EXPIRED
National Institutes of Health (NIH)
Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54)
U54 Specialized Center- Cooperative Agreements
Reissue of PAR-15-146
PAR-16-329
PAR-15-315, R21 Exploratory/Developmental Research Grant
PAR-16-330, U01 Research Project Cooperative Agreements
PAR-16-331, U01 Research Project Cooperative Agreements
93.853, 93.867, 93.846, , 93.113
This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54s). The mission of the CounterACT program is to foster and support research and development of new and improved therapeutics for chemical threats. Chemical threats are toxic chemicals that could be used in a terrorist attack or accidentally released from industrial production, storage or shipping. They include traditional chemical warfare agents, toxic industrial chemicals, and pesticides. The scope of the research includes target and candidate identification and characterization, through candidate optimization and demonstration of in vivo efficacy, consistent with the product's intended use in humans For applicants submitting U54 renewal applications, research under this FOA should culminate in an optimized lead compound ready for advanced development. The Centers will contain at least three research projects supported by administrative and up to three optional scientific cores, and a research education core. Each research project must include milestones that create discrete go or no-go decision points in a progressive translational study plan.
June 15, 2016
August 13, 2016
30 days prior to the application due date
September 13, 2016; September 12, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
February 2017; February 2018
May 2017; May 2018
July 2017; July 2018
September 13, 2017
Not Applicable
NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.
Required Application Instructions
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of the Announcement
Section
I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
The overall goal of the NIH CounterACT program is to reduce mortality and morbidity during and after emergency events involving the release of chemical threat agents. Chemical threat agents are toxic chemicals that could cause mass casualties after being released by a deliberate terrorist attack, or by industrial accident or natural disaster. This Funding Opportunity Announcement (FOA) encourages applications for Countermeasures Against Chemical Threats (CounterACT) Research Centers of Excellence (U54s).
The NIH CounterACT Research program includes a network of Research Centers of Excellence, individual research projects, contracts and Interagency Agreements with the Department of Defense. The network conducts basic and translational, and pre-clinical research aimed at the discovery and/or identification of better medical countermeasures against chemical threat agents, and it supports their development in preparation for more advanced studies required for FDA approval and to ensure they are effective and safe for use in humans. The CounterACT U54 program described in this FOA is a central component of this overall larger effort, and is designed to support research centers consisting of three or more projects and scientific cores that synergistically produce rigorous interdisciplinary research of the highest quality. The Center will also include an administrative core to provide oversight, and a research education core to strengthen the research skills of the scientific workforce in the chemical countermeasures field of study. To ensure that the supported research is consistent with the overall goals of the program, CounterACT Research Centers of Excellence are milestone-driven cooperative agreements with substantial scientific and programmatic involvement by NIH staff.
CounterACT cooperative agreement U54 Program Directors/Principal Investigators (PDs/PIs) will become members of the CounterACT research network, and will be able to utilize its resources such as the CounterACT Preclinical Development Facility (CPDF). They will be required to participate in annual meetings of the national CounterACT research network to share information and ideas. The CounterACT program at NIH is part of the larger biodefense program coordinated by the National Institute of Allergy and Infectious Diseases (NIAID) that includes biological and radiation/nuclear threats. Also see www.medicalcountermeasures.gov which facilitates communication between federal government agencies and public stakeholders to enhance the Nation's public health emergency preparedness.
The civilian chemical threat spectrum includes chemical warfare agents (e.g., sarin), toxic industrial chemicals (e.g., cyanide), pesticides (e.g., parathion), and other chemicals. These agents are included on the current Department of Homeland Security (DHS) Chemical Terrorism Risk Assessment (CTRA) list, which is for USG official use only and cannot be included in this FOA. Applicants are strongly urged to contact the Scientific/Research staff listed in this FOA to determine if their proposed threat agent(s) is of interest to the NIH. Applications that propose research on chemical threats that are not included on the CTRA list will not be selected for funding. Therefore, it is critical to contact NIH staff early, before time and effort are invested in developing an application to support research on a chemical or group of chemicals that is not a priority to the NIH.
