Opportunity Information: Apply for PAR 16 129
Apply for PAR 16 129
- The HHS-NIH11 in the environment, health sector is offering a public funding opportunity titled "Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.846, 93.853, 93.867.
- This funding opportunity was created on Mar 10, 2016 and posted on Mar 10, 2016.
- Applicants must submit their applications by Sep 11, 2018. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $300,000.00 in funding.
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For profit organizations other than small businesses, Small businesses, Others (see text field entitled Additional Information on Eligibility for clarification).
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Opportunity Summary:
The Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01) opportunity (PAR-16-129) is a National Institutes of Health (NIH) funding announcement under HHS-NIH that supports early translational research aimed at finding promising treatments for injuries caused by hazardous chemical exposures. The broader CounterACT mission is focused on developing new and improved medical countermeasures that can either treat or prevent harm from chemical threats, including both classic chemical warfare agents and toxic industrial chemicals that might be released intentionally (for example, during a terrorist event) or unintentionally through accidents in manufacturing, storage, or transportation.
This award uses the Cooperative Agreement (U01) mechanism, meaning the funded work is not purely investigator-driven in the way a standard grant might be; it is designed for projects where NIH expects substantial scientific involvement and coordination as the research progresses. The central purpose is to move candidate therapies to a point where at least one strong "lead compound" has been identified and is ready to enter more advanced development. The FOA is specifically oriented toward identifying either small-molecule drugs or biologic candidates that have credible potential to become real-world therapeutics for chemical-injury indications.
The scientific scope covers the key steps needed to justify a candidate as a true lead rather than just an interesting hit. Projects are expected to confirm and validate the molecular target or mechanism that the therapeutic is intended to act on, demonstrate meaningful in vitro activity (showing the candidate does what it is supposed to do in relevant cell-based or biochemical assays), and generate preliminary in vivo proof-of-concept efficacy data (early animal or other living-system evidence that the approach can reduce injury, improve survival, or otherwise provide benefit in a relevant exposure model). In addition, applicants are expected to begin characterizing how the candidate behaves as a drug by providing early ADME/Tox information (absorption, distribution, metabolism, excretion, and toxicity) along with initial pharmacokinetics and pharmacodynamics (PK/PD) data. In practical terms, this means the program is not simply looking for discovery biology; it is looking for evidence that a candidate is plausibly deliverable, active at realistic exposures, and not obviously unsafe at the stage appropriate for lead identification.
A major required outcome is the selection of at least one lead compound that is both biologically active and synthetically feasible, with key properties already established. The FOA describes lead compounds as those for which specificity, affinity, potency, target selectivity, efficacy, and safety have been sufficiently demonstrated to justify advancement. The intent is that successful projects hand off a validated lead into more intensive optimization and development, potentially through a companion CounterACT program focused on optimization of therapeutic lead compounds. In other words, this announcement is positioned as the front end of a pipeline: it is meant to produce a well-supported lead candidate that is ready for the next stage rather than funding the full downstream development pathway within the same project.
From a development framework perspective, the FOA aligns with Technical Readiness Level (TRL) 3, which corresponds to early proof-of-concept stages where experimental evidence supports feasibility but the technology or therapeutic is not yet near clinical readiness. Consistent with that translational emphasis, each project must include annual milestones that function as clear go/no-go decision points. Those milestones are meant to keep the work on a disciplined trajectory, forcing periodic, evidence-based decisions about whether a candidate is meeting predefined criteria for advancement, should be modified, or should be discontinued in favor of better options. This milestone structure is also consistent with the cooperative agreement model, where NIH program staff may engage with investigators to ensure progress stays aligned with program goals.
Eligibility is broad and includes many types of organizations that could contribute to countermeasure development, such as public and private institutions of higher education, federal and non-federal tribal entities and tribal organizations, state and local governments, special districts, independent school districts, nonprofits (with or without 501(c)(3) status), public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), and small businesses, with additional eligibility details referenced in the FOA text. The activity category is listed under Environment and Health, and associated CFDA numbers include 93.113, 93.846, 93.853, and 93.867. The award ceiling is listed as $300,000, and the original and current closing date shown in the provided source is September 11, 2018 (indicating this specific posting is historical, though the summary describes what the opportunity supported).
