Department of Health and Human Services
Part 1. Overview Information

 

Participating Organization(s)

National Institutes of Health (NIH)

Components 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)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue PAR-16-329

Related Notices

None

Funding Opportunity Announcement (FOA) Number

PAR-18-657

Companion Funding Opportunity

PAR-18-721, R21 Research Projects
PAR-16-330, U01 Research Project - Cooperative Agreements

PAR-16-331, U01 Research Project - Cooperative Agreements

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. 

Key Dates

 

Posted Date

February 13, 2018

Open Date (Earliest Submission Date)

August 11, 2018

Letter of Intent Due Date(s)

30 days prior to the application due date

Application Due Date(s)

September 11, 2018; September 10, 2019; September 9, 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)

Not Applicable

Scientific Merit Review

February 2019; February 2020; February 2021

Advisory Council Review

May 2019; May 2020; May 2021

Earliest Start Date

July 2019; July 2020; July 2021

Expiration Date

September 10, 2020

Due Dates for E.O. 12372

Not Applicable

** 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 review.

Required Application Instructions

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.


There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Table of Contents

    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


    Part 2. Full Text of Announcement
    Section I. Funding Opportunity Description
    A. Overview

    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.   

    B. Chemical Threats

    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 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.

    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 are not limited to:      

    • 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 efficacy data;
    • 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 through this program.  

    E. Scientific Goals and Preparation for Advanced Development

    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 Authority (BARDA).

    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 established.
    • 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 Review Division.
    • 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.

    F. Milestones

    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 TRLs 3 through 5.

    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 the proposed research.

    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 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.

    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 project period.

    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

    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 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 weeks before a due date.

    See Section VIII. Other Informationfor award authorities and regulations.

    Section II. Award Information
    Funding Instrument

    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 for this FOA.  

    Application Types Allowed

    New
    Renewal
    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

    Clinical Trial

    Optional: Accepting applications that either propose or do not propose clinical trial(s)

    Need 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.

    Award Budget

    Application budgets may not exceed $2.5 million in direct costs per year.

    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.

    Award Project Period

     The total project period may not exceed 5 years.  

    NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

    Section III. Eligibility Information
    1. Eligible Applicants
    Eligible Organizations

    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 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
    Foreign Institutions

    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.

    Required Registrations

    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.
    • o   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.

    Eligible Individuals (Program Director/Principal Investigator)

    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.

    2. Cost Sharing

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

    3. Additional Information on Eligibility
    Number of Applications

    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).
    Section IV. Application and Submission Information
    1. Requesting an Application Package

    A button to access the online ASSIST system is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

    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.

    2. Content and Form of Application Submission

    It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, 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.

    Letter of Intent

    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
    Email: jettd@ninds.nih.gov
     

    Page Limitations

    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.

    Instructions for the Submission of Multi-Component Applications

    The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

    The application should consist of the following components:

    • Overall: Required
    • Administrative Core: Required; maximum of 1
    • Scientific Core: Optional; maximum of 3
    • Research Education Core: Required; maximum of 1
    • Project: Required; minimum of 3, maximum of 5
    Overall Component

    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.

    SF424 (R&R) Cover (Overall)

    Complete entire form.

    PHS 398 Cover Page Supplement  (Overall)

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

    Research & Related Other Project Information (Overall)

    Follow standard instructions.

    Other Attachments:

    Intellectual Property Strategy:  Applications, with a pre-identified proposed therapeutic(s), are expected to include an Intellectual Property (IP) strategy that is no more than one page (if multiple therapeutics have been pre-identified then no more than one page per compound). Applications that exceed this limit will be withdrawn. This attachment should be entitled "IP_Strategy_CompoundName.pdf" and reflected in the final image. Applicants are encouraged to prepare this section of the application in consultation with their institution's technology transfer officials, if applicable.

