New Government-Wide Policy for Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential in May 2025

Last month, the White House Office of Science and Technology Policy (OSTP) published the Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential to expand the scope of research requiring additional scrutiny and strengthen government coordination with institutions to ensure robust review and oversight.

The policy takes effect on May 6, 2025.

OSTP also published Implementation Guidance for the United States Government Policy for Oversight of Dual Use Research of Concern and Pathogens with Enhanced Pandemic Potential.

We encourage you to read the Policy and Guidance, and to monitor for additional instruction on this topic in the future. 

ICYMI: NIAID Sets Final R01, R03, and R21 Paylines for FY 2024

As explained on our NIAID Paylines webpage, we set initial paylines conservatively and set final paylines later in the fiscal year (FY). For FY 2024, we now have final paylines for all award types that use paylines, including:

• Research Projects (R01) for established investigators—10 percentile
• Research Projects (R01) for new and early-stage investigators—14 percentile
• Small Grants (R03)—28 overall impact score
• Exploratory/Developmental Grants (R21)—28 overall impact score

Consider subscribing to NIAID Payline Email Alerts; we email subscribers each time NIAID sets or revises a payline number or status. You can also find updates through @NIAIDNews on X.

NIH Increases Childcare Support for NRSA Fellows and Trainees

Beginning with fiscal year 2024 competing awards, NIH is increasing childcare support to $3,000 for National Research Service Award (NRSA) individual fellowships and institutional training awards. 

Each fellow may request $3,000 per budget period to defray childcare costs. For trainees, NIH will provide an annual $3,000 for each full-time trainee appointment slot when the new, renewal, or continuation award is made.

Previously, NIH capped childcare support at $2,500.

To be eligible, childcare must be provided by a licensed childcare provider. Recipients must maintain all supporting documentation (e.g., proof provider is licensed) and make it available to NIH officials upon request. NIH does not require recipients to submit this supporting documentation with each request.

For further explanation, read the May 22, 2024 Guide notice.

NIAID will support administrative supplement awards to promote the development of pediatric chemical research models and medical countermeasures (MCM) discovery under the Chemical Countermeasures Research Program (CCRP). There is currently an unmet need in understanding the natural history, pathophysiology, and treatment of critical illness in infants, children, adolescents, and young adults after exposure to highly toxic, Department of Homeland Security-designated chemicals of concern (CoCs).  

The administrative supplements will fund pilot preclinical projects by CCRP-supported researchers that focus on 1) basic research to elucidate mechanistic differences in susceptibility to CoCs between pediatric and adult populations or 2) applied research towards the discovery and early development of pediatric-safe MCMs. 

Research Objectives 

Through Notice of Special Interest (NOSI): Chemical Countermeasures Research Program (CCRP) Administrative Supplements to Promote the Development of Pediatric Research Models of Chemical Injury and Medical Countermeasures Discovery, current CCRP award recipients are eligible to receive supplemental funds to incorporate pediatric relevant chemical MCM research efforts, within the scope of the approved award, that were unforeseen when the new or renewal application or grant progress report for noncompeting continuation support was submitted. 

Examples of relevant research areas include developing new pediatric research models and MCM efficacy studies. Applicants must propose research that, if successful, would contribute to a greater understanding of the health, well-being, or medical treatment of the pediatric population during and after a public health emergency involving CoCs. 

CCRP will prioritize recipients with research project grants (e.g., R01, R21, R34) over those working under cooperative agreements (e.g., U01, UG3/UH3, U54, U2C).  

Application and Submission Information 

Submit an application for this initiative using the following notice of funding opportunity (NOFO) or its subsequent reissued equivalent. 

• Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp, Clinical Trial Optional) 

Follow all instructions in the SF 424 (R&R) Application Guide and the parent administrative supplements NOFO, with the following additions: 

• Budgets are limited to lesser of the amount of the current award or $99,999 in direct costs, and must be spent within the currently approved project period. 
• Applications are due on May 6, 2024; March 17, 2025; or March 16, 2026, by 5:00 p.m. local time of the applicant organization. 
• You must include “NOT-AI-24-022” 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. 

We encourage you to notify the program official listed on your Notice of Award that you are submitting a request in response to this NOSI to facilitate efficient processing of your request. 

Refer to the NOSI, linked above, for additional application instructions.

Apply to NIAID’s notice of funding opportunity (NOFO) Novel Approaches for Radiation Biodosimetry Assays and Devices Development (U01, Clinical Trial Not Allowed) for funding to conduct research on radiation biodosimetry assays and devices. The NOFO supports radiation research at all stages of development for identifying biomarkers of injury and developing assays or devices for the purpose of triage, including assessing absorbed dose or predicting health outcomes of acute or delayed injuries resulting from radiation exposure during a public health emergency.  

