Key Dates

Related Announcements

• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272.

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in supporting research aimed at fostering collaborations between researchers throughout the NIAID/Radiation and Nuclear Countermeasures Program (RNCP)-funded grant and cooperative agreement portfolio (e.g., U01, U19, R21, R01, P01). The NIAID/RNCP has been tasked with developing safe and effective medical countermeasures (MCMs) and biodosimetry tools for civilians that can be used at least 24 hours post-exposure in a radiological or nuclear public health emergency. The multidisciplinary nature of radiation research lends itself to the establishment of formal partnerships across projects with similar goals, which enables collaborating research groups to achieve outcomes that would likely be impossible without the expertise, models, and facilities available at other institutions. The goal of NOSI is to foster collaborations that will allow awardees to develop data that can be leveraged for new funding that will enhance the state-of-the-science.

Background

The NIAID/RNCP sponsors early-stage and applied research, product development programs, and targeted initiatives focused on development of products to mitigate and/or treat complications of Acute Radiation Syndrome (ARS) and Delayed Effects of Acute Radiation Exposure (DEARE). Investment in this portfolio has led to the establishment of small and large animal models to assess the impact of radiation on several organ systems, including the bone marrow, gastrointestinal tract, lungs, skin, kidney, heart, vasculature, and central nervous system. These models are critical for licensure of radiation MCMs under the U.S. Food and Drug Administration (FDA) Animal Rule (21 CFR 314.600-650 for drugs; 21 CFR 601.90-95 for biologics; effective July 1, 2002). The program also supports studies to advance new formulations of existing radionuclide blocking and decorporation products, as well as novel approaches to remove dangerous radioactive material (internal contamination) from the body.

Another area of interest in the NIAID/RNCP portfolio is the radiation biodosimetry program, which supports 1) basic mechanistic research to elucidate novel approaches for rapid and precise assessment of radiation exposure; 2) advanced development of promising biodosimetry devices and/or approaches; and 3) research to identify biomarkers and/or assays to predict acute and/or delayed radiation injuries to tissues and organs. The goal of this program is to develop a triage tool to identify biological responses that can be accurately, quickly, and non-invasively assessed in large numbers of potentially irradiated people to guide medical management in the wake of a radiation public health emergency.

Research Objectives

Because the radiation research field has cultivated certain core competencies in laboratories across the NIAID/RNCP-funded grant and cooperative agreement portfolio, it will be beneficial to allow researchers with unique models, MCMs, biomarker signatures, and/or facilities to work together to share their expertise with other investigators, through a targeted funding opportunity. Examples of the kind of studies that could be supported by this Notice of Special Interest include, but are not limited to:

• Establishing 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., different animal strains or species, different animal ages or sex, transgenic animals, different organ system focus, or radiation dose level, etc.).
• Testing of a MCM in an irradiator available to researchers in one laboratory but not another (e.g., mixed gamma/neutron field, LINAC, X-ray; gamma-ray source, etc.).
• Conducting studies in which two MCMs under development in different laboratories are tested in combination in the same animal model (polypharmacy approach).
• Identifying different biomarkers (e.g., cytogenetic, genomic, proteomic, metabolomic, microRNA, etc.) in similar samples obtained by different institutions, across a range of radiation exposure levels, and/or detection devices.
• Looking for similar biomarkers of radiation injury across a variety of animal models and/or types of radiation exposures available at different institutions.

Scope of Support

Administrative supplements can be used to meet costs associated with increased animal needs and personnel to carry out the proposed work. Applicants should propose research that, if successful, would help to enhance understanding of radiation-induced pathways for injury, advance biomarkers, or MCMs along the product development pathway, and contribute to the health and well-being of civilian populations after a radiation incident. All science proposed must be within the scientific scope of the parent award being supplemented.

Specific Considerations

Applicants are strongly encouraged to discuss their proposed supplement project with the NIAID/RNCP Program Official of the approved parent award prior to submission of a supplement application to ensure that the proposed activity is within the scientific priorities of NIAID/RNCP and the scope of the existing award. Collaborations within established NIAID/RNCP-funded consortia are permitted, as are collaborations across the entire portfolio (e.g., with awardees in other consortia or parts of the program).

Application and Submission Information

Applications for this initiative must be submitted 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)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) October 2, 2023, October 2, 2024, and October 2, 2025, by 5:00 PM local time of applicant organization.
• For funding consideration, applicants must include NOT-AI-23-044 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Eligibility
  • Only existing grant or cooperative agreement recipients of the NIAID/RNCP awards are eligible to apply.
  • This opportunity is not open to pilot project awardees from the NIAID CMCRC program.
  • This opportunity is not open to SBIR awardees due to hard budget caps, which do not permit supplement awards that exceed allowable amounts (specific to the award phase).
• Applicants:
  • Applicants must partner with another NIAID/RNCP grant or cooperative agreement recipient (such that each program is represented) and submit their own unique applications. Applicants must describe the specific aim(s) from each collaborator and the role that each PD(s)/PI(s) will play in both submissions.
  • An award will only be made if both parties submit their application and are selected for the collaborative supplement.
  • Each grant or cooperative agreement can only be awarded a maximum of two collaborative administrative supplements per PD(s)/PI(s), per eligible budget year, through this NOSI.
• Applications
  • The Research Strategy section of the application is limited to 6 pages and the work proposed must be within the scope of the parent award.
• Budget
  • The budget cannot exceed $100,000/year in total costs for each collaborator.
  • Requests will be awarded for one year at a time, dependent 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 one year of funding remaining on their parent budget at the time of award.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact(s)

Andrea L. DiCarlo-Cohen, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3492
Email: [email protected]

Financial/Grants Management Contact

Tamia Powell
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2982
Email: [email protected]