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NINDS Exploratory Clinical Trials for Small Business (R44) - Clinical Trial Required

PAR
Thursday, February 1, 2018
Clinical Trials Research
Wednesday, January 6, 2021
R44
PAR-18-618

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to provide a vehicle for Small Business Concerns (SBCs) submitting Small Business Innovation Research (SBIR) grant applications for investigator-initiated exploratory clinical trials to the National Institute of Neurological Disorders and Stroke (NINDS). The projects must focus on products related to the mission and goals of the NINDS and may evaluate drugs, biologics, devices, or diagnostics, as well as surgical, behavioral or rehabilitation therapies. Only SBIR Phase II and Fast-Track applications are supported under this program. SBIR Phase I applications are only accepted as part of a Fast-track application.

Change of Grantee Organization (Type 7 Parent Clinical Trial Optional)

PA
Friday, January 26, 2018
Clinical Trials Research
Tuesday, January 26, 2021
777
PA-18-590

Funding Opportunity Purpose

The National Institutes of Health (NIH) hereby notify grantee organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of grantee organization may be submitted in response to this FOA. This assumes such a change is programmatically permitted for the particular grant. Applications for change of grantee organization are considered prior approval requests (as described in Section 8.1.2.7 of the NIH Grants Policy Statement) and will be routed for consideration directly to the Grants Management Specialist named in the current award. Although requests for change of grantee organization may be submitted through this FOA, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission.

Successor-in-Interest (Type 6 Parent Clinical Trial Optional)

PA
Friday, January 26, 2018
Clinical Trials Research
Tuesday, January 26, 2021
666
PA-18-589

Funding Opportunity Purpose

The National Institutes of Health (NIH) hereby notify grantee organizations holding specific types of NIH grants, listed in the full Funding Opportunity Announcement (FOA), that applications for change of grantee organization status, often referred to in this announcement as Successor-In-Interest, may be submitted in response to this FOA. Applications for change of grantee organization status are considered prior approval requests (as described in Section 8.1.2.8 of the NIH Grants Policy Statement) and will be routed for consideration directly to the Grants Management Specialist named in the current award. Although successor-in-interest requests may be submitted through this FOA, there is no guarantee that an award will be transferred to the new organization. All applicants are encouraged to discuss potential requests with the awarding IC before submission.

Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp - Clinical Trial Optional)

PA
Thursday, January 25, 2018
Tuesday, January 26, 2021
333
PA-18-591

Funding Opportunity Purpose

The National Institutes of Health (NIH) hereby notify Program Directors/Principal Investigators (PD(s)/PI(s)) holding specific types of NIH research grants listed in the full Funding Opportunity Announcement (FOA) that funds may be available for administrative supplements to meet increased costs that are within the scope of the approved award, but were unforeseen when the new or renewal application or grant progress report for non-competing continuation support was submitted. Applications for administrative supplements are considered prior approval requests (as described in Section 8.1.2.11 of the NIH Grants Policy Statement) and will be routed directly to the Grants Management Officer of the parent award. Although requests for administrative supplements may be submitted through this FOA, there is no guarantee that funds are available from the awarding IC or for any specific grant. All applicants are encouraged to discuss potential requests with the awarding IC. Additionally, prior to submission, applicants must review the awarding IC's web site to ensure they meet the IC's requirements. A list of those web sites is available at https://grants.nih.gov/grants/guide/admin_supp/index.htm.

Research Supplements to Promote Re-Entry into Biomedical and Behavioral Research Careers (Admin Supp - Clinical Trial Not Allowed )

PA
Thursday, January 25, 2018
Wednesday, September 8, 2021
333
PA-18-592

Funding Opportunity Purpose

The Office of Research on Women's Health (ORWH) and participating Institutes and Centers (ICs) of the National Institutes of Health (NIH) announce the continuation of the program for administrative supplements to research grants to support individuals with high potential to re-enter an active research career after an interruption for family responsibilities or other qualifying circumstances. The purpose of these supplements is to encourage such individuals to re-enter research careers within the missions of all the program areas of NIH. This program will provide administrative supplements to existing NIH research grants for the purpose of supporting full-time or part-time research by these individuals to update their existing research skills and knowledge.

NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44 - Clinical Trials Optional)

PAR
Tuesday, January 9, 2018
Clinical Trials Research
Wednesday, January 6, 2021
U44
PAR-18-563

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) that propose exploratory and confirmatory clinical trials focused on promising interventions, as well as biomarker-or outcome measure validation studies that are immediately preparatory to trials in stroke prevention, treatment, and recovery. The program will utilize the cooperative agreement mechanism to enable milestone-drive projects. Successful applicants will collaborate and conduct the trial within the NIH StrokeNet. Following peer review, NINDS will prioritize trials among the highest scoring to be conducted in the NIH StrokeNet infrastructure. The NIH StrokeNet National Coordinating Center (NCC) will work with the successful applicant to implement the proposed study efficiently and the National Data Management Center (NDMC) will provide statistical and data management support. The NIH StrokeNet Regional Coordinating Centers (RCCs) and their affiliated clinical sites will provide recruitment/retention support as well as on-site implementation of the clinical protocol. The NIH StrokeNet network will also be uniquely poised to collaborate with other US and international consortia necessary to conduct larger, definitive trials of promising interventions for stroke treatment, prevention, and recovery.

Analytical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional)

PAR
Friday, December 22, 2017
Translational Research, Clinical Trials Research
Tuesday, September 8, 2020
U44
PAR-18-549

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support applications from Small Business Concerns (SBCs) to perform rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines. Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.

Clinical Validation of a Candidate Biomarker for Neurological Disease (U44 - Clinical Trial Optional)

PAR
Friday, December 22, 2017
Translational Research, Clinical Trials Research
Tuesday, September 8, 2020
U44
PAR-18-548

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is encourage applications from Small Business Concerns (SBCs) to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of neurological disease for use in multi-site clinical trials and clinical practice.

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

PAR
Thursday, December 21, 2017
Translational Research, Clinical Trials Research
Friday, May 8, 2020
U44
PAR-18-541

Funding Opportunity Purpose

The Blueprint Neurotherapeutics Network (BPN) encourages applications from small businesses seeking support to advance their small molecule drug discovery and development projects into the clinic. Participants in the BPN are responsible for conducting all studies that involve disease- or target-specific assays, models, and other research tools and receive funding for all activities to be conducted in their own laboratories. In addition, applicants will collaborate with NIH-funded consultants and can augment their project with NIH contract research organizations (CROs) that specialize in medicinal chemistry, pharmacokinetics, toxicology, formulations development, chemical synthesis including under Good Manufacturing Practices (GMP), and Phase I clinical testing. Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry, or at the Development stage, to advance a development candidate through Investigational New Drug (IND)-enabling toxicology studies and phase I clinical testing. Projects that enter at the Discovery stage and meet their milestones may continue on through Development. BPN awardee institutions retain their assignment of IP rights and gain assignment of IP rights from the BPN contractors (and thereby control the patent prosecution and licensing negotiations) for drug candidates developed in this program.

BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44 Clinical Trial Required)

RFA
Thursday, December 21, 2017
Translational Research, Clinical Trials Research
Thursday, October 22, 2020
U44
RFA-NS-18-022

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) to pursue translational non-clinical studies and clinical studies for recording and/or stimulating devices to treat nervous system disorders and thereby better understand the human brain. The program will utilize a cooperative agreement mechanism to support the non-clinical studies necessary for the submission of an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, and the subsequent small clinical trial (e.g., Early Feasibility Study). Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, and pursuit of regulatory approval for, and implementation of, a single small clinical trial. The small clinical trial should provide data to answer key questions about the function or final design of a device. This final device design may require most, if not all, of the non-clinical testing on the path to more advanced clinical trials and market approval. The clinical trial is expected to provide information that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.

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