DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: April 17, 2024

Department of Defense
Congressionally Directed Medical Research Programs (CDMRP)
Toxic Exposures Research Program
Anticipated Funding Opportunities for Fiscal Year 2024 (FY24)

The FY24 Defense Appropriations Act provides funding for the Toxic Exposures Research Program (TERP) to support high-impact toxic exposures research. The managing agent for the anticipated program announcements/funding opportunities is the CDMRP at the U.S. Army Medical Research and Development Command (USAMRDC).

The TERP is providing the information in this pre-announcement to allow investigators time to plan and develop ideas for submission to the anticipated FY24 funding opportunities. This pre-announcement should not be construed as an obligation by the government. The FY24 TERP funding opportunity announcements for the following award mechanisms will be posted on the Grants.gov website. Pre-application and application deadlines will be available when the announcements are released.

Applications submitted to the FY24 TERP must address one or more of the following Program Goals:

Program Goals are not listed in order of importance.

  1. Elucidate mechanisms of how military-related toxic exposures result in adverse effects, including but not limited to toxicities, malignancies, neurologic and respiratory disorders, cardiac complications, sleep disorders, immune system dysfunction, gastrointestinal issues, etc.
    • Understand the full range of effects from military-related environmental and toxic exposures, including by not limited to long-term illness such as Gulf War illness (GWI), cancers, cardiopulmonary and airway conditions, Parkinson's disease and other neurologic disorders, etc.
    • Evaluate the effects of epigenetic and genomic mechanisms on potential long-term and/or heritable outcomes.
    • Identify biological and/or psychosocial variables that can impact disease outcomes.
    • Identify risk factors/genetic predictors for various diseases/conditions that may occur as a result of toxic exposure.
    • Understand complex, multi-exposure/physiological or non-chemical stressors (e.g., hormonal, sleep disorders, thermal stress) combinations and how exposure impacts outcome.
    • Address the need for preclinical models that capture the adverse outcomes of human toxic exposures.

  2. Diagnose the effects of military-related toxic exposures, understand the phenotypic, pathological and clinical outcomes associated with short-term and long-term exposures, and predict disease progression.
    • Identify behavioral factors (smoking, substance abuse, etc.), comorbidities and preexisting medical conditions that may impact exposure outcomes.
    • Identify biomarkers of exposure to individual or multiple toxic substances alone or in combination with physiological/non-chemical stressors.
    • Develop diagnostic screens/assays/devices for toxic exposures.

  3. Predict and prevent military-related toxic exposures by identifying strategies that can anticipate, identify, monitor and prevent Service Members and the American public from adverse effects of exposures to toxic substances.
    • Develop assays/devices to identify military-related exposures across environments that lead to adverse health effects.
    • Develop personal monitoring devices to detect and characterize toxic exposures.
    • Advance exposure assessment methodologies, including but not limited to direct-reading, integrated measurements and machine learning.

  4. Develop therapeutics, treatments and strategies to minimize symptoms and disease progression associated with military-related toxic exposures.
    • Evaluate existing therapeutics, treatments and strategies.
    • Advance new therapeutics, treatments and strategies.

Applications submitted to the FY24 TERP must address at least one of the following Topic Areas.

Topic Areas are not listed in order of importance.

  1. Neurotoxin Exposure
  2. Gulf War Illness (GWI) and Its Treatment
  3. Airborne Hazards and Burn Pits
  4. Other Military Service-Related Toxic Exposures in General, Including Prophylactic Medications, Pesticides, Organophosphates, Toxic Industrial Chemicals, Materials, Metals and Minerals

Award Mechanism Eligibility Key Mechanism Elements Funding
Investigator-Initiated Research Award (IIRA) Independent intramural (DOD) and extramural investigators at all academic levels (or equivalent).

Pre-application submission is required; full application submission is by invitation only.

