Funding Opportunity PA-18-531 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to stimulate research focused on the role of early-life factors (maternal-paternal, in utero, birth and infancy, puberty, adolescence, and young adult years) in cancer development later in life. Given that the current emerging evidence from limited research indicates a potentially important role for early-life events and exposures in cancer development, it is necessary to better understand 1) the early-life (maternal-paternal, in utero, birth and infancy, puberty, adolescence, and young adult years) factors that are associated with later cancer development; 2) how early-life factors mediate biological processes relevant to carcinogenesis; and 3) whether predictive markers for cancer risk based on what happens biologically at early life can be measured and developed for use in cancer prevention strategies. Markers that predict malignancy or pre-malignant conditions would allow assessment of early-life exposures with relevant outcomes without having to wait decades for cancer development. Ultimately, a better mechanistic understanding of how early-life events and exposures contribute to the etiology of cancer later in life will allow for the development of effective interventions during pregnancy or early life that may have a profound impact on cancer prevention.

Funding Opportunity PA-18-532 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to stimulate research focused on the role of early-life factors (maternal-paternal, in utero, birth and infancy, puberty, adolescence, and young adult years) in cancer development later in life. Given that the current emerging evidence from limited research indicates a potentially important role for early-life events and exposures in cancer development, it is necessary to better understand 1) the early-life (maternal-paternal, in utero, birth and infancy, puberty, adolescence, and young adult years) factors that are associated with later cancer development; 2) how early-life factors mediate biological processes relevant to carcinogenesis; and 3) whether predictive markers for cancer risk based on what happens biologically at early life can be measured and developed for use in cancer prevention strategies. Markers that predict malignancy or pre-malignant conditions would allow assessment of early-life exposures with relevant outcomes without having to wait decades for cancer development. Ultimately, a better mechanistic understanding of how early-life events and exposures contribute to the etiology of cancer later in life will allow for the development of effective interventions during pregnancy or early life that may have a profound impact on cancer prevention.

Funding Opportunity PA-18-529 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA)is to stimulate research focused on the role of early-life factors (maternal-paternal, in utero, birth and infancy, puberty, adolescence, and young adult years) in cancer development later in life. Given that the current emerging evidence from limited research indicates a potentially important role for early-life events and exposures in cancer development, it is necessary to better understand 1) the early-life (maternal-paternal, in utero, birth and infancy, puberty, adolescence, and young adult years) factors that are associated with later cancer development; 2) how early-life factors mediate biological processes relevant to carcinogenesis; and 3) whether predictive markers for cancer risk based on what happens biologically at early life can be measured and developed for use in cancer prevention strategies. Markers that predict malignancy or pre-malignant conditions would allow assessment of early-life exposures with relevant outcomes without having to wait decades for cancer development. Ultimately, a better mechanistic understanding of how early-life events and exposures contribute to the etiology of cancer later in life will allow for the development of effective interventions during pregnancy or early life that may have a profound impact on cancer prevention.

Funding Opportunity PAR-18-534 from the NIH Guide for Grants and Contracts. The purpose of this funding opportunity announcement (FOA) is to support clinical studies that will fill gaps in the design of upcoming clinical trials in rare neurological or neuromuscular diseases by validating clinical outcome measures or biomarkers, or by characterizing cohorts of relevant patients. Through the support of trial readiness studies, NINDS expects to accelerate the initiation of clinical trials for rare diseases and to increase the likelihood of success in those trials.

Funding Opportunity PAR-18-514 from the NIH Guide for Grants and Contracts. This funding opportunity (FOA) encourages small business-based (STTR) research and development of commercial pharmaceutical interventions to extend lifespan and/or healthspan, to prevent, treat, and/or slow the progression of symptoms associated with Alzheimer's disease (AD) and Alzheimer's disease related dementia (ADRD) in human cells and/or tissue, in-vitro models, and/or non-human animals.

Funding Opportunity PAR-18-512 from the NIH Guide for Grants and Contracts. This funding opportunity (FOA) encourages small business-based (SBIR) research and development of commercial pharmaceutical interventions to extend lifespan and/or healthspan, to prevent, treat, and/or slow the progression of symptoms associated with Alzheimer's disease (AD) and Alzheimer's disease related dementia (ADRD) in human cells and/or tissue, in-vitro models, and/or non-human animals.

