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The purpose of this program announcement (PA) is to encourage the submission of applications for research to enhance animal stem cells as model biological systems. Innovative approaches to isolate, characterize and identify totipotent and multipotent stem cells from nonhuman biomedical research animal models, as well as to generate reagents and techniques to characterize and separate those stem cells from other cell types is encouraged. Studies involving human subjects are not allowed under this PA. This PA supersedes PA-02-147 issued earlier by the NCRR.

The goal of this Program Announcement is to solicit applications on lysosomal storage disorders (LSDs) focused on improving CNS treatment outcomes, enhancing the effectiveness of delivery and targeting of cells, enzymes, drugs and genes into the brain, and developing novel therapeutic modalities, such as implantable biocapsules and micro-electro-mechanical systems (MEMS)-based devices. Lysosomal storage disorders constitute a group of recessive genetic diseases resulting from cellular enzymatic deficiencies of acid hydrolases that normally catalyze the metabolism of glycoproteins, glycolipids and other macromolecules, or from defects in transporter proteins leading to pathogenic accumulation of these substances in lysosomes. Treatment modalities for LSDs are currently limited to bone marrow transplantation (BMT) and enzyme replacement therapy (ERT). These approaches while providing significant promise for treatment of the visceral manifestations of LSDs, do little to address CNS pathologies for this group of disorders. Thus this announcement specifically encourages the transition from basic studies in LSDs to translational research for improved delivery of therapeutic cells, proteins, genes, and small molecules across the blood-brain barrier.

The participating Institutes, Centers and Offices of the National Institutes of Health (NIH) and the Agency for Healthcare Research and Quality (AHRQ) invite investigators to submit R03 research grant applications on health literacy. The goal of this Program Announcement is to increase scientific understanding of the nature of health literacy and its relationship to healthy behaviors, illness prevention and treatment, chronic disease management, health disparities, risk assessment of environmental factors, and health outcomes including mental and oral health. Increased scientific knowledge of interventions that can strengthen health literacy and improve the positive health impacts of communications between healthcare and public health professionals (including dentists, healthcare delivery organizations, and public health entities), and consumer or patient audiences that vary in health literacy, is needed. Such knowledge will help enable healthcare and public health systems serve individuals and populations more effectively and employ strategies that reduce health disparities in the population. Healthy People 2010 defines health literacy as the “degree to which individuals have the capacity to obtain, process and understand basic health information and services needed to make appropriate health decisions” (U.S. Department of Health and Human Services, 2000). Many factors affect individuals’ ability to comprehend, and in turn use or act on, health information and communication. Proficiency in reading, writing, listening, interpreting, oral communication, and visual analysis is necessary as the modern health system typically relies on a variety of interpersonal, textual, and electronic media to present health information. Individuals and families both must be able to: communicate with health professionals; understand the health information in mass communication; understand how to use health- related print, audiovisual, graphical and electronic materials; understand basic health concepts (e.g., many health problems can be prevented or minimized) and vocabulary (e.g., about the body, diseases, medical treatments, etc.); and connect this health-related knowledge to health decision-making and action-taking. Access to and understanding of health information and services is a reciprocal process among health professionals, communication professionals and patients. For instance, these professionals must use science-based strategies and tactics, develop resources and materials, and understand communication interactions between providers and patients. Research on health literacy should assist NIH in its mission of communicating scientifically-based health information to the public and to the health care providers and related professionals who serve the public. The application of scientific knowledge from health literacy research may also strengthen the health information knowledge and communication skills of the public, and further one of the national goals of Healthy People 2010, to improve health literacy by the decade’s end.

The purpose of the Midcareer Investigator Award in Patient-Oriented Research is to provide support for clinician investigators to allow them protected time to devote to patient-oriented research (POR) and to act as research mentors primarily for clinical residents, clinical fellows and/or junior clinical faculty. This award is primarily intended for clinician investigators who are at the Associate Professor level or are functioning at that rank in an academic setting or equivalent non- academic setting, and who have an established record of independent, peer-reviewed Federal or private research grant funding in POR. This award is intended to advance both the research and the mentoring endeavors of outstanding patient-oriented investigators. It is expected, for example, that investigators will obtain new or additional independent peer-reviewed funding as the PI for POR and establish and assume leadership roles in collaborative POR programs; and that there will be an increased effort and commitment to mentor beginning clinician investigators in POR to enhance the research productivity of the investigator and increase the pool of well-trained clinical researchers of the future. With a view to achieving these objectives, the maximum level of allowable Research Development Costs has been increased in this announcement from $25,000 to $50,000 per year. For the purposes of this award, and in agreement with the recommendations of the NIH Director’s Panel on Clinical Research, (http://www.nih.gov/news/crp/97report/index.htm), patient-oriented research is defined as research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena)for which an investigator directly interacts with human subjects. This area of research includes 1) mechanisms of human disease; 2) therapeutic interventions; 3) clinical trials, and; 4) the development of new technologies. Studies falling under Exemption 4 for human subjects research are not included in this definition.

