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The NINDS seeks to fund high quality clinical trials to evaluate treatments for neurological disorders. This Funding Opportunity Announcement (FOA) invites applications under the NINDS Clinical Trial Planning Grant Program, the purpose of which is to provide support for the organization of activities critical for the successful implementation of high-risk, complex, or large-scale clinical trials. The planning grant is intended to (a) allow for early peer review for the rationale and design of the proposed clinical trial; (b) provide support for the development of a detailed manual of operations and procedures; and (c) provide support to develop essential elements of a clinical trial, such as the development of tools for data management and oversight of the research, the definition of recruitment strategies, the finalization of the protocol, analytical techniques, facilities, administrative procedures, obtaining IND/IDE, and the establishment of collaborative arrangements. The purpose of the NINDS planning grant is not to obtain preliminary data or to conduct pilot studies to support the rationale or the clinical trial. The expected product of the planning grant is a detailed clinical trial research plan including a complete manual of operations and procedures. Included in the planning grant application must be a completed study protocol and projected direct costs for the future phase III trial.

-This programannouncement (PA) is being issued in conjunction with PA-06-419, BIOENGINEERING RESEARCH GRANTS, and PA-06-418, EXPLORATORY/DEVELOPMENTAL (R21) BIOENGINEERING RESEARCH GRANTS. -This funding opportunity will use the NIH R01 research grant award mechanism. -Participating Institutes and Centers (ICs) of the National Institutes of Health (NIH) invite applications for R01 awards to support Bioengineering Research Partnerships (BRPs) for basic, applied, and translational multi-disciplinary research that addresses important biological or medical research problems. -In the context of this program, a partnership is a multi-disciplinary research team that applies an integrative, systems approach to develop knowledge and/or methods to prevent, detect, diagnose, or treat disease or to understand health and behavior. -The partnership must include appropriate bioengineering or allied quantitative sciences in combination with biomedical and/or clinical components.

-This Funding Opportunity Announcement (FOA), the Fogarty “International Research Collaboration – Basic Biomedical” Sciences Research Award (FIRCA-BB) facilitates collaborative basic biomedical research between scientists supported by the National Institutes of Health (NIH) and investigators in developing countries. For behavioral and social sciences research, see the companion FOA, Fogarty “International Research Collaboration – Behavioral, Social Sciences” Research Award program (FIRCA-BSS), PAR-06-437. -Funding of total direct costs of up to $100,000 over three years in modules of $25,000 (one module in year one and year three, two modules in year two) is available. -The anticipated number of awards is 30-40 per year. -This program uses the NIH Small Grant R03 mechanism with additional eligibility, project period, and funding restrictions.

-This Funding Opportunity Announcement (FOA), the Fogarty “International Research Collaboration- Behavioral, Social Sciences” Research Award (FIRCA-BSS) facilitates collaborative behavioral and social science research between scientists supported by the National Institutes of Health (NIH) and investigators in developing countries. For basic biomedical research, see the companion FOA, Fogarty “International Research Collaboration - Basic Biomedical” Sciences Research Award Program (FIRCA-BB), PAR-06-436. -Funding of total direct costs of up to $100,000 over three years in modules of $25,000 (one module in year one and year three, two modules in year two) is available. -The anticipated number of awards is 10-20 per year.

This Funding Opportunity Announcement (FOA) solicits NIH Small Research Grant (R03) applications for the support of research which is aimed at characterizing, understanding and treating etiological and pathophysiological mechanisms common to both Fragile X syndrome (FXS) and autism (including autism spectrum disorders such as Rett syndrome). Between 2.5% and 6% of individuals with autistic feature have FXS, and approximately 15% to 25% of children with FXS have autism. An additional 50% to 90% of children with FXS exhibit some symptoms and features associated with autism, including poor eye contact, hand flapping, hand biting, speech perseveration and other language abnormalities and problems, as well as tactile defensiveness, mental retardation in the moderate to severe range, developmental delay, sensory hyperarousal, and social anxiety with mood liability. Researchers have argued that autism and autistic symptoms in FXS reflect a common etiological or pathophysiological pathway underlying the two conditions. Ongoing basic neuroscience research on FXS in model systems like the mouse and fly are providing a wealth of information at multiple levels – subcellular, cellular, and intercellular networks or circuits – to delineate the neurobiology of this disorder. These studies should dissect components of the neurobiology of autism, especially in patients with both FXS and autism, and identify novel targets for new drugs to treat both disorders. Applications submitted in response to this FOA should focus on a topic related to understanding neural pathways, circuits, systems and molecules that play a role in the etiology or pathophysiology of FXS and may be implicated in autism (including autism spectrum disorders such as Rett syndrome). Studies emphasizing the identification of drug targets for new therapeutic drugs to treat FXS and autism are particularly encouraged. Research projects supported under this FOA that include human subjects should include children affected with both FXS and autism and animal studies may include several models systems, e.g., mouse, fly and zebrafish. Basic neuroscience research in model systems should focus on both FXS and autism. Research more exclusively focused on autism that would not be covered under this FOA may be submitted under PA-06-390, PA-06-391, or PA-06-392, Research on Autism and Autism Spectrum Disorders.

