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)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)

Funding Opportunity Title

Countermeasures Against Chemical Threats (CounterACT) Exploratory/Developmental Projects in Translational Research (R21)

Activity Code

R21 Exploratory/Developmental Research Grant Award

Announcement Type

Reissue of PAR-10-019

Related Notices

  • June 3, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • 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.

Funding Opportunity Announcement (FOA) Number

PAR-13-005

Companion Funding Opportunity

See Companion PAR-13-208.

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.853, 93.867, 93.846, 93.865, 93.113, 93.859 

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages applications for exploratory/developmental translational research on therapeutics for reducing mortality and morbidity caused by acute exposures to chemical threat agents. Chemical threats include chemical warfare nerve agents such as sarin and VX, toxic industrial chemicals such as cyanide and phosgene, and toxic agricultural chemicals such as parathion and sodium fluoroacetate. Projects supported by this FOA are expected to generate preliminary preclinical, screening and efficacy data that would enable the development of competitive applications for more extensive support from the NIH CounterACT program (see www.ninds.nih.gov/counteract for a description) and other related translational research programs. 

Key Dates
Posted Date

October 3, 2012

Open Date (Earliest Submission Date)

December 30, 2012  

Letter of Intent Due Date

30 days before the application due date

Application Due Date(s)

January 30, 2013, 2014, 2015 , by 5:00 PM local time of applicant organization.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May 2013, 2014, 2015

Advisory Council Review

August 2013, 2014, 2015

Earliest Start Date(s)

September 30, 2013, 2014, 2015

Expiration Date

January 31, 2015

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the SF 424 (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.


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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

This FOA  encourages applications for exploratory and developmental translational research projects on therapeutics for reducing mortality and morbidity caused by acute exposures to chemical threat agents.  Chemical threat agents are toxic chemicals that could be released by a deliberate terrorist attack against civilians, or by accident or natural disaster causing mass casualties (see below for categories and examples). CounterACT Exploratory/Developmental Projects in Translational Research (R21) will be utilized to support 1-2 year pilot studies to generate tools and proof-of-principle data for therapeutics to treat exposures to chemical threats.  Pilot studies may include the creation and validation of screening assays for therapy development, identification of candidate therapeutics, and development of preliminary proof of principle data on the efficacy of candidate therapeutics.  A well-structured application will include clear rational experimental approaches yielding significant preliminary data in support of more advanced drug discovery and development efforts.  The application should include a description of the intended product (drug) and how it will be used in humans, i.e., how and when it will be administered in the context of a chemical emergency event.  It is expected that the preliminary data from these R21 studies will be used in research applications for transition to related research and development programs, to include milestone-driven Cooperative Agreement funding programs within the NIH CounterACT Program (see www.ninds.nih.gov/counteract).

Background

The NIH has developed a comprehensive CounterACT Research Program that includes Research Centers of Excellence, individual research projects, exploratory and developmental translational research projects, SBIR projects, contracts, and Interagency Agreements with the Department of Defense (see www.ninds.nih.gov/counteract). The network conducts basic, translational, and clinical research aimed at the discovery and/or identification of better medical countermeasures against chemical threat agents, and their movement through the regulatory process.  The overarching goal of this research program is to enhance our medical response capabilities during an emergency. CounterACT translational research R21 Program Directors/Principal Investigators (PD(s)/PI(s)) will become members of the CounterACT research network, and will be able to utilize its resources, such as the CounterACT preclinical development contract 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 coordinated by the National Institute of Allergy and Infectious Diseases (NIAID) that includes biological and radiation/nuclear threats (http://www3.niaid.nih.gov/topics/BiodefenseRelated/).  Also see www.medicalcountermeasures.gov which facilitates communication between federal government agencies and public stakeholders to enhance the Nation's public health emergency preparedness. 

Specific Areas of Research Interest

Categories of chemical threat agents that will be supported by the CounterACT Translational Research R21 program include:

Chemicals not included on this list may also be eligible.  Applicants should contact the Scientific/Research Contacts listed in this FOA to determine if their proposed threat agent or countermeasure (including concept of operation) is of programmatic priority to be considered for funding under the CounterACT R21 program.

This R21 program 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:

Due to the urgency in need, lengthy time, and expense in bringing a new compound to regulatory approval, applicants are encouraged to consider drugs that are already approved by the Food and Drug Administration (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.

This FOA will only support translational research that is clearly relevant to the development of new or improved therapeutic drugs that will enhance our medical response capabilities during an emergency. New medical countermeasures that have no practical use during a mass casualty situation will not be considered.  Drugs only effective if administered prior to chemical insult (pre-treatment) 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 the drug should be discussed within the application (i.e., concept of operation), including timing and route of administration that is consistent with its effective use in an emergency setting. For example, drugs that are only effective when administered intravenously would be of low priority since its use would be impractical at the scene of a mass casualty situation. Therapeutics that prevent long-term or delayed effects from acute exposures may also be considered, and in this case, may be appropriate for administration in the hospital. 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, the pregnant, and/or 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.

