Opportunity Information: Apply for PAR 16 331
Apply for PAR 16 331
- 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 Jun 15, 2016 and posted on Jun 15, 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 opportunity titled "Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01)" (Funding Opportunity Number PAR-16-331) is a cooperative agreement grant designed to move promising medical countermeasures closer to real-world use. The core purpose is to support the next stage of development for therapeutics that could treat or prevent injury after exposure to dangerous chemicals, whether those chemicals come from deliberate misuse (such as a terrorist attack involving chemical warfare agents) or from accidental industrial releases during manufacturing, storage, or transport. In practice, the program targets both classic chemical warfare agents and a broad set of toxic industrial chemicals and materials, reflecting the kinds of hazards that could plausibly affect civilian populations and emergency responders.
This FOA is not meant for early discovery or basic screening. To be eligible, applicants must already have a previously identified lead compound, either a small molecule or a biologic, that has cleared an initial bar for credibility and feasibility. The announcement defines a lead as a biologically active compound or hit for which affinity, potency, target selectivity, and preliminary safety have already been established. In other words, the project has to start with something that looks like a genuine therapeutic candidate, not just a hypothesis or an unvalidated hit from a high-throughput screen. The funding is aimed at optimization work that strengthens the candidate and reduces key risks that typically prevent leads from advancing into formal preclinical development.
The research scope is explicitly translational and is aligned with Technical Readiness Levels (TRLs) 4-5. That generally corresponds to moving from proof-of-concept into more rigorous validation in relevant systems, including demonstrating performance in models that better approximate how the therapy would be used in humans. A major component can involve developing or refining human-relevant animal models for the specific chemical threat and injury mechanism being addressed, then producing in vivo efficacy data that fits the intended clinical use case. That emphasis matters because chemical countermeasures often face unique constraints: exposures can be sudden, doses can vary, and the therapeutic may need to work under emergency conditions where treatment timing and route of administration are critical.
Beyond efficacy modeling, the FOA supports several practical development activities that are often required to make a candidate "development-ready." These include bioanalytical assay development and validation (so drug levels, biomarkers, and exposure-response relationships can be measured reliably), manufacturing work at both laboratory scale and scale-up levels (to ensure the product can be produced consistently enough for advanced studies), and non-GLP toxicity and pharmacology studies. The non-GLP framing signals that the work is intended to build a strong data package and de-risk the candidate before the more formal, regulated GLP toxicology stage, while still generating credible safety and pharmacology evidence that informs dose selection and development decisions.
Because this is a U01 cooperative agreement, NIH typically expects substantial programmatic involvement, meaning awardees should anticipate an active partnership with NIH staff rather than a purely investigator-directed research grant. A defining feature of the required project structure is the use of annual milestones that create clear go/no-go decision points. The intent is to force disciplined, progressive development: each year should produce discrete, decision-relevant outputs (for example, meeting predefined potency/selectivity targets, achieving exposure levels tied to efficacy in vivo, demonstrating acceptable tolerability in a defined study, establishing manufacturability benchmarks, or validating assays to agreed performance criteria). If those benchmarks are not met, the project can be redirected or stopped rather than continuing without a realistic path forward.
Eligibility is broad and includes many organization types that could reasonably carry out translational therapeutic development work. Eligible applicants include federal recognized tribal governments and tribal organizations, state and local governments, public and private institutions of higher education, nonprofits with or without 501(c)(3) status (with exclusions noted in the FOA text), public housing authorities/Indian housing authorities, for-profit organizations other than small businesses, and small businesses, among others. The sponsoring agency is the U.S. Department of Health and Human Services through NIH (listed as HHS-NIH11), and the activity area is categorized under environment and health, with CFDA numbers 93.113, 93.846, 93.853, and 93.867.
The opportunity was posted on June 15, 2016, with an original and current closing date of September 11, 2018, indicating this particular announcement cycle has passed. Still, the structure and expectations reflected here are typical of CounterACT translational development funding: applicants are expected to come in with a credible lead, then use a milestone-driven plan to optimize the therapeutic, validate its performance in relevant in vivo models, put supporting analytical and manufacturing capabilities in place, and produce the early safety/pharmacology evidence needed to justify later-stage regulated development.
Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The opportunity is titled "Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01)" under Funding Opportunity Number PAR-16-331.
What is the main purpose of PAR-16-331?
The purpose is to move promising medical countermeasures closer to real-world use by supporting the next stage of development for therapeutics that could treat or prevent injury after exposure to dangerous chemicals.
What kinds of chemical threats does the FOA cover?
The FOA targets classic chemical warfare agents as well as a broad range of toxic industrial chemicals and materials, including threats arising from deliberate misuse (such as terrorism) and accidental industrial releases during manufacturing, storage, or transport.
What type of NIH award mechanism is this?
This is a U01 cooperative agreement, which typically involves substantial NIH programmatic involvement and an active partnership with NIH staff.
How is a U01 cooperative agreement different from a standard research grant?
Based on the FOA description, a key difference is that NIH expects active involvement and that projects are structured around annual milestones with go/no-go decision points, rather than being purely investigator-directed without formal stop/redirect checkpoints.
Is this opportunity intended for early discovery or basic screening projects?
No. The FOA is not meant for early discovery or basic screening. Projects must start with a previously identified lead compound that already has preliminary supporting data.
What does the FOA mean by a "lead compound" for eligibility?
A lead is described as a biologically active compound or hit for which affinity, potency, target selectivity, and preliminary safety have already been established. The project must begin with something that resembles a genuine therapeutic candidate rather than an unvalidated screening hit or hypothesis.
