PAR-26-116-Full-Announcement.html

Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

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)

Funding Opportunity Title

Opportunities for Collaborative Research at the NIH Clinical Center (U01 Clinical Trial Optional)

Activity Code

U01 Research Project – Cooperative Agreements

Announcement Type

Reissue of

PAR-21-343

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

PAR-26-116

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.313, 93.242, 93.867, 93.394, 93.395, 93.855, 93.121, 93.853, 93.837, 93.838, 93.839, 93.840, 93.233, 93.273, 93.846, 93.213, 93.173, 93.865

Funding Opportunity Purpose

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.

Funding Opportunity Goal(s)

The goals of the agency are:

Key Dates

Posted Date

Open Date (Earliest Submission Date)

January 05, 2026

The following table includes NIH standard due dates marked with an asterisk.

February 05, 2026 *

March 05, 2026 *

Not Applicable

December 2026

February 05, 2027 *

March 05, 2027 *

Not Applicable

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.

Due Dates for E.O. 12372

Not Applicable

Expiration Date

March 06, 2027

Required Application Instructions

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.

Table of Contents

Part 1. Overview Information Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

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.

Section II. Award Information

Funding Instrument

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.

Application Types Allowed

New

Renewal

Resubmission

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.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

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.

Award Project Period

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.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

Eligible Agencies of the Federal Government

U.S. Territory or Possession

Other

Independent School Districts

Public Housing Authorities/Indian Housing Authorities

Native American Tribal Organizations (other than Federally recognized tribal governments)

Faith-based or Community-based Organizations

Regional Organizations

Non-domestic (non-U.S.) Entities (Foreign Organizations)

Foreign Organizations/International Collaborations

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.

Required Registrations

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.

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 registrations; 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.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with 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.

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).

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 (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.

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

Instructions for Application Submission

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.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

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.).

SF424(R&R) Senior/Key Person Profile

R&R or Modular Budget

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.

R&R Subaward Budget

PHS 398 Cover Page Supplement

PHS 398 Research Plan 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:

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.

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.

PHS Human Subjects and Clinical Trials Information 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

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.

PHS Assignment Request Form

Foreign Organizations 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.

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

4. Submission Dates and Times 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.

6. Funding Restrictions All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

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.

Mandatory Disclosure

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.

Post Submission Materials 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.

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 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.

Scored Review Criteria

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.

Factor 1. Importance of the Research (Significance and Innovation)

Innovation

Factor 2. Rigor and Feasibility (Approach)

Rigor: