PAR-25-156: Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science (RC2 Clinical Trials Optional)

PAR-25-156: Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science (RC2 Clinical Trials Optional) is sponsored by National Institutes of Health (NIH). This opportunity supports mission-aligned projects and measurable outcomes.

PAR-25-156: Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science (RC2 Clinical Trials Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Center for Advancing Translational Sciences ( NCATS ) Funding Opportunity Title Limited Competition: High Impact Specialized Innovation Programs in Clinical and Translational Science (RC2 Clinical Trials Optional) RC2 High Impact Research and Research Infrastructure Programs March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . May 9, 2018 - National Center for Advancing Translational Sciences (NCATS) Policy for Support of Phase III Clinical Trial Activities for a Rare Disease or Condition. See Notice NOT-TR-18-025 .

Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3. Additional Information on Eligibility .

Assistance Listing Number(s) Funding Opportunity Purpose This is a limited competition.

The purpose of the High Impact Specialized Innovation Programs (SIPs) is to support the development and demonstration of unique hub capabilities, research platforms and/or resources to address in a timely manner critical gap areas and/or roadblocks in clinical and translational science at awarded UM1 Clinical and Translational Science Awards (CTSA) Program Hubs ( PAR-24-272 ).

Successful programs supported through this funding opportunity are expected to lay a strong foundation for future adoption and/or dissemination of capabilities to additional CTSA Program Hubs. Open Date (Earliest Submission Date) Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

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.

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.

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information 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 Research Objectives and Purpose: The development and implementation of clinical interventions is a complex, iterative, and time-consuming process that takes years before discoveries in biomedical research result in health benefits for patients and communities.

The National Center for Advancing Translational Sciences (NCATS) has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist in the translational process and developing innovative solutions that will ultimately benefit research across a range of diseases and conditions.

This disease-agnostic approach to enhancing the efficiency and effectiveness of all translational research is known as translational science, which focuses on building the evidence base for effective scientific and operational approaches in translational research.

NCATS conducts and supports research in the science of translation to discover the scientific, mechanistic, and operational principles of the intervention development and dissemination processes, thereby providing the scientific foundation for improvements in translational efficiency that will accelerate the realization of interventions that improve human health.

The purpose of the High Impact Specialized Innovation Programs (SIPs) is to support unique activities, resources, capabilities and/or expertise at awarded CTSA UM1 ( PAR-24-272 ) hubs to help advance one or more of the NCATS CTSA Program goals .

The SIPs initiative is envisioned as part of the current innovation ecosystem to support the generation of a research resource and/or foster discovery-based or hypothesis-generating science that can have a significant impact in Clinical and Translational Science (CTS).

Specifically, this limited competition Notice of Funding Opportunity (NOFO) seeks to support novel approaches in areas that address specific knowledge gaps, scientific opportunities, new technologies/platforms, data generation and/or analysis, or novel research methods that will advance clinical and translational science (CTS) and research (CTR) at CTSA UM1 hubs .

Resources, activities, and expertise supported through the RC2 mechanism are expected to be available to enhance the development and demonstration activities or projects within a CTSA hub. These include utilization of resources, expertise, tools and platforms for pilot projects, research projects and other CTS activities within hubs.

Examples of SIPs areas in clinical and translational science include but are not limited to digital health, decentralized clinical trials, pragmatic trials, artificial intelligence/machine learning algorithms, point-of-care clinical decision support systems, data science and statistical methods, real-world data and real-world evidence, innovative clinical trial designs, genetics and genomics.

In addition, novel strategies and/or approaches for dissemination and implementation, rural health, clinical informatics, biostatistics, community outreach and engagement, regulatory science, telehealth, and other areas of need for specialized programs.

Scope and Specific Requirements: Through the RC2 mechanism, SIPs should address one or more of the following objectives: Groundbreaking, innovative, high impact and cross-cutting research, resources and/or activities that address one or more of the CTSA Program Goals and have the highest potential to improve and accelerate biomedical research at UM1 hubs.

Programs in Clinical and Translational Science that could fundamentally enhance the research enterprise and that require the participation, interaction, coordination, and integration of activities within a CTSA UM1 hub . Creation of unique resources and/or development of transformative technologies and/or platforms that can benefit a wide range of projects and/or activities related to CTS at CTSA UM1 hubs.

High-impact discovery-based projects or hypothesis-generating science. While preliminary data is not required, it is important to provide a strong rationale and justification for the goals of the application. Applications for SIP must include: a UM1 and RC2 Coordination and Integration Plan, a Program Milestones table and a Program Evaluation and Sustainability Plan as separate attachments (see Section IV.

Application and Submission Information SF424(R&R) Other Project Information) Potential applicants are highly encouraged to contact NCATS Scientific/Research Contacts listed in this NOFO to discuss the scope of the project, required materials, responsiveness, and clinical trials status designation prior to submission of an application.

Collaborations with other components of the CTSA UM1 hub and/or with institutions listed as partners and/or collaborators are encouraged. Also, collaborations with other CTSA UM1 and UL1 hubs and with non-CTSA organizations are encouraged. The requested project period may be up to 5 years.

Applications Not Responsive to this NOFO: The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding.

Applications that propose: Feasibility/Pilot projects intended to: (1) explore possible innovative new leads or new directions for established investigators; (2) stimulate investigators from other areas to lend their expertise in research in CTS; and (3) provide initial support to establish proof of concept. Pilot projects are supported through the CTS Pilot Module within the UM1.

Traditional investigator-initiated, hypothesis-driven and highly focused studies (best supported through CTSA UM1 CTS Research Projects) or specific projects requiring multiple collaborators (best supported through CTSA Collaborative Innovation Awards ). Dissemination and implementation of novel resources/activities/projects at other hubs. Ancillary studies or research that is a logical extension of ongoing work.

Core (or related) services to supplement the budgets of existing UM1 efforts. Funds may not directly support any clinical trial beyond Phase IIB with the exception of Phase III clinical trials for treatment of rare diseases. Projects that do not meet these clinical trial limitations will not be reviewed.

See NOT-TR-18-025. See Section VIII. Other Information for award authorities and regulations.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed Resubmission - Resubmission of Applications submitted to PAR-24-054 and 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).

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. Funding of the RC2 will be contingent upon the funding of the primary CTSA UM1 hub at the time of award.

Application budgets are limited to no more than $500,000/year in direct costs excluding consortium/contractual F&A costs. Requested project period may be up to 5 years. 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 All applicant organizations and/or active award recipients for PAR-24-272 Clinical and Translational Science Award (UM1 Clinical Trial Optional) are eligible to apply under this NOFO. Only the primary UM1 CTSA program hub organization is eligible to apply (not partner or collaborator institutions).

RC2 companion optional applications may be submitted under the following scenarios: -concurrently with the UM1 -while the UM1 application is under review consideration -after the UM1 application is funded -while the UM1 is under consideration for funding RC2 applications will only be awarded if there is an awarded UM1 application from the RC2 applicant organization.

Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

Applicant organizations 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.

The single PD/PI (or contact PD/PI for a multiple PI application) must be employed by and/or a recipient of funding and/or have an academic appointment from a CTSA Program UM1 hub prime institution as defined above in Eligible Organizations.

Investigators from UM1 hub partners or collaborators who wish to co-lead a SIP, can co-direct in partnership with a contact PD/PI who is employed by and/or a recipient of funding and/or has an academic appointment at a CTSA Program UM1 prime hub institution using the multiple PD/PI option. See required Letters of Support. (see Section IV.

Application and Submission Information, 2. Content and Form of Application Submission, PHS 398 Research Plan.) 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 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 ). Other information on eligibility and number of applications: An active (not in an extension period) UM1 hub institution can submit up to two RC2 applications for SIPs per cycle as the primary institution. A CTSA UM1 hub may have up to two RC2 SIPs awards as the primary recipient at a given time.

No more than two RC2 applications may be submitted by a UM1 hub as a primary per application due date and no more than two RC2 applications may be awarded to an active (not in an extension period) CTSA UM1 hub as a primary recipient, at a given time.