Overall, this FOA is best understood as a focused, milestone-driven translational funding mechanism intended to bridge the gap between early discovery and later-stage product development for medical countermeasures. It prioritizes projects that can convincingly validate targets, demonstrate activity in relevant experimental systems, generate early efficacy and drug-like property data, and deliver at least one defensible therapeutic lead that is ready to be optimized and advanced through subsequent development programs.
Frequently Asked Questions (FAQs)
What is the CounterACT: Identification of Therapeutic Lead Compounds (U01) opportunity (PAR-16-129)?
PAR-16-129 is a National Institutes of Health (NIH) funding announcement under HHS-NIH within the Countermeasures Against Chemical Threats (CounterACT) program. It supports early translational research aimed at finding promising treatments for injuries caused by hazardous chemical exposures.
What is the overall mission of the CounterACT program?
The broader CounterACT mission is to develop new and improved medical countermeasures that can treat or prevent harm from chemical threats. This includes classic chemical warfare agents and toxic industrial chemicals that may be released intentionally (for example, during a terrorist event) or unintentionally through accidents in manufacturing, storage, or transportation.
What type of funding mechanism is used for this opportunity?
This opportunity uses the Cooperative Agreement (U01) mechanism. Under a U01, the funded work is not purely investigator-driven in the way a standard grant might be; it is designed for projects where NIH expects substantial scientific involvement and coordination as the research progresses.
What is the central purpose of this FOA?
The central purpose is to move candidate therapies to a point where at least one strong lead compound has been identified and is ready to enter more advanced development.
What kinds of therapeutic candidates does this FOA support?
The FOA is specifically oriented toward identifying either small-molecule drugs or biologic candidates that have credible potential to become real-world therapeutics for chemical-injury indications.
What stage of research is this FOA designed to support?
This FOA supports early translational research focused on lead identification. It is intended to bridge the gap between early discovery and later-stage product development by producing a well-supported lead candidate suitable for the next development stage.
How does the FOA define the difference between a "hit" and a "lead compound"?
Based on the description, the FOA is not focused on producing only an interesting hit. Projects are expected to generate the evidence needed to justify a candidate as a true lead, including target/mechanism validation, meaningful in vitro activity, preliminary in vivo proof-of-concept efficacy, and early drug-like property data (such as ADME/Tox and PK/PD).
What scientific activities are expected to support lead identification?
The scope includes confirming and validating the molecular target or mechanism, demonstrating meaningful in vitro activity, generating preliminary in vivo proof-of-concept efficacy data, and beginning to characterize drug-like behavior through early ADME/Tox and initial PK/PD information.
What does "confirm and validate the molecular target or mechanism" mean in the context of this FOA?
Projects are expected to show that the therapeutic is acting on a defined target or mechanism and that this target/mechanism is relevant to the chemical-injury indication being addressed, as part of establishing a credible foundation for lead selection.
What in vitro evidence is expected?
Applicants are expected to demonstrate meaningful in vitro activity, showing that the candidate does what it is intended to do in relevant cell-based or biochemical assays.
What in vivo evidence is expected?
Projects are expected to generate preliminary in vivo proof-of-concept efficacy data, meaning early evidence in animals or other living systems that the approach can reduce injury, improve survival, or otherwise provide benefit in a relevant exposure model.
What is meant by early ADME/Tox information?
Early ADME/Tox refers to initial information on absorption, distribution, metabolism, excretion, and toxicity. The FOA expects applicants to begin characterizing these properties to support the plausibility of the candidate as a deliverable and not obviously unsafe therapeutic at the lead-identification stage.
What is meant by PK/PD data in this FOA?
