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NeuroNEXT Small Business Innovation in Clinical Trials (U44 Clinical Trial Optional)

PAR
Wednesday, May 5, 2021
small business, Clinical Trials Research
Saturday, April 6, 2024
U44
PAR-21-224
Codrin Lungu

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages small business applications for exploratory clinical trials of investigational agents (drugs, biologics, surgical therapies or devices) that may contribute to the justification for and provide the data required for designing clinical studies. Diseases chosen for study should be based on the NINDS strategic plan and clinical research interests (www.ninds.nih.gov/funding/areas/index.htm). Successful applicants will be given access to the NeuroNEXT infrastructure. Following peer review, NINDS will prioritize and order trials that are given access to the NeuroNEXT infrastructure. The NeuroNEXT Clinical Coordinating Center (CCC) will work with the successful applicant to efficiently implement the proposed study. The NeuroNEXT Data Coordinating Center (DCC) will provide statistical and data management support. The NeuroNEXT clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. Applicants do not need to be part of the existing NeuroNEXT infrastructure.

Translational Neural Devices (U44 Clinical Trial Optional)

RFA
Wednesday, April 28, 2021
Wednesday, February 21, 2024
U44
RFA-NS-21-022

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to pursue translational activities and small clinical studies to advance the development of therapeutic and diagnostic devices for disorders that affect the nervous or neuromuscular systems. The translational device activities, including translational bench and animal studies, are expected to lead to submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) or Institutional Review Board (IRB) application for a Non-Significant Risk (NSR) study. This cooperative agreement will also support the subsequent small clinical study to collect safety and effectiveness data required to support a marketing application or to inform final device design.

Blueprint Neurotherapeutics Network (BPN): Biologic-based Drug Discovery and Development for Disorders of the Nervous System (U44 Clinical Trial Optional)

PAR
Friday, April 23, 2021
Saturday, April 6, 2024
U44
PAR-21-233
Ann-Marie Broome

Funding Opportunity Purpose

The Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) provides support for biologic-based therapeutic discovery and development, from lead optimization through phase I clinical testing. This Funding Opportunity Announcement (FOA) supports preclinical discovery and development of potential therapeutic Biotechnology Products and Biologics including, but not limited to, large biologic macromolecules, (e.g., proteins, antibodies, and peptides), gene-based therapies (i.e., oligonucleotide- and viral-based), cell therapies, and novel emerging therapies (e.g., microbial and microbiome therapies). Applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in manufacturing, scaling, pharmacokinetics, toxicology, and Phase I clinical testing. BPN-Biologics awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN-Biologics contractors (and thereby control the patent prosecution and licensing negotiations) for biotherapeutic candidates developed in this program.

Notice of Special Interest (NOSI): Availability of Funds to defray Childcare Costs for NCI, NIA, NIDCR, NIDDK, and NIH Blueprint Predoctoral to Postdoctoral Fellow Transition Programs F99 Awardees

Notice of Special Interest
Friday, April 23, 2021
Monday, January 8, 2024
333
NOT-CA-21-053

Funding Opportunity Purpose

NIH recognizes that the high cost of childcare impacts graduate students and post-doctoral researchers funded through NIH fellowships, and their ability to successfully complete their training and fully participate in the extramural research workforce. Therefore, this Notice announces that NCI, NHGRI, NIA, NIDCR, NIDDK, and NINDS (on behalf of the NIH Blueprint DSPAN) will defray childcare costs to recipients of Predoctoral to Postdoctoral Fellow Transition Award (F99/K00) programs during the F99 phase of the award.

Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp Clinical Trial Not Allowed)

Notice of Special Interest
Friday, April 23, 2021
Wednesday, June 2, 2021
333
NOT-NS-21-048

Funding Opportunity Purpose

The NIH Helping to End Addiction Long TermSM (HEAL) Initiative NIH aims to improve our understanding, management and treatment of pain by funding high quality scientific research in this relatively understudied area of medicine. For the HEAL Initiative and NIH to meet their long-term goals of providing effective non-opioid options for the treatment of pain conditions and innovative approaches for treating opioid use disorders, it will be necessary to train a new generation of clinical pain researchers. Leveraging HEAL Initiative clinical research programs to train novice researchers and investigators new to pain research in the mechanics, techniques, and best practices of clinical pain research will maximize the impact of HEAL funding for both current and future research endeavors. Increasing the number of individuals trained in high quality clinical pain research is a critical step toward ensuring the highest impact of HEAL, with studies that encompass a broad range of pain conditions and have the potential to include, address the needs of, and positively impact diverse and traditionally underserved patient populations.

