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Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U44
PAR-21-057

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable analytical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of analytical methods for biomarker measurements, including evaluation of the detection method, its performance characteristics, and the optimal conditions that will generate reproducibility and accuracy consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed, and 3) the research and/or clinical need and potential context of use has been identified.

Clinical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders (U44 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U44
PAR-21-059

Funding Opportunity Purpose

The purpose of this Program Announcement (PAR) is to enable clinical validation of strong candidate biomarkers for neurological diseases and conditions. Specifically, the goal of this PAR is to enable the rigorous validation of biomarker measurements within the clinical population of interest to establish the positive and negative predictive values of the candidate biomarker consistent with FDA guidelines. This PAR assumes that 1) a candidate biomarker has already been identified, 2) detection method technology has already been developed and analytically validated, and 3) the research and/or clinical need and potential context of use has been identified.

Notice of Special Interest: Administrative Supplement for Research and Capacity Building Efforts Related to Bioethical Issues (Admin Supp Clinical Trial Optional)

Notice of Special Interest
Tuesday, November 17, 2020
Friday, March 5, 2021
333
NOT-OD-21-020

Funding Opportunity Purpose

The NIH Office of Science Policy (OSP) within the Office of the Director (OD) announces the availability of administrative supplements to support 1) research on bioethical issues to develop or support the development of an evidence base that may inform future policy directions, and/or 2) certain efforts to develop or augment bioethics research capacity. Applicants may propose to supplement parent awards focused on bioethics or to add a component related to bioethics to a parent award in which bioethics was not the focus. Note that applications must be within the general scope of the parent award.

Research Supplements to Promote Diversity in Health-Related Research (Admin Supp Clinical Trial Not Allowed)

PA
Monday, November 16, 2020
Monday, May 8, 2023
333
PA-21-071

Funding Opportunity Purpose

The National Institutes of Health (NIH) and the Centers for Disease Control and Prevention hereby notify Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) holding specific types of research grants (activity codes listed above) that funds are available for administrative supplements to enhance the diversity of the research workforce by recruiting and supporting students, postdoctorates, and eligible investigators from diverse backgrounds, including those from groups that have been shown to be underrepresented in health-related research. 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 clinical trial. Applicants to this FOA are permitted to propose research experience in a clinical trial led by a mentor or co-mentor.

Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)

Notice of Special Interest
Monday, October 19, 2020
Thursday, May 16, 2024
333
NOT-NS-20-107

Funding Opportunity Purpose

This Notice encourages eligible awardees in the HEAL Initiative community to apply for administrative supplements in response to PA-20-222, Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed). The NIH has a strong interest in the diversity of the NIH-funded workforce (see NOT-OD-20-031) and encourages institutions to diversify their populations by enhancing the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral, and social sciences.

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

PA
Tuesday, October 13, 2020
Tuesday, October 24, 2023
333
PA-20-272

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.

Notice of Special Interest: Administrative Supplements for Connecting Pre-mortem Clinical Information with Post-Mortem Brain Analysis

Notice of Special Interest
Wednesday, August 26, 2020
Tuesday, June 29, 2021
333
NOT-NS-21-001

Funding Opportunity Purpose

The Lewy Body Dementias (LBD) are frequently misdiagnosed or underdiagnosed during life, and despite the development of diagnostic criteria at multiple expert consensus conferences, the gold standard for diagnosis remains post-mortem brain analysis. Improvement in diagnostic accuracy during life, and the development of good quality diagnostic biomarkers, would be greatly facilitated if comprehensive, longitudinal clinical and biological data obtained on patients during life were regularly linked with detailed post-mortem brain examination. In response to recommendations from the Alzheimer's Disease Related Dementias (ADRD) Summits convened by the NINDS in 2013, 2016, and 2019, longitudinal clinical data and biospecimens are being collected from patients with LBD and shared with the research community through the Parkinsons Disease Biomarker Program (PDBP). The PDBP is an NINDS-funded resource that collects standardized clinical data and biospecimens longitudinally on patients with Parkinson's Disease (PD) and PD-related disorders (including LBD) with the goal of accelerating the pace of biomarkers research. The PDBP currently has data and biospecimens on about 1900 subjects, some of whom have gone to autopsy, though relatively little post-mortem data on these subjects is available in PDBP at this time. This NOSI encourages researchers with extensive pre- and post-mortem data on patients with LBD to apply for supplemental funds to be used for the purpose of adding this data to the existing NINDSPDBP repository. Supplements may be requested by: Researchers who have previously contributed clinical and biospecimen data to the PDBP on patients with LBD while alive, and who wish to add the post-mortem autopsy data they have collected on the same patient(s) after their death.

PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

PA
Tuesday, July 14, 2020
Tuesday, April 6, 2021
R41/R42
PA-20-265

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH) invites eligible United States small business concerns (SBCs) to submit Small Business Technology Transfer (STTR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH awarding components identified in this FOA are encouraged to submit STTR grant applications in response to identified topics (see PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. This Parent Funding Opportunity Announcement does not accept clinical trials.

PHS 2020-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)

PA
Tuesday, July 14, 2020
Tuesday, April 6, 2021
R43/R44
PA-20-260

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA), issued by the National Institutes of Health (NIH), the Centers for Disease Control and Prevention (CDC), and the Food and Drug Administration (FDA), invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications. United States SBCs that have the research capabilities and technological expertise to contribute to the R and D mission(s) of the NIH, CDC, and FDA awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics (see PHS 2019-2 SBIR/STTR Program Descriptions and Research Topics for NIH, CDC, and FDA. This Parent Funding Opportunity Announcement does not accept clinical trials.

SBIR/STTR Commercialization Readiness Pilot (CRP) Program Technical Assistance and Late Stage Development (SB1 Clinical Trial Required)

PAR
Friday, July 10, 2020
Wednesday, April 6, 2022
SB1
PAR-20-130

Funding Opportunity Purpose

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. This Funding Opportunity Announcement requires that at least 1 clinical trial be proposed. The proposed project must be related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) based on their scientific missions.

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