    Applicants should describe the IP landscape surrounding their proposed therapeutic(s). This should include any known constraints that could impede the development of their medical countermeasure (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar approaches that are under patent and/or on the market, etc.) and how these issues could be addressed as appropriate and consistent with achieving the goals of the program.  If the applicant proposes using a compound whose IP is not owned by the applicant's institution, the applicant should address any questions that may constrain or impede its ability to operate and move the compound forward. Applicants should include a letter (see Letters of Support) from the entity that owns the IP indicating whether the entity will provide the compound, if there are any limits on the studies that can be performed with that compound, and agreement about public disclosure of results (including negative results), and whether there is an agreement already in place.

    If patents pertinent to the therapeutic(s) being developed under this application have been filed, the applicants should indicate the details of filing dates, what types of patents are filed, application status, and associated United States Patent Office (USPTO) links, if applicable.  Applicants should also discuss future IP filing plans. For a multiple-PD/PI, multiple-institution application, applicants should describe the infrastructure of each institution for bringing the compound(s) to practical application and for coordinating these efforts (e.g., how IP will be shared, licensing, managing IP) among the institutions.

    Project/Performance Site Location(s) (Overall)

    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.

    Research & Related Senior/Key Person Profile (Overall)

    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.

    Budget (Overall)

    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.

    PHS 398 Research Plan (Overall)

    Introduction to Application: For Resubmission 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, 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.  A diagram is often useful in this regard.
    • 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 NIH believes that applications that propose preclinical research 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. Investigators are encouraged, 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. For applications seeking a second (or more) renewal, a clear track record of developing products that were transitioned to advanced development should be described.

    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.
    • If applying from an academic institution, include a letter of support from the technology transfer official(s) who will be managing existing and future intellectual property associated with the Center. The letter of support should confirm IP will be managed consistent with achieving goals of the program.
    • If research will be performed at more than one institution, include a letter of support from each institution clarifying how intellectual property will be shared or otherwise managed across the institutions. A letter of support from the technology transfer official(s) who will be managing existing and future intellectual property at each institution should be included and confirm IP will be managed consistent with achieving goals of the program.
    • If collaborating with a private entity (e.g., regulatory support), include a letter of collaboration that addresses any agreement to provide service(s), any limits on the services that can be performed, any limitations on sharing of data (including negative results), and whether a licensing agreement(s) is in place, if applicable. This letter should come from an official within the private entity who has the appropriate authority.

    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 apply 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 (https://grants.nih.gov/grants/policy/data_sharing).

    Appendix:

    Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

    PHS Human Subjects and Clinical Trials Information (Overall)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Delayed Onset Study

    All instructions in the SF424 (R&R) Application Guide must be followed.

    PHS Assignment Request Form (Overall)

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    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.

    SF424 (R&R) Cover (Administrative 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 (Administrative Core)

    Enter Human Embryonic Stem Cells in each relevant component.

    Research & Related Other Project Information (Administrative 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.

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

    Project /Performance Site Location(s) (Administrative 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 (Administrative 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.
    •  The PD/PI should be the director of the Administrative Core and should commit at least 1.2 Person Months to these responsibilities, in addition to his/her own CounterACT research and other activities, if applicable. 
    Budget (Administrative Core)

    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. Post-doc, junior, and diverse investigators are encouraged to attend these meetings and budgets should be planned accordingly.

    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 (Administrative Core)

    Introduction to Application: For Resubmission 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:

    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:

    Limited items are allowed in the Appendix.Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.  

    PHS Human Subjects and Clinical Trials Information (Administration Core)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trials Information

    All instructions in the SF424 (R&R) Application Guide must be followed.

    Delayed Onset Study

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    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 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 Scientific Core description 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: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. 

    PHS Human Subjects and Clinical Trials Information (Scientific Core)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trial Information

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Delayed Onset Study

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Project

    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 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 project.  

