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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - 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 How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

The NIH Director's Early Independence Award provides an opportunity for promising, newly graduated scientists to accelerate their entry into an independent research career by forgoing the traditional post-doctoral training period. Though most newly graduated doctoral-level researchers would benefit from post-doctoral training, a small number of capable investigators are ready to launch independent research careers. The Early Independence Award is intended for these select investigators, who have already established a record of scientific innovation and research productivity and have demonstrated unusual scientific vision and maturity. Typical post-doctoral training would unnecessarily delay their entry into independent research. The award also provides an opportunity for institutions to invigorate their research programs by bringing in fresh scientific perspectives of the awardees they host.

The Early Independence Award assists the transition to independence by supporting research projects at host institutions that provide independent research positions for newly graduated scientists. To be eligible, investigators must complete their terminal doctoral degree or clinical training sometime between May 1, 2023, and September 30, 2025. To be consistent with the NIH definition of Early Stage Investigators, eligible clinical training includes clinical residency and clinical fellowship (see Section III. Eligibility Information for more information). By the end of the award period, Early Independence Award investigators are expected to be competitive for continued funding of their research program through other NIH funding activities and for permanent research-oriented positions.

To support innovative and novel research across the NIH mission, the NIH recognizes the need to foster a diverse research workforce across the nation. Talented researchers from diverse backgrounds (including individuals from underrepresented racial and ethnic groups, individuals with disabilities, individuals from disadvantaged backgrounds, and women; see Notice of NIH's Interest in Diversity), are strongly encouraged to work with their institutions to develop applications for this funding opportunity. As outstanding research is conducted at a broad spectrum of institutions, applications from the full range of eligible institutions (including institutions that provide services to underrepresented or underserved communities, those that may be less research-intensive, and from all domestic geographic locations) are encouraged to apply. 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 broad impact.

Prospective applicants are invited to a pre-application webinar on June 26, 2024, from 1:00-2:30 PM EDT. NIH staff will discuss the initiative and answer questions about the application and review process. Questions for the webinar should be submitted ahead of time to [email protected] by 11:59 PM local time on June 21, 2024. Additional questions may be taken during the webinar if time allows. Register for the webinar and join on Webex. The webinar will be recorded and posted on the Early Independence Award website.

The NIH Director's Early Independence Award is part of the High-Risk, High-Reward Research 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.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

All organizations administering an eligible parent award may apply for a supplement under this NOFO.

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 - Including the NIH Intramural Program
• 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 Organizations) 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 How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information. 

• 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 individuals from 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.

Requirements:

• Single PD/PI: Only single PD/PI applications are allowed. Multiple PD/PIs applications will not be accepted. Only the PD/PI may be listed as a Senior/Key Person and provide a Biographical Sketch.
• Citizenship: U.S. citizenship is not required. For non-U.S. citizens, the applicant institution is responsible for ensuring the PD/PI's U.S. visa status will allow them to conduct the proposed research at the applicant institution for the entire project period.
• Degree Receipt Date: The receipt date of the PD/PI’s terminal doctoral degree or end of post-graduate clinical training must be between May 1, 2023, and September 30, 2025. The degree receipt date is that which appears on the official transcript for the degree. The end of post-graduate clinical training includes residency and fellowship periods. At the time of award, either:

1. The PD/PI must have received a PhD, MD, DO, DC, DDS, DVM, OD, DPM, ScD, EngD, DrPH, DNSc, ND (Doctor of Naturopathy), PharmD, DSW, PsyD, or equivalent doctoral degree from an accredited domestic or foreign institution (it is the responsibility of the sponsoring institution to determine if a foreign doctoral degree is equivalent).
2. Or an authorized official of the degree-granting or training institution must certify that all degree requirements have been met and that the receipt date of the degree (as will appear on the transcript) will be before September 30, 2025. An authorized official of the host institution must certify that the PD/PI will be able to conduct independent research at the institution at the time of the project start date.

