Notice NOT-OD-25-042 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-25-363 from the NIH Guide for Grants and Contracts. The purpose of this NOFO is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. Multidisciplinary teams of scientists and clinicians must focus on generating preclinical data that will lead to the development of biological, pharmacological, medical device and/or combination product interventions. The ultimate goal of this program is to make new technological, biological and pharmacological resources available to clinicians and their patients. The steps towards this goal should be clearly delineated in a series of milestones that support the development of a therapeutic or device that will lead to an Investigational New Drug (IND) or Investigational Device Exception (IDE) application to the U.S. Food and Drug Administration (FDA) and/or testing in a clinical trial. The R33 is to focus on advancing a single therapeutic candidate through IND/IDE -enabling studies, filing an IND package with the FDA, and designing future clinical trials. Applicants pursuing early stage applied research should consider the companion (R61/R33) NOFO PA-23-XXX.

Funding Opportunity PAR-25-335 from the NIH Guide for Grants and Contracts. The purpose of this Notice of Funding Opportunity (NOFO) is the rapid and efficient translation of innovative laboratory research findings into therapeutics for use by clinicians to treat visual system diseases or disorders. Multidisciplinary teams of scientists and clinicians must focus on generating preclinical data that will lead to the development of biological, pharmacological, medical device and/or combination product interventions. The ultimate goal of this program is to make new technological, biological and pharmacological resources available to clinicians and their patients. The steps towards this goal should be clearly delineated in a series of milestones that support the development of a therapeutic or device that will lead to an Investigational New Drug (IND) or Investigational Device Exception (IDE) application to the U.S. Food and Drug Administration (FDA) and/or testing in a clinical trial. This NOFO will utilize a bi-phasic, milestone-driven mechanism of award. The R61 phase will support research that has demonstrated significant preliminary data but has not advanced to the level of clinical translation. The R33 phase will support research that is in the final states of preclinical development with potential for near-term clinical development. Support for a single phased award that does not need the R61 Exploratory phase is available in the companion R33, PAR-23-205.

Funding Opportunity RFA-RM-24-013 from the NIH Guide for Grants and Contracts. This notice of funding opportunity (NOFO) invites applications from eligible organizations to establish the New Approach Methodologies (NAMs) Data Hub and Coordinating Center (NDHCC) for the NIH Common Fund Complement Animal Research In Experimentation (Complement-ARIE) program. The goal of Complement-ARIE is to implement better models for understanding human health and disease outcomes across diverse populations that complement traditional models and make biomedical research more efficient and effective. The award made through this announcement will support Complement-ARIE by providing a centralized data hub, building a searchable repository for various NAMs data types, establishing standards for data reporting and model credibility, developing and implementing an Integrated Testing Strategies (ITS), developing strategies for interoperability, sustainability data reuse, and developing tools for data analytics, dissemination, and sharing. The awardee will also serve as the coordinating center for the overall Complement-ARIE program.

Notice NOT-CA-25-030 from the NIH Guide for Grants and Contracts

Notice NOT-NR-25-010 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-25-324 from the NIH Guide for Grants and Contracts. The National Cancer Institute (NCI) Method to Extend Research in Time (MERIT) (R37) Award provides extended grant support to Early Stage Investigators (ESIs). By providing such an opportunity for longer term support to ESIs, the NCI intends to offer flexibility and opportunity for creativity and innovation and additional time to successfully launch their careers and to become more established before having to submit renewal applications (NOT-CA-18-037). The objective of the NCI's ESI MERIT Award is to allow eligible investigators the opportunity to obtain up to 7 years of support in two segments:

Funding Opportunity PAR-25-343 from the NIH Guide for Grants and Contracts. The NIDCD is committed to identifying effective interventions for the treatment or prevention of communication disorders by supporting well designed and well executed clinical trials. This funding opportunity announcement (FOA) supports a cooperative agreement between an NIDCD Project Scientist and an investigator to support a clinical trial that meets ANY of the following criteria: requires FDA oversight, is intended to formally establish efficacy, or has a higher risk to potentially cause physical or psychological harm.

