DEPARTMENT OF DEFENSE - CONGRESSIONALLY DIRECTED MEDICAL RESEARCH PROGRAMS

NEWS RELEASE

Released: May 17, 2023

Department of Defense
Congressionally Directed Medical Research Programs (CDMRP)
Toxic Exposures Research Program
Anticipated Funding Opportunities for Fiscal Year 2023 (FY23)

The FY23 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 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 FY23 funding opportunities. This pre-announcement should not be construed as an obligation by the government.

The FY23 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 FY23 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 progression from acute toxicity to long-term illness (including but not limited to Gulf War Illness (GWI), cancers, respiratory conditions, Parkinson’s disease, and other neurologic disorders, etc.).
    • Evaluate epigenetic and genomic mechanisms and potential long-term and/or heritable outcomes.
    • Identify biological and/or psychosocial variables that can impact disease outcome.
    • Identify risk factors/genetic predictors for various diseases/conditions that may occur as a result of toxic exposure.
    • Understand complex, multi-exposure 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.
    • Understand individual or mixture exposures and their links to individual disease outcomes.
    • Identify behavioral factors (smoking, substance abuse, etc.), comorbidities and preexisting medical conditions that may impact exposure outcomes.
    • Develop diagnostic screens/assays for short-term and persistent/chronic toxic exposures (e.g., biomarkers).
    • Predict long-term effects from single, intermittent, mixture, or repetitive short-term 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.
    • Identify military service-related exposures across environments that lead to adverse health effects.
    • Advance exposure assessment methodologies, including but not limited to direct-reading and integrated measurements.

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

Applications submitted to the FY23 TERP must address at least one of the following Topic Areas. Addressing at least one of the FY23 Focus Areas is encouraged however, applications may propose “Other” research outside of the listed Focus Areas as long as at least one Program Goal and at least one Topic Area are addressed.

Neither Topic Area nor Focus Area are listed in order of importance.

TOPIC AREA: Neurotoxin Exposure

Focus Areas

  1. Understand the relationship between toxic exposures and long-term neurologic disorders including, but not limited to, Parkinson’s disease, Alzheimer’s disease, or other neurologic disease phenotypes.
  2. Elucidate basic mechanisms of neurotoxicity/neurodegeneration resulting from toxic exposures.
  3. Predict, assess, and prevent neurotoxin exposures.
  4. Develop innovative treatments for people outside of the short-term therapeutic window following neurotoxin exposure.
  5. Identify clinical signs and symptoms or biomarkers of chronic low-level neurotoxin exposures in order to provide effective therapeutics before permanent damage occurs.
  6. Understand the relationship between neurotoxin exposures and concurrent and/or comorbid neurological and psychological disorders.
  7. Other research focused on neurotoxin exposure that addresses a TERP Program Goal.

TOPIC AREA: Gulf War Illness (GWI) and Its Treatment

Focus Areas

  1. Rapidly advance effective treatments for ill Gulf War Veterans with an emphasis on those treatment regimens that can be repurposed and are readily and clinically available.
  2. Identify and validate objective biomarkers for the diagnosis and monitoring of GWI and its progression and/or for assessing treatment efficacy.
  3. Evaluate the pathological and molecular mechanisms associated with GWI.
  4. Evaluate non-pharmacologic treatments (e.g., therapies/programs/services) that will significantly benefit the quality of life for the GWI patient community.
  5. Other research focused on GWI and its treatment that addresses a TERP Program Goal.

TOPIC AREA: Airborne Hazards and Burn Pits

Focus Areas

  1. Develop noninvasive diagnostic screening, tests, and assays that can differentiate among respiratory diseases/conditions.
  2. Improve exposure assessment methodologies to detect and understand respiratory exposures, associated risk of exposures, and potential outcomes.
  3. Identify toxicants associated with airborne hazards and elucidate mechanisms of associated effects on human health.
  4. Determine long-term outcomes of toxic exposures associated with burn pits and other militarily relevant airborne hazards, focusing on longitudinal studies of Service Members and Veterans.
  5. Understand clinical phenotypes associated with burn pit and airborne hazard exposure and integrate with exposure assessment data.
  6. Other research focused on airborne hazards and burn pits that addresses a TERP Program Goal.

TOPIC AREA: Other Military Service-Related Toxic Exposures in General, Including Prophylactic Medications, Pesticides, Organophosphates, Toxic Industrial Chemicals, Materials, Metals, and Minerals

Focus Areas

  1. Understand the effects, impacts and outcomes of various timescale exposures (short-term, sub-chronic, and chronic) and complex exposures (repeated and mixtures) as they pertain to multiple human biologic systems and pathways.
  2. Elucidate mechanisms associated with direct (irritant) and systemic effects of exposure to chemicals, metals, materials, and minerals.
  3. Investigate mechanisms of adverse outcomes associated with exposure to novel compounds and/or prophylactic medications including, but not limited to, quinoline antimalarial drugs (e.g., mefloquine), and pyridostigmine bromide.
  4. Evaluate long-term effects of military toxicant exposures in exposed human populations, including Veterans.
  5. Other research focused on other military Service-related toxic exposures that addresses a TERP Program Goal.


Award Mechanism Eligibility Key Mechanism Elements Funding
Investigator-Initiated Research Award (IIRA) Independent intramural (DOD) and extramural investigators at all academic levels (or equivalent).
  • 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 FY23 TERP Program Goals.
  • Must address at least one of the FY23 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.
  • Letter of Intent is required. An invitation to submit a full application is not required.
  • 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)

  • 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 FY23 TERP Program Goals
  • Must address at least one of the FY23 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.
  • Letter of Intent is required. An invitation to submit a full application is not required.

      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).

  • 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 FY23 TERP Program Goals
  • Must address at least one of the FY23 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.
  • Letter of Intent is required. An invitation to submit a full application is not required.

      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) 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. 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, May 17, 2023