National Institutes of Health (NIH)
Office of The Director, National Institutes of Health (OD)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute of Mental Health (NIMH)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)
National Cancer Institute (NCI)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Research on Women's Health (ORWH)
U01 Research Project – Cooperative Agreements
The goal of this program is to support collaborative translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. It encourages high quality science demonstrating the potential to result in understanding an important disease process or lead to new therapeutic interventions, diagnostics, or prevention strategies within the research interests and priorities of the participating NIH Institutes/Centers (ICs).
Specifically, the program seeks to broaden and strengthen patient-centric translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science by promoting partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs outside the NIH), and by providing support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center by conducting clinical research projects in collaboration with NIH intramural investigators.
In order to be eligible for this program, the application must include at least one intramural scientist as a co-Program Director/Principal Investigator (co-PD/PI), and at least some of the clinical research must be conducted at the NIH Clinical Center. Through this collaboration, external researchers may gain access to the NIH Clinical Center and leverage the wide variety of Clinical Center resources, expertise, and infrastructure available to test promising laboratory-and animal-based discoveries with potential for advancing disease diagnosis, treatment and prevention. The special environment of the Clinical Center can support studies that may not be readily supported elsewhere. This may include collaborations that propose targeted increases in new patients enrolled in protocols at the Clinical Center. For this initiative, patients must be seen at the NIH Clinical Center. Projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked samples or data, will not be considered for funding.
The goals of the agency are:
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| February 05, 2026 * | March 05, 2026 * | Not Applicable | July 2026 | October 2026 | December 2026 |
| February 05, 2027 * | March 05, 2027 * | Not Applicable | July 2027 | October 2027 | December 2027 |
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.
Not Applicable
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 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.
The goal of this Notice of Funding Opportunity (NOFO) is to support collaborative, patient-centric translational research projects aligned with NIH efforts to enhance the translation of basic biological discoveries into clinical applications that improve health. This opportunity is specifically to promote partnerships between NIH intramural investigators (e.g., those conducting research within the labs and clinics of the NIH) and extramural investigators (e.g., those conducting research in labs and clinics outside of the NIH). It will provide support for extramural investigators to take advantage of the unique research opportunities available at the NIH Clinical Center (https://ocreco.od.nih.gov/new_u01/new_u01.html) by conducting research projects in collaboration with NIH intramural investigators. For this initiative, while some study participants may be seen at extramural sites, other study subjects must be seen at the NIH Clinical Center. Projects that take only minimal advantage of Clinical Center resources, such as projects only utilizing banked specimens or data, would not be considered for funding.
While translating basic research into clinical practice is increasingly difficult, time-consuming, and expensive, translational research is crucially important in converting basic scientific discoveries into new diagnostics and therapies for patients. As such, this NOFO intends to broaden and strengthen translational research collaborations between basic and clinical researchers both within and outside NIH to accelerate and enhance translational science. All teams must have at least one intramural and one extramural investigator.
This program will provide access for external researchers to the NIH Clinical Center and will leverage the wide variety of Clinical Center resources, expertise, and infrastructure available to test promising laboratory- and animal-based discoveries with potential implications for disease diagnosis, treatment and prevention in human subjects. The NIH Clinical Center is a hospital exclusively dedicated to clinical research, thus research is the culture and research studies are routine. Its mission includes the support of clinical studies that are considered intellectually challenging and risky but with the potential of high reward with new breakthroughs in medicine. The special environment of the Clinical Center supports studies that may not be readily supported elsewhere. This includes collaborations that propose targeted increases in new patients enrolled in protocols at the Clinical Center.
Examples of the special resources of the Clinical Center include:
For entry to the program, projects must have a collaborating Investigator in the NIH Intramural Program. As a collaborative partner, the intramural investigator will be actively involved in the planning and execution of the research project. Applicants are strongly encouraged to contact the appropriate Scientific/Research contact listed in Section VII if the collaborating intramural investigator is from an NIH Institute or Center that is different from the Institute or Center expected to receive the X02/U01 applications. Additional information is available on the "Frequently Asked Questions" website for the program (https://ocreco.od.nih.gov/new_u01/faqs.html).
