Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54s)

Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54s) is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

Expired PAR-18-657: Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 Clinical Trial Optional) This notice has expired. Check the NIH Guide for active opportunities and notices. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) of Participating Organizations National Institute of Neurological Disorders and Stroke ( NINDS ) National Eye Institute ( NEI ) National Institute of Arthritis and Musculoskeletal and Skin Diseases ( NIAMS ) National Institute of Environmental Health Sciences ( NIEHS ) National Institute on Drug Abuse ( NIDA ) Funding Opportunity Title Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 Clinical Trial Optional) U54 Specialized Center- Cooperative Agreements Notices of Special Interest associated with this funding opportunity December 21, 2020 - This PAR has been reissued as PAR-20-316 .

July 10, 2020 - Notice of Change to Key Dates for PAR-18-657. See Notice NOT-NS-20-086 . July 8, 2020 - Notice of New Budget Limitation for PAR-18-657.

See Notice NOT-NS-20-085 . March 10, 2020 - Reminder: FORMS-F Grant Application Forms & Instructions Must be Used for Due Dates On or After May 25, 2020- New Grant Application Instructions Now Available. See Notice NOT-OD-20-077 .

Notice of Special Interest: Countermeasures Against Chemical Threats (CounterACT) U54 Centers of Excellence will only support targeted chemical threats of interest. See Notice Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research. See Notice Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research.

See Notice NOT-OD-19-128 . November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228 .

June 14, 2018 - Notice of New Budget Limitation for PAR-18-657 Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54 Clinical Trial Optional).. See Notice NOT-NS-18-072 .

Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity PAR-20-253 , R21 Exploratory/Developmental Research Grant PAR-18-721 , R21 Research Projects U01 Research Project Cooperative Agreements PAR-19-040 , Research Project Cooperative Agreements Additional Information on Eligibility . Catalog of Federal Domestic Assistance (CFDA) Number(s) 93. 853, 93.

867, 93. 846, 93. 865, 93.

113, 93. 279 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.

Open Date (Earliest Submission Date) Letter of Intent Due Date(s) 30 days prior to the application due date September 11, 2018; September 10, 2019; September 9, 2020,October 8, 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. AIDS Application Due Date(s) February 2019; February 2020; February 2021 May 2019; May 2020; May 2021 July 2019; July 2020; July 2021 New Date October 9, 2020 per issuance of NOT-NS-20-086 .

(Original Expiration Date: September 10, 2020 ) ** ELECTRONIC APPLICATION SUBMISSION REQUIRED** NIH's new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants. gov to NIH.

Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.

gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts ) and where instructions in the Application Guide are directly related to the Grants.

gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV .

When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review. Part 1.

Overview Information Part 2. Full Text of the Announcement I. Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Full Text of Announcement Section I. Funding Opportunity Description The overall goal of the NIH Countermeasures Against Chemical Threats (CounterACT) program is to reduce mortality and morbidity during and after emergency events involving the release of chemical threat agents.

Chemical threat agents are toxic chemicals that could cause mass casualties after being released by a deliberate terrorist attack, or by industrial accident or natural disaster. This Funding Opportunity Announcement (FOA) encourages applications for CounterACT Research Centers of Excellence (U54s). The NIH CounterACT Research program includes a network of Research Centers of Excellence and individual research projects.

This grants program is complemented by contracts and Interagency Agreements with the Department of Defense.

The network conducts basic and translational, and pre-clinical research aimed at the discovery and/or identification of better medical countermeasures against chemical threat agents, and it supports their development in preparation for more advanced studies required for FDA approval and to ensure they are effective and safe for use in humans.

The NIH CounterACT U54 program described in this FOA is a central component of this overall larger effort, and is designed to support research centers consisting of three or more projects and scientific cores that synergistically produce rigorous interdisciplinary research of the highest quality.

The Center will also include an administrative core to provide oversight, and a research education core to strengthen the research skills of the scientific workforce in the chemical countermeasures field of study.

To ensure that the supported research is consistent with the overall goals of the program, CounterACT Research Centers of Excellence are milestone-driven cooperative agreements with substantial scientific and programmatic involvement by NIH staff.

CounterACT cooperative agreement U54 Program Directors/Principal Investigators (PDs/PIs) will become members of the CounterACT research network, and will be able to utilize its resources such as the CounterACT Preclinical Development Facility ( CPDF ). They will be required to participate in annual meetings of the national CounterACT research network to share information and ideas.

The CounterACT program at NIH is part of the larger biodefense program coordinated and overseen by the National Institute of Allergy and Infectious Diseases (NIAID) that includes biological and radiation/nuclear threats. Also see www. medicalcountermeasures.

gov which facilitates communication between federal government agencies and public stakeholders to enhance the Nation's public health emergency preparedness. The civilian chemical threat spectrum includes traditional chemical warfare agents (e.g., sarin, chlorine), 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 Terrorism 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 to the NIH.