A UM1 hub that is in an extension period is not allowed to submit an RC2 application as the primary institution unless a pending UM1 application has been submitted or is under review or funding consideration. Resubmission of a RC2 application without the required UM1 application is only allowed if the companion UM1 application is awarded.

For the purpose of this NOFO, an RC2 in an extension period counts towards the maximum of two RC2s that may be awarded to an active UM1 hub as a primary, at a given time. Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the 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. 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.

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

The application must include the following 3 attachments. Please use the filenames suggested below. The filename provided for each document added to the section “Other Attachments” will be the name used for the bookmark in the electronic application in eRA Commons.

Attachment #1 (Up to 2 pages in length) called "UM1 and RC2 Coordination and Integration Plan" must be uploaded under Other Attachments. The UM1 and RC2 Coordination and Integration Plan must provide a specific plan describing the collaboration, support, equipment, coordination, synergy and integration between the UM1 hub and any of its elements and modules and other UM1 companion NOFOs and the proposed RC2 Program.

Applications that do not include UM1 and RC2 Coordination and Integration Plan will not be reviewed. Attachment #2 (Up to 1 page in length) called “Program Milestones” must be uploaded under Other Attachments. The Program Milestones must include a table with key milestones to be achieved throughout the RC2 program period.

Both short-term/interim (monthly or quarterly) and long-term (yearly) milestones should be clearly outlined in word table format. Each milestone should be constructed to succinctly include: (a) the goals and timeline for completion, (b) the criteria for success, including quantitative and/or qualitative metrics that will be used to assess success.

Final program milestones for each RC2 may be changed based on suggestions from reviewers or NIH program staff and will be negotiated with program staff prior to funding the application. The final agreed upon and approved milestones will be specified in the Notice of Award (NoA). Applications that do not include Program Milestones will not be reviewed.

Attachment #3 (Up to 2 pages in length) called “Program Evaluation and Sustainability Plan” must be uploaded under Other Attachments. The Program Evaluation and Sustainability Plan must provide a clear plan to evaluate the success and impact of the proposed program based on the pre-determined milestones and SIP utilization at participating institutions.

List key metrics and measures of success to be utilized to evaluate the overall impact of the program and how success will be measured in an objective and tangible manner on a regular basis.

In addition, outline plans for sustainability of the SIP beyond the RC2 grant period (once grant funding ends) and how do applicants envision their Specialized Innovation Program to continue through partnerships, collaborations, support, etc. after the RC2 ends. Applications that do not include the Program Evaluation and Sustainability Plan will not be reviewed.

Applications that do not include one or more of these attachments will be considered incomplete and will not be reviewed. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed with the following additional instructions: Key Personnel salaries derived from the grant will depend on the effort provided and institutional salary as well as existing NIH policies. It is recommended that the contact PD/PI devote at least one to two person months of his/her efforts to the project.

No overlap of time or effort between this award and separately funded projects is permitted. Consultants and any associated costs (consultant fees, per diem, travel) may be included when their services are required and justified within the award. RC2 budget should include travel expenses for appropriate personnel (up to three people) to attend a yearly in-person meeting to present RC2 progress, lessons learned and impact.

If additional staff are identified to attend, additional justification is required as part of the Budget Justification. All instructions in the How to Apply-Application Guide must be followed. PHS 398 Cover Page Supplement 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: Briefly state the specific aims of the project indicating how the hub will develop and/or demonstrate a highly innovative and specialized clinical and translational science program that addresses one or more of the CTSA Program goals .

This opportunity may support high impact unique activities, resources, expertise or capabilities that may lay the foundation for new fields of investigation; accelerate breakthroughs; stimulate early and applied research on cutting-edge technologies/platforms; foster new approaches to improve the interactions among multi- and interdisciplinary research teams to help advance the clinical and translational research enterprise in a way that could stimulate future growth and investments and advance public health and health care delivery.

This activity code may support either a specific question related to the advancement of clinical and translational science or propose the creation of a unique infrastructure/resource designed to accelerate clinical and translational science at UM1 hubs. A description of the specialized team(s) that is/are part of the proposed SIP as well as their experience is expected.

