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Regenerative Medicine Innovation Projects (RMIP) (U44 - Clinical Trial Not Allowed)

RFA
Wednesday, August 1, 2018
Saturday, October 20, 2018
U44
RFA-HL-18-035

Funding Opportunity Purpose

The National Institutes of Health (NIH), participating NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U44) applications to support small business research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.

Regenerative Medicine Innovation Projects (RMIP) (UT2 - Clinical Trial Not Allowed)

RFA
Wednesday, August 1, 2018
Saturday, October 20, 2018
UT2
RFA-HL-18-033

Funding Opportunity Purpose

The National Institutes of Health (NIH), participating NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (UT2) applications to support small business research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.

Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Clinical Trials (UG3/UH3 Clinical Trial Required)

RFA
Wednesday, August 1, 2018
Saturday, October 20, 2018
UG3/UH3
RFA-HL-18-031

Funding Opportunity Purpose

The National Institutes of Health (NIH), participating NIH Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite exploratory/developmental phased award cooperative agreement (UG3/UH3) applications to support investigator-initiated clinical trials (Phase I or later phase) aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that use RM products with demonstrated readiness to be advanced into clinical trials through appropriate product development and pre-clinical studies. Trials for which this FOA applies 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). This FOA utilizes a bi-phasic, milestone-driven cooperative agreement mechanism of award. This FOA seeks applications that present a strong scientific rationale for the clinical trial and a comprehensive scientific and operational plan. It is anticipated that applications will consist of plans for project management, subject recruitment and retention, performance milestones, scientific conduct of the trial, data sharing, and dissemination of results. Before the time of award and if applicable, successful applicants must obtain an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) application authorization or approval, respectively, to administer the product to humans. Due to the complex nature of conducting a clinical trial, applicants are strongly encouraged to contact the appropriate Scientific/Research contact prior to submitting an application. Staff will be able to assist applicants in meeting the objectives of this FOA.

Regenerative Medicine Innovation Projects (RMIP) Investigator-Initiated Studies (Collaborative U01 Clinical Trial Not Allowed)

RFA
Wednesday, August 1, 2018
Saturday, October 20, 2018
U01
RFA-HL-18-030

Funding Opportunity Purpose

The National Institutes of Health (NIH) participating Institutes and Centers, in coordination with the U.S. Food and Drug Administration, invite cooperative agreement (U01) applications to support investigator-initiated clinical research studies aimed at furthering the field of regenerative medicine (RM) using adult stem cells. These applications are expected to focus on innovative projects that propose solutions to widely recognized issues in the development of safe and effective RM therapies. Emphasis will be given to projects that address critical issues in product development relevant for regulatory submissions. Areas of focus may include improved tools, methods, standards, or applied science that support a better understanding and improved evaluation of in-depth product characterization, manufacturing, potency, identity, quality, safety, in vivo function and integration, or effectiveness. Toward these ends, the NIH will consider applications for late-stage preclinical research studies involving adult stem cells in the context of generating or supplementing the necessary evidence for clinical development, including, but not limited to, the submission of an Investigational New Drug (IND) or Investigational New Device Exemption (IDE) package; or to support such research conducted under an authorized IND or IDE.

BRAIN Initiative: Development Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research (SBIR) (R43/R44 - Clinical Trial Not Allowed)

PA
Tuesday, July 24, 2018
Friday, May 7, 2021
R43/R44
PA-18-871

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the Small Business Innovation Research (SBIR) program to advance the field of neuroscience research. This FOA specifically supports the development of novel neurotechnologies as well as the translation of technologies developed through the BRAIN initiative or through other funding programs, towards commercialization. Funding can support the iterative refinement of these tools and technologies with the end-user community, with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience research.

BRAIN Initiative: Development Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research (STTR) (R41/R42 - Clinical Trials Not Allowed)

PA
Tuesday, July 24, 2018
Friday, May 7, 2021
R41/R42
PA-18-870

Funding Opportunity Purpose

The purpose of this funding opportunity announcement (FOA) is to support the development of novel tools and technologies through the Small Business Technology Transfer (STTR) program to advance the field of neuroscience research. This FOA specifically supports the development of novel neurotechnologies as well as the translation of technologies developed through the BRAIN initiative or through other funding programs, towards commercialization. Funding can support the iterative refinement of these tools and technologies with the end-user community, with an end-goal of scaling manufacture towards reliable, broad, sustainable dissemination and incorporation into regular neuroscience practice.

BRAIN Initiative: Data Archives for the BRAIN Initiative (R24 Clinical Trial Optional)

RFA
Tuesday, July 17, 2018
Saturday, September 7, 2019
R24
RFA-MH-19-145

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications to develop web-accessible data archives to capture, store, and curate data related to BRAIN Initiative activities. The data archives will work with the research community to incorporate tools that allow users to analyze and visualize the data, but the creation of such tools is not part of this FOA. The data archives will use appropriate standards to describe the data, but the creation of such standards is not part of this FOA. A goal of this program is to advance research by creating a community resource data archive with appropriate standards and summary information that is broadly available and accessible to the research community for furthering research.

BRAIN Initiative: Integration and Analysis of BRAIN Initiative Data (R01 Clinical Trial Not Allowed)

RFA
Tuesday, July 17, 2018
Friday, March 5, 2021
R01
RFA-MH-19-147

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications to develop informatics tools for analyzing, visualizing, and integrating data related to the BRAIN Initiative or to enhance our understanding of the brain.

BRAIN Initiative: Standards to Define Experiments Related to the BRAIN Initiative (R01 Clinical Trial Not Allowed)

RFA
Tuesday, July 17, 2018
Saturday, September 7, 2019
R01
RFA-MH-19-146

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) solicits applications to develop standards that describe experimental protocols that are being conducted as part of the BRAIN Initiative.It is expected that applications will solicit community input at all stages of the process. It is recommended that the first step of standard development will involve sharing data between different key groups in the experimental community in order to ensure that the developing standard will cover the way that all of those groups are collecting data. The developed standard is expected to be made widely available.

Administrative Supplements to Promote Diversity in Small Businesses-SBIR/STTR (Admin Supp Clinical Trial Not Allowed)

PA
Wednesday, June 20, 2018
Sunday, September 5, 2021
333
PA-18-837

Funding Opportunity Purpose

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) hereby notify Small Business Concerns (SBCs) holding Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) grants that funds are available for administrative supplements to improve the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from groups that have been shown to be nationally underrepresented in health-related research or in the SBIR program. This supplement opportunity is also available to PD(s)/PI(s) of research grants who are or become disabled and need additional support to accommodate their disability in order to continue to work on the research project. Administrative supplements must support work within the scope of the original project. This Funding Opportunity Announcement (FOA) is designed specifically for applicants proposing research that does not involve leading an independent clinical trial, a clinical trial feasibility study, or an ancillary study to a clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

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