Part 1. Overview Information

Key Dates

All applications are due 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.

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 NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the NOFO) 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.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

1. Use the NIH ASSIST system to prepare, submit and track your application online.
2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.
   
   
3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of 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. Notice of Funding Opportunity Description

Background

In 2007 the NIH Director’s New Innovator Award was launched as part of the Common Fund’s High-Risk, High-Reward Research program, which was created to accelerate the pace of biomedical discoveries by supporting exceptionally creative scientists with highly innovative research. The NIAID New Innovator Awards (DP2) program was developed in 2019 to fulfill additional goals within the institute. Unlike the Common Fund DP2 program, the NIAID DP2 program does not require faculty appointment at the time of application. The purpose of the NIAID DP2 program is two-fold: research focused, and person focused. The NIAID DP2 program will provide support for creative, novel, high-impact research concepts that may be risky or at a stage too early to fare well in the traditional peer review process.

NIAID DP2 Program

The NIAID DP2 program seeks to support creative, original and insightful research concepts with the potential to produce a major impact, test scientific paradigms, or advance key concepts on broad, important problems in biomedical research of priority to NIAID. Applications proposing unexpected convergence of disciplines, new scientific directions, or use of novel methodologies are encouraged.

The application review process will emphasize the individual’s distinct contributions to research, potential to move in new scientific directions particularly as they differ from current postdoctoral training and/or involve novel methodologies and approaches, and the creativity and originality of the proposed research. Proposed approaches should be insightful and based on strong premise; although preliminary data is not required, demonstration of the potential of the applicant and strong rationale indicating the likelihood of success of the proposed concepts are highly recommended.

The NIAID DP2 program is only available to postdoctoral, non-independent, or newly independent investigators who also have Early Stage Investigator status (defined as a Program Director / Principal Investigator (PD/PI) who has completed their terminal research degree or end of post-graduate clinical training, whichever date is later, within the past 10 years and who has not previously competed successfully as PD/PI for a substantial NIH independent research award) with the following additional requirements:

For all applicants:

• applicants must have a research or clinical doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD, or equivalent doctoral degree), or a combined research and clinical doctoral degree.
• both U.S. and non-U.S. citizens may apply.
• $300K in direct costs per year for up to five years may be requested.
• applicants must have Early Stage Investigator status.

For newly independent applicants:

• the applicant must be within the first year of a faculty position or equivalent at a U.S. based institution at the time of application submission.

For postdoctoral and other non-independent applicants:

• if selected for award, applicants must transition to an independent faculty position or equivalent at a U.S.-based institution within one year in order to activate the award.

For more information on eligibility see additional information under Eligible Individuals (Program Directors/Principal Investigators).

The NIAID mission is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. Applications in any topic within the broad mission of NIAID are welcome.

NIH strongly encourages applications from researchers from diverse backgrounds (see NOT-OD-20-031, Notice of NIH’s Interest in Diversity and NOT-OD-22-019, Reminder: Notice of NIH’s Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities).

Please note that the DP2 activity code does not allow Human Fetal Tissue research (see NOT-OD-19-128).

Two program meetings will be held over the project period to foster collaborations, report progress, seek new research directions and ideas, and update NIAID. These meetings will be attended by the PD(s)/PI(s) and NIAID staff. The location of the meetings will be in the Bethesda Maryland area. 

For more details regarding this DP2 NOFO, please see FAQs on the NIAID website (https://www.niaid.nih.gov/grants-contracts/questions-answers-par-ai-dp2).

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Government

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

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

Non-domestic (non-U.S.) components of U.S. Organizations are 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.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registration; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account.  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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

Applicants for DP2 awards are encouraged to follow the ORCID link from their Personal Profiles in the eRA Commons, where they can either link their eRA profiles to existing ORCID accounts or create ORCID profiles and link them back to the eRA Commons. For more information see https://grants.nih.gov/grants/guide/notice-files/NOT-OD-19-109.html.

