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Reissue of RFA-NS-15-009. This Funding Opportunity Announcement (FOA) invites applications to support the National Institute of Neurological Disorders and Stroke (NINDS) Human Cell and Data Repository (NHCDR). The repository will maintain the current collection of fibroblast and induced pluripotent stem cell (iPSC) lines as well as develop, characterize, expand source cells and iPSCs, and where appropriate, genetically modify new high-quality iPSC lines accordance with the NINDS mission. The NINDS Human Cell and Data Repository will distribute human cell resources broadly to qualified academic and industry researchers to advance basic and translational research in neurological disorders.

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration (FDA), seeks highly meritorious clinical trial applications proposing to explore and enable the development of safe and effective regenerative medicine (RM) interventions using adult stem cells. This Funding Opportunity Announcement (FOA), issued as part of the Regenerative Medicine Innovation Project (RMIP), represents one step in fulfilling a statutory provision set forth in the 21st Century Cures Act. Applications submitted in response to this bi-phasic, milestone-driven cooperative agreement FOA are expected to propose highly innovative projects with a focus on solutions to widely-recognized issues in the development of safe and effective RM therapies. Of particular interest are projects using RM products that have undergone appropriate product development and pre-clinical studies and have demonstrated readiness to advance into clinical trials. This FOA seeks Phase I and beyond clinical trial applications that present a strong scientific rationale for the proposed clinical trial and a comprehensive scientific and operational plan. Trials must be relevant to the research mission of one or more participating NIH Institutes and Centers and meet the NIH definition of a clinical trial (see NOT-OD-15-015). Applications are expected to include plans for project management, participant recruitment and retention, performance milestones, conduct of the trial, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) authorization or Investigational New Device Exemption (IDE) approval to administer the product to humans. Successful applicants proposing the use of adult stem cells as a clinical intervention will be asked to make available representative samples of the source stem cell and clinical-grade stem cell-derived product for in-depth and independ

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R and D throughout the award.

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from small business concerns (SBCs) to the newly re-authorized Commercialization Readiness Pilot (CRP) program. The FOA aims to facilitate the transition of previously or currently funded SBIR and STTR Phase II and Phase IIB projects to the commercialization stage by providing additional support for technical assistance and later stage research and development (R and D) not typically supported through Phase II or Phase IIB grants or contracts. This may include independent replication of key studies, Investigational New Drug (IND)-enabling studies, clinical studies, manufacturing costs, regulatory assistance, or a combination of services. Although a significant amount of the work in a CRP award may be subcontracted to other institutions, the Small Business Concern (SBC) is expected to maintain oversight and management of the R and D throughout the award.