• Post-doctoral Experience: The PD/PI must not have served as a post-doctoral fellow for more than 12 months following a previous, non-terminal doctoral degree (this only applies to PD/PIs with multiple doctoral degrees who served in a 12+ month post-doctoral fellowship before their terminal degree).
• Level of Effort: In the first and second years of the project period, the PD/PI must commit at least 9.6 person-months of effort to the Early Independence Award project each year (80% effort per year). In years 3-5 of the project period, the PD/PI may reduce their effort on the Early Independence Award project but must still conduct at least 9.6 person-months of general independent research each year (80% effort per year). General independent research includes the effort spent on the Early Independence Award project and any other independent research projects the PD/PI is working on.
• Non-independence at Time of Application: Individuals are eligible only if they do not have research independence at the time of application submission. Research non-independence is defined functionally rather than by position title and must have all the following characteristics:
  1. The PD/PI's current research agenda is set through concurrence with mentors.
  2. The PD/PI's research is funded primarily through support to other investigators (mentored fellowships such as NIH F31 or F32 Fellowships or NSF Graduate Research Fellowships do not preclude eligibility).
  3. The PD/PI does not have any space assigned directly by the institution for the conduct of their research.
  4. The PD/PI cannot apply for an NIH R01 grant without a special waiver or exemption from the institution according to institutional policy.

Though PD/PIs must not be functionally independent at the time of application submission, they may become functionally independent prior to time of award and still retain eligibility.

• Independent Research Position: An independent research position at a host institution is required, and the PD/PI must be able to begin independent research by the project start date. The position need not be permanent or tenure-track and may be contingent upon receipt of the Early Independence Award. Prospective PD/PIs should contact appropriate institutional leaders to seek an appointment to an independent research position. Alternatively, institutions may actively recruit eligible scientists to apply for support through this initiative. In either case, the institution is expected to provide substantial support to the PD/PI as detailed in the Facilities & Other Resources section. To foster independence, PD/PIs may benefit from being hosted by an institution at which they have not previously studied or trained.
• Career Awards: PD/PIs may apply for a research career development (K) award and DP5 at the same time, but NIH policy prohibits scientific overlap. A PD/PI may not hold a DP5 and career development award concurrently: The career development award must be relinquished to receive the DP5.
• Site Visit: NIH staff will conduct a one-time site visit at the end of the first year to assess the PD/PI's progress and to ensure they are receiving the institutional resources and support outlined in the application. NIH staff will meet with the PD/PI, lab personnel, mentors, faculty, and institutional leadership. Failure to provide independence and/or support may lead to NIH actions, including reduction of funds.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Only two applications per institution (normally identified by having a Unique Entity Identifier (UEI) number or NIH IPF number) are allowed.

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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - 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)
• Participating institution
• Names of other key personnel
• Number and title of this funding opportunity

The letter of intent should be sent to:

Becky Miller, Ph.D.
Office of Strategic Coordination
Office of the Director
Email: [email protected]

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed,

with the following additional instructions:

Agency Routing Identifier Field (in Field 4b): Enter science area designations

Using the list below, designate the most appropriate scientific area of the proposal. An optional secondary scientific area may also be designated.

• 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

For each area, enter the one-digit code and abbreviation (e.g., 1 BSS). If selecting two science areas, enter the primary area first followed by a semicolon, then add the secondary area (e.g., 1 BSS; 7 NS).

The areas of science listed above are very broad and frequently overlap. Choose the primary (and optional secondary) science area that is most appropriate for your proposed project. The scientific areas are used solely as an aid to assign panel reviewers, who are chosen for their breadth of knowledge and expertise and will be able to review a broad range of applications. Science area designations do not affect an application’s funding potential, and application requirements and instructions are identical for all science areas. All applications are reviewed in the same time period, with the same review criteria, and compete for a single source of dedicated funds.

Note: The science area designations (one-digit code with abbreviation) must also be included at the beginning of the Research Strategy essay.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed. Name and upload the Facilities & Other Resources document as "FacilitiesandOtherResources."