Funding Opportunity RFA-DC-25-005 from the NIH Guide for Grants and Contracts. 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.

Funding Opportunity RFA-DC-25-003 from the NIH Guide for Grants and Contracts. 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.

Notice NOT-CA-25-029 from the NIH Guide for Grants and Contracts

Funding Opportunity PAR-25-089 from the NIH Guide for Grants and Contracts. This NOFO invites applications for investigator-initiated, high-risk multi-center observational studies involving more than one clinical center. Proposed studies should be hypothesis-driven and focus on a disease relevant to the mission of NIDDK. Planning activities must be completed prior to submission and are not permitted under this NOFO. Applicants who require a planning phase may first apply for an implementation planning cooperative agreement (U34; see TEMP9971).Consultation with NIDDK Scientific/Research staff is strongly encouraged prior to the submission of either a U34 or U01 application.

Notice NOT-HG-25-016 from the NIH Guide for Grants and Contracts

Notice NOT-HG-25-015 from the NIH Guide for Grants and Contracts

Notice NOT-EY-25-004 from the NIH Guide for Grants and Contracts

Notice NOT-DA-24-064 from the NIH Guide for Grants and Contracts

Funding Opportunity PA-25-147 from the NIH Guide for Grants and Contracts. This NOFO invites applications for investigator-initiated, high-risk multi-center clinical trials involving more than one clinical center. Proposed trials should be hypothesis-driven, have the potential to change clinical practice and/or public health, and focus on a disease relevant to the mission of NIDDK. Planning activities must be completed prior to submission and are not permitted under this NOFO. Applicants who require a planning phase may first apply for an implementation planning cooperative agreement (U34; see TEMP9971).Consultation with NIDDK Scientific/Research staff is strongly encouraged prior to the submission of either a U34 or U01 application.

Funding Opportunity PAR-25-329 from the NIH Guide for Grants and Contracts. The purpose of this Notice of Funding Opportunity (NOFO) is to support the discovery and development of medications to prevent and treat substance use disorders (SUDs) and overdose. The UG3/UH3 Phase Innovation Awards Cooperative Agreement involves 2 phases. The UG3 is to support a project with specific milestones to be accomplished by the end of the 2-year period. The UH3 is to provide funding for 3 years to a project that successfully completed the milestones set in the UG3. UG3 projects that have met their milestones will be administratively considered by NIDA and prioritized for transition to the UH3 phase. Investigators responding to this NOFO must address both UG3 and UH3 phases. Application may include preclinical or clinical research studies that will have high impact and quickly yield the necessary results to advance closer to FDA approval medications that are safe and effective to prevent and treat SUDs and overdose. The compounds to be evaluated can be small molecules, biologics, or natural products. They can be tested in pre-clinical models and/or for the clinical manifestations of SUDs such as withdrawal, craving, relapse, or overdose. Applications may focus on the development of new chemical entities, new formulations of marketed medications available for other indications, or combinations of medications that hold promise for the treatment of SUDs and overdose. Through this NOFO, NIDA seeks to fast-track the discovery and development of medications to prevent and treat SUDs or overdose and to advance them in the FDA's drug development approval pipeline.

Funding Opportunity PAR-25-328 from the NIH Guide for Grants and Contracts. The purpose of this notice of Funding Opportunity (NOFO) is to accelerate the development of medication for the treatment of Substance Use Disorders (SUDs) by encouraging research applications to support a diverse array of preclinical and/or clinical research projects. The goal is to fund medication studies that will have high impact and quickly yield the necessary results to advance medications closer to FDA approval. It is expected that these U01s will be short-term (funded for up to 3 years) and large (up to $5 million per year) cooperative agreements with close monitoring and significant scientific involvement of NIDA staff. This funding opportunity will enable critical medications development studies that would not be feasible using the traditional R01 activity code.

Notice NOT-NR-25-009 from the NIH Guide for Grants and Contracts