Prevention and Intervention Approaches for Fetal Alcohol Spectrum Disorders (R34 Clinical Trial Optional)
National Institute on Alcohol Abuse and Alcoholism

This Notice of Funding Opportunity (NOFO) for R34 planning grant applications focuses on prevention and intervention strategies for fetal alcohol spectrum disorders (FASD) throughout the lifespan. The intent of this NOFO is to support research that advances (1) prevention approaches to reduce prenatal alcohol exposure and incidence of FASD and (2) interventions for FASD.

Identification of Drug-related and Formulation-Related Factors that Result in Alcohol Dose Dumping of Modified Release Oral Drug Products (U01) Clinical Trial Not Allowed
Food and Drug Administration

The purpose of this research is to develop tools that 1) facilitate the development of MR generic drug products that have a low potential for ADD, 2) support regulatory decision making during the assessment of such products, and 3) provide evidence that enables FDA to develop more specific recommendations for efficiently demonstrating a low or comparative potential of alcohol dose dumping for MR oral drug products containing high risk drugs.

Synthesis and Biological Activity Assessment of Different Diastereomers in siRNA Drug LEQVIO (Inclisiran) (U01) Clinical Trial Not Allowed
Food and Drug Administration

The purpose of this research is to systematically evaluate the diastereomeric composition of LEQVIO (Inclisiran), an FDA-approved, N-acetyl galactosamine (GalNAc)-conjugated siRNA drug, and to understand the biological/pharmacological activity of each diastereomer in LEQVIO through stereo chemically controlled synthesis and biological activity assessment using in vitro and animal models. The proposed studies will focus on 1) synthesis of each diastereomer of LEQVIO (Inclisiran) in stereo chemically pure form; 2) assessment of the biological activity of each stereo chemically pure diastereomer in inhibiting PCSK9 activity using in vitro assays and in a transgenic mouse model; 3) development of analytical methods to identify and characterize the stereochemical structure of each diastereomer in LEQVIO; and 4) assessment of the individual contribution of each diastereomer to the overall pharmacological activity of LEQVIO. Tools developed in this research can also be applied to other similar GalNAc-conjugated siRNAs specifically, and other siRNAs in general. Knowledge gained from this research will also contribute to the sameness evaluation of generic siRNAs, and to the quality control of oligonucleotide drugs.

OMHHE Educational Funding Opportunity: Expanding education on skin lightening products (U01) Clinical Trials Not Allowed
Food and Drug Administration

The purpose of the funding opportunity is to expand and advance FDA's Office of Minority Health and Health Equity (OMHHE) work with stakeholders and partners for education, outreach, and public awareness activities on potential risks from skin lightening products containing hydroquinone and/or mercury.

Applicants will research and propose innovative and community-based strategies and activities that have the potential to strengthen the science base for education and public health awareness on the use of and potential risks from over-the-counter (OTC) skin lightening products.

NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00 - Independent Basic Experimental Studies with Humans Required)(PAR-23-288)National Cancer InstituteThe purpose of the NCI Pathway to Independence Award for Early-Stage Postdoctoral Researchers (K99/R00) program is to increase and maintain a strong cohort of new and talented, NCI-supported, independent investigators. This program is designed for postdoctoral fellows with research and/or clinical doctoral degrees who do not require an extended period of mentored research training beyond their doctoral degrees. The objective of this award is to facilitate a timely transition of these fellows from their mentored, postdoctoral research positions to independent tenure-track (or equivalent) faculty positions. The program will provide independent NCI research support during this transition to help awardees launch competitive, independent research careers. Researchers in the scientific areas of cancer control, cancer prevention and cancer data sciences are especially encouraged to work with their institutions to apply.

Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required)(PAR-24-035)National Institute of Arthritis and Musculoskeletal and Skin Diseases. This Notice of Funding Opportunity (NOFO) is designed to facilitate clinical trials that can be completed within a limited time frame. A broad range of types of exploratory studies may be submitted to this NOFO. The trials must address research questions related to the mission and goals of the NIAMS and may evaluate interventions with drugs, biologics, devices, or surgical, dietary, behavioral or rehabilitation therapies.

Multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities (UG3/UH3, Clinical Trial Required)(PAR-24-053) The purpose of this NOFO is to support projects to test prospective multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities. These research projects will be part of the Multi-Sectoral Preventive Interventions (MSPI) Research Network, which will also include a Coordinating Center (RFA-OD-24-006). Funded under a cooperative agreement, projects participating in the MSPI Research Network will collaborate to share approaches, methods, and data, working closely with NIH Institutes, Offices and Centers. Applicants applying to this NOFO are encouraged to review the Coordinating Center NOFO to fully understand the MSPI Research Network structure and activities.

Phased Research to Support Substance Use Epidemiology, Prevention, and Services Studies (R61/R33 Clinical Trials Optional)(PAR-24-062) The purpose of this notice of this funding opportunity (NOFO) is to support translational research across epidemiology, addiction services, and prevention to, ultimately, reduce the burden of substance use on public health. This NOFO encourages research that facilitates rapid translation from one discipline to another (e.g., epidemiology to prevention); supports community/stakeholder engagement in substance use treatment and prevention clinical trials; or reduces the research to practice gap through the rapid transition from pilot study to clinical trial, or effectiveness to implementation study.  The goal is to support translational research improving our ability to  1) identify and characterize malleable individual, familial, behavioral, developmental, and socio-cultural/environmental factors (within the population or precise subgroups) with the potential for multi-directional transfer of knowledge;  2) prevent initiation of substance use or progression to misuse or use disorder; and  3) maximize the efficient delivery of high-quality, personalized addiction treatment and related services to ultimately inform and facilitate real world responses designed to reduce the burden of substance use, misuse and/or addiction on the health of the population. This NOFO invites projects for which preliminary feasibility or pilot data are not available. 

Ethical, Legal and Social Implications (ELSI) Exploratory/Developmental Research Grant (R21 Clinical Trial Optional)(PAR-23-294) This Notice of Funding Opportunity (NOFO) invites Exploratory/Developmental Research Grant (R21) applications that propose to study the ethical, legal and social implications (ELSI) of human genetic or genomic research. Applications may propose studies using either single or mixed methods, that break new ground, extend previous discoveries in new directions, or develop preliminary data in preparation for larger studies.

Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH2/UH3 Clinical Trial Not Allowed)(PAR-23-313) Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) invites applications to support the 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 support investigator-initiated research for both analytical, and clinical validation of assays to be used in cancer treatment, control, or prevention trials supported by the NCI. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants should have assays that work on human samples and whose importance is well justified for development into clinical assays. As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously.

Single Source: AIDS and Cancer Specimen Resource (ACSR; UM1 Clinical Trials Not Allowed)(RFA-CA-23-043) Through this single source, cooperative agreement Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) solicits an application to fund a single award to George Washington University for the continuation of the AIDS and Cancer Specimen Resource (ACSR). If awarded, the applicant institution will be expected to maintain the cooperative group structure and the activities of the ACSR. The primary objective of the ACSR will be to acquire, store, and equitably distribute tumor tissues, biological fluids, and associated demographic data from patients with human immunodeficiency virus (HIV)-associated malignancies. In addition to serving acquired immunodeficiency syndrome (AIDS) and cancer researchers at large, the ACSR will specifically provide biorepository functions for another NCI supported initiative, the AIDS Malignancy Consortium (AMC). The AMC performs clinical trials research in the treatment and prevention of HIV-associated malignancies in the United States, Sub-Saharan Africa, and Latin America. It is expected that the ACSR, will strategically enrich the existing inventory of rare and difficult to obtain specimens through a series of specimen sparing and optimizing initiatives. 

Advancing Hearing and Balance Research Using Auditory and Vestibular Organoids (R21-Clinical Trial Not Allowed)(PAS-24-057)National Institute on Deafness and Other Communication Disorders. The purpose of this NIDCD initiative is to encourage research in the development, characterization, and reproducibility/reliability of human auditory and vestibular organoids. Applications investigating animal organoids are allowable but only if accompanying comparative or other integrated companion studies with human organoids. Singular animal organoid studies alone are not responsive to this funding opportunity. This funding opportunity encourages innovative, reproducible, and novel methodologies and technologies that will drive the reproducibility and holistic longevity of hearing/balance sensory organoids as model systems. The development of novel tools to deliver genes, proteins, molecules, and synthetics that might lead to the successful expansion and longer-term survivability of organoid populations in a stable, reliable, and reproducible manner is highly encouraged. Subsequent characterization of the organoid platforms must be shown to mimic and recapitulate the native correlative biological function. Applications that provide approaches that remove current barriers and lessen challenges to improve current reproducibility and stability are highly encouraged

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