Notice of Special Interest (NOSI): Administrative Supplements to Promote Diversity for NINDS Alzheimer's Disease and Alzheimer's Disease-Related Dementias (AD/ADRD) Awardees

Notice of Special Interest
Thursday, April 22, 2021
Sunday, March 31, 2024
333
NOT-NS-21-047

Funding Opportunity Purpose

The purpose of this NOSI is to encourage eligible NINDS awardees in the Alzheimers Disease and Alzheimers Disease-Related Dementias (AD/ADRD) research community to apply for administrative supplements in response to PA-21-071, "Research Supplements to Promote Diversity in Health-Related Research," or any reissues of this announcement through the expiration date of this Notice. The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-20-031 for details) and encourages institutions to diversify their student populations by enhancing the participation of individuals from groups that are underrepresented in the biomedical, clinical, behavioral, and social sciences. Goal 1 of The National Plan to Address Alzheimers Disease is to prevent and effectively treat AD/ADRD by 2025. This initiative addresses the critical need to increase the number of health professionals who are trained to meet the expanding demand for cognitive impairment and dementia diagnosis, care, and clinical research to meet Goal 1.

Notice of Special Interest (NOSI): Administrative Supplements to Support Collaborations to Improve the AI/ML-Readiness of NIH-Supported Data

Notice of Special Interest
Friday, April 16, 2021
Thursday, May 27, 2021
333
NOT-OD-21-094

Funding Opportunity Purpose

This Notice announces the availability of supplements to active grants which are intended to support collaborations that bring together expertise in biomedicine, data management, and artificial intelligence and machine learning (AI/ML) to make NIH-supported data useful and usable for AI/ML analytics. This initiative is aligned with the NIH Strategic Plan for Data Science, which describes actions aimed at modernizing the biomedical research data ecosystem and making data FAIR (Findable, Accessible, Interoperable, and Reusable) with high impact for open science. For the purposes of this Notice, AI/ML is inclusive of machine learning (ML), deep learning (DL), and neural networks (NN).

Notice of Special Interest (NOSI): Administrative Supplements for Workforce Development at the Interface of Information Sciences, Artificial Intelligence and Machine Learning (AI/ML), and Biomedical Sciences

Notice of Special Interest
Monday, April 12, 2021
Saturday, May 15, 2021
333
NOT-OD-21-079

Funding Opportunity Purpose

The NIH Office of Data Science Strategy announces the availability of funds for Administrative Supplements to institutions with NIGMS-funded training (T32, T34), institutional career development (K12), or certain research education program (R25, see eligibility below) awards. The funds will support the development and implementation of curricular or training activities at the interface of information science, artificial intelligence and machine learning (AI/ML), and biomedical sciences to develop the competencies and skills needed to make biomedical data FAIR (Findable, Accessible, Interoperable, and Reusable) and AI/ML-ready. For the purposes of this Notice, AI/ML is inclusive of machine learning (ML), deep learning (DL), and neural networks (NN). See https://www.go-fair.org/fair-principles/ for a fuller description of FAIR principles.

Notice of Special Interest (NOSI): Administrative Supplements to Support Enhancement of Software Tools for Open Science

Notice of Special Interest
Monday, April 5, 2021
Sunday, May 16, 2021
333
NOT-OD-21-091

Funding Opportunity Purpose

This Notice announces the reissue of administrative supplements to active awards that focus on biomedical software development or have a significant software development component. The goal of these supplements is to invest in research software tools with recognized value in a scientific community to enhance their impact by leveraging best practices in software development and advances in cloud computing. This initiative is part of a plan for implementing the NIH Strategic Plan for Data Science which describes actions aimed at modernizing the biomedical research data ecosystem and making data findable, accessible, interoperable, and reusable (FAIR) with high impact for open science. The supplements are intended to support collaborations between biomedical scientists and software engineers to enhance the design, implementation, and cloud-readiness of research software. Through these awards, the NIH Office of Data Science Strategy (ODSS) intends to help researchers who have developed scientifically valuable software to make tools sustainable, contribute to open science, and take advantage of new data science and computing paradigms.

Notice of Special Interest: Support for existing data repositories to align with FAIR and TRUST principles and evaluate usage, utility, and impact

Notice of Special Interest
Monday, April 5, 2021
Friday, May 21, 2021
333
NOT-OD-21-089

Funding Opportunity Purpose

The goal of this Notice of Special Interest (NOSI) is to strengthen NIH-funded biomedical data repositories to better enable data discoverability, interoperability, and reuse by aligning with the FAIR and TRUST principles and using metrics to measure their effectiveness. This NOSI provides an opportunity for existing repositories to increase FAIR-ness and TRUST-worthiness to improve their usage, utility, and impact throughout the data resource lifecycle.

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