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; 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 review.

Required Application Instructions

It is critical that applicants follow the 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

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The overall goal of the NIH 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 Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54s).

The NIH CounterACT Research program includes a network of Research Centers of Excellence, individual research projects, 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 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 subprojects 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; http://www.ninds.nih.gov/research/counterterrorism/cpdf.pdf). 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 by the National Institute of Allergy and Infectious Diseases (NIAID) that includes biological and radiation/nuclear threats (http://www3.niaid.nih.gov/topics/BiodefenseRelated/). 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 chemical warfare agents (e.g., sarin), toxic industrial chemicals (e.g., cyanide), pesticides (e.g., parathion), and other chemicals. Applicants are strongly urged to contact the Scientific/Research staff listed in this FOA to determine if their proposed threat agent(s) is included on the current Department of Homeland Security (DHS) Chemical Threat Risk Assessment (CTRA) list, which is designated For Official Use Only. 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 to the NIH.

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 more than one chemical.

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’s Medical Research Institute of Chemical Defense (http://chemdef.apgea.army.mil/) 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 are not limited to:

• Basic mechanistic research to identify targets for therapeutic development
• Creation and development of screening assays for therapy development that are validated and the method of validation well-justified, e.g., appropriate pharmacology, robustness, relevant pathology, etc
• Creation and validation of natural history animal models of lethality and serious morbidity caused by chemical threats that can be extrapolated to humans, and with the intended use of therapeutic development
• Identification of candidate therapeutics using primary and secondary screening efforts
• Generating preliminary proof-of-principle data on the in vitro and in vivo efficacy of candidate therapeutics
• Advanced efficacy studies with appropriate animal models. These studies should be based on the intended use in humans including the route and timing of administration at human equivalent doses
• Preliminary and advanced preclinical research including safety and pharmacokinetic studies with candidate therapeutics

One goal of the research supported under this FOA is to prepare for advanced development. Most of the advanced development activities required for regulatory approval are not usually covered 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 Authority (BARDA) (see http://www.phe.gov/about/barda/Pages/default.aspx). Once research funded under this FOA is completed, you should have the following before exploring the possibility of additional funding through BARDA for advanced development.

• At least one lead compound. Lead compounds are biologically active compounds or hits where affinity, potency, and selectivity have been established.
• Efficacy in an appropriate animal model
• Initial pharmacology and toxicology studies
• Stable and scalable synthesis of the lead compound
• Preliminary regulatory strategy including a Target Product Profile and regulatory expertise
• Commercialization plan for other indications if applicable
• Intellectual Property Rights

If a specific new therapy has not yet been identified, the proposed translational research should demonstrate a clear path towards identification of a lead compound by the end of the project period.

Important links to FDA Guidance and other regulatory information can be found under the Related Information section on the CounterACT website (see http://www.ninds.nih.gov/research/counterterrorism/CounterACT_Core_Resources.htm)

Milestone-driven research is used to ensure research is focused on a well-defined goal, thus 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 http://www.ninds.nih.gov/research/counterterrorism/developing_milestones.htm.

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 or revision applications.

NIH emphasizes the importance of the robustness and reproducibility of experimental results. In some cases, conducting additional critical experiments will be important for NIH to have confidence in making a funding decision. Therefore, NIH Program staff, in consultation with the PD/PI, may add experiments that need to be conducted to the milestones prior to or during the award. In some cases, these studies will be supported by additional funds or support from NIH.

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.

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., development of new and/or improved anticonvulsants, new approaches to counteract 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 fibrosis in the lung, etc.
• Studies on 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

Because of the urgency in need, and the lengthy time and expense for bringing a new compound to regulatory approval, applicants are encouraged to consider drugs that are already approved by the FDA for other indications. 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 urged to contact the Scientific Contacts listed in this FOA for more information related to the FDA..

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 to 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 porposed 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 consideration.

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.

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 inter-related 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 project period.

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
• One Research Education Core

Administrative 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, monitoring progress, and ensuring that a strategic plan is implemented in an 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.