Applications for this program will be submitted by the extramural institution with the participation of the intramural investigator(s) integrated into the application as described in the Collaboration Plan, and with the budget requirements for the NIH Clinical Center (if any) and for the intramural investigators included in the Budget form of the application. Funded projects will include an award to the applicant organization which will exclude any funds requested to support the participation of the Clinical Center. Support for intramural participation will first be determined, then provided if applicable by a budget allocation within the NIH. Annual progress reports will be prepared and submitted by the extramural institutions, with the participation and input of the intramural investigator(s) and should include the project findings, publications, impact of the project, a description of which Clinical Center unique resources were utilized and any new intramural- extramural partnerships that developed.
NIH Clinical Center Costs
No Clinical Center costs will be charged to the grant except for the cost of all drugs that are the subject of the study, including controls (standard of care drugs will be free). Resources required need to be determined before the research protocol can be approved by the Clinical Center. The collaborating intramural investigator is responsible for coordination with the Clinical Center to assure that any Clinical Center related costs are clearly identified and documented in a timely manner. If there are such Clinical Center costs, the (extramural) applicant will enter this amount as a "subaward" budget in the budget section of the application, using "NIH Clinical Center Costs" as the descriptor. More detailed information about Clinical Center costs may be found at https://ocreco.od.nih.gov/new_u01/budget.html.
F&A (Indirect) Costs: Applicant organizations are reminded that Facilities and Administrative (F&A) or "indirect costs" are allowable for only the allowable extramural costs of the project. F&A will not be paid for any NIH Clinical Center services or intramural investigator costs.
Budget Justification: Detailed information about intramural investigator costs and any NIH Clinical Center costs should be included in the narrative "Budget Justification" section.
Additional Guidance on Budget Preparation
The budget requests for this NOFO are more complex and will require more coordination than those of other programs. Therefore, extramural investigators are encouraged to begin discussions about logistics and budget issues with their intramural collaborators and with NIH staff in the early phases of application preparation. Determination of any Clinical Center costs will require coordination between the intramural investigator and the Clinical Center Office of the Chief Financial Officer, and sufficient time should be allowed for this process. Specific questions about budget preparation may be addressed to the Agency Contacts listed in Section VII or to ClinicalCtrPartner@mail.nih.gov.
Letters of Support
Applications must include Letters of Support (LOS) from the NIH Clinical Center and one of the participating NIH Institutes/Centers.
Requests for Letters of Support should be made through the Request for LOS process. Instructions for submitting requests can be found at https://ocreco.od.nih.gov/new_u01/letters_of_support.html.
Applicants must send requests by October 31st to:
David J. Eckstein, PhD
Program Director, Strategic Partnerships
NIH Office of Clinical Research
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov
IMPORTANT: Applicants are strongly encouraged to consult with the Scientific/Research Contacts for the area of science for which they are planning to develop an application. Early contact provides an opportunity for IC staff to discuss the program scope and goals, and to provide information and guidance. Other aspects of an application that are unique to this program including collaboration with Intramural Investigators may also be discussed.
For a more complete listing of resources in these research areas at the NIH Clinical Center and for assistance in how to apply, please refer to the website for the program at https://ocreco.od.nih.gov/new_u01/new_u01.html.
Non-Responsive Applications:
Applications will be considered non-responsive if they take only minimal advantage of Clinical Center resources, such as utilizing only banked samples or data.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this NOFO.
The OER Glossary and the How to Apply Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.
Optional: Accepting applications that either propose or do not propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets need to reflect the actual needs of the proposed project. The maximum amount available per application is $500,000 direct costs per year; this amount includes extramural recipient costs, Clinical Center costs and intramural investigator's costs attributed to the proposed research project. The total of all three types of cost must not exceed $500,000 (direct costs) per year.
The NIH Clinical Center costs and intramural investigator's costs will not be included in the award issued to the recipient.
The scope of the proposed project should determine the project period. For projects that do not need a planning year, the maximum project period is 4 years. If the project needs to include a planning year as part of the research plan, a fifth year can be proposed (grant year 1) at a reduced budget level.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
Higher Education Institutions - Includes all types
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.
Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.
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 the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.
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.
For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the How to Apply-Application Guide.
This program requires the full collaboration of the extramural PD/PI of the applicant institution and the intramural investigator.
Applications must include at least one intramural scientist as either a co-Program Director/Principal Investigator or collaborator, and at least some of the clinical research must be conducted at the NIH Clinical Center. Intramural investigators whose involvement would not be classified as substantial should be assigned a collaborator role.
This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.
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:
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.
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 (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). 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.
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.
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
Other Attachments
The following attachments must be included, as applicable.
Collaboration Plan
Applications must include a proposed Collaboration Plan, describing how the proposed collaborations will be maintained throughout the duration of the award. The following areas should be addressed:
Description of how research teams will communicate (e.g., videocast, web meeting, etc.).
All instructions in the How to Apply- Application Guide must be followed.
All instructions in the How to Apply- Application Guide must be followed.
The budget request for this NOFO must distinguish between extramural costs, the NIH intramural investigator costs, and NIH Clinical Center costs. Extramural costs are associated with the extramural investigator and the applicant organization. NIH intramural investigator costs are those required by the intramural investigator for carrying out the proposed work and which are specifically identified with the project. NIH Clinical Center costs are additional costs to the Clinical Center that directly result from the proposed research project.
Extramural Grantee Costs
Extramural costs may include such items as salary support for the extramural PD/PI and staff at the applicant organization, supplies, laboratory animals, data analysis, and other allowable costs for work performed at the (extramural) applicant organization, as well as travel costs for the extramural investigator(s). Extramural costs may also include travel costs for any patients not already at the NIH Clinical Center.
Intramural Investigator Costs
Each NIH Institute and Center maintains individual policies with respect to the scope of resources available for intramural collaboration. The 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). These 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. Resources required need to be determined before the research protocol can be approved by the respective NIH Institute/Center. Prospective applicants are strongly encouraged to contact staff at the participating NIH Institute/Center to discuss intramural investigator costs, because individual Institutes/Centers may have different policies regarding support for the intramural portion of the project.
Once the intramural investigator costs are known, the extramural applicant will enter this amount as a "subaward" budget in the application, and attach appropriate justification and documentation, including any spreadsheets as appropriate. The NIH Clinical Center costs and intramural investigator's costs will not be included in the award paid to the grantee. Support for intramural participation will be provided by a budget allocation within the NIH.
Intellectual property will be managed in accord with established policy of 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.
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: Specific Aims for the proposed research project should be included in the U01 application.
Research Strategy: Within the Research Strategy, the applicant must describe how the application fulfills the requirements of this program. Specifically, the application must include at least one (NIH) intramural scientist as co-PD/PI, and at least some of the research must be conducted at the NIH Clinical Center. Applications will be considered non-responsive if they take only minimal advantage of Clinical Center resources, such as utilizing only banked samples or data.
In describing the collaboration between the extramural applicant and the intramural investigator and the research they will conduct, applicants should demonstrate that each investigator will devote an appropriate amount of time/effort to the project and briefly describe the responsibilities of each investigator.
In describing the research to be conducted at the NIH Clinical Center, applicants should provide the following information, as applicable:
Patient/Community Engagement and Study Design: Patient and stakeholder (parent, caregiver, support and advocacy group) experiences, perspectives, needs and priorities, should be meaningfully incorporated into decisions and activities. Applicants are strongly encouraged to specify the process for including disease community engagement (research subjects) in study design. For studies with clinical outcome endpoints, define whether research subject perspectives were included in defining clinical outcome measures (e.g. surveys distributed at patient conferences, direct meetings with patients and support group representatives, patient representation on any study design group).
Consortium/Contractual Arrangements: The Clinical Center collaboration should be described here.
Letters of Support:
Applications submitted to this NOFO must include a current (i.e. within 3 months of application due date) letter from the NIH Clinical Center and a current letter from the respective NIH Institute/Center to confirm that the Clinical Center facilities will be able to accommodate the proposed research and that the intramural scientist from the respective NIH Institute/Center will be able to collaborate on the project.
