EXPIRED
National Institutes of Health (NIH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Eye Institute (NEI)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
Countermeasures Against Chemical Threats (CounterACT) Exploratory/Developmental Projects in Translational Research (R21 Clinical Trial Not Allowed)
R21 Exploratory/Developmental Research Grant
Reissue of PAR-15-315
PAR-18-721
PAR-18-657, U54 Specialized Centers - Cooperative Agreements
PAR-19-039, U01 Research Project Cooperative Agreements PAR-19-040, U01 Research Project Cooperative Agreements93.853, 93.867, 93.846, 93.867; 93.279; 93.113
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.
March 28, 2018
April 30, 2018
30 days prior to the application due date
New Date May 30, 2018; May 28, 2019; June 30, 2020, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
November 2018, November 2019, November 2020
January 2019, January 2020, January 2021
July 2019, July 2020, July 2021
New Date July 1, 2020 per issuance of NOT-NS-20-064. (Original Expiration Date: May 27, 2020)
Not Applicable
A. Overview
This FOA encourages applications for exploratory and developmental translational research projects to identify and develop novel medical countermeasures (drug or biologic) to reduce mortality and morbidity resulting from acute exposures to chemical agents identified by the U.S. Government (USG) as threats to the population. Chemical threat agents are toxic compounds that could be released by a deliberate terrorist attack against civilians, or by accidental or natural disaster causing mass casualties. CounterACT Exploratory/ Developmental Projects in Translational Research (R21) will be utilized to support 1-2 year pilot studies to generate preliminary efficacy data for therapeutics to treat injuries resulting from exposure to these chemicals. Pilot studies may include the creation and validation of screening assays for therapy development, identification of candidate therapeutic targets, and development of proof-of-principle efficacy data for the candidate therapy compounds. It is expected that the preliminary data from these R21 projects will be used in support of research applications for transition to related chemical medical countermeasures research and development programs, to include NIH CounterACT supported milestone-driven Cooperative Agreement programs.
B. Background
The CounterACT program is part of the larger NIH Biodefense program and the Chemical Countermeasures Research Program (CCRP) coordinated by the National Institute of Allergy and Infectious Diseases (NIAID). CounterACT and the CCRP are part of the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE), which coordinates medical countermeasures-related efforts across the Department of Health & Human Services (HHS) and other USG partners.
The overarching goal of the CounterACT program is to integrate cutting-edge research with the latest technological advances in science and medicine to enhance the nation's medical response capabilities during chemical emergencies. This is a trans-NIH effort, involving partnerships with the NEI, NIAID, NIAMS, NICHD, NIEHS, NIDA, and NINDS to execute the overall NIH Strategic Plan and Research Agenda for Medical Countermeasures Against Chemical Threats.
The NIH has developed a comprehensive research and product development program that includes Research Centers of Excellence (U54), individual research projects (U01), exploratory and developmental translational research projects (R21), SBIR projects, contracts, and Interagency Agreements with the Department of Defense (DoD) and HHS. The program supports basic, translational, and preclinical research aimed at the discovery and/or identification of better medical countermeasures against chemical threat agents, and guides their movement through the regulatory process in collaboration with other federal departments, agencies, and initiatives, such as the Biomedical Advanced Research and Development Authority (HHS BARDA), FDA Medical Countermeasures Initiative (MCMi), and the Defense Threat Reduction Agency (DoD DTRA).
CounterACT Translational Research R21 Program Directors/Principal Investigators (PDs/PIs) will become members of the CCRP, and will be able to utilize its resources, such as the CounterACT Preclinical Development Facility (CPDF). They will be expected to participate in annual meetings of the CounterACT Network to share information and ideas.
C. Chemical Threats of Research Interest
The civilian chemical threat spectrum includes chemical warfare agents (e.g., sarin, chlorine, sulfur mustard), toxic industrial chemicals (e.g., hydrogen sulfide, cyanide), pesticides (e.g., parathion, brodifacoum), pharmaceutical-based agents (e.g., opioids), and other chemicals. These agents are included on the current Department of Homeland Security (DHS) Chemical Threat Risk Assessment (CTRA) list, which is for USG official use only and cannot be included in this FOA. Applicants are strongly urged to contact the Scientific/Research staff listed in this FOA to determine if their proposed threat agent(s) is of interest for this FOA. Applications that propose research on chemical threats that are not included on the CTRA list will not be selected for funding. Therefore, it is critical to contact NIH staff early, before time and effort are invested in developing an application to support research on a chemical or group of chemicals that is not a priority for this FOA.
Antidotes that are chemical-threat specific will be considered; however, applicants should also consider research on acute effects and pathologies that are common to several chemical threat agents, so that the therapeutics being developed will have a broader spectrum of activity, i.e., efficacious against more than one chemical threat.