Research and Development Projects

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(s)

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.

Research Education

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.

Program Oversight

CounterACT 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.

External Advisory Committee:

Awardees will form an External Advisory Committee. This committee will provide subjective evaluation of the annual or progress of the Center, and make recommendations to the Center PD/PI. The Committee should meet once per project year. In order 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.

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 weeks before a due date.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made in response to 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:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• 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
• Regional Organizations

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.

• Dun and Bradstreet 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.
  • NATO 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.
• eRA Commons - Applicants 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 submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

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 not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• 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 application pending appeal of initial peer review (see NOT-OD-11-101).

In addition, the NIH will not accept a resubmission (A1) application that is submitted later than 37 months after submission of the new (A0) application that it follows. The NIH will accept submission:

• To an RFA of an application that was submitted previously as an investigator-initiated application but not paid;
• Of an investigator-initiated application that was originally submitted to an RFA but not paid; or
• Of an application with a changed grant activity code.

Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

David A. Jett, Ph.D.
Telephone: 301-496-6035
Fax: 301-402-4225
Email: jettd@ninds.nih.gov

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	12
Admin Core	12
Core (used for Scientific Core and Research Education Core)	6
Project	12

Additional page limits 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 a multi-component application.

Revision applications must include an Overall component and the components that are affected by the revision. Therefore, the component requirements listed below may not apply to the revision application.

The application should consist of the following components:

• Overall: required
• Administrative Core: required
• Scientific Core: optional; Maximum of 2
• Research Education Core: required
• Project: Minimum of 3 required; Maximum of 5

When preparing your application in ASSIST, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: The specific aims should briefly but specifically describe the goals of the proposed research of the overall Center, and summarize the expected outcome(s), including the impact the proposed research will exert on the field.

Research Strategy: The Overall Research Strategy should present the overall vision for the proposed CounterACT Center including the following segments:

• Describe a unifying well-defined goal of the research and development program, e.g., lead series of compounds, validated targets or animal models, pre-IND package, etc. Include the overall vision of the research even if it is beyond the proposed project period.
• In support of these overall goals, provide Center Milestones; include the year of projected completion. Center milestones should reflect discrete steps towards the overall goal(s) of the Center during the entire project period. They should be supported by annual subproject milestones described below. Milestones toward therapeutic intervention are not a description of specific aims and experiments, but rather are discrete goals that create go or no-go decision points that include quantitative success criteria.
• Describe how the Center research will enhance medical response capabilities during a chemical emergency, including exactly how the therapeutic(s) would be used in a mass casualty situation. The ultimate intended use of a drug should be discussed within the application, including timing and route of administration that are consistent with its effective use in an emergency civilian setting. Or if focused on model development only, how the models will be used to advance therapeutic development, and why they are relevant to serious morbidity and/or mortality in humans. It is noted however that because of the usual large size and scope of a typical Research Center of Excellence, animal model development usually is accompanied by testing of therapeutic candidates.
• Describe how each project relates and contributes to the others, including how they would yield results beyond those achievable if each project were pursued separately without formal interaction among the participating investigators.
• Outline the major strength of the research team in the context of the proposed area of focus; characterize the relevant expertise of team members and the advantages of their respective research environments.
• As the research strategy is prepared, it is important to note that NINDS believes that applications that propose preclinical research, or clinical applications that are based on previous preclinical data, will be greatly strengthened if the design, execution, and interpretation of the proposed studies and supporting data are adequately described. NINDS encourages investigators, whenever possible, to address these elements directly in their applications. Investigators are urged to discuss these issues with Scientific/Research staff prior to submission of applications.
• For renewal applications only, describe progress of CounterACT Research Center to date.

Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. Letters of support for the CounterACT U54 overall should be included with the Overall component. Letters of support for individual scientific projects or cores should be included with those components of the application. If restricted chemical agents will be used at collaborating laboratories, the approval to use these by appropriate authorities should be included in the letter of support.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

The Data Sharing Plan should be submitted in the Overall component and should appl to all components of the application. A plan for distribution of data or samples generated in Research Projects should be included, and should conform to the NIH policy on data and resource sharing (http://grants.nih.gov/grants/policy/data_sharing)

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Admin Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Facilities and Other Resources: Describe institutional commitment; include any relationships to other affiliates, clinical or medical centers at the Center as appropriate.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
• The PD/PI should be the director of the Administrative Core and should commit at least 10% Person Months to these responsibilities, in addition to his/her own CounterACT Center research and other activities, if applicable.

Budget forms appropriate for the specific component will be included in the application package. When appropriate, awardees will be expected to collaborate; share novel reagents, assays, and animal models; and share both positive and negative results that would help guide the research and development activities of other CounterACT awardees. These activities will be facilitated by annual meetings of CounterACT investigators. Budgets should include cost for travel to one annual meeting of CounterACT investigators each of the proposed project years, in addition to other anticipated travel associated with the research.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: The specific aims should briefly but specifically describe the goals of the administrative core.

Research Strategy: The Administrative Core description should:

• Describe the organization of the leadership structure and overall Center structure (provide respective organizational diagrams); roles of program managers and other personnel if applicable
• Outline the responsibilities of PD(s)/PI(s) [avoid duplication with the standard required item Multiple PD/PI Leadership Plan (see below)]
• Describe the overall plans for the participation in CounterACT Center Steering Committee and External Advisory Committee, including frequency of meetings, teleconferences, video or web meetings
• Outline the organization and functioning of the Administrative Core, including support staff.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Omit the Sharing Plans here as they were provided in the Overall section.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Scientific Core)

• Complete only the following fields:
• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Scientific Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Scientific Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Scientific Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Scientific Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Scientific Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Scientific Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: The specific aims should briefly but specifically describe the goals of the scientific core.

Research Strategy: The research strategy for the scientific core should:

• Provide a clear justification for each scientific core and how it will support the research projects, including how they will be utilized by at least two of the projects.
• Describe how each scientific core supports the overall goals of the center.
• If repositories for cells, tissues, data, or reagents are included, describe methods to obtain, protect, and archive relevant pathological, clinical, and family history information. In addition, appropriate informatics capability should be provided to track data and link to other data sets.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Omit the Sharing Plans here as they were provided in the Overall section.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Scientific Core)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Scientific Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Project.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Project)

• Complete only the following fields:
• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Project)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Project)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: The specific aims should briefly but specifically describe the goals of the Research and Development Project.

Research Strategy: The Research Strategy section should:

• Follow PHS398 instructions, including sub-sections describing Significnace, Innovation, Approach, and Preliminary Studies for New Applications, or a Progress Report for Renewal and Revision Applications.
• Describe the research project in sufficient detail to enable reviewers to judge its scientific merit.
• In support of the Specific Aims of the project, provide annual milestones. Milestones toward therapeutic intervention are not a description of specific aims and experiments, but rather are discrete goals that create go or no-go decision points that include quantitative success criteria.
  (For examples of acceptable milestones, see http://www.ninds.nih.gov/research/counterterrorism/developing_milestones.htm)
• Disicuss the ultimate intended use of a drug, including timing and route of administration that are consistent with its effective use in humans in an emergency civilian setting

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Omit the Sharing Plans here as they were provided in the Overall section.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Project)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Project)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

When preparing your application in ASSIST, use Component Type Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Research Education Core)

• Complete only the following fields:
• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Education Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Education Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Education Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Education Core)

In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.

In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.

Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.

If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Education Core)

Budget forms appropriate for the specific component will be included in the application package.

A minimum of $50,000 in direct costs must be allocated to the Research Education Core activities.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Research Education Core)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is allowed for each component.

Specific Aims: The specific aims should briefly but specifically describe the goals of the Research Education Core.

