Opportunity Information: Apply for PAR 19 039
The National Institutes of Health (NIH) funding opportunity titled "Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-19-039) supports early-stage, translational research aimed at finding and validating therapeutic lead compounds that could eventually become medical countermeasures for dangerous chemical exposures. It is part of the NIH CounterACT program, whose broader mission is to accelerate the discovery and development of new and improved treatments for chemical threats that might be used deliberately (for example, in terrorism) or encountered through accidental industrial release during production, storage, or transport. The chemical threat landscape covered here is wide and includes classic chemical warfare agents, toxic industrial chemicals, pharmaceutical-based agents, and pesticides, reflecting real-world risks spanning both security and public health emergencies.
This announcement uses the cooperative agreement mechanism (U01), which generally means NIH staff will have substantial scientific and programmatic involvement during the life of the award, beyond what is typical for a standard research grant. The focus is specifically on identifying small-molecule drugs or biologic candidates that show enough promise to justify subsequent optimization and more advanced development. The work is positioned as "lead identification" rather than late-stage preclinical development or clinical evaluation, and clinical trials are explicitly not allowed under this FOA. The technical maturity expected aligns with Technical Readiness Levels (TRL) 1 through 3, meaning projects should concentrate on foundational discoveries and early proof-of-concept steps that set up a viable development path rather than deliver near-market products.
The scientific scope emphasizes the practical evidence needed to credibly nominate at least one lead compound for further optimization. Supported activities include confirming and strengthening the case for a molecular target that is appropriate for therapeutic intervention, demonstrating meaningful in vitro activity for candidate therapeutics, and generating preliminary in vivo proof-of-concept efficacy data where appropriate. Applicants are also expected to begin characterizing drug-like behavior and safety signals early, through preliminary ADME/Tox work (absorption, distribution, metabolism, excretion, and toxicity) and pharmacokinetics/pharmacodynamics (PK/PD) data. Taken together, these studies are meant to move a candidate beyond a simple "hit" and toward a bona fide lead that is biologically active, synthetically feasible, and supported by evidence for specificity, affinity, potency, target selectivity, efficacy, and an initial safety profile.
A key expectation is that each funded project will be managed like a staged translational program rather than an open-ended exploratory study. The FOA requires annual milestones that create clear, discrete go/no-go decision points. In practice, that means applicants need to lay out a progressive plan where each year has measurable criteria for success (for example, target engagement thresholds, in vitro potency benchmarks, exposure levels achieved in vivo, or minimum safety margins) and where failure to meet those criteria would logically trigger course correction or discontinuation. The intent is to keep projects tightly aligned with the goal of producing at least one lead compound that is ready for the next phase of development, potentially under a companion program focused on lead optimization (referenced in the FOA as "CounterACT Optimization of Therapeutic Lead Compound (U01)").
Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants include state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. It also includes public housing authorities/Indian housing authorities and federally recognized tribal governments, along with tribal organizations that are not federally recognized. The FOA further highlights eligibility for a range of mission- and community-focused institutions such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and certain regional organizations. U.S. territories and possessions are also included.
At the same time, the FOA draws firm boundaries around foreign participation. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, "foreign components" are permitted as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may be able to include specific foreign collaborations or activities when appropriately justified and structured under NIH policy.
From an administrative standpoint, the opportunity is listed as a discretionary grant program with a cooperative agreement funding instrument, and it falls under NIH-associated CFDA numbers 93.113, 93.279, 93.846, 93.853, and 93.867. The opportunity was created on 2018-10-26, and the original closing date shown in the source is 2021-09-14. The listed award ceiling is $300,000. While the expected number of awards is not specified in the provided source data, the overall design of the FOA suggests NIH is looking for well-structured, milestone-driven projects that can credibly deliver a development-ready lead compound within an early translational timeframe.
In plain terms, this FOA is best suited for teams that already have a strong starting point, such as a validated or highly plausible target and candidate molecules or biologics that can be advanced through a disciplined package of in vitro activity testing, early in vivo efficacy, and initial PK/PD plus ADME/Tox profiling. The end goal is not a finished drug, but a defensible lead candidate positioned for optimization and later-stage development programs that can carry it further toward an actual medical countermeasure for chemical exposure.Apply for PAR 19 039
- The National Institutes of Health in the education, environment, health sector is offering a public funding opportunity titled "Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.113, 93.279, 93.846, 93.853, 93.867.
- This funding opportunity was created on 2018-10-26.
- Applicants must submit their applications by 2021-09-14. (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.
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Frequently Asked Questions (FAQs)
What is the name of this NIH funding opportunity?
The funding opportunity is titled "Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01 Clinical Trial Not Allowed)" (Funding Opportunity Number PAR-19-039).