Antidotes that are specific to a chemical will be considered; however, applicants should also consider research on acute effects and pathologies that are common to several chemical threat agents, so that the therapeutics being developed will have a broader spectrum of activity against more than one chemical.
Many of the chemical threat agents of interest are extremely hazardous to humans. This FOA will only consider supporting studies deemed safe for research personnel and the environment by appropriate official institutional biosafety review. Special biosafety certifications may be required to conduct research with some chemical threat agents, e.g., nerve agents. Therefore, when applicable, applicants are encouraged to collaborate with laboratories that are certified to work with restricted chemical agents, such as the US Army Medical Research Institute of Chemical Defense (USAMRICD) and certain contract research facilities. Applicants are strongly encouraged to contact the NINDS Scientific/Research Contact listed in this FOA for further information on working with restricted chemical agents.
This FOA supports translational research. Translational research is the process of applying ideas, insights, and discoveries generated through basic scientific inquiry to the treatment or prevention of human disease. The categories of research supported under this program include but are not limited to:
One goal of the research supported under this FOA is to prepare for advanced development. Most of the advanced development activities required for regulatory approval are not covered under this FOA (to include GLP IND-enabling safety studies and pivotal efficacy studies in animals, cGMP production, and human safety clinical trials), but could potentially be supported by other federal agencies or industry once the NIH-supported research is completed. The HHS advanced development agency relevant to this FOA is the Biomedical Advanced Research and Development Authority (BARDA). Once research funded under this FOA is completed, you should have the following before exploring the possibility of additional funding through BARDA for advanced development.
Proposed research to this announcement should strive to meet the above list by the end of the project period. 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. For the purpose of this FOA, lead candidates(s) are defined as biologically active and synthetically feasible compounds where specificity, affinity, potency, target selectivity, efficacy, and safety have been established.
Milestone-driven research is used to ensure research is focused on a well-defined goal, thus achieving that goal with greatest efficiency. As translational research is inherently high-risk, the use of milestones provides clear indicators of a project's continued success or emergent difficulties.
Milestones should describe the goal of the work and not just a statement that the work will be completed. Given the high-risk and progressive nature of therapeutics discovery and development, results at any stage of a project might indicate a dead end, for example a toxicology study may reveal that a molecule is unsuitable for human use. Thus, the milestone should indicate the desired outcome of a study and not simply that the study was conducted. The milestones must provide objective and quantitative outcomes by which to justify advancing the project. The criteria for success of the studies conducted should be objective measures. These should be measures that would be recognizable as appropriate endpoints in the specific scientific area. They should also have clear success criteria that can be used for evaluation by NIH. For examples of acceptable milestones, see http://www.ninds.nih.gov/research/counterterrorism/developing_milestones.htm.
Annual milestones may be modified in negotiations with NIH program officials before an initial award is made, and during the review of annual non-competitive applications. Unmet milestones and an incomplete data package that prevents an adequate interpretation of the results will have a negative impact on the review and approval of these annual non-competing applications. Partial budget reductions and/or restrictions in a given project year may also occur if certain aspects of the project are deemed futile, but others still show promise.
The NIH encourages the awardees and/or their collaborators to obtain and retain any IP developed around the therapy during the project period. Recipients of awards are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the therapy development process. PDs/PIs are expected to work closely with their institutional technology transfer officials to ensure that royalty agreements, patent filings, and all other necessary IP arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project. It is recognized that in the case of medical countermeasures, commercialization may be challenging. Therefore, applicants are encouraged to discuss alternative strategies with NIH Scientific/Research staff to get further guidance.
In general, the scope of research covered in this FOA can also be described by Technology Readiness Levels (TRLs). The TRLs covered in this FOA should fall between TRLs 3 through 5.
Specific examples of relevant research topics include but are not limited to those listed below:
Because of the urgency in need, and the lengthy time and expense for bringing a new compound to regulatory approval, applicants are encouraged to consider drugs that are already approved by the FDA for other indications. Some of these drugs have been shown to be effective in treating victims of chemical exposures, and in some cases, the length of time to regulatory approval for a new indication may be shorter than for a new chemical entity. Applicants are urged to contact the Scientific Contacts listed in this FOA for more information related to the FDA.