Resubmission or renewal applications will need to obtain new letters of support.
APPLICATIONS SUBMITTED WITHOUT EITHER LETTER WILL BE CONSIDERED INCOMPLETE AND WILL NOT BE REVIEWED.
In addition, letter(s) from the collaborating intramural investigator(s) along with any other collaborators/consultants should also be included.
Planning Activities: For projects where additional time may be needed for planning prior to starting the trial, it would be allowable to submit a 5-year Research Plan where the first year of the project focuses on planning activities, and a commensurately smaller budget for that year, with the actual trial commencing in years 2-5 of the project period. Such planning activities could include development of a Manual of Procedures, creation of a Data Safety and Monitoring Board charter, development of data handling and statistical analysis plans, establishment of recruitment sites, preparation of preliminary submissions for regulatory approvals, development of training materials, credentialing at the NIH Clinical Center, and other tasks essential to a clinical trial. For applications taking that approach, these activities should also be included in the study timeline and milestones. If a planning year is proposed as part of the Research Plan, it is expected that any planning activities will be completed and planning milestones accomplished prior to commencing the trial in years 2-5.
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):
All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:
Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.
If the project includes a clinical protocol, the following additional documents must be included in the Appendix material:
If a protocol is part of the application, the complete Clinical Protocol must be included. Investigators are referred to the NIH-FDA Clinical Trials Protocol Template with guidance and sample text to help write protocols.
Note: There may be situations where the complete Clinical Protocol is not available at the time of submission -- for example, if the protocol cannot be developed until after results have been obtained from basic research that is being proposed. In such a situation, the attachment should provide a justification to explain why the Clinical Protocol is not available and the Milestones should address when the Clinical Protocol will be finalized. Failure to justify this adequately could adversely affect the score.
If any of these documents are not available at the time of submission, the applicant should attach a justification, and the Milestone Plan should address when these materials will be available.
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.
The following modifications may also apply:
Section 2 - Study Population Characteristics
2.7 Study Timeline
If the research involves a clinical trial, a Milestone Plan must be included. The milestone plan must include a timeline for the following general milestones, as applicable:
Section 3 - Protection and Monitoring Plans
3.2 Is this a multi-site study that will use the same protocol to conduct non-exempt human subjects research at more than one domestic site?
Applicants are reminded that the use of a single Institutional Review Board (sIRB) is required for any multi-site study that will conduct non-exempt human subjects research at more than one domestic site. (Please see: https://grants.nih.gov/policy/clinical-trials/single-irb-policy-multi-site-research.htm.)
3.3 Data and Safety Monitoring Plan
Section 4 - Protocol Synopsis
4.1.c Interventions
If appropriate to the study, a description and justification for the selection of the dose, frequency and administration of the intervention(s).
4.3 Statistical Design and Power
The statistical analysis plan is critical to knowing whether applicants have selected the correct cohort size based on proper power calculations and/or are using the most appropriate methods to analyze the resulting data and make correct conclusions at the end of the study. The ability to make conclusions of primary outcomes other than safety will be particularly important in small studies.
4.5 Will the study use an FDA-regulated intervention?
4.5.a If yes, describe the availability of Investigational Product (IP) and Investigational New Drug (IND)/Investigational Device Exemption (IDE) status
If the research involves an FDA regulated intervention, a statement addressing the need (if applicable) for IND/IDE approval from the FDA must be provided, including the date of submission and disposition of the IND/IDE application; if FDA staff have determined that IND/IDE approval is not required, a copy of the FDA letter/email stating no IND/IDE is required and the date of the decision.
To assist investigators, the NIH Clinical Center Office of Regulatory Support can provide consultation on issues related to the regulatory requirements and assistance in protocol navigation and attaining approvals (For more details, please see: https://www.cc.nih.gov/translational-research-resources/faq-2-applying.html)
Section 5 - Other Clinical Trial-related Attachments
5.1 Other Clinical Trial-related Attachments
A description of the data management and quality control plan, including methods for monitoring the quality and consistency of the intervention(s) and data collection; policies and methods for ensuring blinding of study results; and data confidentiality and subject privacy.
