Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
Office of Strategic Coordination (Common Fund)
This Funding Opportunity Announcement (FOA) is developed as a Common Fund initiative (https://commonfund.nih.gov/) through the Office of the NIH Director, Office of Strategic Coordination (https://dpcpsi.nih.gov). All NIH Institutes and Centers participate in Common Fund initiatives.
Reissue of RFA-RM-19-006
None
There is no limit to the number of applications an institution may submit. Individuals may submit only one application as PD/PI in response to this FOA. See Section III. 3. Additional Information on Eligibility.
93.310
The NIH Director’s New Innovator Award Program supports early stage investigators of exceptional creativity who propose highly innovative research projects with the potential to produce a major impact on broad, important areas relevant to the mission of NIH. For the program to support the best possible researchers and research, applications are sought which reflect the full diversity of the research workforce. Individuals from diverse backgrounds and from the full spectrum of eligible institutions in all geographic locations are strongly encouraged to apply to this Funding Opportunity Announcement. In addition, applications in all topics relevant to the broad mission of NIH are welcome, including, but not limited to, topics in the behavioral, social, biomedical, applied, and formal sciences and topics that may involve basic, translational, or clinical research. The NIH Director's New Innovator Award Program complements other ongoing efforts by NIH and its Institutes and Centers to fund early stage investigators. The NIH Director’s New Innovator Award Program is a component of the High-Risk, High-Reward Research (HRHR) Program of the NIH Common Fund.
Not Applicable
August 21, 2020
No late applications will be accepted for this Funding Opportunity Announcement.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
August 21,2020
No late applications will be accepted for this Funding Opportunity Announcement.
All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).
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.
March 2021
May 2021
September 2021
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide,except where instructed to do otherwise (in this FOA or in a Notice from 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.
The NIH Director's New Innovator Award addresses two important goals: stimulating highly innovative research and supporting promising Early Stage Investigators. Early Stage Investigators may have exceptionally innovative research ideas, but not the preliminary data required to fare well in the traditional NIH peer review system. As part of NIH's commitment to increasing opportunities for Early Stage Investigators, it has created the NIH Director's New Innovator Award to support outstandingly creative Early Stage Investigators who propose highly innovative research projects with the potential for unusually high impact. This award complements ongoing efforts by the NIH and its Institutes and Centers to fund Early Stage Investigators through R01 grants and other mechanisms. The definition of Early Stage Investigator is provided here.
The NIH Director's New Innovator Award is different from traditional NIH grants in several ways. It is designed specifically to support unusually creative investigators with highly innovative research ideas at an early stage of their career when they may lack the preliminary data required for an R01 grant application. The emphasis is on innovation and creativity; preliminary data are not required but may be included. No detailed, annual budget is requested in the application. The review process emphasizes the individual’s creativity, the innovativeness of the research approaches, and the potential of the project, if successful, to have a significant impact on an important biomedical or behavioral research problem.
In order to support the most innovative and impactful research, the NIH recognizes the need to foster a diverse research workforce across the nation. Applications to this award program should reflect the full diversity of potential PD/PIs, applicant institutions, and research areas relevant to the broad mission of NIH. Researchers from diverse backgrounds, including those from underrepresented racial and ethnic groups, persons with disabilities, and women are strongly encouraged to work with their institutions to develop applications for this Funding Opportunity Announcement. Since outstanding research is conducted at a broad spectrum of institutions, it benefits the national scientific enterprise to support exceptionally innovative and impactful science that represents this breadth. Therefore, this Funding Opportunity Announcement encourages applications from the full range of eligible institutions, including those serving primarily underrepresented groups, those that may be less research-intensive, and from all domestic geographic locations. Applications are welcome in all research areas broadly relevant to the mission of NIH. These areas include, but are not limited to, the behavioral, medical, natural, social, applied, and formal sciences. Research may be basic, translational, or clinical. The primary requirements are that the research be highly innovative and have the potential for unusually broad impact.
Investigators who were not selected for an award in prior years may submit applications this year as long as they retain eligibility requirements (including ESI status) described in this FOA; however, all applications must be submitted as new applications regardless of any previous submission to the program. No reference to any prior application may be included. Any reference to a prior application may be grounds for administrative withdrawal.
The NIH Director's New Innovator Award is part of the High-Risk, High-Reward Research (HRHR) Program funded through the NIH Common Fund, which supports cross-cutting programs that are expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and often risky approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Need help determining whether you are doing a clinical trial?