This FOA will only support translational research that is clearly relevant to the development of therapeutics that will enhance our medical response capabilities during an emergency. New medical countermeasures that have no practical use during or shortly after a mass casualty situation are not appropriate to this FOA. Drugs only effective if given prior to chemical insult (prophylaxis), or those that must be given within a very short period (1-15 minutes) after the insult, will be of low priority. Since many chemical threats have rapid modes of action, the drug should act rapidly to counter these effects. The experimental design of proposed studies should be consistent with the timing and route of administration intended for use in humans during a chemical emergency. For example, drugs that are only effective when administered intravenously in the pre-hospital setting would be of low priority since their use would be impractical in a mass casualty situation. However in some cases drugs may be given in-hospital to prevent long-term effects after acute exposures. Model development, screening activity and efficacy studies should be designed and justified with these ultimate requirements under consideration.
Special consideration will be given to research relevant to people who are particularly vulnerable, including the young, the elderly, and individuals with pre-existing medical conditions. Pregnant women, infants and children are particularly vulnerable to the effects of chemical agents. Animal models and studies that address these vulnerabilities will be of high priority.
There should be a unifying well-defined goal or problem area of research to which each project relates and contributes, thereby producing a synergistic research environment that allows each research effort to share the resources and creative strengths of the others. There is the expectation that support of inter-related projects and collaborating investigators would yield results beyond those achievable if each project were pursued separately without formal interaction among the participating investigators. All investigators should contribute to, and share in, the responsibilities of fulfilling the Center objectives and milestones.
Milestones for the overall Center should be developed. These Center milestones should reflect the overall goals and objectives of the Center, and be supported by the milestones proposed in the subprojects. There may only be 3 or 4 Center milestones per year over the course of the entire project period.
Each CounterACT Research Center of Excellence should include the following components:
Administrative Core for Center Management and Operations
Research and Development Projects
These projects should be scientifically linked. Examples of how these projects could be linked include:
Scientific Core(s)
Scientific core facilities may be proposed if they will be utilized by at least two of the projects. Such core facilities should provide services that are already available, fully developed, and cannot be funded through other means for the purposes proposed. If subprojects are removed, replaced, or redirected during the funding period, core facility funds may be rebudgeted within the individual CounterACT Center upon approval by the NIH. Scientific core facilities may include clinical, statistical, technical, or other supportive activities.
Research Education
One goal of the CounterACT program is to increase the number and capabilities of researchers and other personnel in applied toxicological research related to chemical threats. In general, the research education core should be multidisciplinary and provide short-term education for technicians, medical or graduate students, postdoctoral fellows, and/or independent investigators, either within or beyond the CounterACT Center. Formal graduate programs are excluded from this FOA.
The proposed core should build on the strengths of the Center investigators, although outside instructors may be incorporated on occasion to provide cross-disciplinary depth.
Proposed activities within the core should facilitate the development of skills in the use of assays, methods, reagents, animal models, or technologies to develop new products through the regulatory process.
Program Oversight
CounterACT Center Steering Committee:
A Steering Committee for each CounterACT Center will make strategic decisions with regard to goals and research implementation of the Center to ensure that scientific milestones are met, resources are shared, and productive collaborations are established. The Center Steering Committee will meet as frequently as possible utilizing various modes of communication, and be composed of the PD/PI, subproject investigators and other members with relevant scientific expertise. The NIH program official will serve on this committee.
External Advisory Committee:
Awardees will form an External Advisory Committee. This committee will provide subjective evaluation of the annual or progress of the Center, and make recommendations to the Center PD/PI. The Committee should meet once per project year. In order to maintain the largest possible reviewer pool for this FOA, applicants should not propose specific external advisors and should not contact potential members prior to NIH review of the application.
As a cooperative agreement, implementation will involve the participation of NIH Program staff in the planning and execution of the therapy-directed projects. Applicants are strongly encouraged to consult with NIH Scientific/Research staff when planning an application. Early contact provides an opportunity for NIH Scientific/Research staff to provide further guidance on program scope, goals, developing appropriate milestones, and budget. Applicants should contact NIH Scientific/Research staff at least 12 weeks before a due date.
See Section VIII. Other Information for award authorities and regulations.
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.
New
Renewal
Resubmission
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets may not exceed $2.5 million in direct costs per year over the maximum five-year project period.
Many applications will not need to request the maximum budget and the size and duration of the awards will vary because the nature and scope of research programs will vary.
The total project period may not 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
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
o Hispanic-serving Institutions
o Historically Black Colleges and Universities (HBCUs)
o Tribally Controlled Colleges and Universities (TCCUs)
o Alaska Native and Native Hawaiian Serving Institutions
o Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.
Program Directors/Principal Investigators (PD(s)/PI(s))
All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.
Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
Applicants can access the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.
Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.
It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
David A. Jett, Ph.D.
Telephone: 301-402-4225
Email: [email protected]
Component Types Available in ASSIST |
Research Strategy/Program Plan Page Limits |
Overall |
12 |
Admin Core |
12 |
Core (used for Scientific Core and Research Education Core) |
6 |
Project |
12 |
Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.
The application should consist of the following components:
When preparing your application in ASSIST, use Component Type Overall .
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete entire form.
Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.
Follow standard instructions.
Other Attachments:
Intellectual Property Strategy: Applications, with a pre-identified proposed therapeutic(s), are expected to include an Intellectual Property (IP) strategy that is no more than one page (if multiple therapeutics have been pre-identified then no more than one page per compound). Applications that exceed this limit will be withdrawn. This attachment should be entitled "IP_Strategy_CompoundName.pdf" and reflected in the final image. Applicants are encouraged to prepare this section of the application in consultation with their institution's technology transfer officials, if applicable.
A goal of this program initiative is to advance research towards the development of products that will mitigate mortality or morbidity after exposure to threat chemicals. Accordingly, applicants should describe the IP landscape surrounding their proposed therapeutic(s). This should include any known constraints that could impede the development of their medical countermeasure (e.g., certain restrictions under transfer or sharing agreements, applicants' previous or present IP filings and publications, similar approaches that are under patent and/or on the market, etc.) and how these issues could be addressed as appropriate and consistent with achieving the goals of the program. If the applicant proposes using a compound whose IP is not owned by the applicant's institution, either an investigational therapeutic, FDA-approved therapeutic, or other licensed product, the applicant should address any questions that may constrain or impede its ability to operate and move the compound forward consistent with achieving the goals of the program. Applicants should include a letter (see Letters of Support) from the entity that owns the IP indicating whether the entity will provide the compound, if there are any limits on the studies that can be performed with that compound, and agreement about public disclosure of results (including negative results), and whether there is an agreement already in place.
If patents pertinent to the therapeutic(s) being developed under this application have been filed, the applicants should indicate the details of filing dates, what types of patents are filed, application status, and associated United States Patent Office (USPTO) links, if applicable. Applicants should also discuss future IP filing plans. For a multiple-PD/PI, multiple-institution application, applicants should describe the infrastructure of each institution for bringing the compound(s) to practical application and for coordinating these efforts (e.g., how IP will be shared, licensing, managing IP) among the institutions.
Enter primary site only.
A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.
Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.
A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.
The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.
A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.
Introduction to Application: For Resubmission applications, an Introduction to Application is required in the Overall component.
Specific Aims: The specific aims should briefly but specifically describe the goals of the proposed research of the overall Center, and summarize the expected outcome(s), including the impact the proposed research will exert on the field.
Research Strategy: The Overall Research Strategy should present the overall vision for the proposed CounterACT Center including the following segments:
Letters of Support: Include letters of support/agreement for any collaborative/cooperative arrangements, subcontracts, or consultants. Letters of support for the CounterACT U54 overall should be included with the Overall component. Letters of support for individual scientific projects or cores should be included with those components of the application.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
The Data Sharing Plan should be submitted in the Overall component and should apply to all components of the application. A plan for distribution of data or samples generated in Research Projects should be included, and should conform to the NIH policy on data and resource sharing (https://grants.nih.gov/grants/policy/data_sharing).