  • Supports studies that will make an important contribution toward research and/or patient care for a disease or condition associated with military-related toxic exposures.
  • Research projects may focus on any phase of research from basic laboratory research through translational research, including preclinical studies in animal models and human subjects, as well as correlative studies associated with an existing clinical trial. New Approach Methods may also be used.
  • Research involving human subjects and human anatomical substances is permitted; however, the IIRA may not be used to conduct clinical trials.
  • Must address at least one of the FY24 TERP Program Goals.
  • Must address at least one of the FY24 TERP Topic Areas.
  • Collaboration with military and/or VA researchers and clinicians is encouraged.
  • Preliminary Data are required. The rationale for a research idea may be derived from a laboratory discovery, population-based studies, a clinician's firsthand knowledge of patients, or anecdotal data. These data may be unpublished or from published literature.
  • Maximum funding of $500,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.
Translational Research Award (TRA) Initiating Investigator: Extramural and intramural (DOD) investigators at or above the level of Assistant Professor (or equivalent)

Partnering Principal Investigator (PI) Option:
Partnering extramural and/or intramural (DOD) investigators at or above the level of Assistant Professor (or equivalent)

Pre-application submission is required; full application submission is by invitation only.

  • Supports translational research that will accelerate the movement of promising ideas in military-related toxic exposure research into clinical applications including health care products, interventions, technologies, and/or clinical practice guidelines.
  • Research involving human subjects and human anatomical substances is permitted; however, the TRA may not be used to conduct clinical trials.
  • Must address at least one of the FY24 TERP Program Goals.
  • Must address at least one of the FY24 TERP Topic Areas.
  • Participation of at least one military or Veteran consumer as a member of the research team is strongly encouraged.
  • Collaboration with military and/or VA researchers and clinicians is encouraged.
  • Preliminary Data are required. Preliminary data must support the feasibility of the study. Any unpublished preliminary data provided should originate from the laboratory of the Principal Investigator (PI) or a member(s) of the research team.

      Partnering PI Option:

  • At least two and up to three PIs partner in one overarching study. This option supports interdisciplinary partnerships such as those between clinicians and research scientists that will accelerate the movement of promising ideas into clinical applications. Each PI is expected to bring distinct contributions to the application.
  • Maximum funding of $800,000 for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.

      Partnering PI Option:
  • Maximum funding of $1.6 million (M) for direct costs (plus indirect costs).
  • Maximum period of performance is 3 years.
Clinical Trial Award (CTA) Initiating Investigator: Extramural and intramural (DOD) investigators at or above the level of Assistant Professor (or equivalent).

Partnering Principal Investigator (PI) Option:
Partnering extramural and/or intramural (DOD) investigators at or above the level of Assistant Professor (or equivalent).

Pre-application submission is required; full application submission is by invitation only.

  • Supports the rapid implementation of clinical trials with the potential to have a significant impact on the prevention, treatment, or management of symptoms, diseases, or conditions associated with or resulting from military-related toxic exposures.
  • Proposed projects may range from small proof-of- concept clinical trials (e.g., pilot, first-in-human, phase 0) to demonstrate the feasibility or inform the design of more advanced trials through large- scale trials to determine efficacy in relevant patient populations.
  • Clinical trials may be designed to evaluate promising new products, pharmacologic agents (drugs or biologics), devices, clinical guidance, and/or emerging approaches and technologies.
  • Clinical trials are expected to be initiated within 12- 18 months of the award date.
  • Preclinical studies (including animal research) are not allowed.
  • Must address at least one of the FY24 TERP Program Goals.
  • Must address at least one of the FY24 TERP Topic Areas.
  • Participation of at least one military or Veteran consumer as a member of the research team is strongly encouraged.
  • Collaboration with military and/or VA researchers and clinicians is encouraged.
  • Inclusion of at least one clinician on the study team is strongly encouraged.
  • Preliminary data relevant to the proposed clinical trial are required. The proposed clinical trial must be based on a sound scientific rationale that is established through logical reasoning and critical review and analysis of the relevant literature.

      Partnering PI Option:

  • At least two and up to three PIs partner in one overarching study with each PI bringing distinct contributions to the project.
  • Maximum funding of $1.5M for direct costs (plus indirect costs).
  • Maximum period of performance is 4 years.

      Partnering PI Option:
  • Maximum funding of $2.5M for direct costs (plus indirect costs).
  • Maximum period of performance is 4 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 funding opportunity announcements that will be available for 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 funding opportunity announcements are released. For email notification when 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 TERP or other CDMRP-administered programs, please visit the CDMRP website (https://cdmrp.health.mil).


Point of Contact:

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


Last updated Wednesday, April 17, 2024