure to American frameworks can shape long-term professional trajectories. Project Goal:   The goal is to establish the United States as Algeria's preferred partner for artificial intelligence development by embedding American AI tools, standards, and governance frameworks within Algeria's emerging technology ecosystem. This long-term goal envisions a generation of Algerian technology leaders who routinely adopt U.S.-aligned AI methodologies, promote democratic values of transparency and ethical technology development, and serve as multipliers who expand American technological influence throughout Algerian institutions and communities. This goal directly aligns with U.S. foreign policy priorities of advancing American technological leadership globally, promoting democratic governance in digital spaces, and strengthening bilateral partnerships with a strategic partner in North Africa. Project Objectives: ·         Objective 1: Train a minimum of 150 participants across five American Spaces (Algiers, Bechar, Constantine, Oran, and Ouargla) in U.S.-aligned AI tools, standards, and governance frameworks, with at least 80% of participants completing all hands-on labs and collaborative projects by the end of the 12-month program period. ·         Objective 2: Achieve measurable knowledge gains among participants, with pre- and post-program assessments demonstrating at least 30% improvement in understanding of U.S.-aligned AI standards, ethical frameworks, and practical application methodologies ·         Objective 3: Establish a cohort of at least 10 trained local facilitators who can independently deliver the AI curriculum at American Spaces, ensuring program sustainability and enabling continued delivery beyond the initial funding period. ·         Objective 4: Generate tangible outputs demonstrating practical AI proficiency, with participants producing artifacts such as prompt libraries, automated report templates, and localized AI applications that address real challenges in education, health, agriculture, or community service. ·         Objective 5: Create a sustainable community of practice connecting program alumni, facilitators, and American Spaces, with at least 60% of participants remaining engaged through online platforms and contributing to knowledge-sharing activities six months after program completion. 2.  Substantial Involvement N/A READ FULL ANNOUNCEMENT IN THE ATTACHMENTS

The U.S. Department of State’s Embassy Bridgetown announces an open competition to implement a two-year EducationUSA Regional Advising Program based in Barbados to expand access to U.S. higher education opportunities across the Eastern Caribbean through comprehensive virtual and in-person advising services. The part-time adviser will deliver monthly webinar series targeting prospective students, virtual outreach programs providing individual and cohort advising for students and parents, and partnership development with at least 15 U.S. universities and regional institutions. The adviser will also assist in developing social media strategies on the Eastern Caribbean EducationUSA page and support key activities including college fairs and educational events. Project Goals and Objectives Expand access to U.S. higher education for Eastern Caribbean youth by establishing comprehensive, professional regional advising services that strengthen people-to-people ties and advance democratic values throughout the Caribbean. Objective 1: Deliver at least 24 monthly webinars over the two-year program period, reaching a minimum of 1,000 unique participants (prospective students, parents, and educators) with comprehensive information about U.S. higher education pathways, application processes, and financial aid opportunities, with at least 50% of participants reporting increased knowledge and confidence in navigating U.S. college applications. Objective 2: Provide individualized and cohort-based virtual advising services to at least 400 prospective students and their families over two years, resulting in at least 200 students submitting complete applications to U.S. universities and at least 100 students successfully enrolling in U.S. higher education institutions, representing measurable growth beyond the current regional baseline of 1,500 annual students. Objective 3: Establish formal partnerships with at least 15 U.S. universities and regional educational insti

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.

The National Human Genome Research Institute (NHGRI) seeks to broaden the types of knowledge, skills, expertise, experience, and perspectives brought to bear in research addressing the ethical, legal and social implications (ELSI) of advances in human genetics or genomics. This Notice of Funding Opportunity (NOFO) solicits UM1 applications from domestic organizations located in the United States and its territories that received less than $30 million per year in total NIH funding for the past three fiscal years. These organizations are underrepresented among those receiving NHGRI funding for ELSI research. The Building Partnerships and Broadening Perspectives to Advance Ethical, Legal, and Social Implications (ELSI) Research (BPAER) Program will support: 1) transdisciplinary ELSI research addressing timely, complex, and understudied topics, 2) the establishment of research teams that include representatives from relevant communities who are affected by and have an interest in the proposed research, 3) research capacity building to develop, conduct and sustain ELSI research, and 4) workforce development opportunities for early career scholars, research team members, and other research project staff. Transdisciplinary ELSI research projects require involvement from two or more fields of knowledge and use of multiple research approaches. Relevant communities must be actively and meaningfully involved on ELSI research teams across all phases of proposed research projects. Research capacity building plans must be informed by a needs assessment. Given the complex structure, a strategic management plan, evaluation plan, and sustainability plan are required to ensure successful completion of the program.

This funding opportunity aims to support high risk clinical trials for 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. Structural and functional aspects, including visualizing dynamic elements, are important to developing 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. Research supported in response to this RFA is expected to significantly advance the ability to visualize auditory and vestibular components, such as hair cells, otoliths, membranes, ions, and vasculature, in detail in awake patients in a clinical setting using non-invasive techniques. To achieve this goal, a multidisciplinary team approach that takes advantage of the expertise of each team member is highly encouraged. Studies in humans must be proposed to develop,advance, or test 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.