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
All instructions in the SF424 (R&R) Application Guide must be followed.
When preparing your application in ASSIST, use Component Type Admin Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
Complete only the following fields:
Enter Human Embryonic Stem Cells in each relevant component.
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Facilities and Other Resources: Describe institutional commitment; include any relationships to other affiliates, clinical or medical centers at the Center as appropriate.
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Budget forms appropriate for the specific component will be included in the application package. When appropriate, awardees will be expected to collaborate; share novel reagents, assays, and animal models; and share both positive and negative results that would help guide the research and development activities of other CounterACT awardees. These activities will be facilitated by annual meetings of CounterACT investigators. Budgets should include cost for travel to one annual meeting of CounterACT investigators each of the proposed project years, in addition to other anticipated travel associated with the research.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: The specific aims should briefly but specifically describe the goals of the administrative core.
Research Strategy: The Administrative Core description should:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Omit the Sharing Plans here as they were provided in the Overall section.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Inclusion Enrollment Report (Administrative Core)
When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Scientific Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Scientific Core)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Scientific Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Scientific Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Scientific Core)
Budget (Scientific Core)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Scientific Core)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: The specific aims should briefly but specifically describe the goals of the scientific core.
Research Strategy: The research strategy for the scientific core should:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Omit the Sharing Plans here as they were provided in the Overall section.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Inclusion Enrollment Report (Scientific Core)
When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Project.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Project)
Complete only the following fields:
PHS 398 Cover Page Supplement (Project)
Enter Human Embryonic Stem Cells in each relevant component.
Research & Related Other Project Information (Project)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Project /Performance Site Location(s) (Project)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Project)
Budget (Project)
Budget forms appropriate for the specific component will be included in the application package.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Project)
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: The specific aims should briefly but specifically describe the goals of the Research project.
Research Strategy: The Research Strategy section should:
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Omit the Sharing Plans here as they were provided in the Overall section.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Inclusion Enrollment Report (Project)
When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
When preparing your application in ASSIST, use Component Type Core.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.
SF424 (R&R) Cover (Research Education Core)
Complete only the following fields:
PHS 398 Cover Page Supplement (Research Education Core)
Follow all instructions provided in the SF424 (R&R) Application Guide
Research & Related Other Project Information (Research Education Core)
Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.
Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.
Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.
Facilities & Other Resources. Describe the educational environment, including the facilities, laboratories, participating departments, computer services, and any other resources to be used in the development and implementation of the proposed program. List all thematically related sources of support for research training and education following the format for Current and Pending Support.
Project /Performance Site Location(s) (Research Education Core)
List all performance sites that apply to the specific component.
Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.
Research & Related Senior/Key Person Profile (Research Education Core)
Budget (Research Education Core)
Budget forms appropriate for the specific component will be included in the application package.
A minimum of $50,000 in direct costs must be allocated to the Research Education Core activities.
Include all personnel other than the PD(s)/PI(s) in the Other Personnel section, including clerical and administrative staff.
Use the section on Participant/Trainee Support Costs to include all allowable categories of funds requested to support participants in the program.
Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.
PHS 398 Research Plan (Research Education Core)
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Introduction to Application: For Resubmission applications, an Introduction to Application is allowed for each component.
Specific Aims: The specific aims should briefly but specifically describe the goals of the Research Education Core.
Research Strategy: This section must include the following subsections:
Proposed Research Education Program. While the proposed research education program may complement ongoing research training and education occurring at the applicant institution, the proposed educational experiences must be distinct from those research training and research education programs currently receiving federal support. When research training programs are on-going in the same department, the applicant organization should clearly distinguish between the activities in the proposed research education program and the research training supported by the training program. The proposed research education program should plan to create/expand local and remote capabilities for facilitating the development of key skill sets for investigators such as technicians, medical or graduate students, postdoctoral fellows, and/or independent investigators, either within or beyond the CounterACT Center. These skills may be related to the use of assays, methods, reagents, animal models, or technologies.