    Research Strategy:   The Research Strategy section should:

    • Follow standard application instructions, including sub-sections describing Significance, Innovation, Approach, and Preliminary Studies for New Applications, or a Progress Report for Renewal 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 https://www.ninds.nih.gov/Funding/Apply-Funding/Application-Support-Library//CounterACT-Milestone-Example.
    • Discuss 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.
    • If a potential therapeutic hit(s)/lead(s) was pre-identified, this section should also contain a detailed description of the compound(s) to include chemical structure information and discussion of its potential for drug development, including possible optimization plans to further develop the compound(s). The lack of structural information for the potential therapeutic hit(s)/lead(s) may adversely affect assessment of its optimization potential. NIH has multiple safeguards to protect the integrity of and to maintain confidentiality in peer review.
    • Drug development plans, e.g., specific optimization studies, should entail clear and quantitative goals to be achieved. These studies may include, but are not limited to, refining the compound's chemical, biological, and safety properties by addressing properties such as potency, selectivity, ADMET, hERG, Ames activity, etc.
    • If a lead product was identified, the proposed plan should address the regulatory strategies necessary to advance the proposed medical countermeasure, e.g., addressing essential elements described in the relevant FDA Guidance for Industry - Product Development Under the Animal Rule (e.g., suitability of the proposed animal species, etc.) Estimating the Maximum Safe Starting Dose in Initial Clinical Trials for Therapeutics in Adult Healthy Volunteers (e.g., dose selection and translation to humans), Co-development of Two or More New Investigational Drugs for Use in Combination, etc.
    • Regulatory input, preferably from the FDA, should be provided for efforts to develop large animal models, e.g., swine, ovine, nonhuman primates.

    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: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. 

    PHS Human Subjects and Clinical Trials Information (Project)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trial Information

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Delayed Onset Study

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Research Education Core

    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.

    Facilities & Other Resources: Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.

    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 per year must be allocated to the Research Education Core activities.

    Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.

    Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.

    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 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 must include the following subsections:

    Proposed Research Education Program: While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program.  The proposed research education program should plan 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.          

    Core Lead(s): Describe arrangements for administration of the program.  Provide evidence that the Core Lead(s) is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs; their leadership approach, and governance appropriate for the planned project.          

    Program Faculty: Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.        

    Program Participants: Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.       

    Recruitment Plan to Enhance Diversity: Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053). Every facet of the United States scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.

    Research shows that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogenous teams. Scientists and trainees from diverse backgrounds and life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. There are many benefits that flow from a diverse NIH-supported scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the researchers, advancing the likelihood that underserved or health disparity populations participate in, and benefit from health research, and enhancing public trust.

    In spite of tremendous advancements in scientific research, information, educational and research opportunities are not equally available to all. NIH encourages institutions to diversify their student and faculty populations to enhance the participation of individuals from groups identified as underrepresented in the biomedical, clinical, behavioral and social sciences, such as:

    A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.

    B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended.  See NSF data at, https://www.nsf.gov/statistics/2017/nsf17310/.

    C. Individuals from disadvantaged backgrounds, defined as:

    1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at https://aspe.hhs.gov/poverty-research.

    2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.   

    The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.

    Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and mathematics https://eric.ed.gov/?id=EJ931610).

    New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of participants from underrepresented backgrounds and may wish to include data in support of past accomplishments.

    Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:

    Individuals who applied for admission to the research education program,

    Individuals who were offered admission to the research education program,

    Individuals who participated in the research education program.

    For those individuals who participated in the research education program, the report should include information about the duration of education and aggregate information on the number of individuals who finished the program in good standing. Additional information on the required Recruitment and Retention Plan to Enhance Diversity is available at Frequently Asked Questions: Recruitment and Retention Plan to Enhance Diversity (Diversity FAQs).

    Applications lacking a Recruitment Plan to Enhance Diversity will not be reviewed.