(The attachment should be called "Data Management Plan.pdf")
If any of these documents are not available at the time of submission, the applicant should attach a justification, and the Milestone Plan should address when these materials will be available.
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.
Foreign (non-U.S.) organizations must follow policies described in the NIH Grants Policy Statement, and procedures for foreign organizations described throughout the How to Apply- Application Guide.
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.
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 components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.
Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.
Applicants are required to follow the instructions for post-submission materials, as described in the policy
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.
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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.
Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score.
Significance
Innovation
Approach
Rigor:
Feasibility:
Investigator(s)
Evaluate whether the investigator(s) have demonstrated background, training, and expertise, as appropriate for their career stage, to conduct the proposed work. For Multiple Principal Investigator (MPI) applications, assess the quality of the leadership plan to facilitate coordination and collaboration.
Environment
Evaluate whether the institutional resources are appropriate to ensure the successful execution of the proposed work.
As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, 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, evaluate: 1) the justification for the exemption; 2) human subjects involvement and characteristics; and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
When the proposed research includes Vertebrate Animals, evaluate the involvement of live vertebrate animals 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. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
When the proposed research includes Biohazards, evaluate whether specific materials or procedures that will be used are significantly hazardous to research personnel and/or the environment, and whether adequate protection is proposed.
As applicable, evaluate the full application as now presented.
As applicable, evaluate the progress made in the last funding period.
As applicable, evaluate the appropriateness of the proposed expansion of the scope of the project.
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.
For projects involving key biological and/or chemical resources, evaluate the brief plans proposed for identifying and ensuring the validity of those resources.
Evaluate whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by CSR, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications 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 Advisory Council or Board. The following will be considered in making funding decisions:
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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.
Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. 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 the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.
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.
A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.
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.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk. For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.
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).
The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:
All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.
By applying for or accepting federal funds from HHS, recipients certify compliance with all federal antidiscrimination laws and these requirements and that complying with those laws is a material condition of receiving federal funding streams. Recipients are responsible for ensuring subrecipients, contractors, and partners also comply.
Applicants and recipients are strongly encouraged to refer to the NIH Director’s Statement of Priorities, entitled “Advancing NIH’s Mission Through a Unified Strategy.”
Recipients are responsible for ensuring that their activities comply with all applicable federal regulations. Pursuant to 2 CFR 200.340, by accepting an NIH award, the recipient agrees that continued funding for the award is contingent upon the availability of appropriated funds, recipient satisfactory performance, compliance with the Terms and Conditions of the award, and may also otherwise be terminated, to the extent authorized by law, if the agency determines that the award no longer effectuates the program goals or agency priorities, in line with 2 CFR 200.340(a)(4).
Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.
Successful recipients under this NOFO agree that:
When recipients, subrecipients, or third-party entities have:
Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information.
The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (HHS) grant administration regulations at 2 CFR Part 200, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and NIH as defined below.
The PD(s)/PI(s) will have the primary responsibility for:
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: a designee of the recipient one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
T&C Inclusions and Modifications
The Terms and Conditions of Award will include references to the currently approved versions of the Collaboration Plan and the Multiple PD(s)/PI(s) Leadership Plan, if applicable; Timeline and Milestone Plans; and the Sharing Plans for Resources and Data. Before the initial award is made, NIH and the recipients may negotiate changes or additions to the versions of these plans in the application. Future changes or additions to these plans may be developed by the NIH and the PD(s)/PI(s). Changes will be documented by an exchange of correspondence and the updated plans will become part of the Terms and Conditions of a revised Notice of Award.
Program Evaluation
In addition to ongoing monitoring by program staff, the NIH plans to conduct a prospective and comprehensive evaluation of the Opportunities for Collaborative Research at the NIH Clinical Center (U01) program, including (but not necessarily limited to) the processes supporting the collaboration and the various types of projects and their outcomes relative to meeting the strategic goals of this announcement. Accordingly, potential areas of interest to this evaluation may include understanding the manner in which research review, funding, or administrative processes and procedures influenced the outcomes of the collaborations; and identifying the scope and impact of the research projects that were implemented their publications; the range and types of resources utilized, including patient; and the formation of new research partnerships. To support this effort, the NIH will request that recipients participate in various aspects of the evaluation. In addition, recipients are hereby notified that they may be contacted during or after the completion of this award for information helpful in assessing the program's overall impact.
