DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: December 22, 2020

Defense Health Program
Department of Defense Amyotrophic Lateral Sclerosis Research Program
Anticipated Funding Opportunities for Fiscal Year 2021 (FY21)

The Fiscal Year 2021 (FY21) Defense Appropriations Bill has not been signed into law. Although FY21 funds have not been appropriated for the Department of Defense Amyotrophic Lateral Sclerosis Research Program (ALSRP), the ALSRP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY21 funding opportunities. This pre-announcement should not be construed as an obligation by the Government.

The FY21 Defense Appropriations Act is anticipated to provide $40M to the Department of Defense ALSRP to support innovative and high-impact research into the development of effective treatments for Amyotrophic Lateral Sclerosis. As directed by the Office of the Assistant Secretary of Defense for Health Affairs, the Defense Health Agency J9, Research and Development Directorate manages the Defense Health Program (DHP) Research, Development, Test, and Evaluation (RDT&E) appropriation. The managing agent for the anticipated Program Announcements/Funding Opportunities is the Congressionally Directed Medical Research Programs (CDMRP) at the U.S. Army Medical Research and Development Command (USAMRDC).

Subject to the FY21 Congressional appropriation for ALSRP funding, FY21 ALSRP Program Announcements and General Application Instructions for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the Program Announcements are released.

Award Mechanism Eligibility Key Mechanism Elements Funding
Therapeutic Development Award Independent investigators at all academic levels (or equivalent)
  • Supports secondary preclinical validation and IND-enabling studies of therapeutics for ALS.
  • Preliminary data are required, including efficacy of a lead molecule/class of compounds in at least one ALS-relevant model system.
  • Biomarker development and/or characterization, in parallel to the main therapeutic effort, is a critical component of the TDA.
  • Submission of a pre-application is required; full application submission is by invitation only.
  • Maximum funding of $1,000,000 for direct costs plus indirect costs.
  • Maximum period of performance is years.
Therapeutic Idea Award Independent investigators at all academic levels (or equivalent)
  • Supports hypothesis-driven preclinical therapeutic development.
  • Projects focusing primarily on investigating ALS pathophysiology are outside the scope of this award mechanism.
  • Preliminary data are not required.
  • Early Career Investigators are encouraged to apply.
  • Biomarker Option: Applications that include development of biomarkers in parallel to the main therapeutic effort, and that meet criteria outlined in the Funding Opportunity Announcement, will qualify for a higher level of funding.
  • Submission of a pre-application is required; full application submission is by invitation only.
  • Maximum funding of $500,000 for direct costs plus indirect costs.
  • Maximum funding of $600,000 for direct costs plus indirect costs if applying for the Biomarker Option.
  • Maximum period of performance is years.
Clinical Development Award Independent investigators at all academic levels (or equivalent)
  • Supports correlative clinical research and leveraging of human-based ALS resources.
  • Types of efforts that will be supported include:
    • Using human subject-based resources to better define subtypes, predict therapeutic response, or assess prognosis;
    • Correlating clinical trial-related biosamples, imaging, or epidemiological data with clinical outcomes;
    • Adding a biomarker companion or observational aim to an anticipated/ongoing clinical trial;
    • Observational studies to optimize components of current ALS clinical care such as respiratory care strategies, use of approved devices, or specific symptom management strategies and assistive technologies.
  • Early Career Investigators and/or Early Career Physician Scientists are encouraged to apply.
  • Submission of a pre-application is required; full application submission is by invitation only.
  • Maximum funding of $500,000 for direct costs plus indirect costs.
  • Maximum period of performance is years.
NEW! Therapeutic/Biomarker Pilot Trial Award Independent investigators at or above the level of Assistant Professor (or equivalent)
  • Supports exploratory clinical trials to demonstrate feasibility or inform the design of more advanced trials for the treatment or management of ALS.
  • Must support a clinical trial and may not be used for preclinical research studies.
  • Preliminary data are required.
  • Biomarkers must be incorporated into the trial design. Biomarkers may measure target engagement, drug pharmacodynamics, and/or be predictive/cohort-selective.
  • Submission of a pre-application is required; full application submission is by invitation only.
  • Maximum funding of $2,000,000 for direct costs plus indirect costs.
  • Maximum period of performance is years.

A pre-application is required and must be submitted through the electronic Biomedical Research Application Portal (eBRAP) at https://eBRAP.org prior to the pre-application deadline. All applications must conform to the final Program Announcements and General Application Instructions that will be available for electronic downloading from the Grants.gov website. The application package containing the required forms for each award mechanism will also be found on Grants.gov. A listing of all CDMRP and other USAMRDC extramural funding opportunities can be obtained on the Grants.gov website by performing a basic search using CFDA Number 12.420.  

Submission deadlines are not available until the Program Announcements are released. For email notification when Program Announcements are released, subscribe to program-specific news and updates under “Email Subscriptions” on the eBRAP homepage at https://eBRAP.org. For more information about the ALSRP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.army.mil).

Point of Contact:

CDMRP Public Affairs
301-619-9783
usarmy.detrick.medcom-cdmrp.mbx.cdmrp-public-affairs@mail.mil


Last updated Tuesday, December 22, 2020