Funding Opportunity PAR-18-519 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications that propose either basic, clinical, or a combination of basic and clinical studies to investigate how functional changes in the sensory and/or motor systems impact the development and progression of Alzheimers disease. Studies may include older adults and/or animal models and may employ a variety of approaches, including cellular, molecular, imaging, physiological and genetic, to address this need. For clinical studies, leveraging of existing longitudinal cohorts already collecting sensory and motor assessments is highly encouraged.

Funding Opportunity PAR-18-523 from the NIH Guide for Grants and Contracts. The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer and stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance, requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring for patient safety. For purposes of this Funding Opportunity Announcement (FOA), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of linked companion grant awards including the Chairs Grant, the Coordinating Center, and Resource Centers, when appropriate. For less organizationally complex projects, details pertaining to data management and statistical analyses, resource center and recruitment activity may be included as part of the Chair's Grant application. Specifically, this FOA encourages applications for the Chair's grant, which includes the scientific rationale, study aims and significance of the research project

Funding Opportunity PAR-18-522 from the NIH Guide for Grants and Contracts. The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer and stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance, requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring for patient safety. For purposes of this Funding Opportunity Announcement (FOA), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of linked companion grant awards including the Chairs Grant, the Coordinating Center, and Resource Centers, when appropriate. For less organizationally complex projects, details pertaining to data management and statistical analyses, resource center and recruitment activity may be included as part of the Chair's Grant application. Specifically, this FOA encourages applications for the Resource Center grant which provides imaging, laboratory, or other requisite services for a multi-center clinical trial or other complex or high risk clinical trial.

Funding Opportunity PAR-18-521 from the NIH Guide for Grants and Contracts. The NEI uses UG1 cooperative agreement awards to support investigator-initiated large-scale clinical trials, human gene-transfer and stem cell therapy trials, and other complex or high resource- or safety-risk clinical trials. These projects are multifaceted and of high public health significance, requiring clear delineation of study organization including roles and responsibilities and require careful performance oversight and monitoring for patient safety. For purposes of this Funding Opportunity Announcement (FOA), the proposed study must be intended to evaluate interventions aimed at screening, diagnosing, preventing, or treating vision disorders, or to compare the effectiveness of two or more established interventions. The NEI UG1-supported studies are typically funded as a group of linked companion grant awards including the Chairs Grant, the Coordinating Center, and Resource Centers, when appropriate. For less organizationally complex projects, details pertaining to data management and statistical analyses, resource center and recruitment activity may be included as part of the Chair's Grant application. Specifically, this FOA encourages applications for the Coordinating Center grant, which provides details of the Coordinating Center's responsibilities and operations.

Funding Opportunity PAR-18-543 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

Funding Opportunity PAR-18-542 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) supports the development of therapeutic Biotechnology Products and Biologics (e.g., peptides, proteins, oligonucleotides, gene therapies, cell therapies, and novel emerging therapies) for disorders identified under the NINDS mission. An identified clinical candidate with sufficient bioactivity, stability, manufacturability, bioavailability, in vivo efficacy and/or target engagement, and other favorable properties that are consistent with the desired clinical application, is required for entry to this CREATE Bio Development Track. Therefore, this FOA supports Investigational New Drug (IND)-enabling studies for a therapeutic candidate and the inclusion of an optional small delayed-onset first in human Phase I clinical trial. At the end of the funding period, a successful project should have at least an IND application submitted to the U.S. Food and Drug Administration (FDA).

Funding Opportunity RFA-TR-18-005 from the NIH Guide for Grants and Contracts. The purpose of this Funding Opportunity Announcement (FOA) is to invite cooperative agreement applications for the Tissue Chip Testing Center (TCTC) Microphysiological Systems (MPS) Data Center (MPS DC), which supports the NIH Tissue Chip Consortium. The Consortium facilitates the development, validation and dissemination of tissue chip (TC) technology through support for collaborative research in 1) development of tissue chips for toxicity and safety testing of promising therapeutics (RFA-RM-11-022); 2) development of tissue chips for disease modeling and efficacy testing (RFA-TR-16-017 and RFA-TR-16-019); and 3) independent validation of tissue chip platforms through the TCTCs (RFA-TR-16-006). The MPS DC is expected to be the central clearinghouse for TC data management, and will incorporate novel approaches and technologies for data management, data mining and meta-analyses, and data sharing across many organs and tissues, diseases, data types, and TC platforms. The MPS Data center is expected to provide different levels of public and tiered access to TC information for basic and clinical researchers, academic and practicing physicians, the pharmaceutical industry, NIH, FDA and other government agencies, patients, and the lay public. The MPS Data Center will work with IQ Consortium members to develop and make available a secure, customizable coordinated data management system for collection, storage, and analyses of diverse data types from multiple TC platforms being developed and used for drug screening, safety and efficacy testing.