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 Antidotes that are specific to a chemical 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 against C.

Special Biosafety Certification Many 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., nerve agents.

Therefore, when applicable, applicants are encouraged to collaborate with laboratories that are certified to work with restricted chemical agents, such as the US Army Medical Research Institute of Chemical Defense ( USAMRICD ) and certain contract research facilities. Applicants are strongly encouraged to contact the NINDS Scientific/Research Contact listed in this FOA for further information on working with restricted chemical agents.

This FOA supports translational research. Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease. The categories of research supported under this program include but Basic mechanistic research to identify targets for therapeutic development.

Demonstration of in vitro activity of candidate(s), and generation of preliminary in vivo proof-of-concept Identification of lead candidate therapeutics using primary and secondary screening efforts, and other methods as described in PAR-16-330 Identification of Therapeutic Lead Compounds (U01) ; Optimization of lead candidate therapeutics using human-relevant animal models, bioanalytical assay development, laboratory-scale and scale-up manufacturing, and other methods described in PAR-16-331 Optimization of Therapeutic Lead Compounds (U01) .

CounterACT Research Centers of Excellence should strive to develop a comprehensive drug discovery and development program that includes all the above components (target identification, lead identification, and lead optimization).

The development of a pipeline of candidate therapeutics should be designed to support several projects at once, thereby increasing the probability of achieving the goal of at least one successful lead or optimized lead compound by the end of the project period. Although clinical trials are optional in this FOA, the scientific scope does not necessarily include clinical trials or studies.

Good Laboratory Practices (GLP) IND-enabling safety studies and pivotal efficacy studies in animals, cGMP production, and other studies required for most clinical trials will not be supported in this FOA.

However, in some rare cases when sufficient preclinical studies have been completed, the opportunity for a small mechanistic clinical trial may arise and may be included if this research facilitates the overall goals within the above stated scientific scope of the FOA (i.e. basic research through lead optimization).

Only mechanistic studies that meet the NIH clinical trial definition will be supported; mechanistic trials are studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. Phase 1 and higher trials are generally not supported E.

Scientific Goals and Preparation for Advanced For NEW applications, if a specific new therapy has not yet been identified, the proposed translational research should at minimum demonstrate a clear path towards identification of a lead compound by the end of the project period.

For this FOA, lead candidates(s) are defined as biologically active and synthetically feasible compounds where specificity, affinity, potency, target selectivity, efficacy, and safety have been established. For RENEWAL applications, research under this FOA should culminate in at least one optimized lead/candidate medical countermeasure ready to enter advanced development studies such as IND-enabling GLP and GMP level studies.

Most of the advanced development activities required for regulatory approval (including Phase 1 human safety trials) are not supported under this FOA, but could potentially be supported by other federal agencies or industry once the NIH-supported research is completed.

The HHS advanced development agency relevant to this FOA is the Biomedical Advanced Research and Development Once research funded under this FOA is completed, you should have the following addressed before exploring the possibility of additional support through BARDA's Broad Agency Announcements ( BAAs ) program for advanced research: At least one lead compound with well understood absorption, distribution, metabolism, and excretion (ADME).

Lead compounds are biologically active compounds or hits where affinity, potency, and selectivity have been Efficacy in an appropriate animal model relevant to the proposed concept of use in humans, i.e., the route and timing of therapeutic administration are consistent with a post-exposure treatment window. Initial pharmacology and toxicology studies. Stable and scalable synthesis of the lead compound.

Preliminary regulatory strategy, e.g., a viable Target Product Profile, regulatory expertise, formal communication with the appropriate FDA Commercialization plan for other indications, if applicable.

Intellectual Property Rights/Freedom to Operate For applications seeking a SECOND (OR MORE) RENEWAL , a clear track record of developing products that were transitioned to advanced development during previous project periods must be established.

Applicants are strongly encouraged to review the HHS BARDA BAA during preparation of the NIH research application to ensure the project outcomes align with the needs of the prospective advanced developer. Milestone-driven research is used to ensure research is focused on a well-defined goal and achieving that goal with greatest efficiency.

As translational research is inherently high-risk, the use of milestones provides clear indicators of a project's continued success or emergent difficulties. Milestones should describe the goal of the work and not just a statement that the work will be completed.

Given the high-risk and progressive nature of therapeutics discovery and development, results at any stage of a project might indicate a dead end, for example a toxicology study may reveal that a molecule is unsuitable for human use. Thus, the milestone should indicate the desired outcome of a study and not simply that the study was conducted.