Applicants are strongly encouraged to consult with NIH Program Staff as plans for an application are being developed. This early contact will provide an opportunity to clarify the applicant's understanding of program goals and guidelines, including the scope of projects within the program. Letters of Intent are requested before full applications are submitted. 

Special Biosafety Certification

Many of the chemical threat agents of interest are extremely hazardous to humans. This R21 program will only consider supporting studies deemed safe for research personnel and the environment by appropriate official institutional biosafety review. This must 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 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. All proposed collaborations should be documented with letter(s) of intent to collaborate on official institutional letterheads. This is especially important for those applications proposing to work with restricted chemicals (e.g., sulfur mustard, sarin, soman, VX).

Note: 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.

Scientific Scope

The evolution and vitality of the biomedical sciences require a constant infusion of new ideas, techniques, and points of view. These may differ substantially from current thinking or practice and may not yet be supported by substantial preliminary data. By using the R21 mechanism, the NIH seeks to foster the introduction of novel scientific ideas, model systems, tools, agents, targets, and technologies that have the potential to substantially advance biomedical research.

The R21 mechanism is intended to encourage new exploratory and developmental research projects. Such projects could assess the feasibility of a novel area of investigation or a new experimental system that has the potential to enhance health-related research.  Another example could include the unique and innovative use of an existing methodology to explore a new scientific area. These studies may involve considerable risk but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of biomedical, behavioral, or clinical research. Therefore, a project that does not necessarily employ novel methodologies may still be essential to advance the field. Consequently, studies may not be innovative using the traditional definition, but would still be acceptable.

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).

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission

The OER Glossary and the SF 424 (R&R) Application Guide provide details on these application types.

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

Although the size of award may vary with the scope of research proposed, it is expected that applications will stay within the budgetary guidelines; direct costs are limited to $250,000 per year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $500,000 for the combined two-year award period.

F&A costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004, November 2, 2004.  

Award Project Period

The total project period for an application submitted in response to this funding opportunity may not exceed 2 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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

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

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Governments

Other

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 must complete the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least 4-6 weeks prior to the application due date.

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/Principal Investigator (PD/PI) 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 SF 424 (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.

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:

Section IV. Application and Submission Information

1. Requesting an Application Package

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.

2. Content and Form of Application Submission

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.

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 NIH staff to estimate the potential review workload and plan the review accordingly.

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

The letter of intent should be sent to:

David Yeung, Ph.D.
Project Manager, NIH CounterACT Research
National Institutes of Health, NINDS
6001 Executive Blvd.
NSC, Room 2195, MSC 9527
Bethesda, MD 20892-9527
Telephone: 301-443-7534
Email: dy70v@nih.gov

Required and Optional Components

The forms package associated with this FOA includes all applicable components, mandatory 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.

Page Limitations

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

Modular Budget Component

All applications should use the Modular Budget Component. Direct costs are limited to $250,000 per year. Applicants may request direct costs in $25,000 modules, up to the total direct costs limitation of $500,000 for the two-year award period.

PHS 398 Research Plan Component

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

Letters of Support

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:

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.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. Applicants are encouraged to submit in advance of the deadline to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications via 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.

Applicants are responsible for viewing their application 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.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. 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.

6. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF 424 (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 SF 424(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 by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.  

Post Submission Materials

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

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.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. An R21 grant application need not have extensive background material or preliminary information. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data. Preliminary data are not required for R21 applications; however, they may be included if available.

Note: The NIH is encouraging applications for translational research that may involve standard methodologies applied toward novel therapeutic approaches. Therefore, a project that does not necessarily employ novel methodologies may still be essential to advance the field.

Overall Impact

Reviewers will provide an overall impact/priority 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

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?

Additional Review Criteria

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/priority score, but will not give separate scores for these items.

FOA-Specific

Does this research significantly advance scientific knowledge that may predictably lead to the development of a medical countermeasure(s)/therapeutic against a chemical threat agent(s) that would be useful in a mass casualty civilian setting?

Is it likely that completion of the exploratory/developmental research objectives will generate tools and/or proof-of-principle data that would facilitate the development of competitive research applications for future support under the NIH CounterACT and/or other relevant research programs?     

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

Not applicable.

Revisions

Not applicable.

Additional Review Considerations

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/priority 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.

2. Review and Selection Process

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. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

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:

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

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 the DUNS, SAM Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

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.

Cooperative Agreement Terms and Conditions of Award

Not Applicable.

3. Reporting

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

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk (Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

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 Yeung, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-443-7534
Email: dy70v@nih.gov

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

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

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

Hung Tseng, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-5032
Email: tsengh@mail.nih.gov

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

David Siegel, M.D., F.A.A.P.
National Institute of Child Health & Human Development (NICHD)
Telephone: 301-594-8670
Email: siegelda@mail.nih.gov

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

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 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: okitar@nigms.nih.gov

Peer Review Contact(s)

Geoffrey Schofield, Ph.D.
Center for Scientific Review, Room 4180
Telephone: 301-435-1235
Email: geoffreys@csr.nih.gov

Financial/Grants Management Contact(s)

Maxine Davis
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: davisma@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 Parts 74 and 92.


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NIH Funding Opportunities and Notices



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