PK/PD refers to pharmacokinetics and pharmacodynamics. The FOA expects initial PK/PD information to help show how the candidate behaves in a biological system and whether its activity is consistent with realistic exposure and therapeutic use.
What is a major required outcome of the project?
A major required outcome is the selection of at least one lead compound that is both biologically active and synthetically feasible, with key properties already established.
What properties should a lead compound demonstrate under this FOA?
The FOA describes lead compounds as those for which specificity, affinity, potency, target selectivity, efficacy, and safety have been sufficiently demonstrated to justify advancement.
Is the program intended to fund full downstream development of the therapeutic?
No. This announcement is positioned as the front end of a pipeline. It is meant to produce a defensible lead candidate ready for the next stage, rather than funding the full downstream development pathway within the same project.
What happens after a lead compound is identified?
The intent is that successful projects hand off a validated lead into more intensive optimization and development, potentially through a companion CounterACT program focused on optimization of therapeutic lead compounds.
How does this FOA relate to Technical Readiness Levels (TRLs)?
The FOA aligns with Technical Readiness Level (TRL) 3, which corresponds to early proof-of-concept stages where experimental evidence supports feasibility but the therapeutic is not yet near clinical readiness.
Are milestones required?
Yes. Each project must include annual milestones that function as clear go/no-go decision points.
What is the purpose of the annual go/no-go milestones?
The milestones are intended to keep the work on a disciplined trajectory by requiring periodic, evidence-based decisions about whether a candidate is meeting predefined criteria for advancement, should be modified, or should be discontinued in favor of better options.
How do milestones relate to the cooperative agreement (U01) structure?
The milestone structure is consistent with the U01 cooperative agreement model, where NIH program staff may engage with investigators to ensure progress stays aligned with program goals.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education, federal and non-federal tribal entities and tribal organizations, state and local governments, special districts, independent school districts, nonprofits (with or without 501(c)(3) status), public housing authorities/Indian housing authorities, for-profit organizations (other than small businesses), and small businesses. Additional eligibility details are referenced in the FOA text.
What is the activity category associated with this funding opportunity?
The activity category is listed under Environment and Health.
What CFDA numbers are associated with this opportunity?
Associated CFDA numbers include 93.113, 93.846, 93.853, and 93.867.
What is the maximum award amount listed for this opportunity?
The award ceiling is listed as $300,000.
What is the closing date shown for this opportunity?
The original and current closing date shown in the provided source is September 11, 2018, indicating this specific posting is historical.
Does the historical closing date change what the FOA summary describes?
No. The closing date indicates the specific posting is historical, while the summary describes what the opportunity supported: milestone-driven early translational work to identify and justify at least one therapeutic lead compound for chemical threat indications.
What types of chemical threats are within scope?
The scope includes chemical warfare agents and toxic industrial chemicals that could be released intentionally or unintentionally through accidents involving manufacturing, storage, or transportation.
What is the program prioritizing when evaluating whether a candidate is a plausible therapeutic lead?
