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 Allergy and Infectious Diseases (NIAID) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) National Institute of Environmental Health Sciences (NIEHS) National Institute of General Medical Sciences (NIGMS)
Funding Opportunity Title	Countermeasures Against Chemical Threats (CounterACT) Cooperative Research Projects (U01)
Activity Code	U01 Research Project Cooperative Agreements
Announcement Type	Reissue of PAR-11-155
Related Notices	August 6, 2015 - Notice of NINDS Programmatic Priority for PAR-13-208. See Notice NOT-NS-15-035. June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same. August 21, 2013: Removed reference to ASSIST in section IV.3, since ASSIST is currently only available for multi-project applications. May 30, 2013 (NOT-OD-13-074) - NIH to Require Use of Updated Electronic Application Forms for Due Dates on or after September 25, 2013. Forms-C applications are required for due dates on or after September 25, 2013. May 14, 2013 - See Notice NOT-NS-13-029. Notice of Participation of Additional NIH Institutes and Centers.
Funding Opportunity Announcement (FOA) Number	PAR-13-208
Companion Funding Opportunity	PAR-15-315, R21 Exploratory/Developmental Research Grant PAR-15-146, U54 Specialized Center- Cooperative Agreements PAR-13-005, R21 Exploratory/Developmental Research Grant Award
Number of Applications	See Section III. 3. Additional Information on Eligibility.
Catalog of Federal Domestic Assistance (CFDA) Number(s)	93.853; 93.867; 93.855; 93.856; 93.846; 93.113; 93.859
Funding Opportunity Purpose	This Funding Opportunity Announcement (FOA) encourages grant applications for Countermeasures Against Chemical Threats (CounterACT) Cooperative Research Projects (U01s). The mission of the CounterACT U01 program is to develop 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, and pesticides. Applicants are encouraged to contact the Program Officials listed in this FOA to determine if their proposed threat agent(s) or countermeasure(s) is of high program priority for one of the participating Institutes. The scope of the research to be supported includes target and candidate identification and characterization, through candidate optimization and demonstration of in vivo efficacy, through Investigational New Drug (IND) submission when appropriate. Each project must include milestones that create discrete go or no-go decision points in a progressive translational study plan.

Posted Date	April 25, 2013
Open Date (Earliest Submission Date)	August 16, 2013
Letter of Intent Due Date(s)	August 16, 2013; August 16, 2014; August 16, 2015
Application Due Date(s)	September 16, 2013; September 16, 2014; September 16, 2015, by 5:00 PM local time of applicant organization. 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	January 2014; January 2015; January 2016
Advisory Council Review	May 2014; May 2015; May 2016
Earliest Start Date	July 1, 2014; July 1, 2015; July 1, 2016.
Expiration Date	September 17, 2015
Due Dates for E.O. 12372	Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

The overall goal of the NIH CounterACT program is to reduce mortality and morbidity during and after emergency events involving the release of chemical threat agents. Chemical threat agents are toxic chemicals that could cause mass casualties after being released by a deliberate terrorist attack, or by industrial accident or natural disaster. The purpose of this U01 funding opportunity is to foster and support the development of Food and Drug Administration (FDA)-approved therapeutics that can be used effectively to treat individuals during a chemical emergency event.

Background

The NIH has developed a comprehensive CounterACT Research Program that includes a research network of Research Centers of Excellence, individual research projects, contracts and Interagency Agreements with the Department of Defense. The network conducts basic, translational, and clinical research aimed at the discovery and/or identification of better medical countermeasures against chemical threat agents, and it supports their development towards FDA approval. The CounterACT U01 program described in this FOA is designed to support investigator-initiated individual research projects. To ensure that the research is translational in nature, CounterACT research projects are milestone-driven U01 cooperative agreements with substantial scientific and programmatic involvement by NIH staff.

CounterACT cooperative agreement U01 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) (see http://www.ninds.nih.gov/research/counterterrorism/ cpdf.pdf). They will be expected 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 overseen by the National Institute of Allergy and Infectious Diseases (NIAID) that includes biological and radiation/nuclear threats (http://www.niaid.nih.gov/topics/biodefenserelated/Pages/default.aspx). Also see www.medicalcountermeasures.gov which facilitates communication between federal government agencies and public stakeholders to enhance the Nation's public health emergency preparedness.

Chemical Threats

The civilian chemical threat spectrum includes chemical warfare agents, toxic industrial chemicals, pesticides, toxins and other chemicals. Applicants are strongly urged to contact the Program Officials listed in this FOA to determine if their proposed threat agent(s) or countermeasure(s) is of high programmatic priority for funding under the CounterACT U01 program. 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, or does not complement the existing NIH CounterACT research portfolio (see http://www.ninds.nih.gov/research/counterterrorism/counterACT_researchers_projects.htm).

