In an effort to identify novel approaches to treat and mitigate nervous system injuries resulting from mass casualty chemical incidents, NIAID, along with the National Institute of Neurological Disorders and Stroke (NINDS), is calling for basic research applications under CCRP Initiative: NIH Countermeasures Against Chemical Threats (CounterACT) Basic Research on Chemical Threats that Affect the Nervous System (R01, Clinical Trial Not Allowed). The notice of funding opportunity (NOFO) is expected to generate results that shed light not only on the fundamental mechanism(s) of toxicity of highly toxic Chemicals of Concern (CoCs) but also on potential new targets to inform the development of medical countermeasures (MCMs) that would be effective during and after civilian mass exposure situations.  

Research Objectives 

The civilian chemical threat spectrum includes almost 200 highly toxic chemicals that the U.S. government has designated as CoCs, which are broadly categorized by primary mode of toxicity, i.e., toxidrome. 

For this NOFO, the toxidromes of interest are primarily Cholinergic and Convulsant CoCs, however, the following toxidromes will also be considered responsive due to secondary effects on the nervous system: Anticoagulants and Blood/Metabolic (Knockdown) agents. Refer to the NOFO for CoC examples of each of these toxidromes as well as a list of potential research categories that will be supported under this initiative.  

While applicants may choose to investigate all biological systems that their chosen CoC might impact, in all cases, the proposed research must address either immediate, long-term, or both immediate and long-term nervous system effects after a single acute toxic exposure event. We encourage applications that use more than one CoC within a toxidrome to identify overlapping mechanism(s) of toxicity.  

Note, however, that research on toxic effects due to chronic exposures such as environmental, occupational, or residential will not be supported. 

In addition, the following types of studies are not responsive to the NOFO and will not be reviewed: 

• Efficacy studies, e.g., creation and validation of candidate MCMs. 
• Clinical trials. 
• Applications that propose to study chemicals that are not on the Department of Homeland Security CoC list or applications that propose to study CoCs that affects the pulmonary system, skin, and eyes, or respiratory drive. 
• Projects that do not address health outcomes after a single acute exposure, i.e., prolonged or persistent chemical exposure. 

Special Considerations  

Given that many of the CoCs of interest are extremely hazardous, all applications must include a letter from appropriate institutional biosafety officials indicating that studies are deemed safe for research personnel and the environment. Also, NINDS explicitly emphasizes adherence to NIH’s Rigor and Reproducibility in Grant Applications policy and, therefore, the biological rationale for your proposed experiments must be based on rigorous and robust supporting data. 

We strongly encourage applicants to contact the scientific/research contacts listed in Section VII. Agency Contacts of the NOFO to confirm that the proposed CoC is of interest to the program.  

Application Deadlines, Budget Information, and Eligibility  

The first application due date is October 17, 2025, and the second application due date is October 16, 2026. Applicants must use FORMS-I for this opportunity.  

The maximum project period is 3 years, and application budgets may not exceed $300,000 in annual direct costs. NIH intends to support up to four awards. 

Foreign organizations and non-U.S. components of U.S. organizations are not eligible to apply. 

Contact 

For NIAID-related questions, contact Dr. Dave Yeung, at dy70v@nih.gov or 301-761-7237.

Note an Addendum to NIAID’s Financial Management Plan for FY 2025

For competing investigator-initiated R01 applications submitted by new and early-stage investigators, NIAID will fund new awards at their approved funding level (without any percentage reduction). At the outset of fiscal year (FY) 2025, we had not identified this subset of applications as excluded from our approach of funding competing investigator-initiated awards at 97 percent of approved funding level.

Read our FY 2025 Financial Management Plan for additional details. Refer also to Information for New Investigators.

HHS ASPR Posts FAQs on DURC/PEPP Policy

We noted, in our June 5, 2024 news brief “New Government-Wide Policy for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential in May 2025,” that a new Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential would expand the scope of research requiring additional scrutiny and strengthen government coordination with institutions to ensure robust review and oversight.

Our preparation for the May 6, 2025 implementation date is ongoing. Until then, HHS’s Administration for Strategic Preparedness and Response is posting (and answering) frequently asked questions (FAQs) about the policy from the research community. Find them at Frequently Asked Questions: United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.

The government has made ASPRBIO@hhs.gov available for questions and feedback from stakeholders on interpreting or implementing the Policy. Feedback will be used for policy evaluation purposes and may result in FAQs. Not all emails to this email address may receive a direct response.

New Scientific Integrity Policies Focus on Public Trust

In recent months, HHS and NIH have each announced new policies for scientific integrity. Read NIH’s announcement at Final Scientific Integrity Policy of the National Institutes of Health. Note that this is in addition to NIH policies on Research Integrity, which champion trustworthy and professional conduct, methodology, and results reporting within NIH-supported research.

Per the announcement, the new Scientific Integrity Policy is meant to ensure that 1) scientific findings are objective, credible, and readily available to the public, and 2) the development and implementation of policies and programs is transparent, accountable, and evidence-based. Practically speaking, the policy is meant to govern NIH and its staff, rather than the extramural community.