    Plan for Instruction in the Responsible Conduct of Research: All applications must include a plan to fulfill NIH requirements for instruction in the Responsible Conduct of Research (RCR).  The plan must address the five, required instructional components outlined in the NIH policy: 1) Format - the required format of instruction, i.e., face-to-face lectures, coursework, and/or real-time discussion groups (a plan with only on-line instruction is not acceptable); 2) Subject Matter - the breadth of subject matter, e.g., conflict of interest, authorship, data management, human subjects and animal use, laboratory safety, research misconduct, research ethics; 3) Faculty Participation - the role of the program faculty in the instruction; 4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the duration of the program; and 5) Frequency of Instruction –instruction must occur during each career stage and at least once every four years. See also NOT-OD-16-122. The plan should be appropriate and reasonable for the nature and duration of the proposed program. Renewal (Type 2) applications must, in addition, describe any changes in formal instruction over the past project period and plans to address any weaknesses in the current instruction plan. All participating faculty who served as course directors, speakers, lecturers, and/or discussion leaders during the past project period must be named in the application.

    Applications lacking a plan for instruction in responsible conduct of research will not be reviewed.

    Evaluation Plan: Applications must include a plan for evaluating the activities supported by the Core.  The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.

    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: Limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.  

    PHS Human Subjects and Clinical Trials Information (Research Education Core)

    When involving NIH-defined human subjects research, clinical research, and/or clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

    If you answered "Yes" to the question "Are Human Subjects Involved?" on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

    Study Record: PHS Human Subjects and Clinical Trial Information

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    Delayed Onset Study

    All instructions in the SF424 (R&R) Application Guide must be followed. 

    3. Unique Entity Identifier and System for Award Management (SAM)

    See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

    4. Submission Dates and Times

    Part I. Overview Information contains information about Key Dates and times. 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. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

    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. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

    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.

    5. Intergovernmental Review (E.O. 12372)

    This initiative is not subject to intergovernmental review.

    6. Funding Restrictions

    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.

    7. Other Submission Requirements and Information

    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. For assistance with application submission, contact the Application Submission Contacts in Section VII.

    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.

    Post Submission Materials

    Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

    Section V. Application Review Information
    1. Criteria

    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.

    In addition, for applications involving clinical trials:

    A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

    Overall Impact - Overall

    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).

    Scored Review Criteria - Overall

    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.

    Significance

    Does the CounterACT Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?

    How strong are the preliminary data supporting the choice of the proposed injury mechanism and/or therapeutics for the indication, i.e., biological relevance? 

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CounterACT Center? If Early Stage Investigators or those 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?

    Is there adequate statistical and/or regulatory support for the experimental design, analysis, and interpretation of the generated preclinical data?

    Are there adequate personnel to manage existing and future intellectual property associated with this project?

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

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center? 

    Innovation

    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?  

    In addition, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CounterACT Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    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?

    Is the overall timeline reasonable for the work proposed?  For key experiments, does the application explain assumptions for power analysis, describe statistical analysis methods and criteria for data inclusion or exclusion, and detail the procedures of how blinding and randomization will be conducted? Will projects that propose to identify a lead compound do so within the multi-year proposed project period? Will the planned studies and expected result support the proposed indication?

    Are the proposed Center milestones adequate for advancing the goals of the CounterACT Center in a timely manner?  Are these milestones described with quantitative success criteria that facilitate go or no-go decisions? Are the timelines proposed for achieving the milestones realistic and inclusive of necessary steps, but also efficient without unnecessary studies? Would achieving all the proposed milestones in the application allow the Center to achieve the proposed goals?

    Do the specific aims enhance synergism among the projects 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?

    Do the proposed efforts sufficiently address key parameters necessary in the successful development of a product (i.e., drug development), such as compound toxicity/safety, pharmacology, chemistry, and pharmacokinetics/metabolism? Based on the provided structural information of the pre-identified therapeutic hit(s)/lead(s), is the proposed optimization plan acceptable and achievable? Are there any insurmountable roadblocks that may prevent the development of a therapeutic medical product? Are the proposed IP and regulatory strategies appropriate? Are the proposed animal models well justified based on rigorous scientific rationales, particularly from the regulatory aspect, especially for any efforts with large or higher order animal model species?  

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

    Environment

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

    Is the environment safe for personnel conducting research proposed in this application?

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure? 

    Additional Review Criteria - Overall

    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.

    Study Timeline

    Specific to applications proposing clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

    Protections for Human Subjects

    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.

