Opportunity Information: Apply for PAR 16 330
Apply for PAR 16 330
- 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 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.)
- 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 NIH Countermeasures Against Chemical Threats (CounterACT) program grant opportunity "Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01)" (PAR-16-330) supports early translational research aimed at finding promising therapeutic leads that could eventually become medical countermeasures for people exposed to dangerous chemicals. The public health need behind this program is straightforward: chemical threats can come from deliberate terrorist use of chemical warfare agents or from accidental industrial releases during manufacturing, storage, or transport. These threats include classic warfare agents as well as toxic industrial chemicals and materials, and the goal is to build a pipeline of treatments that can prevent or reduce injury after exposure.
This FOA uses the U01 cooperative agreement mechanism, which means NIH staff will typically have substantial scientific involvement compared with a standard research grant. The work being funded is positioned at an early but clearly translational point in the development pathway. The announcement frames its scope around Technical Readiness Level (TRL) 3, essentially focusing on proof-of-concept and early validation activities that move a therapeutic idea from basic discovery toward a development-ready lead. Rather than funding broad exploratory biology, the emphasis is on producing at least one well-supported lead compound that is ready for the next stage of optimization.
The research activities expected under this opportunity cover the practical steps needed to argue that a candidate small molecule or biologic has real potential as a treatment. Projects should confirm and validate the relevant molecular target(s) for therapeutic development, then demonstrate that candidate therapeutics show meaningful activity in vitro. Applicants are also expected to generate preliminary in vivo proof-of-concept efficacy evidence, showing that the approach can work in an appropriate animal model or other relevant in vivo system. On top of efficacy, the FOA expects early developability data: preliminary ADME/Tox evaluations (absorption, distribution, metabolism, excretion, and toxicity) along with pharmacokinetics and pharmacodynamics (PK/PD). The intent is to avoid advancing compounds that look interesting in a dish but fail basic feasibility or safety screens, and to ensure that lead selection is grounded in measurable exposure-response relationships.
A key deliverable is the identification of at least one lead compound that is ready for optimization. In the language of the FOA, a lead is not just any active hit; it should be biologically active and synthetically feasible, with evidence supporting specificity, affinity, potency, target selectivity, efficacy, and safety. In other words, by the end of the project the investigators should be able to point to a compound (or biologic) that has cleared a defined bar across mechanism, performance, and early risk factors, making it a credible candidate for medicinal chemistry or biologic engineering optimization.
The FOA also makes the development pathway explicit by pointing to a companion program for the next step: "CounterACT Optimization of Therapeutic Lead Compound (U01)" (PAR-16-331). This indicates NIH is looking for projects that fit into a staged pipeline, where this award supports lead identification and de-risking, and subsequent support (potentially through the companion FOA or other programs) could push the lead through optimization and more advanced preclinical development.
Milestone-driven management is another central feature. Each project must include annual milestones that function as discrete go/no-go decision points. That requirement pushes applicants to propose a progressive, decision-based plan with clear criteria for success and termination, rather than an open-ended research agenda. Practically, that means defining measurable endpoints (for example, target engagement thresholds, minimum efficacy in vivo, acceptable PK exposure, or toxicity limits) and tying them to yearly deliverables that justify continued investment.
Administratively, the opportunity is issued by HHS/NIH (Agency listed as HHS-NIH11) in the environment and health activity category and is associated with CFDA numbers 93.113, 93.846, 93.853, and 93.867. The eligible applicant pool is broad and includes various levels of government, public and private institutions of higher education, nonprofit organizations (including and not limited to 501(c)(3) entities), for-profit organizations (other than small businesses), small businesses, tribal governments and tribal organizations, and certain housing authorities, with a note to consult the FOA text for any additional eligibility details. The posted award ceiling in the provided source data is $300,000. The opportunity was originally posted June 15, 2016, with the listed closing date of September 11, 2018.
Overall, this FOA is aimed at teams that can move beyond discovery into structured lead identification: validating a target, demonstrating in vitro and early in vivo efficacy, generating early PK/PD and ADME/Tox data, and ending with at least one credible, development-ready lead positioned for optimization and later-stage countermeasure development.
FAQs: Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01) (PAR-16-330)
What is this grant opportunity?
This NIH Countermeasures Against Chemical Threats (CounterACT) funding opportunity, titled "Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01)" (PAR-16-330), supports early translational research to identify promising therapeutic lead compounds that could eventually become medical countermeasures for people exposed to dangerous chemicals.
What public health problem is the program trying to address?
The program is focused on chemical threats that may arise from deliberate terrorist use of chemical warfare agents or from accidental industrial releases during manufacturing, storage, or transport. The threats include classic chemical warfare agents as well as toxic industrial chemicals and related materials. The goal is to build a pipeline of treatments that can prevent or reduce injury after exposure.
What type of funding mechanism does this FOA use?
This FOA uses the U01 cooperative agreement mechanism. Under a U01, NIH staff typically have substantial scientific involvement compared with a standard research grant.
How does a cooperative agreement (U01) affect how the project is run?
Because this is a cooperative agreement, the NIH is expected to be more scientifically involved than it would be under a standard research grant. The FOA describes this as "substantial scientific involvement," which generally implies closer coordination and stewardship consistent with the cooperative agreement model.
What stage of research is this FOA intended to fund?
