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 Mental Health (NIMH)
National Institute on Aging (NIA)
National Institute on Drug Abuse (NIDA)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Exceptional Unconventional Research Enabling Knowledge Acceleration (EUREKA) for Neuroscience and Disorders of the Nervous System (R01)

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of RFA-NS-13-007

Related Notices

  • January 31, 2014 - See Notice NOT-OD-14-047. NIH and AHRQ Extend Due Dates for Applications Due Jan 31-Feb 3 to Feb 4.

Funding Opportunity Announcement (FOA) Number

RFA-MH-14-214

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

 93.853, 93.242, 93.279, 93.866   

Funding Opportunity Purpose

 This Funding Opportunity Announcement (FOA) seeks Research Project Grant (R01) applications addressing exceptionally novel hypotheses and/or remarkably difficult problems in neuroscience and disorders of the nervous system.  This announcement is for support of new rather than ongoing projects, and is not intended for pilot research.  The proposed research may have a high risk of failure, but it must promise results with especially high impact should it be successful.  The research should be groundbreaking, innovative, original and/or unconventional, with the potential to solve important problems or open new areas for investigation.   

Key Dates
Posted Date

November 8, 2013

Open Date (Earliest Submission Date)

January 3, 2014

Letter of Intent Due Date(s)

January 3, 2014  

Application Due Date(s)

(Extended to February 4, 2014 per NOT-OD-14-047), Originally February 3, 2014), by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

May, 2014

Advisory Council Review

August, 2014  

Earliest Start Date

September 15, 2014

Expiration Date

(Extended to February 5, 2014 per NOT-OD-14-047), Originally February 4, 2014  

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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

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

The purpose of the EUREKA (Exceptional Unconventional Research Enabling Knowledge Acceleration) initiative is to foster exceptionally innovative research that, if successful, will have an unusually high impact on the areas of science that are germane to the mission of one or more of the participating NIH Institutes. EUREKA is for new projects, not for continuation of existing projects, and is not intended  for support of pilot projects, i.e., projects of limited scope that are designed primarily to generate data that will enable the PD/PI to seek other funding opportunities.  Rather, it is anticipated that EUREKA projects will begin and be completed during the funding period.

Participating Institutes

Before submitting an application, it is extremely important to verify that the proposed research is of interest to at least one of the NIH Institutes that is participating in this FOA, since applications that are not germane to the mission of one or more of the participating Institutes will not be reviewed.

The participating Institutes for this FOA are listed in Part 1. Overview of this announcement.  Prior to preparing an application, applicants should read the following paragraphs describing the participating Institutes’ missions and goals for this initiative, and consult the appropriate Institute website (listed with each Institute's name at the beginning of this announcement) for details of research areas supported by that Institute.  Applicants are encouraged to contact the appropriate Institute representative listed below in Section VII to ensure that the proposed research will be responsive to this FOA.  As indicated in the application instructions (Section IV, below) applicants are strongly advised to include a cover letter indicating the appropriate Institute.

NIMH:  The NIMH mission is to transform the understanding and treatment of mental illnesses through basic and clinical research, paving the way for prevention, recovery, and cure (http://www.nimh.nih.gov).  To fulfill its mission, the Institute conducts research on mental disorders and the underlying basic science of brain and behavior.  NIMH welcomes EUREKA applications for all program areas supported by the Institute.  Applicants should focus on one of the following NIMH Strategic Objectives:

For this FOA, NIMH will not accept applications for clinical trials.  For information about NIMH support of clinical trials, see NOT-MH-13-022 and related announcements.

NINDS: The mission of the NINDS is to reduce the burden of neurological disease.  In pursuit of this goal, NINDS supports research on the normal and diseased nervous system, including basic cellular/molecular biology and genetics, cognitive/behavioral and systems neuroscience, neuroplasticity, neurodevelopment, neurodegeneration, neurovascular, and studies aimed at detection, prevention, and treatment of neurological diseases.  For more information on NINDS research funding listed by Program Area (including Program staff contact listings), see http://www.ninds.nih.gov/funding/areas/index.htm.  Applicants are encouraged to contact Program staff associated with a given area of research to determine relevance of a particular application.  For this FOA, NINDS will not accept proposals for clinical trials, defined as prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about pharmacologic, behavioral, biologic, surgical, or device interventions.  For questions on NINDS support for clinical research, see http://www.ninds.nih.gov/research/clinical_research/.    