    Inclusion of Women, Minorities, and Children 

    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.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    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.

    Resubmissions

    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.

    Renewals

    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 applications seeking a second (or more) renewal, does the program have a track record of developing products that were transitioned to advanced development?

    Revisions

    Not Applicable

    Additional Review Considerations - Overall

    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.

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

    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).

    Resource Sharing Plans

    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) Genomic Data Sharing Plan .


    Authentication of Key Biological and/or Chemical Resources

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

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

    Review Criteria - Cores

    As applicable for each individual Core, reviewers will provide an assessment of its strengths and weaknesses. The following items should be evaluated while determining scientific and technical merit, and in providing an overall Impact Score for the Core; however, separate scores will not be given for these items.

    For the Administrative Core:

    • Is the organization of the leadership structure and overall Center structure provided and is it effective for overall management of the Center?  Are the responsibilities of the Core Lead clearly defined?
    • Are the overall plans for the participation in CounterACT Center Steering Committee and External Advisory Committee described?

    For the Scientific Cores:

    • 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 the qualifications, experience, and commitment of the Core Lead(s) and other core personnel appropriate?
    • Will the quality of services provided enable Center investigators to achieve their research goals?
    • If repositories for cells, tissues, data, or reagents are included, are the methods to obtain, protect, and archive relevant pathological, clinical, and family history information adequate? Is there appropriate informatics capability to track data and link to other data sets?

    For the Research Education Core:

    • Are the proposed educational experiences distinct from those research training and research education programs currently receiving federal support?
    • Does the proposed research education program facilitate the development of key skill sets for investigators?
    • Is the core leader actively engaged in research and/or teaching in an area related to the proposed program, and able to organize, administer, monitor, and evaluate the research education program?
    • Do the faculty have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles?
    • Is the Recruitment Plan to Enhance Diversity acceptable?        
    • Is the Plan for Instruction in the Responsible Conduct of Research acceptable?
    • Is the plan for evaluating the activities supported by the Core adequate?
    Review Criteria - Research Projects

    Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

    Scored Review Criteria - Research Projects

    Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

    Significance

    Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the project 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?

    How strong are the preliminary data supporting the choice of the proposed injury mechanism and/or therapeutics for the indication, i.e., biological relevance? 

    In addition, for applications involving clinical trials

    Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

    Investigator(s)

    Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those 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?

    In addition, for applications involving clinical trials

    With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

    Innovation

    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?

    In addition, for applications involving clinical trials

    Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?   

    Approach

    Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed?  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? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

    If the project 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?

    Is the overall timeline reasonable for the work proposed? For key experiments, does the application explain assumptions for power analysis, describe statistical analysis methods and criteria for data inclusion or exclusion, and detail the procedures of how blinding and randomization will be conducted? Will projects that propose to identify a lead compound do so within the multi-year proposed project period? Will the planned studies and expected result support the proposed indication?

    Are the proposed project milestones adequate for advancing the goals of the project in a timely manner?  Are these milestones described with quantitative success criteria that facilitate go or no-go decisions? Are the timelines proposed for achieving the milestones realistic and inclusive of necessary steps, but also efficient without unnecessary studies? Would achieving all the proposed milestones in the application allow the project to achieve the proposed goals?

    Do the proposed efforts sufficiently address key parameters necessary in the successful development of a product (i.e., drug development), such as compound toxicity/safety, pharmacology, chemistry, and pharmacokinetics/metabolism? Based on the provided structural information of the pre-identified therapeutic hit(s)/lead(s), is the proposed optimization plan acceptable and achievable? Are there any insurmountable roadblocks that may prevent the development of a therapeutic medical product? Are the proposed IP and regulatory strategies appropriate? Are the proposed animal models well justified based on rigorous scientific rationales, particularly from the regulatory aspect, especially for any efforts with large or higher order animal model species?

    Is the ultimate intended use of a drug, including timing and route of administration, consistent with its effective use in humans in an emergency civilian setting?