NIH intends to commit approximately $80 million for approximately 33 awards in FY 2021. The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Due to multi-year funding reporting requirements, projects must end June 30, 2026. No-cost extensions are not allowed.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from 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:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
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 the purpose of this FOA, multiple PD(s)/PI(s) are not allowed.
Applicants must meet the definition of an Early Stage Investigator (ESI) at the time of submission application. An ESI is a new investigator (defined as a PD/PI who has not competed successfully for a significant NIH independent research award) who is within 10 years of completing his/her terminal research degree or end of post-graduate clinical training. See the Office of Extramural Research website for a complete list that do not disqualify a PD/PI as a new investigator and for frequently asked questions about the NIH Early Stage Investigator (ESI) Policy.
An extension to the 10-year period may be granted under certain circumstances (e.g., childbirth, family care responsibilities, clinical loan repayment requirements, disability or illness, natural or other disaster, etc.). An online vide tutorial is available for more information. It may take several weeks for the review process for the request, so applicants should plan accordingly. Note: If an applicant is not identified as an ESI in the eRA Commons, it may result in the application not being reviewed. Applicants are responsible for reviewing and/or updating their degree information in their eRA Commons account in a timely fashion.
Applicants must hold an independent research position at a domestic (U.S.) institution by September 1, 2021. For this FOA, an independent research position is a position that automatically confers eligibility to the investigator (based on institutional policy) to apply for R01 grants with appropriate institutional commitment of facilities for the conduct of the proposed research. Investigators still in training or mentored status (such as postdoctoral fellows) are not eligible to apply unless they have a written commitment from the institution stating they will be in an independent faculty position by September 1, 2021. The commitment is certified by the institution's submission of the application.
Applicants may submit or have an NIH R01 or other equivalent grant application pending concurrently with their NIH Director’s New Innovator Award application if it does not overlap substantially with their New Innovator Award application. However, if that pending grant becomes active prior to the NIH Director’s New Innovator Award, the applicant is no longer eligible to receive the New Innovator Award.
Awardees are required to commit at least three person-months (25%) of their research effort each year to activities supported by the New Innovator Award.
For more details regarding eligibility requirements, see FAQs on the New Innovator website.
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. Only one application per PD/PI is permitted in response to this FOA.
The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:
The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
All page limitations 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 an application to this FOA.
All instructions in the SF424 (R&R) Application Guide must be followed
with the following additional instructions:
Agency Routing Identifier: Enter Science Area Designations. Designate two scientific areas (a primary and secondary) from the list below. For each area, enter the one-digit code and abbreviation (e.g., 1 BSS).
1 BSS - Behavioral and Social Science
2 CB - Chemical Biology
3 CTR - Clinical and Translational Research
4 IDI - Infectious Diseases and Immunology
5 IE - Instrumentation and Engineering
6 MCB - Molecular and Cellular Biology
7 NS - Neuroscience
8 HIB - High-Throughput and Integrative Biology
9 BCB - Bioinformatics and Computational Biology
The areas of science listed above are very broad and frequently overlapping. New Innovator Award reviewers are chosen for their breadth of knowledge and expertise and will be able to review a broad range of applications. Choose the two science areas that are most appropriate for your proposed project.
The applicant's selection of scientific areas is used solely to aid in the assignment of panel reviewers and does not in itself affect an application’s funding potential. Application requirements and instructions are identical for all the science areas. All applications are reviewed in the same time period, by the same panel, and compete for a single source of dedicated funds.
Important: For each of the two science area designations, enter the one-digit code followed by one space and then the corresponding abbreviation. Enter the primary area first and secondary area second. Separate the two entries by a semicolon.
Correct Example: 1 BSS; 7 NS
Note: The science area designations (two one-digit codes with abbreviations) must also be included at the beginning of the Essay.
Type of Application: Must be New .
Proposed Project: The start date should be August 15, 2021 and the end date should be June 30, 2026. The New Innovator Awards are multi-year funded; all the funds are disbursed in the first year of the project period. By U.S. statute, funds must be spent by the end of the fifth fiscal year. To allow time for reporting, the project period must end by June 30 of the fifth fiscal year (June 30, 2026). Applicants are cautioned that money not spent by the end of the project period is subject to recovery by the U.S Treasury. No-cost extensions are not allowed.