NIDA: NIDA's mission is to lead the nation in bringing the power of science to bear on understanding, preventing and treating drug abuse and addiction. NIDA is interested in fostering technologically innovative and conceptually creative research that advances our understanding of the genetic and environmental antecedents, the behavioral and physiological consequences, and the neurobiological mechanisms of drug abuse and addiction, and in novel prevention and treatment research.  For the EUREKA program, NIDA is interested in supporting high-risk/high-impact innovative research that encompasses the areas aligned with NIDA’s programs, priorities, and strategic plan (see http://www.nida.nih.gov/StrategicPlan/Index.html and http://www.nida.nih.gov/about/organization/Organization.html).  Of particular interest are applications in (1) basic and clinical neuroscience (2) drug discovery for medications development and (3) genetics research involving genetic model systems or human genetics (see http://grants.nih.gov/grants/guide/notice-files/NOT-DA-12-012.html).  Applicants are strongly encouraged to contact NIDA staff to discuss feasibility of their proposed research and relevance to NIDA’s mission.

NIA:  Research supported by the Division of Neuroscience (DN), NIA is intended to address in a systematic way the study of all aspects of the aging brain, the outcome of which should improve our understanding of the aging nervous system with the goal to maintain health and improve the quality of life of the older population.  Three branches constitute the Division’s extramural research program namely, Neurobiology of Aging, Behavioral and Systems Neuroscience, and Dementias of Aging.  DN supports research on all aspects of Alzheimer’s disease (AD) and on a broad spectrum of research aimed at elucidating how the central nervous system and behavior are affected by normal as well as pathological aging.  An emerging focus is how the processes of aging and age-related cognitive decline intersect with the development of AD and other dementias of aging as well as a focus on the etiology, diagnosis, and treatment of AD and other dementias.  For more information on NIA research funding by Program Area, see http://www.nia.nih.gov/research/dn/research-areas.  Applicants are encouraged to contact program staff associated with a given area of research to determine relevance of a particular application. 

The EUREKA Program

To encourage exceptionally innovative research, this FOA seeks applications from investigators who want to test novel, unconventional hypotheses; pursue major methodological or technical challenges; or settle particularly difficult questions. The potential impact of the proposed research must be substantial, in terms of both the size of the scientific community affected and the magnitude of its impact on that community.  The investigator should anticipate starting and completing the project during the term of the award, since this FOA is not for support of ongoing research or for pilot projects, and awards are not renewable.  If it is the hypothesis that is novel, the investigator should be able to prove or disprove that hypothesis by the end of the funding period.  If it is the methodology or technology that is exceptionally innovative, the investigator should be able to develop it by the end of the funding period or demonstrate conclusively that the approach is not feasible.  If the research addresses a longstanding difficult question, the investigator should show that the new approach will provide a clear solution during the project period.

The rationale for EUREKA is that for science to move forward in leaps rather than in incremental steps, investigators must have opportunities to test unconventional, potentially paradigm-shifting hypotheses, and to attempt to use novel, innovative approaches to solve difficult technical and conceptual problems that severely impede progress in a field. However, applications proposing such research are difficult to evaluate in comparison to more typical investigator-initiated R01 research grant applications, in which the emphasis tends to be more on the feasibility of the proposed research than on its novelty.