D. Special Biosafety CertificationMany of the chemical threat agents of interest are extremely hazardous to humans. This FOA will only consider supporting studies deemed safe for research personnel and the environment by appropriate official institutional biosafety review. Special biosafety certifications may be required to conduct research with some chemical threat agents, e.g., chemical warfare agents. Therefore, applicants are encouraged to collaborate with laboratories that are already certified to work with restricted chemical agents, such as the U.S. Army Medical Research Institute of Chemical Defense (USAMRICD) and certain contract research facilities, when applicable. Applicants are strongly encouraged to contact the NINDS Scientific/Research Contact listed in this FOA for further information on working with restricted chemical agents.
E. Scientific Scope/Research TopicsThe CounterACT R21 program will only support translational research that is clearly relevant to the development of new or improved medical countermeasures that will enhance our medical response capabilities during a chemical emergency. Projects supported by this translational research FOA are expected to generate preliminary preclinical, screening, and/or efficacy data that would facilitate the development of competitive applications for more extensive support from the NIH CounterACT Cooperative Agreement programs or other related initiatives. The scope of research supported under this R21 program includes, but is not limited to:
The NIH encourages the awardees and/or their collaborators to obtain and retain any IP developed around the therapy during the project period as appropriate. Recipients of awards are encouraged to work closely with their institutional Technology Transfer (or Industry Relations) Office to identify and foster relationships with potential licensing and commercialization partners early in the therapy development process. In accordance with the NIH Grants Policy Statement, PDs/PIs are expected to ensure that appropriate royalty agreements, patent filings, and all other necessary IP arrangements are managed in a timely manner and that commercialization plans are developed and updated over the course of the project, consistent with achieving the goals of the program. It is recognized that in the case of medical countermeasures, commercialization may be challenging. Therefore, applicants are encouraged to discuss alternative strategies with NIH Scientific/Research staff to get further guidance.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
New
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Not Allowed: Only accepting applications that do not propose clinical trials
Need help determining whether you are doing a clinical trial?
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
The budget for direct costs for the two year project period may not exceed $275,000. No more than $200,000 may be requested in any single year.
The total project period for an application submitted in response to this funding opportunity may not exceed 2 years.
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.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
The letter of intent should be sent to:
Shardell Spriggs, Ph.D.
Telephone: 301-443-8189
Fax: 301-402-1501
Email: shardell.spriggs@nih.gov
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed
The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Attachments: If applicable, applications are encouraged to include an Intellectual Property (IP) strategy section that is no more than 1 page. It is advisable that this be prepared in consultation with their institution's technology transfer officials.All instructions in the SF424 (R&R) Application Guide must be followed.
The proposed budget should include travel support for the PD/PI to attend the Annual CounterACT Network Research Symposium for each of the proposed project years, in addition to other anticipated travel associated with the research. Post-doc, junior, and diverse investigators are encouraged to attend these meetings and budgets should be planned accordingly.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy: An R21 exploratory/developmental grant application in translational research should have a strong biological rationale for the intended approach and the proposed studies must exhibit methodological rigor. A well-structured application should, therefore, include clear rational experimental approaches that can yield significant preliminary data in support of more advanced drug discovery and development efforts in future follow-on applications. Applicants to the program are urged to consider the rationale for the chosen model(s) and endpoints, adequacy of controls, route and timing of therapeutic dosing, justification of sample size, statistical methods, blinding methods, strategies for randomization, and robustness and reproducibility of results. These criteria should also be addressed when describing supporting data (if presented) and in the design of the proposed studies within the Research Strategy section (as appropriate).Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
When involving NIH-defined human subjects research, clinical research, and/or clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions:
Delayed Onset Study
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.
Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.
This FOA is encouraging innovative and exploratory R21 translational research applications that may involve nonstandard methodologies applied toward novel therapeutic development approaches. However, it is also recognized that due to the nature of translational research, some studies such as preclinical safety evaluations, those striving to identify potential differences in vulnerabilities of specific subpopulation groups, or those seeking to determine the preclinical efficacy of FDA-approved/unapproved compounds may include standard routine tests and/or previously established models of chemical-induced injuries. While these may not be considered especially innovative, they may nonetheless still be essential to advance the development of medical countermeasures (and scientific knowledge) to achieve the goals of the CounterACT program.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Is the timeline reasonable for the work proposed? Does the proposed project use sufficient experimental and statistical rigor? For key experiments, does the application explain assumptions for power analysis, describe statistical analysis methods and criteria for data inclusion or exclusion, and detail the procedures of how blinding and randomization will be conducted?
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
Not Applicable
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267
For questions related to ocular injury research:
Houmam Araj, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: arajh@nei.nih.gov
For questions related to pulmonary injury research:
Srikanth S. Nadadur, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-5327
Email: nadadurs@niehs.nih.gov
For questions related to pharmaceutical based agents:
Kristopher Bough, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-443-9800
Email: boughk@nih.gov
Carol Jelsema, Ph.D.
Center for Scientific Review
Telephone: 301-435-1248
Email: cj21t@nih.gov