What types of therapeutics are eligible as lead compounds?
The FOA allows previously identified lead compounds that are either small molecules or biologics.
What development stage is this FOA aiming to support?
The FOA is explicitly translational and aligned with Technical Readiness Levels (TRLs) 4-5, generally corresponding to moving from proof-of-concept into more rigorous validation in relevant systems.
What does TRL 4-5 imply for the kind of work expected?
TRL 4-5 implies strengthening and validating a candidate in more relevant systems, including demonstrating performance in models that better approximate intended human use and generating decision-quality data that reduces key development risks.
What are the main goals of the optimization work supported by this FOA?
The funding is aimed at optimization work that strengthens a therapeutic candidate and reduces key risks that commonly prevent leads from advancing into formal preclinical development.
Does the FOA support developing or refining animal models?
Yes. A major component can include developing or refining human-relevant animal models for the chemical threat and injury mechanism being addressed, and then producing in vivo efficacy data aligned to the intended clinical use case.
Why does the FOA emphasize human-relevant in vivo models and use cases?
The FOA notes that chemical exposures can be sudden, doses can vary, and countermeasures may need to work under emergency conditions where treatment timing and route of administration are critical. These constraints make it important to show efficacy in models that reflect realistic use conditions.
What kinds of efficacy data does the FOA expect?
The FOA emphasizes in vivo efficacy data generated in relevant models that approximate intended human use and address the specific chemical threat and injury mechanism of interest.
Does the FOA support bioanalytical assay development and validation?
Yes. The FOA supports developing and validating bioanalytical assays so that drug levels, biomarkers, and exposure-response relationships can be measured reliably.
Does the FOA include manufacturing activities?
Yes. The FOA supports manufacturing work at laboratory scale and scale-up levels to help ensure the product can be produced consistently enough for advanced studies.
What kinds of safety and pharmacology studies are supported?
The FOA supports non-GLP toxicity and pharmacology studies intended to build a strong data package and de-risk the candidate prior to later, more formal regulated GLP toxicology stages.
What does it mean that toxicity and pharmacology studies are "non-GLP" in this FOA?
It indicates the studies are intended to generate credible early safety and pharmacology evidence and inform dose selection and development decisions, but they are positioned before the more formal, regulated GLP toxicology stage.
How are projects managed under this cooperative agreement?
The FOA requires annual milestones that create clear go/no-go decision points. Each year is expected to produce discrete outputs that support decisions about whether to continue, redirect, or stop the project.
What are examples of milestones or go/no-go benchmarks mentioned in the FOA description?
Examples include meeting predefined potency and selectivity targets, achieving exposure levels tied to in vivo efficacy, demonstrating acceptable tolerability in a defined study, establishing manufacturability benchmarks, and validating assays to agreed performance criteria.
What happens if a project does not meet its milestones?
The FOA states that if benchmarks are not met, the project can be redirected or stopped rather than continuing without a realistic path forward.
Who is the sponsoring agency for this opportunity?
The sponsoring agency is the U.S. Department of Health and Human Services through NIH (listed as HHS-NIH11), under the NIH Countermeasures Against Chemical Threats (CounterACT) program.
What is the activity area/category listed for this opportunity?
The activity area is categorized under environment and health.
Which CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.113, 93.846, 93.853, and 93.867.
What organizations are eligible to apply?
Eligibility is broad and includes federal recognized tribal governments and tribal organizations, state and local governments, public and private institutions of higher education, nonprofits with or without 501(c)(3) status (with exclusions noted in the FOA text), public housing authorities/Indian housing authorities, for-profit organizations other than small businesses, and small businesses, among others.
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations other than small businesses, and also includes small businesses.
Are nonprofits eligible even if they do not have 501(c)(3) status?
Yes. The eligibility list includes nonprofits with or without 501(c)(3) status, with exclusions noted in the FOA text.
Are tribal governments and tribal organizations eligible to apply?
Yes. The eligibility list includes federally recognized tribal governments and tribal organizations.
When was this funding opportunity posted?
The opportunity was posted on June 15, 2016.
What was the closing date for this FOA?
The original and current closing date listed is September 11, 2018.
Is this specific announcement cycle still open?
No. Based on the listed closing date of September 11, 2018, this particular announcement cycle has passed.
What is the overall "typical" structure and expectation described for CounterACT translational development funding (as reflected here)?
Applicants are expected to start with a credible lead compound and execute a milestone-driven plan to optimize the therapeutic, validate performance in relevant in vivo models, put supporting analytical and manufacturing capabilities in place, and generate early safety/pharmacology evidence needed to justify later-stage regulated development.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 16 331) also looked into and applied for these:
| Funding Opportunity |
|---|
| 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 |
| NIH Revision Awards for Creating Virtual Consortium for Translational/Transdisciplinary Environmental Research (ViCTER)(R01) Apply for RFA ES 17 002 Funding Number: RFA ES 17 002 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Summer Research Experiences for Students and Science Teachers (Admin Supp) Apply for PA 17 055 Funding Number: PA 17 055 Agency: National Institutes of Health Category: Environment, Health Funding Amount: Case Dependent |
| Centers for Oceans and Human Health 3: Impacts of Climate Change on Oceans and Great Lakes (COHH3) (P01) Apply for RFA ES 16 009 Funding Number: RFA ES 16 009 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $900,000 |
| Environmental influences on Placental Origins of Development (ePOD) (R01) Apply for RFA ES 17 005 Funding Number: RFA ES 17 005 Agency: National Institutes of Health Category: Environment, Health Funding Amount: $400,000 |
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