Total Federal Funds Requested: Enter $1,500,000.
Total Non-Federal Funds: Enter $0.
Total Federal & Non-Federal Funds: Enter $1,500,000.
Estimated Program Income: Enter $0.
Note: The Budget Request is entered only in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds" as described above. Funds may be requested for personnel (including collaborators), supplies, equipment, sub-contracts, and other allowable costs. Only the entire project period direct cost total ($1.5 million) should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds." Applicable Facilities and Administrative (F&A) costs will be determined at the time of award and should not be included in the budget request. A detailed budget is not requested and will not be accepted.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed
with the following additional instructions:
Bibliography & References Cited: DO NOT USE. Provide essential reference citations in the essay.
Facilities & Other Resources: Upload a brief statement (1-page maximum) of the facilities to be used for the conduct of the research.
Equipment: DO NOT USE.
Other Attachments: DO NOT USE.
All instructions in the SF424 (R&R) Application Guide must be followed
with the following additional instructions:
Profile Project Director/Principal Investigator Field Current and Pending Support: Attach a list of Current and Pending Support from all sources, including current year direct costs and percent effort devoted to each project.
Profile Senior Key Person 1: DO NOT USE. Submit information only for PD/PI. Information on collaborators or other key personnel is not required but may be included in the Essay.
Research and Related Senior/Key Person Profile (Expanded) - Additional Senior/Key Person Profiles(s): DO NOT USE. Only the PD/PI may serve as senior/key personnel.
Research and Related Senior/Key Person Profile (Expanded) - Additional Biographical Sketch(es): DO NOT USE. Only the PD/PI may submit a Biographical Sketch.
All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Specific Aims: DO NOT USE
Research Strategy: Upload Essay here. Submit an essay that addresses: (1) the significance and potential impact of the project, (2) what makes the approaches exceptionally innovative, (3) how will risks and challenges be addressed, and (4) the applicant’s qualifications for this award. The description of the scientific plan should be written at a level appropriate for reviewers who are broadly knowledgeable but may not be directly involved in the proposed area of research. To focus the essay on the goals of the New Innovator Award and the review criteria, presenting the proposed research as a series of specific aims is discouraged. Do not provide a detailed experimental plan. Preliminary data are allowed but not required. The essay should include the following sections within the page limit, in the following order, with the headings shown:
Project science areas: Provide 1-digit code and abbreviation for primary and secondary science areas at beginning of essay. See "Agency Routing Identifier" information above for codes and format.
Project Description: Describe the scientific challenge or opportunity that you propose to address, its importance, and how addressing this would have a major impact on a broad area of research relevant to NIH. Provide the scientific context by summarizing the current landscape of the field and how your research, if successful, would extend substantially beyond current boundaries. Describe the overall approach to be taken. State prominently that to comply with the FOA, a detailed experimental plan and extensive preliminary data are not being provided. However, the essay must be written such that reviewers have a clear sense of what is being proposed to be done and why and are convinced that the research will be performed in a robust and rigorous manner.
Innovativeness: State clearly and concisely what makes your project unusually innovative in the context of the current state-of-the-art of the field. Since the approaches may be highly innovative, and hence risky, what will you do if these approaches are not successful?
Investigator qualifications: Provide evidence to support your claim of innovativeness and creativity in your prior research. For example, what personal qualities and experiences demonstrate your inclination to question paradigms and work with intellectual uncertainties, develop unique collaborations, integrate diverse sources of information, or develop novel approaches when new challenges or opportunities arise?
Suitability for the New Innovator Award program: Why is the planned research uniquely suited to the New Innovator Award rather than a more traditional grant mechanism?
Statement of research effort commitment: A statement must be included that, if chosen to receive an award, the applicant will commit a minimum of three person-months (25%) of his/her research effort to the project supported by the New Innovator Award.
Note: Any bibliographic citations provided must fit within the ten-page limit. To aid in the assessment of scientific rigor, inclusion of the most critical citations is encouraged. Figures and illustrations may be included but must also fit within the ten-page limit. Letters of collaboration will not be accepted. Information on collaborators may be included in the Essay and their names and affiliations should be listed in the PHS Assignment Request Form.
Applicants considering clinical trial research are strongly advised to discuss their research with the scientifically most relevant NIH Institutes or Centers (ICs) to ensure that such research would conform to the clinical trial research policies of those ICs. Funding of applications involving clinical trials is contingent upon conformance to the policies of the IC administering the award. For a list of IC staff contacts, see https://commonfund.nih.gov/highrisk/clinical.