Facilities & Other Resources

A major consideration of this initiative is the institution's commitment to providing an environment in which the PD/PI would thrive as an independent researcher. Applicant institution officials must address all the following items. Be sure to use the corresponding subheading and numbering in the response. No page limits apply; responses should be concise, yet complete. 

Candidate Selection Process

Describe the process and criteria used to select the PD/PI.

Position Details

During the award period, the PD/PI must be scientifically and administratively independent. The appointment need not be permanent or tenure-track and may be contingent upon receipt of the Early Independence Award. Describe in detail the position to which the PD/PI will be appointed and how independence will be ensured during the award.

1. What is the title of the position?
2. Is the position permanent or tenure-track?
3. Is the position contingent upon receipt of the Early Independence Award?
4. Describe the position in detail.
5. How will the PD/PI's independence be ensured during the award?
6. Describe plans for maintaining protected time for the PD/PI so that they can commit at least 9.6 person-months of effort to the Early Independence Award project each year in years 1-2 of the project period. In years 3-5, the PD/PI may reduce their effort towards the Early Independence Award project but must commit at least 9.6 person-months towards general independent research each year. Clinicians should be permitted to perform clinical duties to the extent necessary to maintain credentials.
7. Describe the organizational structure where the PD/PI's position will be administered (e.g., school, department, etc.).
8. Explain how this administrative structure will best meet the goal of supporting the success of the PD/PI. Include details of responsibilities for integrating the PD/PI and their scientific project into the institutional culture and the faculty community.
9. Describe PD/PI access to potential lab personnel, such as access to postdoctoral fellows, graduate students, undergraduates, or technicians.
10. Describe management plans for potential problematic situations.
11. Describe institutional expectations related to the retention or transfer of the PD/PI at the end of the funding period.
12. Affirm that the PD/PI will be able to conduct independent research by the project start date.
13. Affirm that the institution will initiate the PD/PI appointment into the independent research position by the project start date.

Institutional Resources Commitment

1. If the candidate is not a U.S. citizen or permanent resident, the sponsoring institution must include information about the PD/PI's visa status and assurance that the PD/PI's visa provides sufficient time to complete the award at the U.S. institution.
2. Describe details of the laboratory space to be provided to the PD/PI, including physical structure and space layout.
3. Describe support staff and systems available to the PD/PI, including (but not limited to) human resources, supply and equipment ordering systems, and administrative assistance.
4. Describe the institutional financial commitment to the PD/PI. Matching funds are not required; however, an appropriate level of institutional support is expected. Institutional commitment to the development of the PD/PI as a successful and independent research scientist will be given considerable attention during the review and selection process.
5. If the PD/PI already has a commitment of funding for independent research (such as through another independent research program or institutional start-up funds), describe how the Early Independence Award will affect the other funding.

Institutional Commitment to Career Development

1. Describe plans for assuring scientific independence. If the PD/PI is staying at the same institution at which they trained, indicate how independence from degree/fellowship mentors will be established and maintained.
2. Describe plans for integrating the PD/PI into scientific and administrative activities at the institution. Describe the scientific collaborative activities (e.g., attendance at faculty meetings, laboratory meetings, participation in institutional scientific retreats, etc.) and career development resources (e.g., courses in laboratory management and grant writing, etc.) that will be available to ensure the PD/PI is successful.
3. Describe the mentoring structure and include membership, meeting frequency, and meeting format. Though the PD/PI must be scientifically independent, it is important that senior colleagues are available as resources and periodically meet with the PD/PI.
4. The primary goal for the PD/PI is to establish an independent scientific research program. However, if the PD/PI has an interest in (limited) teaching, describe what opportunities will be available.
5. Describe expectations and opportunities for the PD/PI to establish a record of independent funding from sources other than the Early Independence Award.

All instructions in the How to Apply - Application Guide must be followed.

Only the PD/PI may be listed as a Senior/Key person and provide a Biographical Sketch.