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.
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 Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.
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 Section 8.6 Closeout. 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.
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.
Grants.gov Support Center - Questions regarding Grants.gov registration and services (e.g., Workspace, subscriptions).
CLINICAL CENTER PARTNERSHIP
NIH Office of Clinical Research Education and Collaboration Outreach (OD)
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov
Donald F Everett
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8181
E-mail: dfe@nei.nih.gov
Debra Babcock, Ph.D., M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Phone: 301-496-9964
E-mail: dbabcock@mail.nih.gov
Xincheng Zheng, MD, PhD
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-4953
E-mail: zhengx4@mail.nih.gov
Robert Colbert, MD, PhD
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-693-2950
Email: colbertr@mail.nih.gov
Minkyung (Min) H. Song, PhD
National Cancer Institute (NCI)
Telephone: 240-276-6139
Email: songm@mail.nih.gov
Deborah E. Citrin, MD
National Cancer Institute (NCI)
Telephone: 301-496-5457
Email: citrind@mail.nih.gov
Balkissa Ouattara, M.D., Ph.D., MPH
ORWH - Office of Research on Women's Health
Phone: 301-435-8405
E-mail: balkissa.ouattara@nih.gov
Lisa L. Cunningham, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: (301) 443-2766
email: lisa.cunningham@nih.gov
Judith Cooper, Ph.D.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: (301) 496-5061
E-mail: cooperj@nidcd.nih.gov
David Shurtleff, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-435-6826
Email: David.Shurtleff@nih.gov
Maryland Pao, MD
National Institute of Mental Health (NIMH)
Telephone: 301-496-4588
Email: paom@mail.nih.gov
Elizabeth Church, Ph.D.
National Institute of Mental Health (NIMH)
Telephone: 301-520-0395
Email:elizabeth.church@nih.gov
Chelsea Boyd, PhD
National Institute of Allergy Infectious Diseases (NIAID)
Telephone: 301-761-6664
Email: chelsea.boyd@nih.gov
Dena Fischer, DDS, MSD, MS
National Institute of Dental & Craniofacial Research (NIDCR)
Telephone: 301-594-4876
E-mail: dena.fischer@nih.gov
Janice Lee, DDS, MD, MS
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-1647
E-mail: janice.lee@nih.gov
David Schopfer, M.D.
National Heart Lung and Blood Institute (NHLBI)
Telephone: 301-402-3833
Email: david.schopfer@nih.gov
Melissa Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6880
Email: parisima@mail.nih.gov
M. Kathy Jung. Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
301-443-8744
Email: jungma@mail.nih.gov
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
NIH Office of Clinical Research Education and Collaboration Outreach (OD)
Telephone: 301-496-4121
Email: ClinicalCtrPartner@mail.nih.gov
Karen Robinson Smith
NEI - NATIONAL EYE INSTITUTE
Phone: 301-435-8178
E-mail: kyr@nei.nih.gov
Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS))
Email: ChiefGrantsManagementOfficer@ninds.nih.gov
Erik Edgerton
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Telephone: 301-594-7760
NIAMSGrants@nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov
Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: (301) 435-1404
Email: samantha.tempchin@nih.gov
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov
Heather Weiss
National Institute of Mental Health (NIMH)
Telephone: 301-443-4415
Email: weissh@mail.nih.gov
Nicole Gormley
National Institute of Allergy Infectious Diseases (NIAID)
Telephone: 301-761-5499
Email: nicole.gormley2@nih.gov
Gabriel Hidalgo, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-827-4630
E-mail: gabriel.hidalgo@nih.gov
Office of Grants Management
National Heart, Lung, and Blood Institute (NHLBI)
Email: NHLBIOGMInbox@nhlbi.nih.gov
Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: margaret.young@nih.gov
Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: judy.fox@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.