The milestones must provide objective and quantitative outcomes by which to justify advancing the project. The criteria for success of the studies conducted should be objective measures. These should be measures that would be recognizable as appropriate endpoints in the specific scientific area.

They should also have clear success criteria that can be used for evaluation by NIH. For examples of acceptable milestones, see CounterACT-Milestone-Example . Annual milestones may be modified in negotiations with NIH program officials before an initial award is made, and during the review of annual non-competitive applications.

Unmet milestones and an incomplete data package that prevents an adequate interpretation of the results will have a negative impact on the review and approval of these annual non-competing applications. Partial budget reductions and/or restrictions in a given project year may also occur if certain aspects of the project are deemed futile, but others still show promise. G.

Intellectual Property (IP) The NIH encourages the awardees and/or their collaborators to obtain and retain any IP developed around the therapy during the project period. Recipients of awards are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the therapy development process.

PDs/PIs are expected to work closely with their institutional technology transfer officials to ensure that royalty agreements, patent filings, and all other necessary IP arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project. 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. H. Research Topic Examples In general, the scope of research covered in this FOA can also be described by Technology Readiness Levels (TRLs).

The TRLs covered in this FOA should fall between Specific examples of relevant research topics include but are not limited to those listed below: Therapies based on acute toxicity of the chemical threat agent, e.g., new approaches to counteract neurological effects, pulmonary edema, relevant anti-inflammatory drugs, surfactants, antioxidants, the development of better skin and eye protectants.

Natural history animal models of the acute toxicity of chemical threat agents.

These studies could include characterization of long-term effects after sub-lethal acute exposures to chemical threats agents, e.g., neuroprotectants for neurodegeneration and other neurological sequelae, drugs to prevent long-term pulmonary fibrosis, etc. Studies relevant to the special vulnerabilities of pediatric populations and pregnant women as they relate to the development of therapeutics, e.g., acute effects on the developing brain that have long-term effects, the need for therapeutics dosing schedules and routes of administration that are more suitable for children and pregnant women.

Research on the molecular mechanisms of toxicity for the purpose of identifying novel targets, e.g., the mechanisms of nerve agent-induced long-term neurological effects or seizures with respect to temporal and regional changes, roles of cardiac versus neuronal mitochondria in cyanide toxicity, cellular and molecular basis for agent induced pulmonary edema.

Alternate routes of administration for new or approved therapies that would be safe, effective, and easy to administer during a mass casualty scenario, e.g., intramuscular route. I. Special Considerations Due to the urgency in need and the lengthy time and expense to bring a new compound to regulatory approval, applicants are encouraged to consider drugs that are already approved by the FDA for other indications, i.e., repurposing.

Some of these drugs have been shown to be effective in treating victims of chemical exposures, and in some cases, the length of time to regulatory approval for a new indication may be shorter than for a new chemical entity. Applicants are strongly encouraged to work closely with their institutional technology transfer office to obtain and retain any IP developed around the proposed repurposing effort.

Applicants are urged to contact the Scientific/Research Contacts listed in this FOA for more information related to the FDA as well as to seek out appropriate regulatory expertise in support of This FOA will only support translational research that is clearly relevant to the development of therapeutics that will enhance our medical response capabilities during an emergency.

New medical countermeasures that have no practical use during or shortly after a mass casualty situation are not appropriate for this FOA. Drugs only effective if given prior to chemical insult (prophylaxis), or those that must be given within a very short period (1-15 minutes) after the insult, will be of low priority. Since many chemical threats have rapid modes of action, the drug should act rapidly to counter these effects.

The experimental design of proposed studies should be consistent with the timing and route of administration intended for use in humans during a chemical emergency. For example, drugs that are only effective when administered intravenously in the pre-hospital setting would be of low priority since their use would be impractical in a mass casualty situation.

However, in some cases drugs may be given in-hospital to prevent long-term effects after acute exposures. Model development, screening activity and efficacy studies should be designed and justified with these ultimate requirements under Special consideration will be given to research relevant to people who are particularly vulnerable, including the young, the elderly, and individuals with pre-existing medical conditions.

Pregnant women, infants and children are particularly vulnerable to the effects of chemical agents. Animal models and studies that address these vulnerabilities will be of high priority. J.

Center Goals and Subprojects There should be a unifying well-defined goal or problem area of research to which each project relates and contributes, thereby producing a synergistic research environment that allows each research effort to share the resources and creative strengths of the others.

There is the expectation that support of interrelated projects and collaborating investigators would yield results beyond those achievable if each project were pursued separately without formal interaction among the participating investigators. All investigators should contribute to, and share in, the responsibilities of fulfilling the Center objectives and milestones. Milestones for the overall Center should be developed.