What is the main purpose of PAR-19-039?
The purpose is to support early-stage translational research to find, validate, and justify at least one therapeutic lead compound (small molecule or biologic) that could ultimately become a medical countermeasure for dangerous chemical exposures.
What program is this FOA part of?
This FOA is part of the NIH CounterACT program, which aims to accelerate discovery and development of treatments for chemical threats, whether from deliberate misuse (such as terrorism) or accidental industrial releases during production, storage, or transport.
What kinds of chemical threats are within scope?
The scope is broad and includes classic chemical warfare agents, toxic industrial chemicals, pharmaceutical-based agents, and pesticides. The intent is to reflect real-world security and public health risks.
What stage of research does this FOA support?
This FOA supports "lead identification" work, not late-stage preclinical development and not clinical evaluation. The expected maturity aligns with Technical Readiness Levels (TRL) 1 through 3, emphasizing foundational discoveries and early proof-of-concept activities.
Are clinical trials allowed under this FOA?
No. Clinical trials are explicitly not allowed under this FOA.
What funding mechanism is used, and what does it imply?
The FOA uses the cooperative agreement mechanism (U01). This generally means NIH staff will have substantial scientific and programmatic involvement during the award, beyond what is typical for a standard research grant.
What is the expected outcome by the end of the project?
The expected outcome is a defensible nomination of at least one lead compound that is ready for subsequent optimization and more advanced development. The goal is not a finished drug, but a lead candidate positioned for the next phase.
What types of therapeutics are expected (small molecules vs. biologics)?
The FOA supports identifying small-molecule drugs or biologic candidates that show enough promise to justify follow-on optimization.
What kinds of scientific activities are supported under this FOA?
Supported activities include: confirming and strengthening the rationale for a molecular target; demonstrating meaningful in vitro activity for candidate therapeutics; generating preliminary in vivo proof-of-concept efficacy data where appropriate; and starting early characterization of drug-like behavior and safety signals through preliminary ADME/Tox and PK/PD studies.
Does the FOA require target validation work?
Yes. The scientific scope emphasizes confirming and strengthening the case for a molecular target that is appropriate for therapeutic intervention.
Is in vitro activity data expected?
Yes. Applicants are expected to demonstrate meaningful in vitro activity for candidate therapeutics as part of the evidence package supporting lead nomination.
Is in vivo efficacy work required?
The FOA indicates that preliminary in vivo proof-of-concept efficacy data should be generated where appropriate. This suggests in vivo work may be expected when it is scientifically justified for the proposed therapeutic concept.
What early developability data does NIH expect (ADME/Tox, PK/PD)?
The FOA expects projects to begin characterizing drug-like behavior and safety signals early, including preliminary ADME/Tox (absorption, distribution, metabolism, excretion, and toxicity) and PK/PD (pharmacokinetics/pharmacodynamics) data.
What characteristics should a nominated lead compound demonstrate?
The FOA describes moving beyond a simple "hit" toward a lead that is biologically active, synthetically feasible, and supported by evidence for specificity, affinity, potency, target selectivity, efficacy, and an initial safety profile.
How milestone-driven are projects expected to be?
Projects are expected to be managed like staged translational programs rather than open-ended exploratory studies. The FOA requires annual milestones with clear, discrete go/no-go decision points.
What are "go/no-go" decision points in the context of this FOA?
They are measurable, pre-specified criteria that determine whether the project should proceed as planned, be corrected, or be discontinued. Examples referenced include target engagement thresholds, in vitro potency benchmarks, in vivo exposure levels, or minimum safety margins.
What happens if milestones are not met?
The FOA’s milestone approach implies that failure to meet annual criteria should trigger course correction or discontinuation, keeping the work tightly aligned to delivering a credible lead compound.
Is this FOA intended to produce a near-market product?
No. The FOA is positioned at an early translational stage (TRL 1-3) and aims to produce a development-ready lead candidate, not a near-market product.
Is there a follow-on program mentioned for later development?
Yes. The FOA references a companion program focused on lead optimization, described as "CounterACT Optimization of Therapeutic Lead Compound (U01)."
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based organizations and government entities, such as: state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments are eligible, and tribal organizations that are not federally recognized are also included in the eligibility description.
Are public housing authorities eligible?
Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.
Are U.S. territories and possessions eligible?
Yes. U.S. territories and possessions are included in the eligibility description.
Are minority-serving or community-focused institutions encouraged or included?
The FOA highlights eligibility for a range of mission- and community-focused institutions, including HBCUs, Hispanic-serving institutions, TCCUs, Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs, as well as faith-based or community-based organizations and certain regional organizations.
