Opportunity Information: Apply for PAR 16 128
Apply for PAR 16 128
- The HHS-NIH11 in the environment, health sector is offering a public funding opportunity titled "Countermeasures Against Chemical Threats (CounterACT): Optimization 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.)
- 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 NIH Countermeasures Against Chemical Threats (CounterACT) program is focused on building medical treatments that can prevent or reduce injury after exposure to dangerous chemicals. These chemical threats include both classic chemical warfare agents and toxic industrial chemicals that might be deliberately released during an attack or accidentally released during manufacturing, storage, or transportation. The goal of this particular opportunity is not basic discovery, but practical development work that moves a promising therapy closer to real-world use.
This funding opportunity, titled "Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01)" (PAR-16-128), supports projects that already have a lead therapeutic candidate and are ready to optimize it for development. To be eligible, applicants must start with a previously identified lead compound, either a small molecule or a biologic. In this context, a lead compound is not just an early screening hit; it is something with demonstrated biological activity where key fundamentals have already been established, including affinity, potency, target selectivity, and at least preliminary safety. In other words, the FOA is aimed at teams that have cleared the earliest scientific hurdles and are prepared to do the translational work needed to make the candidate more development-ready.
The activities supported under this FOA cover a set of mid-stage translational tasks commonly needed before a therapy can advance toward formal regulated development. A major emphasis is on generating in vivo evidence that matches how the product is intended to be used in people, which often requires building or refining animal models that are as human-relevant as possible for the chemical injury being addressed. Alongside efficacy work, the FOA also supports the kind of enabling infrastructure that therapeutic development depends on, such as development and validation of bioanalytical assays to measure the drug and relevant biomarkers. It further includes laboratory-scale manufacturing and scale-up efforts, recognizing that many promising leads fail when they cannot be produced consistently, at sufficient purity, or in forms suitable for dosing and testing.
Non-GLP toxicology and pharmacology studies are also within scope. These studies are meant to inform safety and dosing decisions and to identify potential liabilities early, even if they are not yet the formal GLP studies typically required for regulatory submissions. Overall, the FOA is framed around Technical Readiness Levels (TRLs) 4-5, meaning the work is expected to be beyond proof-of-concept and focused on validation and optimization in relevant systems, with increasing rigor and a clear line of sight toward later-stage development.
The award mechanism is a U01 cooperative agreement, which generally means NIH anticipates active involvement with the project beyond standard grant oversight. A defining requirement in this announcement is the use of annual milestones that function as clear go/no-go decision points. Applicants are expected to lay out a progressive translational plan where each year produces concrete deliverables that demonstrate whether the candidate is advancing appropriately or whether the project should be redirected or stopped. This milestone-driven structure is intended to keep projects focused on measurable development progress rather than open-ended research.
From an eligibility standpoint, the FOA is broadly open to many types of organizations, including federal-recognized tribal governments and tribal organizations, state and local governments, public and private universities, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and other entities as described in the full eligibility language. The opportunity is offered by HHS/NIH (listed as HHS-NIH11) under CFDA numbers 93.113, 93.846, 93.853, and 93.867. The original and current closing date listed in the source data is September 11, 2018, and the posting and creation date is March 10, 2016.
In practical terms, this FOA is meant for groups that can show they already have a credible therapeutic lead against a defined chemical threat and can execute the next development steps: optimizing the candidate, proving efficacy in relevant animal models, building the assays and manufacturing capabilities to support further testing, and collecting early safety and pharmacology data. The milestone and TRL framing signals that NIH is looking for disciplined, development-oriented projects that can make objective progress toward a usable medical countermeasure.
FAQs: NIH Countermeasures Against Chemical Threats (CounterACT) - Optimization of Therapeutic Lead Compounds (U01) (PAR-16-128)
What is the purpose of this funding opportunity?
This funding opportunity supports practical, development-focused work to move an existing therapeutic lead closer to real-world use as a medical countermeasure against dangerous chemical exposures. The emphasis is on optimization and validation activities rather than basic discovery.
Which program is sponsoring this opportunity?
The opportunity is part of NIH's Countermeasures Against Chemical Threats (CounterACT) program, which focuses on developing medical treatments that can prevent or reduce injury after exposure to harmful chemicals.
What is the title and mechanism of the award?
The FOA is titled "Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01)" (PAR-16-128). The award mechanism is a U01 cooperative agreement.
What does it mean that this is a U01 cooperative agreement?
A U01 cooperative agreement indicates that NIH anticipates active involvement in the project beyond standard grant oversight. The structure is designed to support development-oriented projects with defined deliverables and decision points.
Is this opportunity intended for basic research or discovery?