Stem cells appear to possess great plasticity, but the cellular mechanisms regulating their behavior and fate are not understood. If these mechanisms can be harnessed to obtain cells specifically required for therapy, diagnosis or drug discovery, it may be possible to restore function to tissues and organ systems that have been compromised by congenital disorders, developmental malfunction, age, injury, disease or drug exposure. The National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Aging (NIA), the National Institute of Child Health and Human Development (NICHD), the National Cancer Institute (NCI), the National Institute of Drug Abuse (NIDA), and the National Institute of Mental Health (NIMH) invite applications for studies on the characterization, behavior and plasticity of human and non-human stem cells, regulation of their replication, differentiation, integration and function in the nervous system, and the identification and characterization of normal and tumor stem cells. An understanding of intrinsic and extrinsic signals, especially those involved in the stem cell niche, age-dependent processes and genetic factors that govern the activities of pluripotent cells is crucial in order to utilize them to develop safe and effective treatments for the restoration of function, or to prevent their transformation into tumor-generating cells. Although animal studies demonstrate that stem or progenitor cells can be derived from a variety of tissues and from hosts of different ages, the requirements and potential for differentiation of each type of pluripotent cell appear to be unique. We lack a clear understanding of the intrinsic properties that distinguish one population from another, and how these populations differ in their response to similar conditions in vitro and in vivo. This Program Announcement, which replaces PA-01-078 (Biology of Non- Human Stem Cells in the Environment of the Nervous System) and PA-02-025 (Plasticity of Human Stem Cells in the Nervous System), encourages applications to study the fundamental properties of all classes of human and non-human stem cells, and to confirm, extend, and compare the behavior of stem cells that are derived from different sources and ages or exposed to different regimes in vitro and in vivo or derived from tumors. Of high priority are studies to develop methods for identifying, isolating and characterizing specific precursor populations at intermediate stages of differentiation into neurons and glia, and their relationship to tumor- generating cells. Projects that address comparisons between different classes of human stem cells and between human and non-human stem cells would also be directly relevant to this PA.

The National Institute of Neurological Disorders and Stroke (NINDS) and the National Institute of Mental Health (NIMH) invite applications for support of Microarray Centers. These Centers will support gene expression profiling in the nervous system through the application of microarray technologies. The Microarray Centers, which will function as a consortium, will provide reagents, services, and training to the neuroscience community, on a fee-for-service basis. The NINDS/NIMH Microarray Consortium was originally funded for three years in June 2002 under RFA-NS-02-001 as a consortium of three Microarray Centers. Information on the structure of the consortium and on the products and services offered to users is available on the consortium website (http://arrayconsortium.tgen.org). Further information on this initiative is available by viewing the transcript of a pre-application meeting that was held at NIH on June 7, 2001 (http://www.ninds.nih.gov/funding/technology_development/rfa-ns-02- 001/meeting_summary.htm). No pre-application meeting will be held for this RFA, which is a reissue of the original RFA. This recompetition of the Microarray Center awards will renew the consortium for five years.