Can a non-U.S. (foreign) institution apply as the main applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply as the applicant organization.
Are non-domestic components of U.S. organizations eligible to apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply.
Are any foreign activities allowed at all?
Yes, foreign components are permitted as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign collaborations or activities when appropriately justified and structured under NIH policy.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $300,000.
Is the expected number of awards provided?
No. The provided source data does not specify the expected number of awards.
What is the funding instrument type?
The opportunity is described as a discretionary grant program using a cooperative agreement funding instrument (U01).
Which CFDA numbers are associated with this opportunity?
The FOA is associated with CFDA numbers 93.113, 93.279, 93.846, 93.853, and 93.867.
When was the opportunity created, and what closing date is shown?
The opportunity was created on 2018-10-26. The original closing date shown in the provided source is 2021-09-14.
What type of project team is this FOA best suited for?
It is best suited for teams that already have a strong starting point, such as a validated or highly plausible target and candidate molecules or biologics that can be advanced through a disciplined package of in vitro testing, early in vivo efficacy (where appropriate), and initial PK/PD plus ADME/Tox profiling.
What is the difference between a "hit" and a "lead" in the way this FOA frames the work?
In the framing used here, a "hit" is an early signal of activity, while a "lead" is a more defensible candidate supported by evidence of specificity, potency, selectivity, feasibility (including synthetic feasibility), efficacy signals, and an initial safety profile, making it ready for optimization.
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Applicants who have applied for this opportunity (PAR 19 039) also looked into and applied for these:
| Funding Opportunity |
|---|
| Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01 Clinical Trial Optional) Apply for PAR 19 040 Funding Number: PAR 19 040 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Promoting Research on Music and Health: Fundamentals and Applications (R21 Clinical Trials Optional) Apply for RFA NS 19 009 Funding Number: RFA NS 19 009 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Immuno-Oncology Translation Network (IOTN): Cancer Immunoprevention Research Projects (UG3/UH3) Apply for RFA CA 19 012 Funding Number: RFA CA 19 012 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $500,000 |
| Emerging Global Leader Award (K43 Independent Clinical Trial Required) Apply for PAR 19 051 Funding Number: PAR 19 051 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Research Project Grant (Parent R01 Clinical Trial Required) Apply for PA 19 055 Funding Number: PA 19 055 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Not Allowed) Apply for PA 19 053 Funding Number: PA 19 053 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
| NIH Exploratory/Developmental Research Grant Program (Parent R21 Clinical Trial Required) Apply for PA 19 054 Funding Number: PA 19 054 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
| NIH Small Research Grant Program (Parent R03 Clinical Trial Not Allowed) Apply for PA 19 052 Funding Number: PA 19 052 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $50,000 |
| NIH Research Project Grant (Parent R01 Basic Experimental Studies with Humans Required) Apply for PA 19 091 Funding Number: PA 19 091 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| NIH Exploratory/Developmental Research Grant Program (Parent R21 Basic Experimental Studies with Humans Required) Apply for PA 19 092 Funding Number: PA 19 092 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $200,000 |
| Midcareer Investigator Award in Patient-Oriented Research (Parent K24 - Independent Basic Experimental Studies with Humans Required) Apply for PA 19 088 Funding Number: PA 19 088 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Emerging Global Leader Award (K43 Independent Clinical Trial Not Allowed) Apply for PAR 19 098 Funding Number: PAR 19 098 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Required) Apply for PA 19 121 Funding Number: PA 19 121 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Midcareer Investigator Award in Patient-Oriented Research (Parent K24 Independent Clinical Trial Not Allowed) Apply for PA 19 122 Funding Number: PA 19 122 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Independent Scientist Award (Parent K02 - Independent Clinical Trial Required) Apply for PA 19 131 Funding Number: PA 19 131 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Independent Scientist Award (Parent K02 - Independent Clinical Trial Not Allowed) Apply for PA 19 132 Funding Number: PA 19 132 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| U.S.-China Program for Biomedical Collaborative Research (R01 Clinical Trial Optional) Apply for RFA CA 19 009 Funding Number: RFA CA 19 009 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $150,000 |
| Bioengineering Research Grants (BRG) (R01 Clinical Trial Not Allowed) Apply for PAR 19 158 Funding Number: PAR 19 158 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
| Summer Research Education Experience Program (Clinical Trials Not Allowed R25) Apply for PAR 19 164 Funding Number: PAR 19 164 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: $100,000 |
| Ruth L. Kirschstein National Research Service Award (NRSA) Individual Senior Fellowship (Parent F33) Apply for PA 19 187 Funding Number: PA 19 187 Agency: National Institutes of Health Category: Education, Environment, Health Funding Amount: Case Dependent |
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