Funding Opportunity RFA-TR-18-006 from the NIH Guide for Grants and Contracts. This Funding Opportunity Announcement (FOA) invites applications for NextGen Tissue Chip Testing Center(s) (NextGen TCTC) that will provide resources and infrastructure for the validation of tissue chips being developed as part of the NIH Tissue Chip (TC) for Drug Screening Program or NIH Microphysiological Systems (MPS) Program. The MPS program supports a consortium of investigators developing accurate cellular and organ microsystems representative of human physiology for the evaluation of drug efficacy and toxicity (RFA-RM-11-022; RFA-TR-16-017; RFA-TR-16-019). The developed in vitro MPS platforms are representative of major organs and tissues in the human body, and need to be validated for their predictive capabilities of the assessment of biomarkers, and the bioavailability, efficacy, and toxicity of therapeutic agents prior to entry into clinical trials. Validation of the tissue chips is currently being conducted through Tissue Chip Testing Centers. These are responsible for testing a select group of compounds using predefined assays and biomarkers, according to pharmaceutical industry standards, and the integration of the data into a public database. NextGen TCTC(s) will aim to accelerate the transition of NIH-supported research innovations and technologies toward a self-sustaining model to continue the validation of various MPS platforms. NextGen TCTC(s) will develop services that promote the use of MPS by industry, regulatory bodies, and biotech sectors, and create significant value and economic stimulus or, advance the research in MPS technology in a way that could stimulate future growth and investments, and advance drug discovery and development. This U24is intended to support research and development (R and D) specifically targeted at activities that can help address the funding gap between promising R and D and transitioning to the market, often called the Valley of Death by contributing the critical funding needed by applicants to pursue the next appropria

Funding Opportunity PA-18-525 from the NIH Guide for Grants and Contracts. The purpose of this Founding Opportunity Announcement (FOA) is to encourage new or renewal Small Business Innovation Research (SBIR) grant applications focused on specific product development activities for radiological/nuclear medical countermeasures leading to Investigational New Drug (IND) or Investigational Device Exemption (IDE) submission packages to the U.S. Food and Drug Administration.

Notice NOT-AR-18-011 from the NIH Guide for Grants and Contracts

Notice NOT-AR-18-010 from the NIH Guide for Grants and Contracts

Funding Opportunity PA-18-508 from the NIH Guide for Grants and Contracts. Funding Opportunity Purpose This Funding Opportunity Announcement (FOA), issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), is intended to support novel research on how prenatal alcohol exposure may contribute to the etiology of chronic diseases and health conditions later in life. Central to this theme is the developmental origins of health and disease (DOHaD) concept which suggests that fetal adaptations in response to adverse intrauterine conditions may increase the risk for childhood and adulthood disease. The goal of this FOA is to stimulate a broad range of research to: 1) leverage existing prospective birth cohorts to define the role of maternal alcohol consumption in the DOHaD process; 2) investigate the biological, cellular, and molecular mechanisms by which prenatal alcohol exposure may impact disease outcomes later in life; and 3) identify biomarkers associated with gestational alcohol exposure that may predict adult disease susceptibility in exposed offspring. Studies supported by this FOA will provide fundamental insights into a possible fetal-basis to adult disease that is influenced by maternal alcohol use.

Funding Opportunity PA-18-507 from the NIH Guide for Grants and Contracts. Funding Opportunity Purpose This Funding Opportunity Announcement (FOA), issued by the National Institute on Alcohol Abuse and Alcoholism (NIAAA), is intended to support novel research on how prenatal alcohol exposure may contribute to the etiology of chronic diseases and health conditions later in life. Central to this theme is the developmental origins of health and disease (DOHaD) concept which suggests that fetal adaptations in response to adverse intrauterine conditions may increase the risk for childhood and adulthood disease. The goal of this FOA is to stimulate a broad range of research to: 1) leverage existing prospective birth cohorts to define the role of maternal alcohol consumption in the DOHaD process; 2) investigate the biological, cellular, and molecular mechanisms by which prenatal alcohol exposure may impact disease outcomes later in life; and 3) identify biomarkers associated with gestational alcohol exposure that may predict adult disease susceptibility in exposed offspring. Studies supported by this FOA will provide fundamental insights into a possible fetal-basis to adult disease that is influenced by maternal alcohol use.

Notice NOT-ES-18-007 from the NIH Guide for Grants and Contracts