The FY22 TERP funding opportunity announcements for the following award mechanisms are posted on the Grants.gov website. 

Applications submitted to the FY22 TERP must address one or more of the following Program Goals:

(not in order of importance)

1. Elucidate mechanisms of how 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. (list is not all inclusive).

• 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 genetic and epigenetic mechanisms and potential long-term and/or heritable outcomes.
• Identify biologic variables that can impact disease outcome including but not limited to sex, age, physical fitness or other modifiers.
• Identify risk factors/genetic predictors for various diseases/conditions that may occur as a result of toxic exposure.  
• Understand the role of inflammation and autoimmunity following toxic exposure and how it relates to disease/condition outcome and patient prognosis.
• Understand complex, multi-exposure combinations and how exposure impacts outcome.
• Address the need for pre-clinical models that capture the adverse outcomes of human toxic exposures.

2. Diagnose the effects of toxic exposures, understand the phenotypic/genotypic and clinical outcomes associated with short-term and long-term exposures and predict disease progression.
   • • Understand individual exposures and their links to individual disease outcomes.
     • Identify behavioral factors (smoking, substance abuse etc.), co-morbidities and pre-existing 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 or repetitive short-term exposures.

 

3. Predict and prevent 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 all military service-related exposures across all 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 toxic exposures.

• Evaluate existing treatments.
• Advance new treatments.

Applications submitted to the FY22 TERP must address one or more of the following Topic Areas:

(not in order of importance)

TOPIC AREA: Neurotoxin Exposure

Focus Areas (not in order of importance)

1. 1. 1. 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. Evaluation of complex exposures (e.g. multiple exposures over different timelines) is encouraged.
         2. Elucidate basic mechanisms of neurotoxicity/neurodegeneration resulting from toxic exposures.

• • • Understanding molecular mechanisms of neurotoxin exposures and associated disease progression to identify novel therapeutic targets is encouraged.
    • Exposures may include but are not limited to neurotoxins and prophylactic medications such as quinoline antimalarial drugs (e.g., mefloquine) and pyridostigmine bromide.
      3. Predict, prevent and assess neurotoxin exposures.

• • • Development of approaches to assess historical exposures are encouraged.
    • Identification of and tracking diverse exposures in military environments are encouraged.
    • Development of immediate post exposure therapeutics to prevent toxic effects are encouraged.
      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 applications focused on neurotoxin exposure will also be considered as long as they address a TERP Program Goal.

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

Focus Areas (not in order of importance)

1. Rapidly advance effective treatments for ill Gulf War (GW) Veterans with an emphasis on those treatment regimens that can be repurposed and are readily and clinically available.
   • • Treatment studies proposing clinical and confirmatory studies using objective biomarkers to demonstrate efficacy are encouraged.
     • Treatments that address symptoms and aim to improve quality of life and/or are individualized for patients are encouraged.
     • Clinical trials with a clear description of transition plan and path forward with FDA compliance to advance treatments are encouraged.
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.
   • • Mechanistic studies having clear implications for translational studies that are relevant to humans are encouraged.
     • Translational studies that have near term impacts on the ill GW Veteran populations are encouraged.
     • Mechanistic studies that consider the aging process and associated comorbidities are encouraged.

 

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 applications focused on GWI and its treatment will also be considered as long as they address a TERP Program Goal.

TOPIC AREA: Airborne Hazards and Burn Pits

Focus Areas (not in order of importance)

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. 

• Studies that focus on health outcomes of airborne/burn pit exposure on any/all bodily systems, including but not limited to respiratory, gastrointestinal, immune, neurologic and cardiac are encouraged.

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.

• Studies that address long-term health outcomes associated with burn pit and airborne hazard exposure including but not limited to cancers (associated mechanisms of carcinogenesis/tumorigenesis), chronic respiratory issues or other diseases/conditions/symptoms that may occur are encouraged.

5. Understand clinical phenotypes associated with burn pit and airborne hazard exposure and integrate with exposure assessment data.

• The use of big data and/or machine learning, including the linkage of multiple databases is encouraged.

6. Other applications focused on airborne hazards and burn pits will also be considered as long as they address 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 (not in order of importance)

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 associated with neurotoxicity or other adverse outcomes associated with exposure to prophylactic medications including but not limited to, quinoline antimalarial drugs (e.g., mefloquine), pyridostigmine bromide, and novel compounds.