NIAID, alongside partnering institutes and centers (ICs), seeks translational exploratory or developmental research to advance the discovery of medical countermeasures (MCMs) through the CCRP Initiative: NIH Countermeasures Against Chemical Threats (CounterACT) Translational Exploratory/Developmental Research Projects (R21, Clinical Trial Not Allowed) notice of funding opportunity (NOFO).

The Chemical Countermeasures Research Program (CCRP) supports research focused on civilian chemical MCMs and the discovery of novel treatment strategies to combat serious morbidity and mortality resulting from high consequence public health chemical emergencies. The civilian chemical threat spectrum includes chemical warfare agents, toxic industrial chemicals, pesticides, ultra-potent synthetic (UPS) opioids, and others that the Department of Homeland Security (DHS) identifies as Chemicals of Concern (CoC).  

CCRP urgently needs MCMs to advance national medical and public health preparedness in response to and in recovery from chemical emergencies.  

Research Objectives 

The CCRP NOFO invites preliminary efficacy or early preclinical development studies towards discovery and validation of novel molecular entities or biologics as candidate MCMs.  

Propose in your application exploratory translational research directly related to the preclinical development of novel treatment strategies/approaches that address adverse health effects after exposure to chemical threats.  

Example Research Topics  

The categories of research supported under this R21 program include:  

• Creation/validation of clinically relevant in vivo or in vitro (including 3D/organoid) models of the post-exposure lethality and serious near- and long-term chronic morbidities for the purpose of investigating treatment and prevention strategies. 
• Preclinical development of new molecular targeting agents, biologics, or novel strategies based on specific changes in signaling pathways and proteins/genes expression during the post-exposure injury process. 
• Evaluation of new combination treatment strategies and development of new agents to enhance the effectiveness of standard-of-care therapies. 
• Performance of high-throughput screens for discovery of chemical probes and molecular targeting agents. 
• Studies that use Artificial Intelligence/Machine Learning models to investigate/discover novel MCM strategies to modulate chemical toxicity. 
• Discovery of candidate therapeutics using primary and secondary screening to generate preliminary proof-of-principle in vitro and/or in vivo efficacy data. 
• Alternate routes of administration and/or dosing regimen for new or already FDA-approved therapies that would be safer, more effective, or easier to administer during a mass casualty scenario or for specific subpopulations (e.g., pediatric and pregnant) that are at higher vulnerability to the adverse effects of chemical intoxication. 
• Proposals seeking to repurpose or expand indications of already approved and authorized products. This may include, but is not limited to: 
  • Alternate routes of administration or dosing regimen that would be safer, more effective, or easier to administer during a mass casualty scenario. 
  • Extending a previously observed protective effect of a promising novel or already FDA-approved compound(s) for one chemical threat to others, i.e., broadening the spectrum of activity. 

Applications Not Responsive to This NOFO 

Review the list below for research that will be considered nonresponsive and will not be reviewed. 

• Applications that do not propose research on chemical threats that are on the DHS CoC list (check with program staff prior to submission). 
• Applications that propose therapeutics unlikely to be amenable during or after a mass casualty scenario, including therapeutics that must be administered prophylactically or within the first 15 to 30 minutes of exposure. For ultra-potent synthetic opioids only, the administration of therapeutic(s) may be as short as 5 minutes post-exposure.  
• Applications addressing health outcomes after chronic chemical exposure, i.e., this NOFO only supports research on health effects after a single acute exposure event. 
• Applications proposing to develop environmental decontamination or analytical detection technologies and strategies. 
• Applications that only include basic research on mechanisms of toxicity from acute exposures of chemical threats. 
• Applications for fundamental studies, such as proposals seeking to characterize pathways or molecular mechanisms of toxicity. 

Include Special Biosafety Certification for All Applications 

Since many of the chemical threat agents of interest are extremely hazardous to humans, all applications must include a letter from appropriate institutional biosafety officials indicating that studies are deemed safe for research personnel and the environment. Applicants may need special biosafety certifications to conduct research with some chemical threat agents, e.g., chemical warfare agents.  

Therefore, NIH encourages applicants to collaborate with laboratories and contract research facilities that are already certified to work with restricted chemical agents, when applicable.  

Applicants are strongly encouraged to contact the scientific/research contacts listed in the NOFO for further information on working with restricted chemical agents.   

Award Information and Deadline  

The award budget for direct costs for the 2-year project period may not exceed $275,000. No more than $200,000 may be requested in any single year. The total project period for an application may not exceed 2 years. 

Applications are due on May 30, 2025, by 5:00 p.m. local time of the applicant organization.  

Contact Information 

Send any inquiries to NIAID’s scientific/research contact, Dr. Dave Yeung, at dy70v@nih.gov or 301-761-7237.

In an effort to accelerate the development of approaches to diagnose, treat, and mitigate injuries resulting from mass casualties, radiological, or nuclear incidents, NIAID has issued a notice of funding opportunity (NOFO), Development of Alternative Human Models of Radiation-Induced Injuries (Extracorporeal Systems) (U01, Clinical Trial Not Allowed). The NOFO supports early- to mid-stage research and development of extracorporeal systems that mimic human responses and test appropriate medical countermeasures (MCMs) to treat civilian populations in case of a radiological or nuclear accident or attack. 