Research Strategy: This section should describe:

• Plans to create/expand local and remote capabilities for facilitating the development of key skill sets for investigators such as technicians, medical or graduate students, postdoctoral fellows, and/or independent investigators, either within or beyond the CounterACT Center. These skills may be related to the use of assays, methods, reagents, animal models, or technologies.
• Relationships with existing graduate or other educational programs from which students may be recruited.
• Any other proposed activities related to research education.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

Omit the Sharing Plans here as they were provided in the Overall section.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Planned Enrollment Report (Research EducationCore)

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

PHS 398 Cumulative Inclusion Enrollment Report (Research Education Core)

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues.

Important reminders:

All PD(s)/PI(s) and component Project Leads 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.

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 (SAM). 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.

Not Applicable

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

Important Update: See NOT-OD-16-006 and NOT-OD-16-011 for updated review language for applications for due dates on or after January 25, 2016.

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.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the CounterACT Center 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 CounterACT Center 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 CounterACT Center that by its nature is not innovative may be essential to advance a field.

Does the CounterACT Center address an important problem or a critical barrier to progress in the field? If the aims of the CounterACT Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Will the proposed therapeutic reduce mortality and morbidity during and after emergency events involving the release of chemical threat agents?

Will the proposed model or assay have utility for developing a therapeutic relevant to this FOA?

For those projects on model development, will the research be clearly aimed at screening for candidate therapeutics, such as studies that develop and validate efficacy screens using the appropriate controls?

For studies that propose work with potential therapeutics, will projects that propose to identify a lead compound do so within the multi-year proposed project period?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CounterACT Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI , do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Are the scientific qualifications, scientific and administrative leadership capabilities, and time commitment of the PD/PI adequate? For applications involving multiple PDs/PIs, are their designated roles and responsibilities well defined, adequate, and appropriate for achieving the goals of the proposed CounterACT Center?

Are the qualifications of core directors and managers adequate?

Are the proposed facilitators experienced in the types of activities proposed in the Research Education Core?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CounterACT Center? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

If the CounterACT Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?

Are the proposed milestones adequate for advancing the goals of the project/core in a timely manner? Are these milestones described with quantitative success criteria that facilitate go or no go decisions?

Do the specific aims enhance synergism among the subprojects and cores? Do they integrate the project into the overall goals, objectives, and milestones of the Center? Does each project relate and contribute to the others, including how they would yield results beyond those achievable if each project were pursued separately without formal interaction among the participating investigators?

Does the Center leadership have a plan for monitoring progress, and ensuring that a strategic plan is implemented in an effective and efficient manner?

Is the Research Education Core well justified, and does it describe a program that will likely increase the number and capabilities of researchers in the field?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Are special biosafety precautions for working with highly toxic chemicals adequate? Have all proposed studies been deemed safe for research personnel and the environment by appropriate official institutional biosafety review? If working with chemical warfare agents, are federal government approvals in place?

Do core resources effectively and efficiently support the research activities in a manner that cannot be supported through available resources?

Does each core provide a specialized resource that is essential for the conduct of project research, or collaborative projects?

Are institutional commitments proposed to enable and facilitate the research objectives tangible and adequate?

As applicable for the CounterACT Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed CounterACT Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

For Renewals, the committee will consider the progress made in the last funding period.

How significant is the contribution of the applicants currently funded CounterACT Research Center to scientific knowledge in the field? How well have the applicants accomplished the specific objectives and milestones proposed in the original CounterACT Research Center application?

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

As applicable for the CounterACT Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS)/Genomic Data Sharing Plan .

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

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 . 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.Whether the chemical threat being proposed for study is included on the CTRA list.
• Relevance of the proposed project to program priorities.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

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.

Annual milestones will be included in the Special Terms and Conditions of the Notice of Award. Failure to meet these annual milestones will have a negative impact on the review of Type 5 non-competitive progress reports. In addition to milestones, the decision regarding continued funding will also be based on the overall robustness of the entire data package that adequately allows an interpretation of the results (regardless if they have been captured in the milestones), and overall progress.

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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:
The PD(s)/PI(s) will have the primary responsibility for defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.

Awardees are responsible for identifying specific milestones toward countermeasure development that will be achieved during the project period.