 

4. Evaluate long-term effects of military toxicant exposures in exposed human populations, including Veterans.

 

5. Other applications focused on other Military Service-related toxic exposures will also be considered as long as they address a TERP Program Goal.

 

 

The list below includes areas of encouragement that are recommended but not required and may apply to all of the above “Other Military Service Related Toxic Exposures” Focus Areas:

• Studies that address toxicodynamics and toxicokinetics are encouraged.
• Approaches to differentiate occupational vs. non-occupational exposures are encouraged.
• Development of treatment and therapeutic strategies for constellations of acute and chronic effects of toxic exposures that will have a near term impact on Service members, Veterans and the American public are encouraged.
• Applications to this topic area are encouraged (but not required) to address one or more of the exposures listed below. Any proposed exposure must be relevant to Military Service Members, Veterans and/or the American public.

• Radiation and electromagnetic field (EMF) exposures in combination with other exposures
• Toxic/rare earth metals
• Other metals
• Plastics, plasticizers, microplastics, di(2- ethylhexyl) phthalate (DEHP) in plastics
• Toxic minerals, including asbestos
• Lipophilic toxicants, including legacy persistent organic pollutants
• Polycyclic aromatic hydrocarbons (PAHs)
• Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) including new generation PFAS (e.g., Gen X), legacy PFAS, or a combination of new and legacy PFAS together
• Particulate matter (PM)
• Prophylactic medications
• Pesticides, nerve agents, herbicides and insect repellants, including but not limited to organophosphates and carbamates
• Endocrine disrupting chemicals
• Fuels and other petroleum products

Funding Opportunities - FY22 Toxic Exposures Research Program, Congressionally Directed Medical Research Programs (CDMRP) (health.mil)

Investigator-Initiated Research Award (IIRA) – Letter of Intent due November 3, 2022

Independent intramural (DOD) and extramural investigators at all academic levels (or equivalent).

• Letter of Intent is required. An invitation to submit a full application is not required.
• Supports studies that will make an important contribution toward research and/or patient care for a disease or condition related to 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.
• Impact is an important aspect of the IIRA.
• Must address at least one of the FY22 TERP Program Goals.
• Must address at least one of the FY22 TERP Topic Areas.
• Collaboration with military or VA researchers and clinicians is encouraged.
• Preliminary data are required.
• Clinical trials are not allowed.

• The maximum allowable funding for the entire period of performance is $500,000 for direct costs.
• Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.
• The maximum period of performance is 3 years.

Translational Research Award (TRA) – Letter of Intent due November 3, 2022

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

• Supports translational research that will accelerate the movement of promising ideas in toxic exposure research into clinical applications including health care products, interventions, technologies, and/or clinical practice guidelines.

• Must address at least one of the FY22 TERP Program Goals.

• Must address at least one of the FY22 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 or VA researchers and clinicians is encouraged.

• Preliminary data are required.

• Clinical trials are not allowed.

• Letter of Intent is required; an invitation to submit full application is not required.

• Partnering PI Option: up to three Principal Investigators(PIs) partner in one overarching study.

The maximum allowable funding for the entire period of performance is $800,000 for direct costs.

• Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

• The maximum period of performance is 3 years. Partnering PI Option:

• The maximum allowable funding for the entire period of performance is $1,600,000 for direct costs.

• Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

• The maximum period of performance is 3 years.

Clinical Trial Award (CTA) – Letter of Intent due November 3, 2022

Extramural and intramural (DOD) investigators at or above the level of Assistant Professor (or equivalent). Partnering PI Option: Partnering extramural and/or intramural (DOD) investigator at or above 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 toxic exposures.

• Proposed projects may range from small proof-of-concept clinical trials (e.g., pilot, first-in-human, phase 0) to demonstrate feasibility or inform the design of more advance 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.

• Must address at least one of the FY22 TERP Program Goals.

• Must address at least one of the FY22 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 or VA researchers and clinicians is encouraged.’

• Preliminary data are required. • Preclinical research is not allowed.

• Letter of Intent is required; an invitation to submit full application is not required.

• Partnering PI Option: up to three Principal Investigators(PIs) partner in one overarching study.

The maximum allowable funding for the entire period of performance is $1,500,000 for direct costs. • Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

• The maximum period of performance is 4 years. Partnering PI Option:

• The maximum allowable funding for the entire period of performance is $2,500,000 for direct costs.

• Indirect costs may be proposed in accordance with the institution’s negotiated rate agreement.

• The 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 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.