The funded work is positioned at an early but clearly translational stage. The FOA frames its scope around Technical Readiness Level (TRL) 3, emphasizing proof-of-concept and early validation activities that move a therapeutic idea from basic discovery toward a development-ready lead.
Is this opportunity meant for broad exploratory/basic discovery research?
No. While the work is early, it is not framed as broad exploratory biology. The emphasis is on producing at least one well-supported lead compound that is ready for the next stage of optimization.
What is the main objective or end product expected from an awarded project?
A key deliverable is the identification of at least one lead compound (small molecule or biologic) that is ready for optimization. The project should de-risk the lead by generating evidence across activity, mechanism, and early developability considerations.
What kinds of therapeutic candidates are in scope?
The FOA specifically references candidate small molecules or biologics as the types of therapeutics that may be proposed as potential treatments for chemical exposure.
What research activities are expected under this opportunity?
Projects are expected to include practical steps that support the case that a candidate therapeutic has real potential as a treatment. The FOA describes expectations that include:
- Confirming and validating relevant molecular target(s) for therapeutic development
- Demonstrating meaningful in vitro activity of candidate therapeutics
- Generating preliminary in vivo proof-of-concept efficacy evidence in an appropriate animal model or other relevant in vivo system
- Producing early developability data, including preliminary ADME/Tox evaluations and PK/PD information
What does the FOA mean by validating a molecular target?
Based on the FOA description, validating the target means confirming and validating the relevant molecular target(s) intended for therapeutic development, as a foundation for selecting and justifying the candidate therapeutic lead.
What level of evidence is expected for in vitro activity?
The FOA expects applicants to demonstrate that candidate therapeutics show meaningful activity in vitro. The specific assays or thresholds are not provided in the summary, but the emphasis is on activity that supports moving toward in vivo proof-of-concept.
Is in vivo efficacy data required?
Yes. Applicants are expected to generate preliminary in vivo proof-of-concept efficacy evidence, showing that the approach can work in an appropriate animal model or other relevant in vivo system.
What developability data does NIH expect at this stage?
The FOA expects early developability data to help avoid advancing candidates that fail basic feasibility or safety screens. This includes preliminary ADME/Tox evaluations (absorption, distribution, metabolism, excretion, and toxicity) and pharmacokinetics/pharmacodynamics (PK/PD).
Why are PK/PD and ADME/Tox included in a lead identification FOA?
The intent is to ensure lead selection is grounded in measurable exposure-response relationships (PK/PD) and to screen for early feasibility and safety risks (ADME/Tox), rather than advancing compounds that only look promising in vitro.
What counts as a "lead compound" under this FOA?
In the FOA language summarized here, a lead is more than an active hit. It should be biologically active and synthetically feasible, with evidence supporting specificity, affinity, potency, target selectivity, efficacy, and safety. The expectation is that the team can identify at least one compound (or biologic) meeting a defined performance bar and ready for the next stage of optimization.
Does the FOA require projects to be milestone-driven?
Yes. Milestone-driven management is a central feature. Each project must include annual milestones that function as discrete go/no-go decision points.
What are "go/no-go" milestones in this context?
They are measurable annual decision points used to determine whether the project is meeting defined criteria for success or whether it should be terminated. The FOA emphasizes a progressive, decision-based plan rather than an open-ended research agenda.
What kinds of milestone endpoints does the FOA suggest?
The summary indicates examples such as target engagement thresholds, minimum in vivo efficacy, acceptable PK exposure, or toxicity limits, tied to yearly deliverables that justify continued investment.
How does this FOA fit into the broader CounterACT development pipeline?
The FOA points to a companion program for the next step: "CounterACT Optimization of Therapeutic Lead Compound (U01)" (PAR-16-331). This signals a staged pipeline, where PAR-16-330 supports lead identification and de-risking, and subsequent support may move a lead into optimization and more advanced preclinical development.
Who is the issuing agency for this opportunity?
The opportunity is issued by HHS/NIH (Agency listed as HHS-NIH11).
What activity category is associated with this opportunity?
The activity category listed is environment and health.
What CFDA numbers are associated with this FOA?
The opportunity is associated with CFDA numbers 93.113, 93.846, 93.853, and 93.867.
Who is eligible to apply?
The eligible applicant pool is described as broad and includes:
- Various levels of government
- Public and private institutions of higher education
- Nonprofit organizations (including, but not limited to, 501(c)(3) entities)
- For-profit organizations (other than small businesses)
- Small businesses
- Tribal governments and tribal organizations
- Certain housing authorities
The summary also notes that applicants should consult the FOA text for any additional eligibility details.
Are small businesses eligible?
Yes. Small businesses are included in the eligible applicant categories listed.
Are for-profit organizations eligible?
Yes. For-profit organizations are listed as eligible, with the note "other than small businesses" as a separate category from small businesses.
What is the posted award ceiling?
The posted award ceiling in the provided source data is $300,000.
When was this opportunity posted and when did it close?
The opportunity was originally posted on June 15, 2016, with a listed closing date of September 11, 2018.
What is the overall focus of projects that are a strong fit for this FOA?
The FOA is aimed at teams that can move beyond discovery into structured lead identification by validating a target, demonstrating in vitro and early in vivo efficacy, generating early PK/PD and ADME/Tox data, and ending with at least one credible, development-ready lead positioned for optimization.
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