In addition, applicants must concisely describe the significance of the problem/roadblock or gap being addressed and their relevance to the goals of the CTSA Program . Applicant should specifically address why the proposed SIP is best suited to respond to UM1 hub needs, as described below.

The application must provide an explanation of how the proposed program will empower research, generate new hypotheses, or contribute a significant resource, platform, tool, data or technology that is currently lacking and could help advance the development of new approaches, solutions, therapeutics, devices and/or diagnostics to improve human health.

Programs are expected to demonstrate the following: The work cannot be reasonably expected to be carried out successfully without support provided by this NOFO. Funding will accelerate the development of innovative resources, approaches, tools, solutions, therapies, diagnostics, devices and/or applications and help overcome roadblocks in clinical and translational science.

The proposed project is something that will help catalyze clinical and translational science locally at UM1 hubs and no other existing project/resource is likely or able to do. The project or generated results and resources can be expected to become integrated into the broader clinical and translational science community locally, regionally and/or nationally.

There is a plan for evaluation and sustainability of applicable research efforts and resources beyond the RC2 funding. Critical Need/Gap Area Addressed: Describe how is the proposed project is unique and how it is expected to solve a real gap or overcome a key roadblock in clinical and translational science. The capability must directly address one or more of the current CTSA Program Goals .

It is expected that the capability or resource will be in an area of need where there are currently no clearly available solutions/tools/resources or where the existing solutions are suboptimal. The identification of a critical gap(s) or area(s) of need should be based on evidence and supported by most up-to-date science in the field.

In addition, applicants must justify how the local innovations developed through their proposed RC2 could impact health and medicine by meaningfully advancing clinical and translational science within their UM1 hub and, if successful, how their proposed RC2 could be more broadly disseminated throughout the CTSA consortium.

Also how does the proposed RC2 changes the landscape of what’s currently being done in the specific field and how it can help advance clinical and translational science and make a difference in medicine and health.

Letters of Support: Applicants must provide a letter from the UM1 hub Principal Investigator describing how the proposed SIP is expected to be integrated within the CTSA hub as well as the resources, expertise that the CTSA hub will provide.

In addition, any resources or expertise outside of the team of investigators, including institutional support through core facilities or resources, must be evidenced by appropriate letters of support from the relevant individual(s). Applications that do not include a letter from the UM1 hub Principal Investigator will not be reviewed.

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. The CTSA Program encourages sharing of resources with broad availability of policies, practices, materials, and tools to facilitate collaboration, reuse, and replication.

To provide further clarification of the NIH policy on disseminating unique research resources, NIH published Principles and Guidelines for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources (64 FR 72090, December 23, 1999; https://sharing. nih. gov/sites/default/files/flmngr/Research_Tools_Federal_Register.

pdf ). This document will assist recipients in determining reasonable terms and conditions for disseminating and acquiring research tools. For the purposes of this NOFO the research tool may include, but is not limited to, software, algorithms, and code.

This may be for extraction and use of data for research from clinical systems; implementation of new efficient workflows for research studies; innovative networking to connect scientists, patient communities, industry, resources, data, and ideas; novel analytic and analysis programs; and educational tools.

The Resource Sharing Plan must include the following: The software should be freely available to biomedical researchers, health care systems, and research institutions or organizations. The terms should also permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or components of it into other software packages.

The terms of software availability should include the ability of individuals outside the applicant institution and its collaborating organizations to modify the source code and to share modifications with other colleagues. Prior to funding, NIH Program Staff may negotiate modifications to the Resource Sharing Plan with the applicant.

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions: Genomic Data Sharing Plan: Awardees are strongly encouraged to deposit large-scale, human genetic data in the database for Genotype and Phenotype “dbGaP” (https://www. ncbi. nlm.

nih. gov/gap). For other data and biospecimens from human genetic or non-genetic studies, awardees are encouraged to use the NICHD Data and Specimen Hub “DASH” (https://dash.

nichd. nih. gov/) or other equivalent broad-sharing data and/or biospecimen repositories.

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. Appendix: Only limited Appendix materials are allowed.

Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

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

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). All instructions in the How to Apply- Application Guide must be followed. PHS Assignment Request Form All instructions in the How to Apply- Application Guide must be followed.

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.