February 6, 2023
PAR-23-089: Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 Clinical Trial Not Allowed)
PAR-22-089: Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
PAR-21-122: Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)
PAR-21-123: Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)
PAR-21-124: Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed)
PA-22-178: PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
PA-22-176: PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
National Institute of Neurological Disorders and Stroke (NINDS)
The purpose of this Notice of Special Interest (NOSI) is to announce that the National Institute of Neurological Disorders and Stroke (NINDS) encourages applications to advance research activities relevant to strategic priorities for the ALS research community identified in a recent planning effort of NINDS.
Background
In 2022, the NINDS conducted a comprehensive and multifaceted process through a Working Group of the National Advisory Neurological Disorders and Stroke Council (NANDSC) to establish strategic priorities for the ALS research community. Comprised of scientists, clinicians, advocates, people living with ALS, pre-manifest ALS gene mutation carriers, and caregivers, the Working Group identified priorities for accelerating research on the biology behind ALS, translating fundamental research into potential ALS therapies, optimizing ALS clinical research, optimizing the quality of life of persons living with ALS and caregivers, and identifying opportunities for collaborations and partnerships. These strategic priorities were endorsed by the NANDSC in February 2023. NINDS is interested in responding in a timely manner to these strategic priorities, including coordination and harmonization of clinical research data and identification and development of novel therapeutics.
The objective of this NOTICE is to advance research activities relevant to several of the strategic priorities:
Data Harmonization, Curation, and Analysis: This priority encourages the establishment of multi-modal data platforms of multi-dimensional and longitudinally collected clinical data to advance understanding of the molecular pathobiology of all forms of ALS, inform therapeutic development, and optimize clinical trials. This should include efforts to aggregate and harmonize available datasets and define standards for future data collections that will promote open data sharing, and ensure diversity, equity and inclusion in clinical ALS research.
Development of Biomarkers and Biomarker Signatures to Optimize Clinical Trials and Clinical Care Decisions: This priority encourages the development of biomarkers or biomarker signatures that will enable earlier diagnosis, patient stratification, and more efficient clinical trials to advance therapeutic development or be used in clinical practice to help guide clinical care decisions. This should include efforts to standardize collection methods and storage of materials for future biosample repositories.
Therapy Development for ALS: This priority encourages the advancement of therapy development for ALS. Exploratory and early-stage therapy development activities are supported, including 1) assay development and therapeutic agent identification for ALS, 2) development and validation of translationally relevant animal models and human/animal tissue ex vivo systems to support future ALS therapy development, and 3) ALS therapeutic agent characterization and in vivo efficacy studies. SBIR/STTR applicants may also pursue late-stage pre-clinical activities such as Investigational New Drug (IND)-enabling studies.
NINDS strives for rigor and transparency in all research it funds. For this reason, NINDS emphasizes the NIH application instructions related to rigor and transparency (https://grants.nih.gov/policy/reproducibility/guidance.htm) and provides additional guidance to the scientific community (https://www.ninds.nih.gov/Funding/grant_policy). Data provided to support the biological rationale of proposed experiments must be rigorous and robust, and proposed experiments should be designed in a manner that minimizes the risk of bias and ensures the validity of experimental results.
Program Directors/Principal Investigators planning to submit applications are strongly encouraged to contact NINDS scientific program staff when developing their projects.
Application and Submission Information
This notice applies to due dates on or after March 14, 2023, and subsequent receipt dates through June 24, 2024.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcements through the expiration date of this notice.
- PAR-23-089: Data Harmonization, Curation and Secondary Analysis of Existing Clinical Datasets (R61/R33 Clinical Trial Not Allowed)
- PAR-22-089: Development of Biomarkers or Biomarker Signatures for Neurological and Neuromuscular Disorders (R61/R33 Clinical Trial Optional)
- PAR-21-122: Neurotherapeutic Agent Characterization and In vivo Efficacy Studies (R61/R33 Clinical Trial Not Allowed)
- PAR-21-123: Development and Validation of Model Systems to Facilitate Neurotherapeutic Discovery (R61/R33 Clinical Trial Not Allowed)
- PAR-21-124: Assay Development and Neurotherapeutic Agent Identification (R61/R33 Clinical Trial Not Allowed)
- PA-22-178: PHS 2022-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)
- PA-22-176: PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed)
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
For funding consideration, applicants must include “NOT-NS-23-062” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.
Scientific/Research Contact(s)
Amelie Gubitz, PhD
Telephone: 301-332-6453
Email: [email protected]
Peer Review Contact(s)
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Financial/Grants Management Contact(s)
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]
and Human Services (HHS)