Several key features of the EUREKA FOA have been designed to emphasize to applicants and peer reviewers that these applications are very different from conventional, investigator-initiated R01s.  The application format, through its page limitations and requirements for explicitly addressing specific issues, focuses attention on the importance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on experimental details.  Reviewers will be instructed to emphasize significance and innovation in their evaluations, and these criteria will be the primary basis for funding decisions.  Although reviewers will be asked to assess the logic of the experimental plan to determine whether the project has some (non-zero) likelihood of success, they will be reminded that risk is a hallmark of exceptionally innovative research and, in most cases, should not detract from the merit of an application.  A PD/PI’s record of overcoming difficult scientific hurdles, appropriate to his/her career stage, may also be useful in assessing the likelihood of success, although the focus of this initiative is on the project rather than the investigator.  These features are intended to steer applicants and reviewers, at each step of the process, toward the goals of the EUREKA initiative, which are to solicit and fund unusually bold and potentially transformative research.

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

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

Funds Available and Anticipated Number of Awards

The following NIH components intend to commit the following amounts in FY 2014:

 NIMH, $1,500,000

NINDS, $1,500,000

NIDA, $1,000,000

NIA, $500,000

Award Budget

 Support may be requested for up to $800,000 in direct costs (excluding consortium Facilities and Administrative [F&A] costs) over a four-year period, prorated for shorter terms ($600,000 for three years, $400,000 for two years). Regardless of the term of support, direct costs (excluding consortium F&A costs) may not exceed $250,000 in any one year.

Because the nature and scope of the proposed research will vary from application to application, it is anticipated that the size and duration of each award will also vary. Although the financial plans of the IC(s) provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds.

Facilities and Administrative (F&A) costs requested by consortium participants are not included in the direct cost limitation. See NOT-OD-05-004.

Award Project Period

 Support may be requested for up to four 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  eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are  eligible to apply.

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

Required Registrations

Applicant Organizations

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

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility


Number of Applications

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

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.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

Within the Research Strategy, the suggested limit for "Approach" is 3 pages.

Within the Research Strategy, the suggested limit for "Timeline" is half a page.

Required and Optional Components

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

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

SF424(R&R) Senior/Key Person Profile

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

Biographical Sketches:

For this FOA, PD(s)/PI(s) must limit the number of citations in the Biosketch (e.g., publications, patents, or meeting abstracts) to ten or fewer items.  Citations should include those that are most relevant to the application, or those that illustrate innovation and significance of past accomplishments. Following each citation, PD(s)/PI(s) should briefly summarize the findings or achievements of the cited item and/or its relevance to the proposed research.  Each summary should not exceed 60 words and all summaries must be provided within a four page limit.

Key personnel other than the PD(s)/PI(s) should submit standard Biosketches, including the personal statement, as described in the SF424 Application Guide.

R&R or Modular Budget

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

PHS 398 Cover Page Supplement

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

Prior to preparing an application, applicants should verify that the proposed research is of interest to one or more of the NIH Institutes participating in this FOA, following instructions described for each Institute in Section I.  Applicants should indicate the appropriate Institute assignment in their cover letter (PHS398 Cover Letter File), submitted as a component of the application.

PHS 398 Research Plan

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

Specific Aims:

The Specific Aims should address, in summary form, the components of the Research Strategy listed below, with particular emphasis on the Challenge and Potential Impact.

Research Strategy:

The Research Strategy should be organized as a single document following the section headings listed below (Challenge, Impact, Approach, Appropriateness for the FOA, Likelihood of Success, and Timeline).  Avoid jargon and use language that can be understood broadly, since applications will be evaluated by reviewers representing a diversity of scientific interests. 

1. The Challenge: What is the hypothesis or problem that will be addressed?  If you are testing an unconventional, exceptionally novel hypothesis, how does it challenge the standard paradigm?  If you are addressing a technological or methodological problem, what makes the problem especially challenging?

2. The Potential Impact: Why is testing the hypothesis or solving the problem particularly important?  What is the full breadth and magnitude of the project's potential impact on science and/or health?  

3. The Approach: A detailed experimental plan is not required.  Instead, provide enough information for reviewers to understand the methodology, rationale, and logic of the proposed research plan.  Describe why this approach is exceptionally novel or important to follow, and how it differs from approaches that have already been tried.   