For all applicants:

• Multiple PD(s)/PI(s) are NOT allowed.
• The PD/PI of the application must be a postdoctoral, non-independent, or newly independent investigator (defined as within the first year of a faculty position or equivalent at a U.S. based institution at the time of application submission) who also has Early Stage Investigator status.  See the list of NIH grants that a PD/PI can hold and still be considered an ESI. Also note that NIH will consider requests to extend the ESI status period for researches with lapses in their research or research training. Please see Early Stage Investigator Extensions for more information.
• Individuals are eligible if they have been, or currently are, the PD/PI of an NIH R03 or R21 grant or an equivalent non-NIH award.
• Applicants may submit or have an NIH R01 or equivalent grant application pending concurrently with their NIAID New Innovator Award application if it does not overlap substantially with their NIAID New Innovator Award application. However, if that pending grant becomes active prior to the NIAID New Innovator Award, the applicant is no longer eligible to receive the NIAID New Innovator Award.
• Applicants may submit or have NIH Research Career Development Awards pending concurrently with their NIAID New Innovator Award application as long as the projects are not highly overlapping. However, NIAID New Innovator Recipients are not eligible for concurrent or subsequent Research Career Development Awards of any type such as mentored K or R00 career development awards. If the applicant is awarded a Research Career Development Award, the NIAID New Innovator Award cannot be awarded until the applicant relinquishes the Research Career Development Award.
• Applicants must have a research or clinical doctorate (including PhD, MD, DO, DC, ND, DDS, DVM, ScD, DNS, PharmD, or equivalent doctoral degree), or a combined research and clinical doctoral degree.
• Both U.S. and non-U.S. citizens are eligible to apply.
• At the time of award, the individual must be a U.S. citizen or a non-citizen national of the U.S. or have been lawfully admitted for permanent residence (i.e., possess a currently valid Permanent Resident Card USCIS Form I-551, or other legal verification of such status), or be a non-U.S. citizen.
• For applications submitted on behalf of non-U.S. citizens with temporary U.S. visas, visa status must allow the PD/PI to conduct and complete the proposed research at a U.S. based institution. The applicant institution at the time of award activation is responsible for determining and documenting, that the candidate's visa will allow him or her to remain in the U.S. long enough to complete the award.
• Recipients are required to commit at least three person-months (25%) of their research effort each year to activities supported by the NIAID DP2 award.
• Applicants must hold an independent research position at a U.S. based institution by the time of award activation. For this NOFO, 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.

The following is provided as an aid to determine whether an applicant should submit as an independent vs non-independent investigator:

Evidence for non-independence may include:

• The candidate’s research is entirely funded by another investigator’s grants.
• The candidate’s research is conducted entirely in another investigator’s assigned space.
• According to institutional policy, the candidate cannot hire postdoctoral fellows or technical staff or be the responsible supervisor of graduate students.
• According to institutional policy, the candidate is not allowed to submit an application as the PD/PI of an NIH research grant application (e.g., R01).
• The candidate lacks other rights and privileges of faculty, such as attendance at faculty meetings.

In addition, the following information is applicable for postdoctoral applicants: 

• The applicant institution is the institution where the postdoctoral applicant is appointed at the time of application submission. 
• Individuals in non-independent positions at an institution that appoints postdoctoral fellows with other titles are encouraged to obtain confirmation of their eligibility before preparing an application. It is incumbent upon the candidate to ensure that the position s/he is in complies with the eligibility requirement prior to submitting an application. 
• Postdoctoral awardees must have transitioned to a faculty position or equivalent at a U.S. based institution prior to award activation. 
• For NIH Intramural Program postdoctoral applicants, the NIAID DP2 award can only be activated after the applicant has transitioned to a faculty position or equivalent at a U.S. extramural institution. 

In addition, the following requirements are also applicable for newly independent applicants: 

• The applicant must be within the first year of a faculty position or equivalent at a U.S. based institution at the time of application submission. It is incumbent upon the candidate to ensure that the position s/he is in complies with the eligibility requirement prior to submitting an application. 