The National Cancer Institute (NCI), the National Institute of Environmental Health Sciences (NIEHS), the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and the National Institute of Neurological Disorders and Stroke (NINDS) invite applications for the development and delivery of novel in vivo image acquisition or enhancement technologies and methods for biomedical imaging and image-guided interventions and therapy. Applications may incorporate limited pilot or clinical feasibility evaluations using either pre-clinical models or clinical studies. This initiative is primarily intended to facilitate the proof-of-feasibility, development, and delivery of novel imaging technologies for early detection, screening, diagnosis, image-guided interventions and treatments of various diseases, and, secondarily, to facilitate limited evaluation studies to show proof-of-concept and functionality. The interests of NCI focus on imaging in vivo for cancer pre-conditions, cancer screening, diagnosis, progression, treatment monitoring, recurrence, and image- based surrogate end points. NCI’s interests include development and delivery of imaging technologies that are cancer specific, and optimization and validation of imaging technologies for cancer applications. The scope includes system integration, contrast agents, pre- and post-processing algorithms and software for imaging, image understanding, and related informatics that are cancer specific. The interests of NIEHS focus on detection of intracellular events including gene expression and signal transduction pathway alterations, screening or diagnosis of tissue and organ toxicities related to exposures to environmental agents. These areas of interest include initiation of toxicity or exacerbation of disease or dysfunction resulting from toxic exposure, treatment, and recovery. The interests of NIDDK focus on diabetes, digestive, and kidney diseases. The interests of NINDS focus on development and delivery of neuroimaging technologies that can be applied to diagnosis and treatment of neurological disorders. This PA is directed toward the development, optimization, and delivery of innovative image acquisition and enhancement methods, including high risk/high gain research on technologies such as: (a) novel single and multi-modality molecular imaging systems, methods, agents, and related software and informatics, including the integration of these technologies with emerging biomedical imaging methods for more effective health care delivery for cancer and other diseases and (b) novel single and multimodality anatomical and functional imaging systems, methods, agents, and related software and informatics for more effective health care delivery for cancer and other diseases. In addition, research partnerships among investigators in both academia and device and drug industries are encouraged to more rapidly translate and deliver completed imaging system developments. This PA will utilize the Small Business Innovation Research and Small Business Technology Transfer Mechanisms but will be run in parallel with a NCI program announcement of nearly identical scope PA-04-095 (http://grants.nih.gov/grants/guide/pa-files/PA-04-095) that utilizes the Phased Innovation Award (R21/33) and the R33 mechanisms for exploratory/developmental studies and which is open to a broad range of organizations. Fast Track applications are encouraged in this solicitation because they benefit from expedited evaluation of progress following Phase I exploratory/feasibility work for immediate decision on transition to Phase II funding for expanded developmental work.

This RFA solicits applications for a cooperative agreement to augment the International HapMap Project by supporting the genotyping of approximately 2.25 million single nucleotide polymorphisms (SNPs) across the genome in 270 samples from four populations, at high quality and at a cost of about 1 cent per genotype. The data from this effort will contribute to the development of a map, called the HapMap, of the haplotype patterns in the human genome and of a set of SNPs that are informative about these patterns and the associations among the SNPs. The HapMap is expected to be a key resource that researchers will use to find genes that affect health, disease, and response to drugs and environmental factors. The genotyping supported by this RFA will augment the current efforts of the HapMap Project by substantially increasing the number of SNPs that will be studied, thereby increasing the quality of the HapMap and its usefulness as a resource for understanding human genetic variation and its role in health and disease. This RFA builds on a previous RFA, HG-02-005 Large-Scale Genotyping for the Haplotype Map of the Human Genome (http://grants.nih.gov/grants/guide/rfa-files/RFA-HG-02-005.html).

The principal limitations in the field of proteomics are technological in nature. Proteomics, and the sub-discipline of glycomics, are rapidly developing, technology-intensive fields. Separations, mass spectrometry, microarray, bioinformatics, and other tools have advanced rapidly to support the explosive growth of biomedical applications in this area. However, technologies and methods remain largely inadequate to address the majority of meaningful biological problems, particularly with respect to quantitative and real time measurements. Continued intensive development of advanced tools is essential to meet two needs. First, improvements in basic bioanalytical technologies are essential to these endeavors. This includes but is not restricted to robotics, sample preparation and pre-fractionation, analytical separations, gel and array imaging, quantitation, mass spectrometry, intelligent automated data acquisition, and database searching. Second, improved informatics technologies are essential for the conversion of data into meaningful results and interaction models. Improved informatics tools will also facilitate the integration and synergistic development of the basic analytical tools mentioned above. Additionally, the translation of advances in proteomics to a clinical setting should be a priority.

This PA replaces PA-01-051. The purpose of this program announcement is to encourage grant applications for the support of research designed to elucidate the diagnosis, epidemiology, etiology, genetics, treatment, and optimal means of service delivery in relation to Autistic Disorder ("autism") and autism spectrum disorders (Rett's Disorder, Childhood Disintegrative Disorder, Asperger's Disorder, Pervasive Developmental Disorder-Not Otherwise Specified, or "Atypical Autism"). This PA is meant to support the broad research goals of the Autism Research Matrix (http://www.nimh.nih.gov/autismiacc/researchmatrix.pdf). In February 2003, Congress requested that the Department of Health and Human Services (HHS) develop a set of autism research goals and activities for the next several years (House Report 109-10). Input into this activity included a meeting of autism investigators with a range of scientific expertise, as well as input from community members. Preparation for specifying this matrix involved a two-day meeting of an expert panel of scientists; public presentation and discussion of a draft matrix at the Autism Summit Conference in Washington DC on November 20, 2003; and adoption of the matrix by the Federal Interagency Autism Coordinating Committee (IACC).