Modular Budget

All instructions in the How to Apply - Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims

The specific aims page must contain three sections with the following headings: "Research Objectives," "Institutional Support," and "Early Independence Rationale." These three sections should contain the information described below.

Research Objectives

• State your research topic and overall approach.
• Why is this area of research significant?
• If you have an overarching hypothesis, what is it?
• What impact will your research have if successful?
• What are the major conceptual or technical innovations you are introducing into this research area?

Institutional Support

• How will the institutional support (including the assurance of research independence) help you accomplish your research objectives?

Early Independence Rationale

• How will your scientific and technical background, research accomplishments, leadership/mentorship attributes, and scientific vision be leveraged to accomplish the research objectives?

Research Strategy

Project Science Area: Provide the 1-digit code and abbreviation for the primary (and optional secondary) science area most appropriate for the proposed research. See "Agency Routing Identifier" information above for codes and format.

 Research Strategy Essay: Address the questions in the numbered subheadings.

1. Rationale for omitting or abbreviating the typical post-doctoral phase
   • Why would omitting or abbreviating the typical post-doctoral fellowship benefit your long-term scientific career?
   • What is driving your desire to pursue an independent research career at an earlier than usual stage?
2. Evidence of transition to an independent position
   • Provide evidence using all the characteristics described in Section III.1. Eligible Individuals (Program Director/Principal Investigator) that, at the time of application submission, you do not have research independence. 
   • Describe any arrangements you may have made to assume an independent research position that would begin prior to award.
3. Personal/career development plan
   • What particular strengths and weaknesses do you have for launching a productive independent research career?
   • How would you use this award period to build on your strengths and address your weaknesses?
   • How would receipt of this award accelerate your establishment of an independent research career (especially if you have already made an agreement for a functionally independent position)?
   • What will your planned career path be if you do not receive an Early Independence Award?
4. Evidence of training ability and leadership:
   • What activities have prepared you to lead a laboratory, train laboratory staff, and perhaps mentor students and post-doctoral fellows? (Note: This information may reference, but not duplicate, information submitted in the Biosketch.)
5. Host institution interactions:
   • What arrangements have you made with your host institution to provide you with the support and feedback necessary to establish your research program while maintaining your intellectual independence?
   • How will you integrate yourself as an active member in your institution's scientific community?
6. Research challenge:
   • What is the scientific challenge that you wish to address in your research?
   • What is the premise of the project, including strengths and weaknesses of prevailing theories?
   • Why is this challenge significant to the biomedical/behavioral research community?
   • What is the expected impact of your research on this challenge?
   • Why did you choose this particular challenge to begin your independent research career?
7. Approach:
   • What is your experimental approach in addressing your research challenge? The description of the approach should convey that you have thought deeply about your project, identified the major potential pitfalls, and considered alternative approaches.
   • Address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects. 
   • Preliminary data are not required but may be included. If included, they will be evaluated in the review process. You may wish to indicate prominently that substantial preliminary data are not being provided per the guidance in the funding opportunity.
   • Describe any collaborative elements of the research.
8. Innovation:
   • What are the particularly innovative aspects of your proposed research?
9. Relationship to previous work:
   • How is the proposed research related to your research as a student/trainee?
   • How does the work differ?
   • How will the work be accomplished independently of your previous mentors?
10. Timeline:
    • Affirm that you will be ready and able to conduct independent research by the project start date.
    • What is the timeline for accomplishing intermediate steps in your award period? This should include steps in establishing a functioning laboratory, meeting career development objectives, as well as achieving your scientific objectives.
    • State that you will commit at least 9.6 person-months of effort towards your Early Independence Award project each year in years 1-2. In years 3-5, you may reduce your effort towards the Early Independence Award project but must commit at least 9.6 person-months towards general independent research each year.

Letters of Support

Collaborators and consultants should provide letters of support that concisely describe their commitment to the research project and the role they will play in conducting the research.