No. The stated goal is not basic discovery. It is aimed at translational, mid-stage development work that advances a promising therapy toward being development-ready for real-world application.
What kinds of chemical threats are covered?
The scope includes classic chemical warfare agents and toxic industrial chemicals. These may involve deliberate releases during an attack or accidental releases during manufacturing, storage, or transportation.
What stage of development should a project be in to fit this FOA?
The FOA is framed around Technical Readiness Levels (TRLs) 4-5. This generally means the work should be beyond proof-of-concept and focused on validation and optimization in relevant systems with increasing rigor and a clear path toward later-stage development.
Do applicants need to already have a lead therapeutic candidate?
Yes. Projects must start with a previously identified lead therapeutic candidate that is ready for optimization for development.
What types of lead candidates are eligible?
The lead candidate may be a small molecule or a biologic, as long as it meets the FOA's expectations for a true lead compound (not merely an early screening hit).
How does the FOA define a "lead compound" for eligibility purposes?
In this FOA, a lead compound is not an early screening hit. It must have demonstrated biological activity and have key fundamentals already established, including affinity, potency, target selectivity, and at least preliminary safety.
What are the main activities and project types supported?
The FOA supports mid-stage translational tasks needed to move a therapy toward formal development. Examples described include generating in vivo evidence aligned with intended human use, developing or refining human-relevant animal models for the chemical injury, developing and validating bioanalytical assays (including biomarkers), laboratory-scale manufacturing and scale-up, and non-GLP toxicology and pharmacology studies.
Is in vivo efficacy work part of the expected scope?
Yes. A major emphasis is on generating in vivo evidence that matches the intended use in people, which can include building or refining animal models that are as human-relevant as possible for the injury being addressed.
Does this FOA support development or refinement of animal models?
Yes. The opportunity explicitly notes that achieving human-relevant in vivo evidence often requires building or refining animal models appropriate to the chemical injury and intended use of the countermeasure.
Are bioanalytical assays and biomarker measurements within scope?
Yes. The FOA includes development and validation of bioanalytical assays to measure the drug and relevant biomarkers, recognizing these tools are enabling infrastructure for therapeutic development.
Is manufacturing or scale-up work allowed under this opportunity?
Yes. The FOA includes laboratory-scale manufacturing and scale-up efforts to support consistent production, purity, and suitable forms for dosing and testing.
Are GLP studies required under this FOA?
The described scope includes non-GLP toxicology and pharmacology studies. These are intended to inform safety and dosing decisions and identify potential liabilities early, even if they are not formal GLP studies typically required for regulatory submissions.
What is meant by "non-GLP" toxicology and pharmacology in this context?
Non-GLP studies in this FOA are early enabling studies used to guide safety and dosing and to surface potential problems before later regulated development steps. The FOA positions these as informative, early-stage studies rather than formal regulatory GLP packages.
How do milestones factor into the application and award?
A defining requirement is the use of annual milestones that act as clear go/no-go decision points. Applicants are expected to propose a progressive translational plan in which each year produces concrete deliverables showing whether the candidate is advancing appropriately or whether the project should be redirected or stopped.
Why does the FOA use a milestone-driven approach?
The milestone structure is intended to keep projects focused on measurable development progress rather than open-ended research, and to support objective decisions about continuation based on annual deliverables.
Who is eligible to apply?
The FOA is broadly open to many organization types, including federal-recognized tribal governments and tribal organizations, state and local governments, public and private universities, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and other entities as described in the full eligibility language.
Which agency is offering this opportunity?
The opportunity is offered by HHS/NIH (listed as HHS-NIH11).
What CFDA numbers are associated with this funding opportunity?
The CFDA numbers listed are 93.113, 93.846, 93.853, and 93.867.
What are the key dates included in the provided information?
The posting and creation date listed is March 10, 2016. The original and current closing date listed in the source data is September 11, 2018.
What kind of teams or applicants are a good fit for this FOA?
Based on the description, it is meant for groups that already have a credible therapeutic lead against a defined chemical threat and can execute development steps such as optimization, efficacy demonstration in relevant animal models, assay development, manufacturing scale-up, and early safety/pharmacology studies under a milestone-driven plan.
What are NIH's expectations regarding project outcomes?
The FOA emphasizes objective, measurable progress toward a usable medical countermeasure, including concrete annual deliverables and increasing rigor consistent with TRL 4-5 development activities.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 16 128) also looked into and applied for these:
| Funding Opportunity |
|---|
| Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01) Apply for PAR 16 129 Funding Number: PAR 16 129 Agency: HHS-NIH11 Category: Environment, Health Funding Amount: $300,000 |
| 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 |
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