Scientific Objective 

This initiative’s end goal is to generate data towards obtaining approval or clearance from the FDA to use in a radiological or nuclear public health emergency. 

NIAID is interested in supporting studies that propose the following example research areas: 

• Evaluating and characterizing radiation-induced biomarkers for the purpose of triage and definitive dose assessment, or identification of those that are predictive of early and delayed injuries, based on markers that could include, but are not limited to, gene or protein expression; DNA or protein modifications; metabolomic, lipidomic, immunomodulatory, cytogenetic, inflammatory, biochemical, and/or physico-chemical changes. 
• Analyzing signature biokinetics (i.e., biomarkers that persist over a range of time, permitting use in a radiation public health emergency – such as 30 minutes to days, weeks, or months post-exposure). 
• Investigating influence of confounders on the kinetics of the technique/biomarker (e.g., sex, age, smoking, health status, comorbidities, and current medications), type of radiation, partial-body irradiation, other combined injuries (e.g., burn, trauma, wound), or use of approved hematopoietic acute radiation syndrome therapeutics. 
• Developing imaging techniques to identify and characterize radiation injury to organs/tissues of physiological systems. 

You must include milestones in your application; NIAID will consider applications not including milestones to be nonresponsive and not review them. Plan detailed, quantitative research milestones and timelines for your project, and, if selected for funding, NIAID staff will use them to better assess your annual progress.

The NOFO also identifies studies that are nonresponsive, e.g., characterization and development of biomarkers of carcinogenesis, projects not specifically addressing radiation injury biomarkers, projects that are focused on medical countermeasures to mitigate or treat radiation-induced injuries, and applications proposing HIV/AIDS studies. If you propose a nonresponsive study, we will not review your application. Refer to the NOFO for the complete list. 

Award and Budget Details  

Application budgets are not expected to exceed $350,000 in annual direct costs and must reflect the actual needs of the project. 

The scope of the proposed project should determine the project period. The maximum project period is 5 years. 

Deadline 

This NOFO has a single due date. Submit your application by May 31, 2024, at 5 p.m. local time of the applicant organization. 

Have Questions? 

Direct inquiries to Dr. Merriline M. Vedamony, NIAID’s scientific/research contact, at Merriline.Satyamitra@nih.gov or 240-669-5432. For concerns specific to peer review, instead contact Dr. Michael Opata at michael.opata@nih.gov or 240-627-3319.

Reach out to Tom Bahrami, NIAID contracting officer, at bharamit@niaid.nih.gov or 240-669-5147 with any questions about the RFP.

NIAID seeks applications for mid-stage research developing candidate medical countermeasures (MCMs) already demonstrating efficacy to mitigate or treat radiation injuries through the notice of funding opportunity (NOFO) Development of Candidate Radiation/Nuclear Medical Countermeasures (MCMs) (U01, Clinical Trial Not Allowed).  

The mission of the Radiation and Nuclear Countermeasures Program (RNCP), guided by the NIH Strategic Plan and Research Agenda for Medical Countermeasures Against Radiological and Nuclear Threats, is to accelerate the development of approaches to diagnose, mitigate, and treat radiation injuries resulting from a mass casualty, radiological, or nuclear incident.  

Research Objectives and Scope 

The focus of this NOFO is to advance development of candidate MCMs with post-irradiation exposure administration data demonstrating efficacy to mitigate or treat radiation injuries from acute radiation syndrome (ARS) or the delayed effects of acute radiation exposure (DEARE). Product development should focus on mitigating ARS or DEARE. Additionally, researchers will elucidate mechanisms of action of MCMs to meet product licensure requirements. 

NIAID will support studies that propose topics such as: 