Research Objectives 

Research activities carried out as part of this effort may include mechanism of tissue injury studies, testing of candidate MCMs to advance product development, development of novel extracorporeal systems, or advancement of existing systems such as human or animal platforms in early stages of development that are being used for radiation research or other indications.  

To that end, applications should either include a plan that develops or advances an extracorporeal human model system that bridges biomarkers from animals to humans; or testing of a single or multiple MCMs that use the developed human model to simulate human responses to the MCMs; or both. Investigators must make sure to select a radiation exposure type, dose level, and dose rate that’s relevant to a radiological or nuclear incident and verified by appropriate dosimetry assessments. Animal ex vivo models are permitted for study only if they are being used in addition to human models and are needed to bridge between in vivo animal and ex vivo human findings. 

Note that applicants proposing to test an MCM in the developed human extracorporeal model must administer the MCM at least 24 hours or more following radiation exposure. MCMs targeting hematopoietic acute radiation syndrome (H-ARS) for neutropenia or thrombocytopenia must be administered 48 hours or later post-radiation exposure.  

The Research Strategy must include annual milestones for the first year of the project and brief milestones for additional years that may be negotiated annually. NIAID staff will use these milestones to assess annual progress and support funding decisions. Applications without milestones will be considered nonresponsive and will not be reviewed.  

Refer to the NOFO for specifics on areas of research that will be considered nonresponsive and will not be reviewed.  

Budget Information and Eligibility 

NIAID will fund six to eight awards in fiscal year 2026. Application budgets are not expected to exceed $350,000 in direct costs per year and should reflect the actual needs of the proposed project. While the scope of the proposed project should determine the project period, the maximum project period is 5 years. 

The deadline to apply is February 6, 2025. Note that applicants will need to use FORMS-I for this opportunity. While the updated forms are not yet available, they will be posted 30 calendar days or more before the application due date.  

Foreign organizations and components as well as non-U.S. components of U.S. organizations are not eligible to apply for this NOFO. 

Contact Information 

For more information, contact Dr. Carmen Rios, NIAID’s scientific/research contact, at carmen.rios@nih.gov or 240-627-3553. For peer review-related inquiries, contact Dr. Hiten Chand, NIAID’s peer review contact, at hiten.chand@nih.gov or 240-627-3245.

NIAID, along with other NIH institutes and centers (ICs), issued Notice of Special Interest (NOSI): An Annual Scientific Meeting to Support the Chemical Countermeasures Research Program (CCRP), which invites applicants to organize a series of annual in-person scientific meetings, conferences, symposia, and workshops to advance innovations in therapeutic and chemical toxicology research within the mission of the CCRP.  

The CCRP, established by NIAID in 2006, is a trans-NIH initiative that supports basic research to better understand the fundamental toxic mechanisms of Chemicals of Concern (CoC) and advance discovery and development of medical countermeasure (MCM) products and strategies to prepare, respond, and recover from disasters and public health emergencies resulting from natural, accidental, and intentional release of these highly toxic substances.  

Meeting Objectives 

The primary goal of these annual scientific meetings—the first of which is expected to take place in 2026—is to provide a forum for the exchange of scientific data and ideas; foster collaboration between scientists at difference institutions and career stages; and provide career development and education opportunities for young scientists.  

Successful applicants will work closely with CCRP program officials to ensure the R13 award will foster innovation and discussions to advance fundamental knowledge of CoCs' toxicities and stimulate research toward discovery and development of new or repurposed products as potential MCMs.  

With almost 200 CoCs identified to date, applicants are encouraged to implement an interdisciplinary team science approach, while also demonstrating an ability to work cooperatively and collaboratively across multiple institutions.  

Applicants must take steps toward openness and transparency such as recording the meetings, posting them online, and promoting them. To that end, we encourage applications to include an implementation plan for encouraging broad participation and recommend that applicants propose additional topics and creative approaches to maximize the outreach and impact of the meetings.  

Finally, we strongly encourage prospective applicants to review the Conference Awards SOP prior to submission and contact NIAID’s scientific/research staff early to verify the consistency and scope of your intended application with the goals of this NOSI. 

Application and Submission Information  

You can submit applications for this initiative using the notice of funding opportunity (NOFO) NIH Support for Conferences and Scientific Meetings (Parent R13, Clinical Trial Not Allowed) or any subsequent reissues of the NOFO through the expiration date of the NOSI. All instructions in the SF 424 (R&R) Application Guide and the NOFO used for submission must be followed, with the following addition: Include “NOT-AI-24-066” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF 424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

NIH will award up to $70,000 in annual direct costs and no more than 5 years of support for the proposed series of annual meetings. Applicants may request full or partial NIH support for the proposed annual scientific meetings.  

The first available due date for this NOSI is December 12, 2024; we will accept applications on NIH’s standard due dates through September 8, 2027.  

Contact 

For questions, contact Dr. Dave Yeung at dy70v@nih.gov or 301-796-7237.