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Analytical Validation of a Candidate Biomarker for Neurological or Neuromuscular Disorders(U01 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U01
PAR-21-056

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 (U01 Clinical Trial Optional)

PAR
Thursday, November 19, 2020
Friday, September 8, 2023
U01
PAR-21-058

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.

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
Khara Ramos

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.

Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Basic Experimental Studies with Humans Required)

PAR
Monday, November 9, 2020
Friday, December 29, 2023
R01
PAR-21-039

Funding Opportunity Purpose

The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Funding Opportunity Announcement (FOA) may not include preliminary data. 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. This Funding Opportunity Announcement is for basic science experimental studies involving humans, referred to in NOT-OD-18-212 as prospective basic science studies involving human participants. These studies fall within the NIH definition of a clinical trial and also meet the definition of basic research. Types of studies that should submit under this FOA include studies that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical or behavioral outcomes in humans for the purpose of understanding the fundamental aspects of phenomena without specific application towards processes or products in mind. Studies conducted with specific applications toward processes or products in mind should submit under the appropriate Clinical Trial Required or Clinical Trial Not Allowed" FOA

Stephen I. Katz Early Stage Investigator Research Project Grant (R01 Clinical Trial Not Allowed)

PAR
Monday, November 9, 2020
Friday, December 29, 2023
R01
PAR-21-038

Funding Opportunity Purpose

The Stephen I. Katz Early Stage Investigator Research Project Grant supports an innovative project that represents a change in research direction for an early stage investigator (ESI) and for which no preliminary data exist. Applications submitted to this Funding Opportunity Announcement (FOA) may not include preliminary data. 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. This Funding Opportunity Announcement does not accept applications proposing clinical trials.

Treatments for Lewy Body Dementias--Exploratory Clinical Trial (U01 Clinical Trial Required)

RFA
Wednesday, October 28, 2020
Wednesday, March 3, 2021
U01
RFA-NS-21-008
Debra Babcock

Funding Opportunity Purpose

This Funding Opportunity Announcement invites applications from experienced investigators seeking to conduct exploratory clinical trials designed to test new treatments for patients with Lewy Body Dementia (LBD). Applicants may propose to conduct either Phase I or Phase II clinical trials depending on the developmental stage of the potential therapeutic, but all trials must include patients with LBD. Proposed therapies may include novel medications or devices, or existing treatments that are potentially beneficial but not currently approved for use in patients with LBD. Treatments intended to prevent or delay disease progression in LBD patients, as well as therapies to alleviate existing motor or non-motor clinical symptoms, are of interest.

BRAIN Initiative Cell Census Network (BICCN) Scalable Technologies and Tools for Brain Cell Census (R01 Clinical Trial Not Allowed)

RFA
Wednesday, October 21, 2020
Friday, March 11, 2022
R01
RFA-MH-21-140

Funding Opportunity Purpose

Reissue of RFA-MH-19-148. This Funding Opportunity Announcement (FOA) intends to accelerate the integration and use of scalable technologies and tools to enhance brain cell census research, including the development of technology platforms and/or resources that will enable a swift and comprehensive survey of brain cell types and circuits. Applications are expected to address limitations and gaps of existing technologies/tools as a benchmark against which the improvements or competitive advantages of the proposed ones will be measured. The improvements include throughput, sensitivity, selectivity, scalability, spatiotemporal resolution and reproducibility in cell census analyses. The projects funded under this FOA will align with the overarching goals of the BRAIN Initiative Cell Census Network (BICCN) and are expected to enable the generation of a substantial amount of cell census data using the proposed technologies or via collaboration with the BICCN.

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
Eric M. Hudak

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.

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