• Research and development of a lead MCM to enhance survival (primary endpoint) or mitigate major morbidities in irradiated animal models predictive of human responses, when administered as a single or multiple-dose regimen after radiation exposure (with administration of the first dose beginning at a minimum of 24 hours or later post-irradiation, and 48 hours or later for neutropenia or thrombocytopenia-targeted hematopoietic subsyndrome (H-ARS) products), with emphasis on broad activity (e.g., multi-syndrome, multi-organ). 
• Research and development of MCMs for mitigation or treatment of potentially lethal ARS, or DEARE, including radiation injuries to the gastrointestinal, cutaneous, pulmonary, renal, cardiovascular, or central nervous system compartments of the body. In addition, MCMs intended to address hematopoietic injuries not associated with neutrophil or platelet loss are of interest; however, if amelioration of radiation-induced neutropenia or thrombocytopenia is the target of the MCM, they must be effective when administered at time points no earlier than 48 hours post-irradiation.  
• MCMs to treat radiation combined injuries (e.g., radiation exposure concomitant with burn, wound, infection, or other physiological trauma). 
• Formulations of products or improvements to existing products for civilian populations that can be easily administered in a mass casualty scenario either by first responders or self-administered are preferred (e.g., via oral, subcutaneous, trans-cutaneous, intramuscular, or inhalation routes, as opposed to intravenous routes which are challenging in a mass casualty setting).  
• Testing of candidate MCMs in animal models that are representative of adult, pediatric, or geriatric human populations, and consideration of any possible sex differences of the radiation or drug response in these models. 
• Testing of small molecules, biologics, and cell products for ARS or DEARE. 
• Identification of early surrogate markers of candidate MCM efficacy post-irradiation (e.g., in hematologic parameters, cytokine or enzyme profiles, histological markers, inflammatory responses) that could potentially be used as secondary endpoints/observations to support mechanisms of action and linkage of pharmacodynamic effects across species. 
• Product development efforts to support submission of an investigational new drug (IND) application to the FDA to facilitate licensure and potential inclusion in the Strategic National Stockpile. Examples include the following: 
  • Efficacy studies to optimize formulation, dose, and dose scheduling, and to inform the design of subsequent Good Laboratory Practice (GLP).  
  • Pivotal efficacy study protocols. 
  • Drug product stability studies. 
  • Drug product current Good Manufacturing Practice manufacturing scale-up. 
  • GLP toxicology and pharmacology safety studies. 
  • Pharmacokinetic (PK) and pharmacodynamic (PD) studies. 

These product development efforts will advance the development of MCMs of radiation injury toward Phase I clinical trial safety studies or GLP animal model pivotal efficacy studies for FDA licensure.

While basic testing of compound efficacy or formulation work may not be considered inherently innovative, application and optimization in target tissues are highly valued. 

Nonresponsive Research Applications 

Do not propose the following research topics in your application or NIAID will consider it nonresponsive and not review it. 

• Studies proposing testing for a radio-protectant compound(s) that must be administered prior to radiation exposure to be efficacious. 
• Studies proposing administration of a candidate MCM at times earlier than 24 hours after radiation exposure (or earlier than 48 hours after radiation exposure for MCMs targeting neutropenia or thrombocytopenia resulting from H-ARS). 
• Clinical trials (all phases). 
• Work proposing dose ranges or exposure parameters that are not relevant to a radiation accident or attack (e.g., studies using fractionated radiation exposures, unless justified by opportunity to collect samples from radiotherapy patients). 
• Biodosimetry devices and biomarkers to be used to determine radiation dose received (radiation triage). 
• Studies to investigate MCMs for thermal-only burns; radiation-induced cancers; cataracts; or other ocular, reproductive, or muscular damage. 
• Lack of preliminary data or milestones. 
• Studies that primarily focus on HIV/AIDS-related research. 

Keep in mind, your research plan must include specific, detailed, explicit, and quantitative annual milestones.

Budget, Deadline, and Project Period Information  

Application budgets are not expected to exceed $350,000 in direct costs per year and should reflect the actual needs of the proposed project. The scope of the proposed project should determine the project period and the maximum project period is 5 years. 

Applications are due by January 26, 2024, at 5 p.m. local time of the applicant organization. 

Contact Information 

Direct any questions to Dr. Carmen Rios, NIAID’s scientific/research contact at carmen.rios@nih.gov or 240-627-3553. If you have peer review questions, contact Dr. Hiten Chand, NIAID’s peer review contact, at hiten.chand@nih.gov or 240-627-3245.

NIAID’s Radiation and Nuclear Countermeasures Program (RNCP) will support collaborative research to advance safe and effective medical countermeasures (MCMs) and biodosimetry approaches through the Notice of Special Interest (NOSI): Administrative Supplement for Collaborative Projects Supported by the NIAID/RNCP. The NOSI’s overarching goal is to develop MCMs and biodosimetry tools for civilians to be used post-exposure in a radiological or nuclear public health emergency.

Only current awardees of the RNCP (with a few exceptions noted in the NOSI) are eligible to apply, and investigators must propose studies that involve a collaboration with researchers at another institution in the RNCP-funded grants portfolio.

Research Objectives

RNCP is specifically looking for research that would enhance the understanding of radiation-induced pathways for injury, advance biomarkers that reflect radiation-induced damage, or accelerate the development of MCMs along the product development pathway; all to contribute to the health and well-being of civilian populations following radiation incidents.