This Funding Opportunity Announcement (FOA) solicits NIH Exploratory/Developmental Research Grant (R21) applications for the support of research which is aimed at characterizing, understanding and treating etiological and pathophysiological mechanisms common to both Fragile X syndrome (FXS) and autism (including autism spectrum disorders such as Rett syndrome). Between 2.5% and 6% of individuals with autistic feature have FXS, and approximately 15% to 25% of children with FXS have autism. An additional 50% to 90% of children with FXS exhibit some symptoms and features associated with autism, including poor eye contact, hand flapping, hand biting, speech perseveration and other language abnormalities and problems, as well as tactile defensiveness, mental retardation in the moderate to severe range, developmental delay, sensory hyperarousal, and social anxiety with mood liability. Researchers have argued that autism and autistic symptoms in FXS reflect a common etiological or pathophysiological pathway underlying the two conditions. Ongoing basic neuroscience research on FXS in model systems like the mouse and fly are providing a wealth of information at multiple levels – subcellular, cellular, and intercellular networks or circuits – to delineate the neurobiology of this disorder. These studies should dissect components of the neurobiology of autism, especially in patients with both FXS and autism, and identify novel targets for new drugs to treat both disorders. Applications submitted in response to this FOA should focus on a topic related to understanding neural pathways, circuits, systems and molecules that play a role in the etiology or pathophysiology of FXS and may be implicated in autism (including autism spectrum disorders such as Rett syndrome). Studies emphasizing the identification of drug targets for new therapeutic drugs to treat FXS and autism are particularly encouraged. Research projects supported under this FOA that include human subjects should include children affected with both FXS and autism and animal studies may include several models systems, e.g., mouse, fly and zebrafish. Basic neuroscience research in model systems should focus on both FXS and autism. Research more exclusively focused on autism that would not be covered under this FOA may be submitted under PA-06-390, PA-06-391, or PA-06-392, Research on Autism and Autism Spectrum Disorders.

-This funding opportunity will utilize the NIH Exploratory/Developmental Grant (R21) award mechanism, and runs in conjunction with PA-06-419_, BIOENGINEERING RESEARCH GRANTS, and PAR-04-023, BIOENGINEERING RESEARCH PARTNERSHIPS. -This Funding Opportunity Announcement (FOA) is intended to encourage innovation and high impact research.While minimal or no preliminary data are expected to be described in the application, applications should clearly indicate the significance of the proposed work and that the proposed research and/or development is scientifically sound, that the qualifications of the investigators are appropriate, and that resources available to the investigators are adequate. -Participating Institutes and Centers of the NIH invite applications for Exploratory/Developmental Bioengineering Research Grants (EBRG) to support innovative, high risk/high impact bioengineering research in new areas that may have minimal or lack preliminary testing or development. -An EBRG application may propose hypothesis-driven, discovery-driven, developmental, or design-directed research.. -The research proposed under this program can explore approaches and concepts new to a particular substantive area; research and development of new technologies, techniques or methods; or initial research and development of data upon which significant future research may be built. -Budget and Project Period:The total project period for an application submitted in response to this funding opportunity may not exceed two years. Direct costs are limited to $275,000 over an R21 two-year period, with no more than $200,000 in direct costs allowed in any single year. -Eligible organizations: For profit organizations; Non-profit organizations; public or private institutions, such as universities, colleges, hospitals and laboratories; units of State and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations; faith-based or community-based organizations; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization. -Eligible Project Directors/Principal Investigators (PDs/PIs): Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. -Applicants may submit more than one application, provided each application is scientifically distinct.