Notice Special Interest: Small Business Innovation Research SBIR) Small Business Technology Transfer STTR) Applications Directed the Adoption the Fast Healthcare Interoperability Resources FHIR®) Standard Notice Number: NOT-OD-19-127 Key Dates Release Date: July 30, 2019 First Available Due Date: September 5, 2019 Expiration Date:April 7, 2020 Related Announcements PA-19-270 PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Allowed) PA-19-271 PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Required) PA-19-272 PHS 2019-02 Omnibus Solicitation the NIH, CDC, FDA Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Allowed) PA-19-273 PHS 2019-02 Omnibus Solicitation the NIH, CDC, FDA Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Required) PA-18-591 Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) NOT-OD-19-150 Issued OFFICE THE DIRECTOR, NATIONAL INSTITUTES HEALTH OD) National Eye Institute NEI) National Heart, Lung, Blood Institute NHLBI) National Human Genome Research Institute NHGRI) National Institute Aging NIA) National Institute Alcohol Abuse Alcoholism NIAAA) National Institute Allergy Infectious Diseases NIAID) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Biomedical Imaging Bioengineering NIBIB) Eunice Kennedy Shriver National Institute Child Health Human Development NICHD) National Institute Deafness Other Communication Disorders NIDCD) National Institute Dental Craniofacial Research NIDCR) National Institute Diabetes Digestive Kidney Diseases NIDDK) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) National Institute General Medical Sciences NIGMS) National Institute Mental Health NIMH) National Institute Neurological Disorders Stroke NINDS) National Institute Nursing Research NINR) National Institute Minority Health Health Disparities NIMHD) National Library Medicine NLM) National Center Complementary Integrative Health NCCIH) National Center Advancing Translational Sciences NCATS) Purpose purpose this Notice to inform SBIR STTR applicants awardees areas special interest related the of Fast Healthcare Interoperability Resources FHIR®) standard the development health information technology health IT) products services. Health can improve health care quality outcomes enabling health care providers effectively share information apply evidence support care decisions. NIH seeking innovative health solutions, implementing FHIR standard, enable effective patient-centered care coordination, population health management, data science research support. FHIR a standardized of transmitting health data one health information system another through API. API a specified set protocols data standards establish ground rules which information system directly communicates another. Software developers seamlessly connect program another computer through FHIR API transmit electronic health data. FHIR enables exchange many different health data types such clinical information, demographics, billing claims data. special relevance, complementary specification, Substitutable Medical Applications, Reusable Technologies SMART) FHIR, enables third party applications apps) access data electronic health record EHR) systems approved purposes, including research. FHIR also specifies of specific coding systems required interoperability health data. Several Federal health agencies promoting use FHIR EHR systems. 21st Century Cures Act requires a health information technology developer entity allow health information…to accessed, exchanged, used without special effort through use application programming interfaces APIs)… including providing access all data elements a patient's electronic health record.”[1] To implement provision, Department Health Human Services, Office the National Coordinator Health Information Technology ONC) proposed new rule support seamless secure access, exchange, use electronic health information.[2] Specifically, proposed rule calls the health care industry adopt standardized APIs using FHIR standard share patient data. NIH issuing Notice highlight interest receiving grant administrative supplement applications focused implementation the FHIR standard health applications including, not limited to, following area(s): Integration patient- population-level data EHR systems Access and management electronic health information Development clinical decision support systems Exchange EHR data health documentation Enhancement privacy security electronic health information Inclusion common data elements CDEs) clinical terminologies improve interoperability EHR data research clinical care Support a common structure sharing clinical research data Integration EHR patient-originated data clinical research data Design monitoring clinical trial protocols Enhancement patient recruitment, enrollment, consent clinical trials Application Submission Information Submit applications this initiative using of following funding opportunity announcements FOAs) any reissues these announcement through expiration date this notice. Activity Code FOA First Available Due Date R43/R44 PA-19-272: PHS 2019-02 Omnibus Solicitation the NIH, CDC, FDA Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Allowed) September 5, 2019 R41/R42 PA-19-270: PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Allowed) September 5, 2019 R43/R44 PA-19-273: PHS 2019-02 Omnibus Solicitation the NIH Small Business Innovation Research Grant Applications Parent SBIR R43/R44] Clinical Trial Required) September 5, 2019 R41/R42 PA-19-271: PHS 2019-02 Omnibus Solicitation the NIH Small Business Technology Transfer Grant Applications Parent STTR R41/R42] Clinical Trial Required) September 5, 2019 R41/R42 R43/R44 PA-18-591: Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) September 5, 2019 Competing grant applications submitted response PA-19-270, PA-19-271, PA-19-272, PA-19-273: Applications be submitted due dates or after September 5, 2019 subsequent receipt dates through April 7, 2020. instructions the SF424 R&R) Application Guide and funding opportunity announcement used submission must followed, the following additions: funding consideration, applicants must include NOT-OD-19-127” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications nonresponsive the terms this notice the FOA used submission be withdrawn Non-competing administrative supplement applications submitted response PA-18-591: Applications be submitted September 5, 2019 through expiration date this notice, April 7, 2020. instructions the SF424 R&R) Application Guide and PA-18-591 must followed, the following additions: Applications due 5:00 PM local time applicant organization. process Streamlined Submissions using eRA Commons cannot used this initiative. funding consideration, applicants must include NOT-OD-19-127” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applicants strongly encouraged notify program contact the Institute supporting parent award a request been submitted response this FOA order facilitate efficient processing the request. 1] Section 4002(D)(iv) the 21st Century Cures Act (P.L. 114 – 255) 2] https://www.federalregister.gov/documents/2019/03/04/2019-02224/21st-ce… Inquiries Please direct inquiries to: Scientific/Research, Peer Review, Financial/Grants Management contacts Section VII the listed funding opportunity announcements.

This Funding Opportunity Announcement (FOA) invites applications to NIA's Small Business Innovation Research (SBIR) program to conduct research leading to the development of innovative products and/or services that may advance progress in preventing and treating Alzheimer's disease (AD) and Alzheimer's-disease-related dementias (ADRD) and/or caring for and treating AD/ADRD patients.

This Funding Opportunity Announcement (FOA) invites applications to NIA's Small Business Technology Transfer Research (STTR) program to conduct research leading to the development of innovative products and/or services that may advance progress in preventing and treating Alzheimer's disease (AD) and Alzheimer's-disease-related dementias (ADRD) and/or caring for and treating AD/ADRD patients.

The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the discovery and/or early evaluation of strong candidate biomarkers and biomarker signatures that can be used as tools to facilitate the clinical development of neurotherapeutics and their use in clinical practice. Specifically, the focus of this FOA is on the identification and initial biological, analytical and clinical evaluation of biomarkers and biomarker signatures for neurological and neuromuscular disorders. Although research supported by this FOA can include animal studies, it must also include preliminary human evaluation using carefully standardized human samples or datasets. The goal of this initiative is to deliver candidate biomarkers or biomarker signatures that are ready for definitive analytical and clinical validation studies.

The goal of this initiative is to elucidate the mechanistic links between blood brain barrier (BBB) dysfunction, Alzheimers disease (AD) and AD-related dementias (ADRD), and how related comorbidities impact the basic molecular mechanisms of BBB health and function.

This Funding Opportunity Announcement (FOA) solicits grant applications in two related but distinct areas. The first area is in the development and testing of novel tools and methods of neuromodulation that go beyond the existing forms of neural stimulation. The second distinct area that this FOA seeks to encourage is the optimization of existing stimulation methods.