Core Lead(s). Describe arrangements for administration of the program. Provide evidence that the Program Director/Principal Investigator is actively engaged in research and/or teaching in an area related to the mission of NIH, and can organize, administer, monitor, and evaluate the research education program. For programs proposing multiple PDs/PIs, describe the complementary and integrated expertise of the PDs/PIs; their leadership approach, and governance appropriate for the planned project.
Program Faculty. Researchers from diverse backgrounds, including racial and ethnic minorities, persons with disabilities, and women are encouraged to participate as program faculty. Faculty should have research expertise and experience relevant to the proposed program and demonstrate a history of, or the potential for, their intended roles.
Program Participants. Applications must describe the intended participants, and the eligibility criteria and/or specific educational background characteristics that are essential for participation in the proposed research education program. Identify the career levels for which the proposed program is planned.
Recruitment Plan to Enhance Diversity: Fostering diversity in the scientific research workforce is a key component of the NIH strategy to identify, develop, support and maintain the quality of our scientific human capital (NOT-OD-15-053). Every facet of the United States scientific research enterprise from basic laboratory research to clinical and translational research to policy formation requires superior intellect, creativity and a wide range of skill sets and viewpoints. NIH’s ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission.
Research shows that diverse teams working together
and capitalizing on innovative ideas and distinct perspectives outperform
homogenous teams. Scientists and trainees from diverse backgrounds and life
experiences bring different perspectives, creativity, and individual enterprise
to address complex scientific problems. There are many benefits that flow from
a diverse NIH-supported scientific workforce, including: fostering scientific
innovation, enhancing global competitiveness, contributing to robust learning environments,
improving the quality of the researchers, advancing the likelihood that
underserved or health disparity populations participate in, and benefit from
health research, and enhancing public trust.
In spite of tremendous advancements in scientific research, information,
educational and research opportunities are not equally available to all. NIH
encourages institutions to diversify their student and faculty populations to
enhance the participation of individuals from groups identified as underrepresented
in the biomedical, clinical, behavioral and social sciences, such as:
A. Individuals from racial and ethnic groups that have been shown by the National Science Foundation to be underrepresented in health-related sciences on a national basis (see data at http://www.nsf.gov/statistics/showpub.cfm?TopID=2&SubID=27) and the report Women, Minorities, and Persons with Disabilities in Science and Engineering). The following racial and ethnic groups have been shown to be underrepresented in biomedical research: Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, and Native Hawaiians and other Pacific Islanders.
B. Individuals with disabilities, who are defined as those with a physical or mental impairment that substantially limits one or more major life activities, as described in the Americans with Disabilities Act of 1990, as amended. See NSF data at, http://www.nsf.gov/statistics/wmpd/2013/pdf/tab7-5_updated_2014_10.pdf.
C. Individuals from disadvantaged backgrounds, defined as:
1. Individuals who come from a family with an annual income below established low-income thresholds. These thresholds are based on family size, published by the U.S. Bureau of the Census; adjusted annually for changes in the Consumer Price Index; and adjusted by the Secretary for use in all health professions programs. The Secretary periodically publishes these income levels at http://aspe.hhs.gov/poverty/index.shtml.
2. Individuals who come from an educational environment such as that found in certain rural or inner-city environments that has demonstrably and directly inhibited the individual from obtaining the knowledge, skills, and abilities necessary to develop and participate in a research career.
The disadvantaged background category (C1 and C2) is applicable to programs focused on high school and undergraduate candidates.
Literature shows that women from the above backgrounds (categories A, B, and C) face particular challenges at the graduate level and beyond in scientific fields. (See, e.g., Inside the Double
Bind, A Synthesis of Empirical Research on Undergraduate and Graduate Women of Color in Science, Technology, Engineering, and mathematics http://her.hepg.org/content/t022245n7x4752v2/fulltext.pdf).
New applications must include a description of plans to enhance recruitment, including the strategies that will be used to enhance the recruitment of participants from underrepresented backgrounds and may wish to include data in support of past accomplishments.