    If a potential therapeutic hit(s)/lead(s) was pre-identified, is a detailed description of the compound(s) to include chemical structure information and discussion of its potential for drug development provided?

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

    Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

    Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

    Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

    Data Management and Statistical Analysis

    Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?    

    Environment

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

    Is the environment safe for personnel conducting research proposed in this application?   

    In addition, for applications involving clinical trials

    If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

    Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

    If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

    If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

    Additional Review Criteria - Research Projects

    As applicable for the project 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.

    Study Timeline

    Specific to applications proposing clinical trials

    Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

    Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

    Protections for Human Subjects

    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.

    Inclusion of Women, Minorities, and Children 

    When the proposed project 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.

    Vertebrate Animals

    The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

    Biohazards

    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.

    Additional Review Considerations - Research Projects

    As applicable for the project 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.

    Applications from Foreign Organizations

    Not Applicable

    Select Agent Research

    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).

    Resource Sharing Plans

    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) Genomic Data Sharing Plan .


    Authentication of Key Biological and/or Chemical Resources

    For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

    Budget and Period of Support

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

    2. Review and Selection Process

    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.
    • Relevance of the proposed project to program priorities.
    • Number of applications from each institution (only one CounterACT Research Center of Excellence may be awarded at any school or college within a university
    3. Anticipated Announcement and Award Dates

    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. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

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

    Section VI. Award Administration Information
    1. Award Notices

    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. 

    Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.  ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain "applicable clinical trials" on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/ 

    Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.  Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

    Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines,

    other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE). 

    2. Administrative and National Policy Requirements

    All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

    Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency.  HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator's scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

    For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

    In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements.  FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award.  An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS.  The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant's integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 "Federal awarding agency review of risk posed by applicants."  This provision will apply to all NIH grants and cooperative agreements except fellowships.

    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 Part 75, 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 purpose of NIH 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:

    • Defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.
    • Initial development and proposal of annual milestones and timeline towards the development of the therapeutic(s) 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 NIH research effort to develop medical countermeasures against chemical threats. This participation includes collaboration and consultation with other CounterACT research awardees and attendance to the annual CounterACT Research Network Symposium. Collaboration may include sharing of information and research materials.
    • Timely acquisition of all appropriate proprietary rights in accordance with the NIH Grants Policy Statement, including securing intellectual property rights, and all materials needed for the applicant to perform the project. Awardees will retain primary intellectual rights and/or property to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.  Before, during, and subsequent to the award, the U.S. Government is not required to obtain for the awardee any proprietary rights, including intellectual property rights, or any materials needed by the awardee to perform the project.
    • 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.
    • Preparation of all materials, e.g., Pre-Pre-IND, Pre-IND, BARDA Tech Watch meeting packages, in support of interactions with regulatory agencies and advanced developers. 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, BARDA, 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 bi-monthly.
    • 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.
    3. Reporting

    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 RPPR, 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. 

    In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

    Section VII. Agency Contacts

    We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

    Application Submission Contacts

    eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
    Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
    Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

    Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
    Email: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-945-7573

    Scientific/Research Contact(s)

    For questions related to the overall CounterACT program and/or neurological injury research:

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

    For questions related to ocular injury research:

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

    For questions related to dermal/vesicant-induced injury research:

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

    For questions related to pulmonary injury research:

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

    For questions related to research on pharmaceutical-based agents:

    Kristopher Bough, Ph.D.
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-443-9800
    Email: boughk@nida.nih.gov

    Peer Review Contact(s)

    Carole Jelsema, Ph.D.
    Center for Scientific Review (CSR)
    Telephone: 301-435-1248
    Email: jelsemac@csr.nih.gov

    Financial/Grants Management Contact(s)

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

    Karen Robinson Smith
    National Eye Institute (NEI)
    Telephone: 301-451-2020
    Email: kyr@nih.gov

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

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

    Amy Connolly
    National Institute on Drug Abuse (NIDA)
    Telephone: 301-827-4457
    Email: connolla@mail.nih.gov

    Section VIII. Other Information

    Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

    Authority and Regulations

    Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.

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