Based on the description, the program prioritizes evidence that the candidate is plausibly deliverable, active at realistic exposures, and not obviously unsafe at the stage appropriate for lead identification, supported by target/mechanism validation, in vitro activity, preliminary in vivo efficacy, and early ADME/Tox and PK/PD data.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 16 129) also looked into and applied for these:
| Funding Opportunity |
|---|
| Mechanism for Time-Sensitive Opportunity in Environmental Health Sciences (R21) Apply for RFA ES 16 005 Funding Number: RFA ES 16 005 Agency: HHS-NIH11 Category: Environment, Health Funding Amount: $200,000 |
| Collaborative Activities to Expedite Environmental Health Science Research, Translation, and Community Engagement Across EHS Core Centers (Admin Supp) Apply for PA 16 327 Funding Number: PA 16 327 Agency: HHS-NIH11 Category: Environment, Health Funding Amount: $100,000 |
| Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54) Apply for PAR 16 329 Funding Number: PAR 16 329 Agency: HHS-NIH11 Category: Environment, Health Funding Amount: $2,500,000 |
| Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01) Apply for PAR 16 331 Funding Number: PAR 16 331 Agency: HHS-NIH11 Category: Environment, Health Funding Amount: Case Dependent |
| Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01) Apply for PAR 16 330 Funding Number: PAR 16 330 Agency: HHS-NIH11 Category: Environment, Health Funding Amount: $300,000 |
| NIH Big Data to Knowledge (BD2K) Enhancing Diversity in Biomedical Data Science (R25) Apply for RFA MD 16 002 Funding Number: RFA MD 16 002 Agency: Department of Health and Human Services, National Institutes of Health Category: Environment, Health Funding Amount: $300,000 |
| Collaborative Activities to Expedite Environmental Health Science Research, Translation, and Community Engagement Across EHS Core Centers (Admin Supp) Apply for PA 17 317 Funding Number: PA 17 317 Agency: Department of Health and Human Services, National Institutes of Health Category: Environment, Health Funding Amount: $100,000 |
| Immuno-Oncology Translation Network (IOTN): Cancer Immunoprevention Research Projects (U01) Apply for RFA CA 17 046 Funding Number: RFA CA 17 046 Agency: Department of Health and Human Services, National Institutes of Health Category: Environment, Health Funding Amount: $500,000 |
| Collaborative Activities to Expedite Environmental Health Science Research, Translation, and Community Engagement Across EHS Core Centers (Admin Supp - Clinical Trial Not Allowed) Apply for PA 18 770 Funding Number: PA 18 770 Agency: Department of Health and Human Services, National Institutes of Health Category: Environment, Health Funding Amount: $100,000 |
| Functional RNA Modifications Environment and Disease (FRAMED) (R21 Clinical Trial Not Allowed) Apply for RFA ES 19 002 Funding Number: RFA ES 19 002 Agency: Department of Health and Human Services, National Institutes of Health Category: Environment, Health Funding Amount: $150,000 |
| Functional RNA Modifications Environment and Disease (FRAMED) (R01 Clinical Trial Not Allowed) Apply for RFA ES 19 001 Funding Number: RFA ES 19 001 Agency: Department of Health and Human Services, National Institutes of Health Category: Environment, Health Funding Amount: $250,000 |
| NIEHS Research Intensive Short Courses and Educational Opportunities (NIEHS RISE) (R25 Clinical Trial Not Allowed) Apply for RFA ES 20 015 Funding Number: RFA ES 20 015 Agency: Department of Health and Human Services, National Institutes of Health Category: Environment, Health Funding Amount: $200,000 |
| Alumni Engagement Innovation Fund 2022 Apply for PAS JOR FY22 003 Funding Number: PAS JOR FY22 003 Agency: Department of State, U.S. Mission to Jordan Category: Environment, Health Funding Amount: $40,000 |
| SBIR E-learning for HAZMAT and Emergency Response (R43/R44) Apply for RFA ES 16 006 Funding Number: RFA ES 16 006 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| The Preconception Exposure Window and Health of the Offspring (R01) Apply for RFA ES 16 007 Funding Number: RFA ES 16 007 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $300,000 |
| Transition to Independent Environmental Health Research (TIEHR) Career Transition Award (K01) Apply for PAR 16 360 Funding Number: PAR 16 360 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Revolutionizing Innovative, Visionary Environmental health Research (RIVER) (R35) Apply for RFA ES 16 008 Funding Number: RFA ES 16 008 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $750,000 |
| Environmental Health Cohorts Maintenance and Infrastructure (R24) Apply for RFA ES 16 004 Funding Number: RFA ES 16 004 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $250,000 |
| Novel Methods for Obtaining Molecular Information from Archived Tissue Samples (R43/R44) Apply for RFA ES 16 012 Funding Number: RFA ES 16 012 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Powering Research through Innovative Methods for mixtures in Epidemiology (PRIME) (R01) Apply for RFA ES 17 001 Funding Number: RFA ES 17 001 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $350,000 |
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