Renewal applications must include a detailed account of experiences in recruiting individuals from underrepresented groups during the previous funding period. Information must be included on successful and unsuccessful recruitment strategies including aggregate information on the distribution of:
For those individuals who participated in the
research education program, the report should include information about the
duration of education and aggregate information on the number of individuals
who finished the program in good standing. Additional information on the
required Recruitment and Retention Plan to Enhance Diversity is available at
Frequently Asked Questions: Recruitment and Retention Plan to Enhance Diversity
(Diversity
FAQs).
Applications lacking a Recruitment
Plan to Enhance Diversity will not be reviewed.
Plan
for Instruction in the Responsible Conduct of Research: All applications
must include a plan to fulfill NIH requirements for instruction in the
Responsible Conduct of Research (RCR). The plan must address the five,
required instructional components outlined in the NIH policy: 1) Format - the required
format of instruction, i.e., face-to-face lectures, coursework, and/or
real-time discussion groups (a plan with only on-line instruction is not
acceptable); 2) Subject
Matter - the breadth of subject matter, e.g., conflict of interest,
authorship, data management, human subjects and animal use, laboratory safety,
research misconduct, research ethics; 3) Faculty
Participation - the role of the program faculty in the instruction;
4) Duration of Instruction - the number of contact hours of instruction, taking into consideration the
duration of the program; and 5) Frequency
of Instruction instruction must occur during each career stage and
at least once every four years. See also NOT-OD-10-019.
The plan should be appropriate and reasonable for the nature and duration of
the proposed program. Renewal (Type 2) applications must, in addition, describe
any changes in formal instruction over the past project period and plans to
address any weaknesses in the current instruction plan. All participating
faculty who served as course directors, speakers, lecturers, and/or discussion
leaders during the past project period must be named in the application.
Applications lacking a plan for instruction in responsible conduct of research will
not be reviewed.
Evaluation Plan: Applications must include a plan for evaluating the activities supported by the Core. The application must specify baseline metrics (e.g., numbers, educational levels, and demographic characteristics of participants), as well as measures to gauge the short or long-term success of the research education award in achieving its objectives. Wherever appropriate, applicants are encouraged to obtain feedback from participants to help identify weaknesses and to provide suggestions for improvements.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:
Omit the Sharing Plans here as they were provided in the Overall section.
Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Inclusion Enrollment Report (Research Education Core)
When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
For information on how your application will be automatically assembled for review and funding consideration after submission go to: https://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Informationcontains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.
The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.
Applicants are required to follow our Post Submission Application Materials policy.
Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the CounterACT Center to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the CounterACT Center proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a CounterACT Center that by its nature is not innovative may be essential to advance a field.
Does the CounterACT Center address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? If the aims of the CounterACT Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Will the proposed therapeutic reduce mortality and morbidity during and after emergency events involving the release of chemical threat agents?
Will the proposed model or assay have utility for developing a therapeutic relevant to this FOA?
For those projects on model development, will the research be clearly aimed at screening for candidate therapeutics, such as studies that develop and validate efficacy screens using the appropriate controls?
How strong are the preliminary data supporting the choice of the proposed injury mechanism and/or therapeutics for the indication, i.e., biological relevance?
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the CounterACT Center? If Early Stage Investigators or New Investigators, or in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Are the scientific qualifications, scientific and administrative leadership capabilities, and time commitment of the PD/PI adequate? For applications involving multiple PDs/PIs, are their designated roles and responsibilities well defined, adequate, and appropriate for achieving the goals of the proposed CounterACT Center?
Are the qualifications of core directors and managers adequate?
Is there adequate statistical and/or regulatory support for the experimental design, analysis, and interpretation of the generated preclinical data?
Is there adequate personnel to manage existing and future intellectual property associated with this project?
Are the proposed facilitators experienced in the types of activities proposed in the Research Education Core?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the CounterACT Center? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the CounterACT Center is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the CounterACT Center involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of children, justified in terms of the scientific goals and research strategy proposed?