-This programannouncement (PA) is being issued in conjunction with PA-06-418, EXPLORATORY/DEVELOPMENTAL (R21) BIOENGINEERING RESEARCH GRANTS (EBRG), and PAR-04-023 BIOENGINEERING RESEARCH PARTNERSHIPS (BRP). Participating Institutes and Centers of the NIH invite applications for R01 awards to support Bioengineering Research Grants (BRGs) for basic and applied multi-disciplinary research that addresses important biological, bioengineering or medical research problems. This funding opportunity will use the NIH R01 research grant award mechanism. The BRGs support multi-disciplinary research performed in a single laboratory or by a small number of investigators that applies an integrative, systems approach to develop knowledge and/or methods to prevent, detect, diagnose, or treat disease or to understand health and behavior. -A BRG application may propose hypothesis-driven, discovery-driven, developmental, or design-directed research -Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the quality, duration, and costs of the applications received. -Eligible organizations include: For profit organizations; Non-profit organizations; public or private institutions, such as universities, colleges, hospitals and laboratories; units of State and local governments; eligible agencies of the Federal government; domestic or foreign institutions/organizations; faith-based or community-based organizations; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization. -Eligible principal investigators include any individual with the skills, knowledge, and resources necessary to carry out the proposed research. -Applicants may submit more than one application, provided they are scientifically distinct.

-This Funding Opportunity Announcement (FOA) solicits applications for collaborative research projects, involving investigators in developed and developing countries, focusing on brain disorders throughout life relevant to developing nations. The collaborative research programs are expected to contribute to the long-term goal of building sustainable research capacity in developing countries to address neurological/neurodevelopmental (including sensory, motor, cognitive and behavioral) function and impairment throughout life. -This FOA will utilize the Exploratory/Developmental (R21) grant mechanism and runs in parallel with an FOA of identical scientific scope, PAR-05-100, which solicits applications under the R01 grant mechanism.  -The anticipated number of awards is six to 15; however, awards issued under this FOA are contingent upon the availability of funds and the submission of a sufficient number of meritorious applications. -Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the mechanism numbers, quality, duration, and costs of the applications received. -Project Period and Award Amounts: Applicants may request a project period of up to two years and a budget for direct costs of up to $100,000 per year in modules of $25,000.  -Eligible organizations: For-profit organizations; Non-profit organizations; Public or private institutions, such as universities, colleges, hospitals (including Veterans’ Administration Hospitals) and laboratories; Units of State government; Units of local government; Domestic institutions/organizations; Foreign institutions/organizations; Faith-based or community-based organizations; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native -American Tribally Designated Organizations. Applications must be submitted as collaborations between developed and developing country investigators/ institutions. For operational and analytic purposes, the World Bank's main criterion for classifying economies, gross national income (GNI), will be employed for this FOA to determine country eligibility. (See Section III, “Eligibility Information”, for definitions and further requirements). -Eligible Project Directors/Principal Investigators (PD/PIs): Any individual at an eligible institution/organization with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support. Women, individuals from underrepresented racial and ethnic groups, as well as individuals with disabilities, are always encouraged to apply for NIH support. -Applicant organizations may submit more than one application, provided each application is scientifically distinct. 

The NIH is interested in promoting research and developments in computational science and technology that will support rapid progress in areas of scientific opportunity in biomedical research.As defined here, biomedical computing or biomedical information science and technology includes database design, graphical interfaces, querying approaches, data retrieval, data visualization and manipulation, data integration through the development of integrated analytical tools, and tools for electronic collaboration, as well as computational and mathematical research including the development of structural, functional, integrative, and analytical models and simulations. -Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. The total amount awarded and the number of awards will depend upon the availability, quality, duration, and costs of the applications received. -The type of award mechanism: R01. -Eligible organizations include: for-profit organizations; non-profit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of State governments; units of local governments; eligible agencies of the Federal government; domestic institutions; foreign institutions; and faith-based or community-based organizations; Indian/Native American Tribal Government (Federally Recognized); Indian/Native American Tribal Government (Other than Federally Recognized); and Indian/Native American Tribally Designated Organization. -Eligible individuals: Any individual with the skills, knowledge, and resources necessary to carry out the proposed research is invited to work with their institution to develop an application for support.Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support. -Applicants may submit more than one application, provided they are scientifically distinct. See Section IV.1 for application materials. -Telecommunications for the hearing impaired is available at: TTY 301-451-0088. -Special receipt dates are specified above. -Additional review considerations are specified in Section V.