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Notice of Special Interest: Administrative Supplements for Existing NIH Countermeasures Against Chemical Threats (CounterACT) Program Research Grants and Cooperative Agreement Awards

Notice of Special Interest
Monday, January 6, 2020
Tuesday, August 4, 2020
333
NOT-NS-20-029

Funding Opportunity Purpose

Notice Special Interest: Administrative Supplements Existing NIH Countermeasures Against Chemical Threats CounterACT) Program Research Grants Cooperative Agreement Awards Notice Number: NOT-NS-20-029 Key Dates Release Date: January 6, 2020 First Available Due Date: August 03, 2020 Expiration Date: August 04, 2020 Related Announcements PA-18-591 NOT-NS-20-030 Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose NIH inviting administrative supplement applications provide additional funds active CounterACT research grants cooperative agreement projects support activities such new collaborations pilot studies were unanticipated the time the new competing continuation application submitted. proposed activities must within original research scope the parent award. Supplemental funding includes direct costs well associated facilities administrative costs. supplement project start any time during budget period must end the last day the budget period. parent award not in terminal no-cost extension going a no-cost extension FY2020. Application budgets limited 75,000 total costs must reflect actual needs the proposed project. Only parent CounterACT research grant cooperative agreement awards funded through following FOAs any reissues these announcements) eligible request supplemental funding under NOSI: PAR-13-208: Countermeasures Against Chemical Threats CounterACT) Cooperative Research Projects U01) PAR-15-146; PAR-16-329; PAR-18-657: Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional) PAR-16-330: Countermeasures Against Chemical Threats CounterACT): Identification Therapeutic Lead Compounds U01 Clinical Trial Allowed) PAR-16-331: Countermeasures Against Chemical Threats CounterACT): Optimization Therapeutic Lead Compounds U01 Clinical Trial Optional) PAR-18-721: Countermeasures Against Chemical Threats CounterACT) Exploratory/Developmental Projects Translational Research R21 Clinical Trial Allowed) Scope Interest overall goal the NIH Countermeasures Against Chemical Threats CounterACT) program to support research development therapeutics can reduce mortality morbidity the event the release chemical threat agents. Chemical threat agents toxic compounds could released a deliberate terrorist attack against civilians, by accidental natural disaster causing mass casualties. include chemical warfare agents e.g., sarin, chlorine, sulfur mustard), toxic industrial chemicals e.g., cyanide, hydrogen sulfide, phosgene), pesticides e.g., parathion, brodifacoum), pharmaceutical-based agents e.g., opioids) other chemicals. Applications proposing research chemical threats are of interest the program not considered funding. research related opioid threats being proposed, NOT-NS-18-019 a description research supported the NIH CounterACT program. Examples topics interest include, are limited to: Facilitating collaborations fellow awardees within CounterACT community Identify and/or recruit new resources such investigators additional expertise, industry partner, research tools, systems, assays enhance outcomes the parent award Limited, pilot studies establish proof-of-principle approaches Investigators planning submit application response this NOSI strongly advised contact discuss proposed research/aims the Program Officer their parent CounterACT award well advance the receipt deadline better determine appropriateness relevance the supplement project Application Submission Information Applications this initiative must submitted using following opportunity its subsequent reissued equivalent. PA-18-591 - Administrative Supplements Existing NIH Grants Cooperative Agreements Parent Admin Supp Clinical Trial Optional) instructions the SF424 R&R) Application Guide PA-18-591 must followed, the following additions Research Strategy part the application, summarize scope the parent supplemental projects describe proposed aims research strategy the new study. Clearly state the supplemental efforts fit the scope the parent award. research strategy should clearly demonstrate the new collaboration(s), resource(s), and/or studies benefit parent award why those otherwise be feasible either within currently funded efforts by rebudgeting funds. Applicants the program urged consider directly address elements rigor reproducibility described NOT-OD-15-103 their experimental design. Administrative Evaluation Criteria the proposed supplemental project outcomes relevant the NIH CounterACT program mission goals? the work proposed within scope the active parent award? Does proposed research/scientific team possess expertise conduct achieve goals the supplemental study? Does supplemental proposal include well-described, rigorous scientific approach? the project yield significant preliminary data support more advanced drug discovery development efforts? the scope budget reasonable the proposed studies? Letters Support Applicants must include letter appropriate institutional biosafety officials indicating studies deemed safe research personnel the environment. formal letter support must provided all newly proposed collaborative, consultative, and/or contract arrangements. Application Due Date(s) – August 3,2020, 5:00 PM local time applicant organization. funding consideration, applicants must include “NOT-NS-20-029” without quotation marks) the Agency Routing Identifier field box 4b) the SF424 R&R form. Applications without information box 4b not considered this initiative. Requests be one year support only. Research Strategy section the application limited 6 pages. Only existing awardees CounterACT program eligible apply. process Streamlined Submissions using eRA Commons cannot used this initiative. Applicants strongly encouraged notify CounterACT Program Officer the parent award a request been submitted response this FOA order facilitate efficient processing the request. application budget cannot exceed 75,000 total costs must reflect actual needs the project. Inquiries Please direct inquiries related the overall NIH CounterACT Program and/or parent awards managed the National Institutes Neurological Disorders Stroke NINDS) to: David A. Jett, PhD Telephone: 301-496-6035 Email: jettd@nih.gov Shardell M. Spriggs, PhD Telephone: 301-443-8189 Email: shardell.spriggs@nih.gov parent awards managed the National Institute Arthritis Musculoskeletal Skin Diseases NIAMS): Hung Tseng, Ph.D. Telephone: 301-594-5032 Email: tsengh@mail.nih.gov parent awards managed the National Eye Institute NEI): Houmam Araj, Ph.D. Telephone: 301-451-2020 Email: arajh@nei.nih.gov parent awards managed the National Institute Environmental Health Sciences NIEHS): Srikanth S. Nadadur, Ph.D. Telephone: 984-287-3296 Email: nadadurs@niehs.nih.gov parent awards managed the National Institute Drug Abuse NIDA): Kristopher Bough, Ph.D. Telephone: 301-443-9800 Email: boughk@nih.gov