Awardees are responsible for establishing an external advisory committee composed of experts not otherwise associated with the activity.

Awardees agree to participate in the overall coordination of NIH CounterACT Research Network. This participation may include collaboration and consultation with other CounterACT research awardees, and the sharing of information, data, and research materials.

Awardees will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

Awardees are responsible for pursuing patent protection.

Awardees are responsible for providing progress reports with completeness that include experimental design with rigor, including assumptions for the design of the experiments, the results of the investigations, interpretations of the results, and for concluding whether milestones have been met or not. In cases when NIH Research/Scientific staff request raw data, awardees agree to provide the data.

Regarding meetings and interactions with regulatory agencies, awardees agree to communicate meeting dates and agenda to the NIH Research/Scientific staff and invite their participation.

Awardees agree to communicate study reports from CROs, meeting minutes (and associated data packages if applicable), letters and other forms of communications with regulatory agencies, and other authorities, if applicable.

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NIH Project Scientist will have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

Each project will have the support of one or more Project Scientists from NIH program staff who are assigned an administrative role for the medical countermeasure(s) being studied and have expertise in the implementation of the CounterACT program.

The NIH Project Scientists will have substantial scientific-programmatic involvement during the conduct of this activity, through technical assistance, advice, and coordination above and beyond normal program stewardship for grants.

NIH Project Scientists will be responsible for assessing the progress of the projects toward the accomplishment of specified milestones, and for recommending if further funds should be released to the project.

The NIH Project Scientists will facilitate the establishment of contacts and collaborations between awardees of the CounterACT program and other persons or organizations whose participation will assist with the accomplishment of project goals. These persons or organizations may include the FDA, disease voluntary organizations, pharmaceutical companies, or research organizations that can provide essential services on contract.

An important part of the CounterACT program is the coordination of research efforts across different funding mechanisms and research structures, and coordination among efforts aimed at different medical countermeasures. NIH Project Scientists will have the primary responsibility for this overall coordination.

Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The assigned program director may also serve as an NIH Project Scientist.

NIH Project Scientist(s), in consultation with the PD/PIs, may add critical experiments that need to be conducted prior to or during the award as an additional milestone(s). In most cases, these studies will be supported by additional funds from NIH.

NIH Program Scientist(s) participates in meetings together with PD/PIs with regulatory agencies related to the funded project.

Areas of Joint Responsibility include:

A Steering Committee will make strategic decisions with regard to goals and research implementation, including the establishment of shared resources and the development of collaborations. The Steering Committee will meet at least annually.

The Steering Committee will be composed of the project PI, and other investigators who are leaders of individual projects within the award or leaders of efforts at consortium sites, if applicable, and one or more NIH Project Scientists. The project PI will serve as chairperson of the Steering Committee.

Each full member will have one vote. The NIH Project Scientists will have a single NIH vote. Awardee members of the Steering Committee will be required to accept and implement policies approved by the Steering Committee.

Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to dispute resolution. A Dispute Resolution Panel composed of three members will be convened. It will have three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone: 301-710-0267
Email: GrantsInfo@nih.gov

David A. Jett, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-6035
Email: jettd@ninds.nih.gov

Houmam Araj, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: arajh@nei.nih.gov

Hung Tseng, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-496-0810
Email: tsengh@mail.nih.gov

Srikanth S. Nadadur, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-5327
Email: nadadurs@niehs.nih.gov

David Siegel, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|
Telephone: 301-594-8670
Email: siegelda@mail.nih.gov

Geoffrey Schofield, PHD
Center for Scientific Review (CSR)
Telephone: 301-435-1235
Email: geoffreys@mail.nih.gov

Tijuanna E. DeCoster, Ph.D., MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: decostert@ninds.nih.gov

William W. Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: darbyw@mail.nih.gov

Lisa Archer Edwards, MBA
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0751
E-mail: archer@niehs.nih.gov

Andrew Jones
National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-0610
Email: jonesan@mail.nih.gov

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

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