Is the overall timeline reasonable for the work proposed? For key experiments, does the application explain assumptions for power analysis, describe statistical analysis methods and criteria for data inclusion or exclusion, and detail the procedures of how blinding and randomization will be conducted? Will projects that propose to identify a lead compound do so within the multi-year proposed project period? Will the planned studies and expected result support the proposed indication?
Are the proposed milestones adequate for advancing the goals of the CounterACT Center in a timely manner? Are these milestones described with quantitative success criteria that facilitate go or no go decisions? Are the timelines proposed for achieving the milestones realistic and inclusive of necessary steps, but also efficient without unnecessary studies? Would achieving all the proposed milestones in the application allow the Center to achieve the ultimate goal of the project to identify and/or optimize therapeutic compound(s)?
Do the specific aims enhance synergism among the projects and cores? Do they integrate the project into the overall goals, objectives, and milestones of the Center? Does each project relate and contribute to the others, including how they would yield results beyond those achievable if each project were pursued separately without formal interaction among the participating investigators?
Does the Center leadership have a plan for monitoring progress, and ensuring that a strategic plan is implemented in an effective and efficient manner?
Is the Research Education Core well justified, and does it describe a program that will likely increase the number and capabilities of researchers in the field?
Do the proposed efforts sufficiently address key parameters necessary in the successful development of a product (i.e., drug development), such as compound toxicity/safety, pharmacology, chemistry, and pharmacokinetics/metabolism? Based on the provided structural information of the pre-identified therapeutic hit(s)/lead(s), is the proposed optimization plan acceptable and achievable? Are there any insurmountable roadblocks that may prevent the development of a therapeutic medical product? Are the proposed IP and regulatory strategies appropriate? Are the proposed animal models well justified based on rigorous scientific rationales, particularly from the regulatory aspect, especially for any efforts with large or higher order animal model species?
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?
Do core resources effectively and efficiently support the research activities in a manner that cannot be supported through available resources?
Does each core provide a specialized resource that is essential for the conduct of project research, or collaborative projects?
Are institutional commitments proposed to enable and facilitate the research objectives tangible and adequate?
As applicable for the CounterACT Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed CounterACT Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.
For Renewals, the committee will consider the progress made in the last funding period.
How significant is the contribution of the applicants currently funded CounterACT Research Center to scientific knowledge in the field? How well have the applicants accomplished the specific objectives and milestones proposed in the original CounterACT Research Center application?
Not Applicable
As applicable for the CounterACT Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan .
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
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:
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.
Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Annual milestones will be included in the Special Terms and Conditions of the Notice of Award. Failure to meet these annual milestones will have a negative impact on the review of Type 5 non-competitive progress reports. In addition to milestones, the decision regarding continued funding will also be based on the overall robustness of the entire data package that adequately allows an interpretation of the results (regardless if they have been captured in the milestones), and overall progress.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.
For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
Cooperative Agreement Terms and Conditions of Award
The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Dispute Resolution:
When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons
registration, submitting and tracking an application, documenting system
problems that threaten submission by the due date, post submission issues)
Finding Help Online: https://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Grants.gov Customer Support (Questions
regarding Grants.gov registration and submission, downloading forms and
application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-945-7573
For questions related to the overall CounterACT program and/or neurological injury research:
David A. Jett, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-6035
Email: [email protected]
For questions related to ocular injury research:
Houmam Araj, Ph.D.
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
For questions related to dermal/vesicant-induced injury research:
Hung Tseng, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-496-0810
Email: [email protected]
For questions related to pulmonary injury research:
Srikanth S. Nadadur, Ph.D.
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-5327
Email: [email protected]
Geoffrey Schofield, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-435-1235
Email: [email protected]
Tijuanna E. DeCoster, Ph.D., MPA
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9231
Email: [email protected]
William W. Darby
National Eye Institute (NEI)
Telephone: 301-451-2020
Email: [email protected]
Lisa A. Edwards, MBA
National Institute of Environmental Health Sciences (NIEHS)
Telephone: 919-541-0751
E-mail: [email protected]
Andrew Jones
National Institute of Arthritis, Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-435-0610
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 Part 75.