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’s Medical Research Institute of Chemical Defense (http://chemdef.apgea.army.mil/). Applicants are encouraged to contact the NINDS Scientific/Research Contact listed in this FOA for further information on working with restricted chemical agents.

Broad Spectrum Therapeutics

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.

This FOA will only support 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:

• Mechanistic research to identify targets for therapeutic development.
• Creation and development of screening assays for therapy development. The assay must also be validated and the method of validation well-justified, e.g. appropriate pharmacology, robustness,relevant pathology, etc.
• Creation and validation of animal models of chemical effects on humans. The goal of this research is to develop models of lethality and serious morbidity that can be extrapolated to humans, and the intended use of the model must be for therapeutic development.
• Identification of candidate therapeutics using primary or secondary screening efforts.
• Development of preliminary proof-of-principle data on the efficacy of candidate therapeutics.
• Advanced efficacy studies with appropriate animal models
• Preliminary and advanced preclinical research including safety and pharmacokinetic studies with candidate therapeutics

The scope of research covered in this FOA can also be described by Technology Readiness Levels (TRLs) that can be found at https://www.medicalcountermeasures.gov/federal-initiatives/guidance/integrated-trls.aspx. The TRLs covered in this FOA generally fall under TRLs 1 through 6, with some possible exceptions when applicable.

Each CounterACT U01 application must include clearly stated project milestones. Milestones toward

therapeutic intervention are not a description of specific aims and experiments, but rather are discreet goals that create go or no-go decision points in the project that include quantitative success criteria. For examples of acceptable milestones, see http://www.ninds.nih.gov/research/counterterrorism/developing_milestones.htm . Annual milestones may be modified in negotiations with NIH program officials before an initial award is made, and during the review of annual non-competitive renewal applications. Unmet milestones will have a negative impact on the review and approval of these annual renewal applications.

If a specific new therapy has not yet been identified, the proposed translational research should demonstrate a clear path towards identification of a lead compound by the end of the project period. Lead compounds are biologically active compounds or hits where affinity, potency, and selectivity have been established. If the project goals are related to model development, then the model(s) should be fully developed and validated by the end of the project period. Validation includes a demonstration of the model’s predictive value for screening compounds for the desired therapeutic effect.

Specific examples of relevant research topics include but are not limited to those listed below:

• Therapies based on acute toxicity of the chemical threat agent, e.g. development of new and/or improved anticonvulsants, new approaches to counteract pulmonary edema, relevant anti-inflammatory drugs, surfactants, antioxidants, the development of better skin and eye protectants.
• Natural history animal models of the acute toxicity of chemical threat agents. These studies could include characterization of long-term effects after sub-lethal acute exposures to chemical threats agents, e.g. neuroprotectants for neurodegeneration and other neurological sequelae, drugs to prevent long-term fibrosis in the lung, etc.
• Studies on the special vulnerabilities of pediatric populations and pregnant women as they relate to the development of therapeutics, e.g. acute effects on the developing brain that have long-term effects, the need for therapeutics dosing schedules and routes of administration that are more suitable for children and pregnant women.
• Research on the molecular mechanisms of toxicity for the purpose of identifying novel targets, e.g. the mechanisms of nerve agent-induced seizures with respect to temporal and regional changes, roles of cardiac versus neuronal mitochondria in cyanide toxicity, cellular and molecular basis for agent induced pulmonary edema.
• Alternate routes of administration for new or approved therapies that would be safe, effective, and easy to administer during a mass casualty scenario, e.g. intramuscular route.

Because of the urgency in need, and the lengthy time and expense for bringing a new compound to regulatory approval, applicants are encouraged to consider drugs that are already approved by the FDA for other indications. Some of these drugs have been shown to be effective in treating victims of chemical exposures, and in some cases, the length of time to regulatory approval for a new indication may be shorter than for a novel compound. Applicants are urged to contact the Scientific Contacts listed in this FOA for more information related to the FDA, including FDA contacts.

For applications beyond the basic research stage, it may be advantageous to establish a collaboration with an industry partner who may be able to assist in developing a plan to advance the studies towards FDA approval and commercialization.

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 a mass casualty situation are not appropriate to this FOA. Drugs only effective if given prior to chemical insult (prophylaxis) or those that must be given within a very short period (1-15 minutes) after the insult will be of low priority. Since many chemical threats have rapid modes of action, the drug should act rapidly to counter these effects. The 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. For example, drugs that are only effective when administered intravenously would be of low priority since their use would be impractical in a mass casualty situation. 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.

To assess the predictive value of preclinical research for therapeutic development, sufficient information must be presented about the proposed study design, execution, and interpretation of the supporting data or results in the grant application. Critical elements of a well-designed study include adequate scientific rigor, control of bias, reproducibility, dose-response, confirmation of mechanism, and transparency of reporting. As such, the NIH urges applicants to this FOA to consider and directly address these elements in their application(s).