For more details regarding eligibility requirements, see FAQs on the NIAID website (https://www.niaid.nih.gov/grants-contracts/questions-answers-par-ai-dp2).

Individuals not affiliated with an organization may apply (specific information is available for unaffiliated candidates).

2. Cost Sharing

This NOFO 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.

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see 2.3.9.4 Similar, Essentially Identical, or Identical Applications)

Section IV. Application and Submission Information

1. Requesting an Application Package

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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this notice of funding opportunity 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.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Caitlin Brennan, PhD
Telephone: 301-761-7792
Email: [email protected]

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 NOFO.

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

Type of Application: Must be "New".

Complete the “Estimated Project Funding” section as follows:

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: Only the five-year total ($1.5 million) should be entered in the fields for "Total Federal Funds Requested" and "Total Federal & Non-Federal Funds." A detailed budget and budget forms are not required and will not be accepted. If the application is selected for funding, detailed budgets including travel costs for the PD/PI to attend the Program Meetings in the Bethesda MD area and applicable F&A will be requested with the 'Just in Time' request. If applicable, detailed subaward budget forms and budget justification will also be requested with the ‘Just in Time’ request.

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 this attachment. Provide reference and bibliography as part of an attachment in the Other Attachments section (see below).

Other Attachments: Attach the following document(s) in this section: Bibliography & References Cited with a filename of “Bibliography_References_Cited.pdf”

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

Profile – Project Director/Principal Investigator Field –

Biographical sketch: All applicants must complete the education/training section of the Biographical sketch. Entries should accurately reflect either postdoctoral or newly independent status and Early Stage Investigator status.

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. Only the PD/PI may serve as senior/key personnel.

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.

Research and Related Senior/Key Person Profile (Expanded) - Additional Current and Pending Support (s): DO NOT USE. Only the PD/PI may submit Current and Pending Support.

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: List in priority order, the broad, long-range objectives and goals of the proposed research plan. Briefly highlight as applicable the new scientific direction of the proposed work, including how the goals are distinct from postdoctoral training and/or involve novel methodologies and approaches.

Research Strategy: The research strategy should broadly include the following: (1) the significance and potential impact of the research, (2) what makes the approach(es) exceptionally creative, (3) a discussion of how the research promotes expansion beyond the applicant’s current research and promotes independence, (4) how risks and challenges will be addressed, and (5) the applicant’s qualifications for this award addressing potential for growth. 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. A detailed experimental plan is not required. Applicants should address unusual or prolonged training periods e.g., more than seven years as a graduate student or more than five years as a postdoctoral fellow.

In addition, the research plan should specifically address the following using clearly marked sections:

Project Description and Approach: Clearly describe the scientific challenge or opportunity to be addressed, its importance, and how addressing this would have a major impact on a broad area of science relevant to the NIAID mission. Provide a coherent strategy which includes the rationale for and/or hypothesis to be tested and clearly describes the overall approach. Include a discussion of how results will be analyzed, interpreted, and used to further future experiments. State clearly and concisely what makes the project creative, original, or novel and discuss how the approach is designed to be insightful and innovative in the context of the current state-of-the-art of the field. Discuss if applicable how the proposed approach promotes an unexpected convergence of scientific disciplines. Discuss alternate plans in the event these approaches are not successful.

Note: Detailed experimental plans and methods should not be provided. However, the applicant must still convey a clear sense of what is being proposed and why. State in the application: To comply with this NOFO, detailed experimental plans and methods are not included.

Note: Preliminary or unpublished results are not required; however, a discussion and strong rationale supporting the likelihood of success of the proposed concepts are required. Preliminary or unpublished results may be included in summary form at the discretion of the applicant.

Investigator qualifications: Provide information on training and experience to date by discussing specific contributions to the field and contributions to publications and presentations noting areas of originality or creative input. Discuss the potential for growth beyond postdoctoral work, expansion beyond the current environment and plans to move towards greater independence. Provide evidence to support claims of innovativeness and creativity in the proposed research concepts. For example, discuss what personal qualities and experiences demonstrate inclinations 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: Indicate why the planned research is uniquely suited to the New Innovator Award rather than a more “traditional” grant mechanism.