Consortium/Contractual Arrangements: DO NOT USE
Letters of Support: DO NOT USE. Letters of Support are not allowed.
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.
The following modifications also apply:
When involving human subjects research, clinical research, and/or NIH-definedclinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following modifications:
Since all applications are received as "Office of the Director" applications and are reviewed by a single Special Emphasis Panel, applicants should not request assignment to a particular review panel (integrated review group) or awarding component (NIH Institute/Center). Since letters of collaboration and biosketches of collaborators are not allowed, provide the names of collaborators and their institutional affiliations. Also, if you wish to request that certain individuals not review your application, list their names, institutional affiliations, and the reasons why they should not serve as reviewers. NIH will consider this request but is not obligated to accept it.
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). 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.
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 How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
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 and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Only documents to inform of unforeseen events, such as natural disasters, that substantially affect the ability to execute the proposed research will be accepted. No publication updates will be allowed as post-submission material.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The NIH Director's New Innovator Award supports innovative research that has the potential to produce a major impact on a broad area of biomedical or behavioral research. A New Innovator Award grant application does not have extensive background material, and the essay focuses on the goals of the New Innovator Award. Preliminary data are not required but may be included. Accordingly, reviewers will provide comments emphasizing the following: 1) the importance of the scientific problem and the potential impact of the research, 2) the novelty and innovativeness of the approach, and 3) evidence of the applicant's potential for creative and innovative research as an early stage investigator.
In addition, for applications involving clinical trials:
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit. An application does not need to be strong in all categories to be judged likely to have major scientific impact.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 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?
In addition, for applications involving clinical trials
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Investigator(s)
Is the PD/PI well suited to the project? Does the PD/PI have the appropriated experience and training? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Is the effort committed sufficient to perform the proposed research?
In addition, for applications involving clinical trials
With regard to the proposed leadership for the project, do the PD/PI and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
In addition, for applications involving clinical trials
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
In addition, for applications involving clinical trials
Does the application adequately address the following, if applicable:
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
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 individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
In addition, for applications involving clinical trials
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Study Timeline
Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
Protections for Human Subjects
For research that involves human subjects but does not involve one of thecategories 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 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 Individuals Across the Lifespan
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 individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable.
Renewals
Not Applicable
Revisions
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Since the Resource Sharing Plans will be provided in the just-in-time information, reviewers will not comment.
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by a scientific review group convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
For this program, the initial peer review proceeds in two phases. In the first phase, all applications submitted in response to the FOA will be reviewed by mail-in reviewers assigned based on the primary and secondary areas designated by the PD/PI in the Agency Routing Identifier field of the application. A second of group reviewers with broad scientific perspective, informed by the results from the first phase, will choose a subset of applications to discuss and score in a panel meeting. The same review criteria will be used in both phases of initial peer review.
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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the Council of Councils. The following will be considered in making funding decisions:
PDs/PIs will be notified of their application status in March 2021. Awardees will be notified by August 2021 and awards will begin in September 2021. 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 theeRA 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.
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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration of all trials whether required under the law or not. For more information, see http://grants.nih.gov/ClinicalTrials_fdaaa/.
Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.
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.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
Progress reports for multi-year funded awards are due annually on or before the anniversary of the budget/project period start date of award. The reporting period for multi-year funded award progress report is the calendar year preceding the anniversary date of the award. Information on the content of the progress report and instructions on how to submit the report using the RPPR are posted at http://grants.nih.gov/grants/policy/myf.htm
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings.Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
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, application errors and warnings, documenting system problems that threatensubmission by the due date, and post-submission issues)
Finding Help Online:http://grants.nih.gov/support/(preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email:GrantsInfo@nih.gov(preferred method of contact)
Telephone: 301-945-7573
Grants.gov Customer Support(Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email:support@grants.gov
Ravi Basavappa, Ph.D.
Office of the Director (OD)
Telephone: 301-435-7204
Email: NewInnovatorAwards@mail.nih.gov
Gene Carstea, Ph.D.
Center for Scientific Review (CSR)
Telephone: 301-408-9756
Email: NewInnovator_Review@mail.nih.gov
Michael Morse
Office of the Director (OD)
Telephone: 301-435-5446
Email: morsem@od.nih.gov
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.