A renewal application must be consistent with the scope of research of this FOA and clearly build upon the scientific advances made during the previous award.

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.
Application Types Allowed	New Renewal Resubmission Revision The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
Funds Available and Anticipated Number of Awards	The participating Institutes intend to commit on average $3 million per year in Fiscal Years 2014, 2015, and 2016 to fund approximately 10-20 awards. Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary.
Award Budget	Application budgets are not limited, but need to reflect the actual needs of the proposed project. For most studies within the scope of this FOA, the expected direct cost for individual awards is $300,000-$500,000 per year for a total of $1.5-2.5 million over a maximum five-year project period.
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 in response to this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Governments

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

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

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

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

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

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

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

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

The letter of intent should be sent to:

David A. Jett, Ph.D.
Program Director, NIH CounterACT Research
National Institutes of Health, NINDS
6001 Executive Blvd.
NSC, Room 2177, MSC 9527
Bethesda, MD 20892-9527
Telephone: 301-496-6035
Fax: 301-402-1501
Email: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate optional components.

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

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

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

Many of the chemical threat agents of interest are extremely hazardous to humans. Applicants must include a letter from appropriate institutional biosafety officials indicating that studies are deemed safe for research personnel and the environment. This must also be addressed in the application, including a description of adequate protection and safeguards if required. Special biosafety certifications may be required to conduct research with some restricted chemical threat agents, e.g. nerve agents. Therefore, when applicable, applicants must include a letter from appropriate Department of Defense (DoD) officials for use of restricted agents under their authority.

A formal letter of collaboration (and estimated budget, if applicable) should be provided with the application for all proposed collaborative arrangements, especially those utilizing restricted chemicals.

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

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

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

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

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

The application should describe in detail how the proposed research will lead to the development of a validated model and/or lead compound, and it should present milestones related to achieving that goal. Milestones for each year of the project should be listed in the Research Strategy section of the application.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) 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.

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

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

Organizations must submit applications to Grants.gov, the online portal to find and apply for grants across all Federal agencies. 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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

This initiative is not subject to intergovernmental review.

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

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

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

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.

Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

In order to expedite review, applicants are requested to notify the NINDS Referral Office by email at [email protected] when the application has been submitted. Please include the FOA number and title, PD/PI name, and title of the application.

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact NIH program staff at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

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.

For this particular announcement, the NIH is encouraging applications for translational research that may involve standard methodologies applied toward novel therapeutic approaches. It is recognized that due to the nature of translational research, some studies such as preclinical safety may include standard routine tests that would not necessarily be innovative.

Additionally, reviewers should consider whether the proposed research significantly advances scientific knowledge that may predictably reduce mortality and morbidity during and after emergency events involving the release of chemical threat agents.

Lastly, reviewers should consider whether the proposed project milestones are adequate for advancing the goals of the project in a timely manner, and if the milestones are described with quantitative success criteria that facilitate go or no-go decisions.

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

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

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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?

Investigator(s)

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

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?

Approach

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

If the project involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

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?

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.

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children

When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

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

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.

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

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.

Revisions

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

As applicable for the 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) Genome Wide Association Studies (GWAS).

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by the Center for Scientific Review, 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 to the NINDS. 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.

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

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

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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

Cooperative Agreement Terms and Conditions of Award

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

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

The PD(s)/PI(s) will have the primary responsibility for:

Defining objectives and approaches, and to plan, conduct, analyze, and publish results, interpretations, and conclusions of their studies.

Awardees are responsible for developing and proposing specific milestones toward the development of therapeutics that will be achieved during the project period.

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 at annual meetings of the CounterACT Research Network. Collaboration may include sharing of information and research materials.

The awardee is solely responsible for the timely acquisition of all appropriate proprietary rights, including intellectual property rights, and all materials needed for the applicant to perform the project.

Intellectual Property: Awardees will retain custody of and have primary rights 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.

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 Scientist(s) from NIH Program staff who are assigned an administrative role for the project and have expertise in the implementation of the CounterACT research program.

NIH Project Scientists will have substantial scientific-programmatic involvement during 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.

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

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

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

Areas of Joint Responsibility include:

None; all responsibilities are divided between awardees and NIH staff as described above.

Dispute Resolution:

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 does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: [email protected]

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]

Primary contact for questions concerning the overall CounterACT program or for questions related to the mission of NINDS and its role in the CounterACT program:

David A. Jett, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-6035
Email: [email protected]

For questions related to the mission of NIGMS and its role in the CounterACT program:

Richard T. Okita, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3827
Email: [email protected]

Jonathan Ivins, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-594-1245
Email: [email protected]

Maxine Davis
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301- 496-9231
Email: [email protected]

Ms. Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: [email protected]

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.

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 Parts 74 and 92.