Notice of Special Interest: Countermeasures Against Chemical Threats (CounterACT) U54 Centers of Excellence will only support targeted chemical threats of interest

Notice of Special Interest
Monday, January 6, 2020
Thursday, September 10, 2020
U54
NOT-NS-20-031

Funding Opportunity Purpose

Notice Special Interest: Countermeasures Against Chemical Threats CounterACT) U54 Centers Excellence only support targeted chemical threats interest Notice Number: NOT-NS-20-031 Key Dates Release Date: 01/06/2020 First Available Due Date: September 09, 2020 Expiration Date: September 10, 2020 Related Announcements PAR-18-657 Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional) Issued National Institute Neurological Disorders Stroke NINDS) National Eye Institute NEI) National Institute Arthritis Musculoskeletal Skin Diseases NIAMS) National Institute Drug Abuse NIDA) National Institute Environmental Health Sciences NIEHS) Purpose NIH Countermeasures Against Chemical Threats CounterACT) program supports research development therapeutics can reduce mortality morbidity the event the release chemical threat agents. important component the CounterACT research network the U54 Research Centers Excellence. U54 Centers designed support three more projects scientific cores having unifying well-defined goal problem area research synergistically produce rigorous interdisciplinary research the highest quality. is expectation support interrelated projects collaborating investigators yield results beyond those achievable each project pursued separately without formal interaction among participating investigators. more information the CounterACT Program, please visit our website. view list currently funded projects, please visit our webpage, CounterACT Research Network Funded Investigators. NIH CounterACT program issuing NOSI provide chemical threat agents will supported grant applications the September 9, 2020 receipt date PAR-18-657 U54 Centers Excellence. only chemical agents will supported the U54 program are: Blood/Metabolic Agents: hydrogen cyanide, potassium cyanide sodium cyanide Organophosphorus OP) Chemical Warfare Agents Pesticides Opioids: carfentanil, fentanyl related analogs, NOT-NS-18-019 Pulmonary Agents: chlorine phosgene Vesicants: sulfur mustard lewisite Applicants strongly encouraged contact CounterACT Program Staff listed the parent funding opportunity announcement PAR-18-657) determine their proposed threat agent(s) of interest the NIH CounterACT program. Applications propose research chemical threats are listed above not considered funding. research related opioid threats being proposed, NOT-NS-18-019 a description research supported the NIH CounterACT program. Application Submission Information Submit applications this initiative using following funding opportunity announcement through expiration date this notice. PAR-18-657 - Countermeasures Against Chemical Threats CounterACT) Research Centers Excellence U54 Clinical Trial Optional) notice applies the September 9, 2020 due date PAR-18-657. instructions the SF424 R&R) Application Guide the funding opportunity announcement used submissionmust followed, the following additions funding consideration, applicants must include NOT-NS-20-031” without quotation marks) the Agency Routing Identifier field box 4B) the SF424 R&R form. Applications without information box 4B not considered this initiative. Applications nonresponsive terms this NOSI be be considered the NOSI initiative. Inquiries Please direct inquiries the Scientific/Research, Peer Review, Financial/Grants Management contacts Section VII the listed funding opportunity announcements.

Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01 Clinical Trial Not Allowed)

PAR
Friday, October 26, 2018
Wednesday, September 15, 2021
U01
PAR-19-039

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Cooperative Agreement (U01) Research Projects for research on the identification of small molecule or biologic lead compounds that are excellent candidates for therapeutic development. The mission of the CounterACT program is to foster and support research and development of new and improved therapeutics for chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pharmaceutical-based agents, and pesticides. The scope of research supported by this FOA includes confirmation of molecular targets for therapeutic development, demonstration of in vitro activity of candidate therapeutics, preliminary in vivo proof-of-concept efficacy data, preliminary adsorption, distribution, metabolism, excretion, and toxicity (ADME/Tox) evaluations and pharmacokinetics/pharmacodynamics (PK/PD) data. These studies should result in the identification of at least one lead compound ready for optimization. Lead compounds are biologically active and synthetically feasible compounds where specificity, affinity, potency, target selectivity, efficacy, and safety have been established. Lead compounds should be ready for more advanced development under possible support from other programs such as the one described in the companion FOA "CounterACT Optimization of Therapeutic Lead Compound (U01)" (PAR-18-NNN). The scope of this FOA encompasses Technical Readiness Level (TRL) 1-3 - see TRLs. Each project must include annual milestones that create discrete go or no-go decision points in a progressive translational study plan.

Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01 Clinical Trial Optional)

PAR
Friday, October 26, 2018
Wednesday, September 15, 2021
U01
PAR-19-040

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Cooperative Agreement (U01) Research Projects for research on the optimization of small molecule or biologic compounds that are excellent candidates for therapeutic development. The mission of the CounterACT Program is to foster and support research and development of new and improved therapeutics for chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pharmaceutical-based agents, and pesticides. A previously identified lead compound is required to be eligible for this funding opportunity. In this regard, lead compounds are defined as biologically active compounds or hits where affinity, potency, target selectivity, and preliminary safety have been established. The scope of research supported by this FOA includes development of appropriate human-relevant animal models and generation of in vivo efficacy data consistent with the intended use of the product in humans. It also includes bioanalytical assay development and validation, laboratory-scale and scaleable manufacturing of the product, and non-GLP toxicity and pharmacology studies. The scope of this FOA encompasses Technical Readiness Levels (TRLs) 4-5 - see TRLs. Each project must include annual milestones that create discrete go or no-go decision points in a progressive translational study plan.

Countermeasures Against Chemical Threats (CounterACT) Exploratory/Developmental Projects in Translational Research (R21 Clinical Trial Not Allowed)

PAR
Wednesday, March 28, 2018
Wednesday, May 27, 2020
R21
PAR-18-721

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) exploratory/developmental translational research (R21). The mission of the CounterACT program is to foster and support research and development of new and improved therapeutics to mitigate the health effects of chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pesticides, and pharmaceutical-based agents. The scope of the research includes basic toxicological research on the chemical threat for the purpose of target and therapeutic hit identification, hit validation, lead optimization, and demonstration of in vivo ADME/Tox and efficacy. Projects supported by this FOA are expected to generate preliminary data that would facilitate the development of competitive applications for more extensive support from the NIH CounterACT Cooperative Agreement programs or other related initiatives.

Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 Clinical Trial Optional)

PAR
Tuesday, February 13, 2018
Thursday, September 10, 2020
U54
PAR-18-657
David A. Jett

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54s). The mission of the CounterACT program is to foster and support research and development of new and improved therapeutics for chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, pharmaceutical-based agents, and pesticides. The scope of the research includes target and candidate identification and characterization, through candidate optimization and demonstration of in vivo efficacy consistent with the product's intended use in humans. For applicants submitting U54 renewal applications, research under this FOA should culminate in an optimized lead compound ready for advanced development. The Centers will contain at least three research projects supported by an administrative core, up to three optional scientific cores, and a research education core. Each research project must include milestones that create discrete go or no-go decision points in a progressive translational study plan.