These Center milestones should reflect the overall goals and objectives of the Center, and be supported by the milestones proposed in the subprojects. There may only be 3 or 4 Center milestones per year over the course of the entire K.

CounterACT Center Structure Each CounterACT Research Center of Excellence should include the following components: one Administrative Core for Center Management and Operations, three to five interrelated Research and Development Projects, up to three Scientific Cores if needed and well justified, and one Research Education Core. L.

Description of CounterACT Center Components Core for Center Management and Operations The PD/PI or Center Director will be responsible for overall planning and management of the CounterACT Center. The PD/PI is permitted but not required to be a subproject or core investigator.

The PD/PI and Administrative Core staff will be responsible for managing, coordinating, and supervising the entire range of Center activities, effective and efficient manner. This may require both an Administrative and Scientific Program Manager to assist the PD/PI.

The PD/PI and Administrative Core staff will be responsible for ensuring that appropriate systems are in place to provide for biosafety and security of materials, data, and facilities. These projects should be scientifically linked. Examples of how these projects could be linked include: One effect: A single or multiple therapeutic(s) to treat a single type of effect, e.g., inflammation.

This may include therapeutic(s) against one or multiple chemical agents that cause inflammation. One chemical threat: A single or multiple therapeutic(s) to treat a single type of chemical threat, e.g. nerve agents. This may include therapeutic(s) against one or multiple kinds of effects caused by nerve agents (e.g., neurological, pulmonary, dermal).

Scientific Core facilities may be proposed if they will be utilized by at least two of the projects. Such core facilities should provide services that are already available, fully developed, and cannot be funded through other means for the purposes proposed.

If subprojects are removed, replaced, or redirected during the funding period, core facility funds may be rebudgeted within the individual CounterACT Center upon approval by the NIH. Scientific Core facilities may include clinical, statistical, technical, or other supportive activities.

One goal of the CounterACT program is to increase the number and capabilities of researchers and other personnel in applied toxicological research related to chemical threats. In general, the research education core should be multidisciplinary and provide short-term education for technicians, medical or graduate students, postdoctoral fellows, and/or independent investigators, either within or beyond the CounterACT Center.

Formal graduate programs are excluded from this FOA. The proposed core should build on the strengths of the Center investigators, although outside instructors may be incorporated on occasion to provide cross-disciplinary depth. Proposed activities within the core should facilitate the development of skills in the use of assays, methods, reagents, animal models, or technologies to develop new products through the regulatory process.

Center Steering Committee: A Steering Committee for each CounterACT Center will make strategic decisions with regard to goals and research implementation of the Center to ensure that scientific milestones are met, resources are shared, and productive collaborations are established.

The Center Steering Committee will meet as frequently as possible utilizing various modes of communication, and be composed of the PD/PI, subproject investigators and other members with relevant scientific expertise. The NIH program official will serve on this committee. Awardees will form an External Advisory Committee.

This committee will provide subjective evaluation of the annual progress of the Center and make recommendations to the Center PD/PI. The Committee should meet once per project year. To maintain the largest possible reviewer pool for this FOA, applicants should not propose specific external advisors and should not contact potential members prior to NIH review of the application.

M. Pre-application Consultation As a cooperative agreement, implementation will involve the participation of NIH Program staff in the planning and execution of the therapy-directed projects. Applicants are strongly encouraged to consult with NIH Scientific/Research staff when planning an application.

Early contact provides an opportunity for NIH Scientific/Research staff to provide further guidance on program scope, goals, developing appropriate milestones, and budget. Applicants should contact NIH Scientific/Research staff at least 12 Information for award authorities and regulations. Section II.

Award Information Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.

2 for additional information about the substantial involvement Application Types Allowed Glossary and the SF424 (R&R) Application Guide provide details on Optional: Accepting applications that either propose or do not propose clinical trial(s) help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications. Application budgets may not exceed $2. 5 million in direct Many applications will not need to request the maximum budget and the size and duration of the awards will vary because the nature and scope of research programs will vary.

The total project period may not described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: o Hispanic-serving Institutions o Historically Black Colleges and Universities (HBCUs) o Tribally Controlled Colleges and Universities (TCCUs) o Alaska Native and Native Hawaiian Serving Institutions o Asian American Native American Pacific Islander Serving Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Nonprofits without 501(c)(3) IRS Status (Other than Institutions For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Institutions) are Non-domestic (non-U.S.) components of U.S. Organizations are not eligible Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

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 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 Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number.

After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application. System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually .

The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code. Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants. gov registration.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to must have an active DUNS number and SAM registration in order to complete the 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.

Eligible Individuals (Program Director/Principal 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 This FOA does not require cost sharing as defined in the NIH Grants Policy Statement . 3.

Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time.

This means that the NIH will A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application. An application that has substantial overlap with another