For example, NIAID is interested in research studies to:

• Establish efficacy, pharmacokinetics, pharmacodynamics, safety, mechanism of action, or other developmental studies of a radiation MCM under investigation in one laboratory in an animal model that was developed at another institution (e.g., mixed gamma/neutron field, LINAC, x-ray; gamma-ray source).
• Test MCMs in an irradiator available to researchers in one laboratory but not another (e.g., mixed gamma/neutron field, LINAC, X-ray; gamma-ray source).
• Conduct studies in which two MCMs under development in different laboratories are tested in combination in the same animal model (polypharmacy approach).
• Identify different biomarkers (e.g., cytogenetic, genomic, proteomic, metabolomic, microRNA) in similar samples obtained by different institutions, across a range of radiation exposure levels, or detection devices.
• Searches for similar biomarkers of radiation injury across a variety of animal models or types of radiation exposures available at different institutions.

Through this NOSI, you would receive funds to establish formal partnerships with other research groups to achieve outcomes that would likely be impossible without the expertise, models, and facilities available at partnering institutions.

For Your Consideration

We strongly encourage you to discuss your proposed supplement project with the NIAID/RNCP program official of the approved parent award before applying to ensure that the proposed activity is within the scientific priorities and the scope of the existing award. Collaborations are permitted within established NIAID/RNCP-funded consortia, as well as across the RNCP portfolio (i.e., with awardees in other consortia or parts of the program).

You can use administrative supplements to meet additional costs associated with increased animal and personnel needs. All science proposed must be within the scientific scope of the parent award.

Application and Submission Information

Apply to this initiative by using the following opportunity or its subsequent reissued equivalent.

• PA-20-272, Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp, Clinical Trial Optional)

Follow all instructions in the SF 424 (R&R) Application Guide and PA-20-272, including the following additions:

• One annual application due date for the next 3 years – October 2, 2023; October 2, 2024; and October 2, 2025, by 5 p.m. local time of applicant organization.
• Include “NOT-AI-23-044” (without quotation marks) in the Agency Routing Identifier field box (box 4B) of the SF-424 R&R form. Applications without this information in box 4B will not be considered.
• The budget request cannot exceed $100,000 in annual total costs for each collaborator.
• NIAID/RNCP will award requests 1 year at a time, depending on scientific merit and availability of funding. The budget period of the request must coincide with the budget period of the parent award. Applicants must have at least 1 year of funding remaining on their parent award’s project period at the time of supplement award.

Contact Information

Direct all inquiries to NIAID’s scientific/research contact, Dr. Andrea L. DiCarlo-Cohen, at cohena@niaid.nih.gov or 240-627-3492.

NIAID is interested in supporting discovery and early development of medical countermeasures (MCMs) against chemical threats through a new notice of funding opportunity (NOFO) CCRP Initiative: Chemical Threat Agent Exposure Resource and Coordination Core (ExRC) (U2C, Clinical Trial Not Allowed). The NOFO seeks to establish Chemical Exposure Resource and Coordination Cores (ExRCs), which will provide infrastructure, management, and research support for basic and translational studies on Chemicals of Concern (CoC), under the Chemical Countermeasures Research Program (CCRP).

The ExRCs, which will be established across geographical regions, are meant to support multidisciplinary CCRP-funded investigators through the development of infrastructure and exposure protocols for selected CoCs. These Cores will provide access to specialized exposure facilities for studies using a variety of models to better characterize pathophysiological mechanisms of response and evaluate efficacy of potential MCMs. Applicants are encouraged to convene a diverse, multidisciplinary skilled team to support the ExRC with the necessary expertise to cover distinct real-world routes of threat agent exposure (e.g., pulmonary, ingestion, and dermal) and different model systems.

Each ExRC will be structured into three core components:

Administrative Core

As the managing component of the ExRC, this core is charged with supervising ExRC governance and policies and enacting continual improvements in the quality and efficiency of its activities. Additionally, it is responsible for overseeing all decision-making processes, managing the ExRC budget, interacting with NIH, and responding to the evolving needs of CCRP and CCRP-supported investigators.

Research Support Core

This core will develop standardized exposure protocols for a minimum of two in vivo models (e.g., rat, mice) and four to six CoCs across different toxidromes, with planned expansion for eight to ten threat agents. These models should include establishing and maintaining efficient data systems and infrastructure necessary for timely collection and transfer of high-quality exposure and physiologic measures and other specialized research needs.

Coordination Core

This core will facilitate ExRC activities for CCRP-supported investigators to coordinate CoC toxicant exposures, biospecimen and data collection, and transfer. 

Award Information

NIH plans to fund one or two awards in fiscal year 2024.

Application budgets are limited to no more than $750,000 annual direct costs and need to reflect the actual needs of the proposed core. 

The scope of the proposed project should determine the project period. The maximum project period is limited to 5 years.

This NOFO has a single application due date: September 28, 2023, at 5 p.m. local time of the applicant organization. We encourage you to send an optional letter of intent 30 days prior.

Contact Information

Direct inquiries to Dr. Dave Yeung at dy70v@nih.gov or 301-761-7237.