Resource Sharing Plan:

Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide.

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 How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

All instructions in the How to Apply - Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed, with the modification that 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 Institute/Center or review panel. Names and affiliations of significant collaborators should be listed as individuals who should not review the application to help exclude conflicts during reviewer assignment.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply - 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 How to Apply - 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 the Office of Strategic Coordination (Common Fund), NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applications Involving the NIH Intramural Research Program

Requests by NIH intramural scientists will be limited to the incremental costs required for participation. As such, these requests will not include any salary and related fringe benefits for career, career conditional or other Federal employees (civilian or uniformed service) with permanent appointments under existing position ceilings or any costs related to administrative or facilities support (equivalent to Facilities and Administrative or F&A costs). Allowable costs may include salary for staff to be specifically hired under a temporary appointment for the project, consultant costs, equipment, supplies, travel, and other items typically listed under Other Expenses. Applicants should indicate the number of person-months devoted to the project, even if no funds are requested for salary and fringe benefits.

If selected, funding will be provided by the NIH Common Fund through the NIH Intramural Program. NIH intramural scientists will participate in this program as PD/PIs in accordance with the Terms and Conditions provided in this funding opportunity. Intellectual property will be managed in accord with established policy of the NIH in compliance with Executive Order 10096, as amended, 45 CFR Part 7; patent rights for inventions developed in NIH facilities are NIH property unless NIH waives its rights.

Should an extramural application include collaboration with an intramural scientist, no funds for the support of the intramural scientist may be requested in the application. The intramural scientist may submit a separate request for intramural funding as described above and in the NIH Intramural Source Book.

Letters of Reference

Letters of reference are an important element of the Early Independence Award application. PD/PIs must arrange to have at least three and no more than five letters of reference submitted on their behalf. Applications with fewer than three letters of reference will be considered incomplete and will not be reviewed. Late letters will not be accepted. PD/PIs are responsible for monitoring the submission of letters in their Commons accounts to ensure that three letters have been submitted prior to the submission deadline. 

Letters of reference are confidential; PD/PIs will not have access to the letters. PD/PIs should not upload letters of reference on behalf of their referees. Confirmed receipt of letters of reference will be sent via email to both the PD/PI and the referee. The confirmation sent to the PD/PI will include the referee’s name and the date and time the letter was submitted. The confirmation sent to the referee will include the referee and PD/PI's names, a confirmation number, and the date and time the letter was submitted.

Instructions to Referees

• Letters may be submitted beginning August 6, 2024, and must be submitted no later than 5:00 p.m. (local time) on September 6, 2024.
• Letters must be submitted electronically at https://public.era.nih.gov/commonsplus/public/reference/submitReferenceLetter.era (paper copies or emails will not be accepted).
  • The letter submission page can be accessed without signing in to the Commons, and referees do not need to be registered in the Commons to submit a letter.
• The PD/PI's name should be placed at the top of the letter.
• Although signatures are not required, the letter must include a signature block with the referee’s full name, title, institution, and contact information.
• In two pages or less, describe the PD/PI's qualities that support the PD/PI's claim to possess the scientific, leadership, mentorship, and management skills necessary to conduct successful, completely independent research. When possible, give specific examples that illustrate these qualities.

Required Referee Information (the individual providing the letter of reference):

• Referee’s First Name
• Referee’s Last Name
• Referee’s Email Address
• Referee’s Institution/Affiliation
• Referee’s Department

Required PD/PI Information (PD/PI must provide this information to their referees):

• PD/PI's Commons User ID (Important – This must be the PD/PI's Commons User ID, not the referee’s; the letter will not be linked to the appropriate application if the PD/PI's User ID is incorrect)
• PD/PI's Last Name (Note: The name must exactly match the PD/PI's name in the Commons)
• Opportunity Number: RFA-RM-24-005
• Reference Letter Confirmation Number (Required only when resubmitting a revised or corrected letter for the current funding opportunity)

Please see detailed instructions on submitting letters of reference and Frequently Asked Questions on the Early Independence Award website. Send question to [email protected].