4. The Appropriateness for the EUREKA FOA: Describe why the proposed research is uniquely suited to the stated goals of this FOA, and why would it not be suitable as a conventional research grant application.  In addition, indicate how the proposed activities differ from ongoing efforts. 

5. The Likelihood of Success: Briefly describe the past achievements that best illustrate your exceptional innovativeness, your ability to make paradigm-shifting discoveries or solve very difficult problems, and the impact of your past discoveries or solutions. The achievements that you highlight need not be conceptually related to the hypothesis or problem that you are addressing in this application. If your previous research was not unusually innovative, and you have not yet made a paradigm-shifting discovery or solved a very difficult problem, which aspect of the logic of the experimental approach suggests that there is some probability that the proposed research will be successful, or that the approach should be tried in spite of the risks?  

6. Timeline: Provide a timeline for the proposed research. To facilitate evaluation of progress reports, indicate when you anticipate that essential components of the project (e.g., optimization of protocols, generation of reagents, critical experiments to verify the hypothesis, validation of novel tools or techniques) will be completed.

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout 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 applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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

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

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 SF424 (R&R) Application Guide.  Paper applications will not be accepted.

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

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Post Submission Materials

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

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:

This initiative is designed to support research projects addressing exceptionally novel hypotheses and/or remarkably difficult problems, using highly innovative or untested approaches.  Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential impact. 

The research approach will be evaluated for logic and novelty.  Although reviewers will consider feasibility, they will not penalize unavoidable risks that are intrinsic to new and innovative approaches.  Also note that reviewers will evaluate the logic of the "Appropriateness for the EUREKA FOA" section of the Research Strategy.

Overall Impact

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

Scored Review Criteria

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?  Is the investigator testing a hypothesis or solving a problem of particular importance?  Are the potential outcomes of the proposed research, as described in the "Potential Impact" of the Research Strategy, truly exceptional?    

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?  Do the investigators' past achievements illustrate exceptional innovation and/or ability to solve very difficult and important problems?  If not, is the logic of the approach compelling, and are the investigator(s) particularly well-positioned to perform the proposed research?  

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?  Are the hypotheses and approaches substantially innovative and/or highly unconventional?  If not, is this a particularly challenging problem that cannot be addressed in a conventional research project grant? 

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 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 logic of the approach compelling, despite lack of experimental details or high risk of failure?  Has this approach been tested before?  Does the approach differ from approaches previously used to test the hypothesis or answer the important question? 

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Children 

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following 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.

Resubmissions

Not Applicable

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 score.

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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), 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:

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

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 submitted in response to this FOA. 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 annual Non-Competing Progress Report (PHS 2590 or RPPR) and financial statements as required in the NIH Grants Policy Statement.

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

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

Section VII. Agency Contacts

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

Application Submission Contacts

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

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov  

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

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov  

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

Scientific/Research Contact(s)

Susan Koester, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: (301) 443-3563
Email: koesters@mail.nih.gov

Edmund Talley, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-1917
Email: TalleyE@ninds.nih.gov)

Susan Volman, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: (301) 435-1315
Email: svolman@mail.nih.gov

Bradley Wise, Ph.D.
National Institute on Aging (NIA)
Telephone: (301) 496-9350
Email: wiseb@nia.nih.gov

Peer Review Contact(s)

David Armstrong, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: (301) 443-3534
Email: armstrda@mail.nih.gov

Financial/Grants Management Contact(s)

Rebecca D. Claycamp  
National Institute of Mental Health (NIMH)
Telephone: (301) 443-2811
Email: rclaycam@mail.nih.gov

Tijuanna Decoster
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: (301) 496-9231
Email: decostert@ninds.nih.gov

Carol Alderson
National Institute on Drug Abuse (NIDA)
Telephone: (301) 933-6196
Email: alsersoc@nida.nih.gov

Richard Proper
National Institute on Aging (NIA)
Telephone: (301) 496-1472
Email: properr@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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