Key Dates

Related Announcements

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

Issued by

National Institute of Allergy and Infectious Diseases (NIAID)

National Eye Institute (NEI)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute on Drug Abuse (NIDA)

National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to highlight NIAID’s interest in supporting research aimed at a collaboration between recipients funded via  the Radiation and Nuclear Countermeasures Program ( RNCP ) and Chemical Countermeasures Research Program ( CCRP ). These collaborations between RNCP- and CCRP-supported researchers will generate data that can be leveraged for new medical countermeasures (MCMs) discovery and early development funding and enhance the state-of-the-science in both research areas.

Background

The RNCP and CCRP were established by NIAID in 2004 and 2006, respectively, to support the discovery and early development of MCMs to mitigate and/or prevent the serious morbidities and mortalities that may occur after a mass casualty civilian radiation/nuclear or chemical incident. Components of both programs include early-stage fundamental and applied research, preclinical product development support service cores, and targeted research project grant and cooperative agreement initiatives.

The RNCP is focused on:

1. Developing MCMs to mitigate and/or treat complications of the acute radiation syndrome (ARS) and the delayed effects of acute radiation exposure (DEARE)
2. Advancing new formulations of existing radionuclide blocking/decorporation agent products, as well as novel approaches to remove radioactive particles from the body
3. Creating a triage tool by developing biodosimetry technologies and biomarker assessments 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 and/or predict development of acute or late complications.

The CCRP is focused on discovery and early development of MCMs against almost 200 highly toxic chemicals that have been designated by the Department of Homeland Security as public health Chemicals of Concern (CoC). Examples of CoC include:

1. Pulmonary Agents, e.g., sulfur mustard, chlorine, acrolein, and phosgene. Chemicals that may induce pulmonary edema, pulmonary capillary leak, and pulmonary fibrosis after exposure.
2. Vesicants, e.g., sulfur mustard, nitrogen mustard, and Lewisite. Chemicals that may cause dermal and/or ocular toxicities (keratopathy) after exposure.
3. Blood/Metabolic Threat Agents, e.g., cyanides, hydrogen sulfide, brodifacoum. Toxidromes of interest include inhibition of cellular respiration and coagulopathy.
4. Ultrapotent Synthetic (UPS) Opioids, e.g., fentanyl, carfentanil, sulfentanil, acetylfentanyl, and derivatives, that cause life-threatening respiratory depression.
5. Chemical Warfare Nerve Agents and Organophosphorus (OP) Pesticides, e.g., sarin, soman, VX, and paraoxon. These chemicals may acutely induce muscarinic and/or nicotinic seizure and long-term chronic neurodegeneration after exposure.

Injuries caused by acute radiation, such as bone marrow myelosuppression, organ fibrosis, acute and delayed lung and skin injuries, acute respiratory distress syndrome, coagulopathy, neurodegeneration, and neovascularization, may manifest similar or identical to conditions observed after chemical exposure and vice versa. As such, the multidisciplinary nature of radiation and chemical injury research potentially lends itself to the establishment of formal partnerships between RNCP- and CCRP-supported researchers. These RNCP-CCRP partnerships would allow leveraging of unique expertise, in vitro and in vivo, small, and large animal models, ex vivo organ systems, specialized exposure facilities, and other core competencies that have been cultivated under the two NIH initiatives.

Research Objectives

The scientific scope of research supported by this Notice of Special Interest include, but are not limited to:

• Validation of potential therapeutic target(s) and/or preliminary characterization of candidate(s) across radiation and chemical injury
• Demonstration of post-exposure, proof-of-principle efficacy of pulmonary, cutaneous, hematopoietic MCMs against ionizing irradiation or CoCs such as nitrogen or sulfur mustard, chlorine, acrolein, and phosgene
• Preclinical characterization, e.g., 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 for a chemical threat at the collaborator’s institution (e.g., different animal strains or species, different animal ages or sex, transgenic animals, different organ system focus, etc.).
• Testing of a MCM in a test system available to researchers in one laboratory but not another (e.g., mixed gamma/neutron field, LINAC, X-ray; gamma source, sulfur mustard, nitrogen mustard, inhalation apparatus).
• Testing a polypharmacy approach using two MCMs being developed in different laboratories and/or for differing clinical indications.
• Identifying different biomarkers (e.g., cytogenetic, genomic, proteomic, metabolomic, microRNA, etc.) in similar samples obtained by different institutions, across a range of radiation or CoC exposure levels, and/or detection devices.

The proposed collaborative activities must be within the scope of the approved aims of the parent award and are expected to generate important new and mutually beneficial opportunities for achieving the goals of the parent project and those of the collaborator. Both collaborating parties may submit applications for concurrent consideration provided the proposed efforts are distinct.

The proposed supplement project must focus on addressing adverse health outcomes after a single acute exposure event; therefore, research on prolonged, persistent, or chronic environmental exposures are not within the scope of this NOSI. Note that clinical trials are not allowed. Applications nonresponsive to the terms of this NOSI will not be considered for award.

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 the overlap between chemical and radiation-induced pathways for injury, advance biomarkers in both mission spaces, or advance MCMs along the product development pathway, and contribute to the nation's medical and public health preparedness for, response to, and recovery from public health radiation or chemical emergencies.

Specific Considerations

Applicants are strongly encouraged to discuss their proposed supplement project with the NIAID/RNCP or NIAID/CCRP 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 the programs and the scope of the approved award. 

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:

• For funding consideration, applicants must include “NOT-AI-23-037” (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.
• Budget:  The requested budget must be less than $99,999/year in direct costs per Program Director (PD)/Principal Investigator (PI). Requests will be awarded for one year, dependent on scientific merit and availability of funding. The budget period of the request should 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.
• Eligibility:  Only existing grant and cooperative agreement recipients of the RNCP or CCRP are eligible to apply. Applicants must partner with another NIAID/RNCP or NIAID/CCRP grant or cooperative agreement recipient (such that each program is represented) and describe the specific aim(s) from each collaborator and the role that each PD/PI will play. Both collaborators may submit their own applications summarizing in each their plan for collaboration and providing details for the research to be done at their own sites. Each grant or cooperative agreement can only be awarded a maximum of two collaborative administrative supplements per PD/PI through this NOSI.
• The Research Strategy section of the application is limited to 6 pages and work proposed must be within the scope of the parent award.
• Note: This opportunity is not open to RNCP or CCRP SBIR recipients due to hard budget caps, which do not permit supplement awards that exceed allowable amounts (specific to the different award phases).

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact

Merriline Vedamony, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5432
Email: merriline.satyamitra@nih.gov

Dave Yeung, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-796-7237
Email: dy70v@nih.gov

Houmam H. Araj, Ph.D.
National Eye Institute (NEI)
Telephone:  301-435-8166
Email:  ha50c@nih.gov

Alexey Belkin, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-827-6475
E-mail: alexey.belkin@nih.gov

Kiran RV. Vemuri, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-435-4446
E-mail: kiran.vemuri@nih.gov

Shardell M. Spriggs, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-443-8189
E-mail: shardell.spriggs@nih.gov

Financial/Grants Management Contact

Tamia Powell
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2982
Email: tamia.powell@nih.gov 

Karen Robinson Smith
National Eye Institute (NEI)
Telephone: 301-435-8178
E-mail: kyr@nei.nih.gov

Sheila Simmons
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-9812
E-mail: simmonss@mail.nih.gov

Pamela G. Fleming
National Institute on Drug Abuse (NIDA)
Telephone: 301-480-1159
E-mail: pfleming@mail.nih.gov