The NIAID is inviting administrative supplement applications from current NIAID awardees that are not currently focused on the research and early development of medical countermeasures (MCMs) against chemical threats to allow them to expand their MCM research focus into this critical field. There must be sufficient progress on the parent project to justify the additional supplemental work. The proposed supplemental activities must be within the scope of the approved aims of the parent award.
Scope of Interest
The Chemical Countermeasures Research Program (CCRP) was established in 2006 by the NIAID to promote the discovery and advancements of MCMs to treat and/or prevent serious morbidities and mortality during or after mass casualty, high consequence, public health events involving the release of highly toxic chemicals. In support of these goals, the CCRP seeks to promote basic research to identify mechanisms of toxic effects and application of the fundamental knowledge gained to support the discovery and early-stage development of MCMs. To learn more, see The National Institutes of Health Chemical Countermeasures Research Program (NIH CCRP): A Collaborative Opportunity to Develop Effective and Accessible Chemical Medical Countermeasures for the American People, published in Drug Development Research.
The research scope of the CCRP is the discovery and efficacy validation of post-exposure MCMs and includes: 1) Treating the acute and chronic health effects of chemical threats; 2) Easy administration in a mass-casualty situation; and 3) Rapidly effective as delayed therapies (treatment window typically ≥ 30 minutes after exposure). For this Notice of Special Interest, the post-exposure treatment window may be reduced to obtain initial proof-of-principle pilot efficacy data for use as preliminary results in subsequent CCRP application submissions for more extensive grant support where utility within a civilian-based mass casualty therapeutic window may then be explored.
Injuries caused by acute exposure to chemicals often manifest similarly or identical to conditions observed in clinical practice such as acute lung injury, acute respiratory distress syndrome, coagulopathy, tissue fibrosis, keratopathy, neovascularization, seizure, neurodegeneration, and respiratory depression, so proposals that contemplate expansion of indications of already approved/authorized therapeutics and/or those still in the exploratory or validation stage for illness, infection, disease, radiation, etc. related physiopathology are highly encouraged.
Examples of clinical indication(s) and chemical agents of interest include, but are not limited to:
- Pulmonary Agents: Discovery of MCMs and/or therapeutic target(s) to prevent and treat lung damage (including pulmonary edema, pulmonary capillary leak, and pulmonary fibrosis) resulting from exposure to agents such as sulfur mustard, chlorine, acrolein, and phosgene. To learn more, see Developing Medical Countermeasures to Treat the Acute and Chronic Effects of Pulmonary Chemical Injuries (A Trans-Agency Scientific Meeting).
- Synthetic Opioids: Discovery of MCMs and/or therapeutic target(s) to treat life-threatening respiratory depression caused by acute opioid intoxication. These post-exposure treatments should be fast-acting and effective against a variety of opioids, including synthetic opioids such as fentanyl, carfentanil, sulfentanil, acetylfentanyl, and derivatives, and must be amenable to emergency use in the field. Candidates should have a mechanism of action different from existing opioid receptor antagonists. Prevention or treatment of opioid use disorder is outside the scope of this NOSI. To learn more, see National Institutes of Health (NIH) Executive Meeting Summary: Developing Medical Countermeasures to Rescue Opioid-Induced Respiratory Depression (a Trans-Agency Scientific Meeting)-August 6/7, 2019, published in Journal of Medical Toxicology.
- Vesicants: Discovery of MCMs and/or therapeutic target(s) to mitigate dermal and/or ocular toxicities after exposure to vesicating agents such as sulfur mustard, nitrogen mustard, and Lewisite. Particular preference is given to therapeutics with the potential to prevent or ameliorate the chronic effects of vesicant exposure such as keratopathy. To learn more, see Considerations in developing medical countermeasures against chemical ocular toxicity, published in Toxicology Letters.
- Blood/Metabolic Threat Agents: Discovery of MCMs and/or therapeutic target(s) to treat acute poisoning from metabolic/ blood agents (e.g., cyanides, hydrogen sulfide, brodifacoum). Toxidromes of interest include inhibition of cellular respiration and coagulopathy.
- Chemical Warfare Nerve Agents and Organophosphorus (OP) Pesticides: Discovery (or label-expansion indications) of already FDA-approved medications and/or therapeutic target(s) that can be repurposed to treat the muscarinic, nicotinic, or seizure-causing effects of nerve agent and OP pesticide exposure. An additional focus is the treatment of benzodiazepine refractory seizures and long-term neurodegeneration.
There are other chemicals of interest in addition to those listed above (and acceptable surrogates for use in traditional academic settings to establish initial proof-of-principle). Applicants are strongly encouraged to contact and discuss their proposed research/aims with the Program Official named in their current Notice of Grant Award and the CCRP Scientific /Program Contact listed below well in advance of the receipt deadline to determine responsiveness, programmatic interest, and relevance.
Only projects that include chemicals (or acceptable surrogates) that have been identified by the DHS as high consequence public health threats will be supported. Additionally, 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 chemical exposure is 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.
- Only existing NIAID-funded awardees are eligible to apply.
- Active awards cannot be in the first or last 12 months of the Project Period, exclusive of time in no-cost extension (NCE), at the time of the due date will be considered. Awards in NCE are ineligible to apply.
- Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Description of circumstances for which administrative supplements are available.
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) – 3 April 2022; 1 March 2023; 1 March 2024, by 5:00 PM local time of applicant organization.
- For funding consideration, applicants must include “NOT-AI-22-030” (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.
- Applicants are strongly encouraged to notify both the Program Official listed on the current Notice of Grant Award of the parent grant and the CCRP that a request has been submitted in response to this NOSI to facilitate efficient processing of the request.
- Application budgets are limited to the amount of the current award or $100,000 direct costs (plus applicable F&A costs), whichever is lower, and must reflect the actual needs of the proposed project.
- For parent awards with large unobligated balances, an explanation and plans for drawdown must be provided.
- The project and budget periods are limited to one year and must be within the currently approved project period for the existing parent award.
- The Research Strategy section of the application is limited to 6 pages, not including the References Cited. As part of the application, include an abstract of the proposed research that clearly demonstrates relevance to discovery of chemical MCMs. Summarize the scope of the parent and supplemental projects, and describe the supplement's specific aims, including research design and methods, and data analysis. Clearly state how the supplemental work relates to the relevant specific aim(s) and scope of the parent award.
- Applicants must include a letter from appropriate institutional biosafety officials, countersigned by the authorized organizational representative/institutional official, indicating that the planned studies are deemed safe for research personnel and the research environment. A formal letter of support (and NIH biographical sketch for any Senior/Key Personnel) must also be provided for all newly proposed collaborative, consultative, and/or contract arrangements.
Please direct all inquiries to:
Dave Yeung, Ph.D.
National Institute of Allergy and Infectious Diseases (NIAID)
Grants Management Contact
Jason A Lundgren
National Institute of Allergy and Infectious Diseases (NIAID)