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 NIH Director's Early Independence Award is designed to accelerate the entry of promising investigators who have recently completed their doctoral degree or clinical training into independent research positions and omitting the traditional post-doctoral training period. Although all review criteria described below will be used, the emphases will be on the qualities of the investigator and the environment provided by the host institution. Substantial preliminary data are not expected; rather, the approach should be compelling based on the logic of the arguments presented.

The review occurs in two phases by two separate and distinct groups of reviewers. The first phase is conducted by topic experts who are knowledgeable in the application’s subject area and are assigned based on close matching of their expertise to the application topic. Each application will have three topic experts assigned to review it. Each expert will provide scores and comments, which are used in the second phase.

The second phase is conducted by an editorial panel composed of scientists from an array of scientific backgrounds. The composition of the panel attempts to capture a wide breadth of scientific expertise, experiences, and perspectives. The editorial panel reviews the applications and uses the comments and scores from the topic experts to help identify a subset of the most meritorious applications. The subset is discussed and scored at the panel meeting. The same review criteria will be used by the topic experts and editorial panel.

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.

Overall Impact

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

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? 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 preliminary data, 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)

Are the PD/PI, 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?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) 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?

Specific to this NOFO: 

• How does the PD/PI’s self-appraisal and rationale justify early independence?
• How has the PD/PI demonstrated the appropriate skills to conduct highly innovative research?
• How has the PD/PI demonstrated the leadership, mentorship, and management abilities necessary to successfully conduct completely independent research?
• To what extent do the letters of reference indicate that the PD/PI is ready to embark upon an independent research career?
• How would the Early Independence Award accelerate the establishment of the PD/PI's independence based on their current career juncture?
• How would the PD/PI's scientific productivity and long-term career benefit from this acceleration?

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? Has the investigator included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Has the investigator 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? Has the investigator 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?

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?

Specific to this NOFO: 

• How compelling is the logic of the approach even though substantial preliminary data are not present?
• How is the scope of the project appropriate for someone who, though highly qualified, is still establishing an independent research program?

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?

Specific to this NOFO: 

• To what extent will the PD/PI be given appropriate access to facilities and resources (shared or otherwise)? 
• How adequate is the evidence that the PD/PI will have the necessary institutional commitment to conduct full-time, independent research for the duration of this award at the level of effort required?
• To what degree will the research activities, environment, and institutional resources support the PD/PI's development and career?
• To what extent will the PD/PI's separation from previous mentors enable intellectual independence?
• How adequate and appropriate are the plans for appointing and integrating the PD/PI into the institutional scientific culture?
• How adequate are institutional management strategies for addressing potential problematic situations?
• How adequate are plans and criteria for institutional leadership and mentors to monitor and assess the immediate and long-term success of the PD/PI?

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.

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 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 three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. 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 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.

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.

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

Applications will remain in the Office of the Director with the National Institute of Dental and Craniofacial Research performing grants management. Applications will compete for available funds with all other recommended applications submitted in response to this funding opportunity. 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:

• 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, including
  • The potential for the PD/PI to lead a vigorous, independent research program
  • Unusually cross-cutting or underrepresented science
  • Scientific balance in the portfolio of Early Independence Award-supported research
  • Potential to invigorate exceptionally innovative and impactful science broadly across the nation

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 2.4.4 Disposition of Applications.

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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.6. 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.

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 and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all 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.

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).

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 Standard Terms and Conditions for Research Grants
• 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.

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website. 

HHS recognizes that NIH 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.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 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

Consistent with the 2023 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

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final 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 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 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 (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Conditions for Recipient Integrity and Performance Matters.

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]

Becky Miller, Ph.D.
Office of the Director (OD)
Telephone: 301-594-9979
Email: [email protected]

Center for Scientific Review (CSR)

Email: [email protected]

Gabriel Hidalgo, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4630
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 2 CFR Part 200.