Statement of research effort commitment: Include a statement indicating 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.

Description of Institutional Environment:

• For postdoctoral or non-independent applicants who have not accepted a faculty position or equivalent at a U.S. based institution only (up to 1 page): Due to the nature of this award, the postdoctoral or non-independent applicant may not have identified a sponsoring institution at the time of application submission. Those applicants should describe the types of facilities, resources, and the institutional research environment needed to conduct the proposed research and aid the development of the applicant’s research career and transition to an independent investigator.
• For newly independent applicants only (up to 1 page): describe how the facilities, resources, and the institutional research environment available to the applicant will aid the development of the applicant’s research concepts and continued growth as an independent investigator.

Letters of Support:

For a postdoctoral or non-independent investigator, a statement from the current mentor/supervisor indicating that the applicant is free to continue the proposed scientific approach outside of the postdoctoral laboratory setting should be included as a Letter of Support.

If applicable, letters of collaboration from any collaborator indicating their support and role in the proposed project may be included as Letters of Support.

All applicants should include individual letter(s) from at least one(1) and up to three (3) current or prior mentors/supervisors of the candidate indicating contributions made by the applicant to previously published work and a description in the mentors'/supervisors' words of the applicant's qualities that would indicate the applicant is a strong NIAID DP2 program candidate (e.g., imagination, depth of knowledge).

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. 

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

When involving human subjects research, clinical research, and/or NIH-defined clinical 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.

Delayed Onset Study

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.

3. Unique Entity Identifier and System for Award Management (SAM)

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.

5. Intergovernmental Review (E.O. 12372)

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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier 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, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria

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 NIAID New Innovator Award (DP2) supports creative, novel, original and insightful research concepts with the potential to produce a major impact, test scientific paradigms, or advance key concepts related to broad, important problems in biomedical research of priority to NIAID. A NIAID DP2 grant application does not require extensive background material and 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 significance and potential impact of the project, (2) creative approach(es), (3) potential of the project to support expansion of the applicant beyond their current research and promote independence, (4) how risks and challenges are addressed, and (5) the applicant’s qualifications for this award and potential for growth.

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.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?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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?

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?

Specific to this NOFO:  How well does the application demonstrate the capability of the researcher to think creatively, and 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?

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?

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?

Specific to this NOFO:  For non-independent applicants, to what extent are the types of facilities, resources, and institutional research environment needed to support the proposed work adequately described and do they support the likelihood of success of the proposed work? For newly independent applicants, to what extent are the facilities, resources, and institutional research environment available to the applicant well-described and likely to support the success of the proposed work?

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 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 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 Animals 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

Reviewers will comment on whether the Resource Sharing Plan(s) (i.e., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by National Institute of Allergy and Infectious Diseases, 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 will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national . The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
  • Despite inherent scientific and technical risks, the potential for the investigator to lead research that may result in scientific breakthroughs of broad potential impact.
  • Unusually cross-cutting or significantly underrepresented science.

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. 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.

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 recipient's business official.

Recipients 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 NOFO 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.

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

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, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a condition of receiving the grant, to administer programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity, The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. See https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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 and 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.”

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

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. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients 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.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200.

Section VII. Agency Contacts

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 threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Diane Lawrence, Ph.D.
Division of AIDS (DAIDS)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3202
Email: [email protected]

Timothy A. Gondré -Lewis, Ph.D.
Division of Allergy, Immunology, and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3566
Email: [email protected]

Susana Mendez, Ph.D.
Division of Microbiology and Infectious Disease (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-5077
Email: [email protected]

Caitlin Brennan, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-7792
Email: [email protected]

Samuel Ashe
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-435-4799
Email [email protected]

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.

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 and 2 CFR Part 200.