Blueprint MedTech Translator (UG3/UH3) is a multi-institute NIH cooperative agreement that funds the translation of medical devices from early-stage concepts toward clinical application. Structured as a phased Exploratory/Developmental award, the program supports up to ,000 per year for qualifying projects.

The UG3 phase funds initial exploratory and developmental work, with successful projects advancing to the UH3 phase for more intensive translational activity. The application deadline is May 28, 2026. This mechanism is intended for investigators pursuing novel medical device innovations with a clear path toward clinical use and commercial viability.

PAR-25-383: Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional) Department of Health and Human Services Part 1.

Overview Information Participating Organization(s) National Institutes of Health ( NIH ) Components of Participating Organizations National Institute of Neurological Disorders and National Eye Institute ( NEI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Biomedical Imaging and Bioengineering ( NIBIB ) Eunice Kennedy Shriver National Institute of Child Health and Human Development ( NICHD ) National Institute of Dental and Craniofacial Research ( NIDCR ) National Institute on Drug Abuse ( NIDA ) National Institute of Mental Health ( NIMH ) National Center for Complementary and Integrative Health ( NCCIH ) 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 Behavioral and Social Sciences Research ( OBSSR ) Funding Opportunity Title Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional) UG3 / UH3 Exploratory/Developmental Phased Award Cooperative Agreement Notices of Special Interest associated with this funding opportunity August 8, 2024 - Notice of Special Interest (NOSI): HEAL Initiative: Development and Translation of Diagnostic and Therapeutic Devices via Blueprint MedTech See Notice NOT-NS-24-075 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 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III.

3. Additional Information on Eligibility . Assistance Listing Number(s) 93.

853, 93. 372, 93. 213, 93.

279, 93. 866, 93. 273, 93.

286, 93. 242, 93. 865, 93.

121, 93.

867 Funding Opportunity Purpose This Notice of Funding Opportunity (NOFO) is to encourage applications from investigators to pursue translational activities and clinical studies to advance the development of medical devices to prevent, monitor, diagnose, and treat disorders within the missions of the participating NIH institutes and centers, as well as the NIH Brain Research through Advancing Innovative Neurotechnologies (BRAIN) and The Helping to End Addiction Long-term (HEAL) Initiatives.

Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities leading to either a submission of an Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) - for a Significant Risk (SR) study - or an Institutional Review Board (IRB) approval - for a Non-Significant Risk (NSR) study.

Additional activities also include subsequent clinical studies, feasibility or pivotal trials, as appropriate. Check the relevant institute interest statements and websites for additional limitations and clinical study requirements.

The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use.

This NOFO is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in negotiating the final project plan before award and monitoring of research progress. Participants in Blueprint MedTech receive funding for all activities to be conducted in their own organization.

In addition, applicants will collaborate with NIH-funded resource and service providers to receive assistance with specialty areas including design optimization; prototype development and pilot-scale manufacturing; bench and safety testing; commercialization planning; legal and intellectual property protection; large animal testing; biocompatibility and sterilization testing; clinical study advising and support; and regulatory, quality system, and reimbursement support.

Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this NOFO or any of the companion opportunities. For more information, see the Blueprint MedTech website: https://neuroscienceblueprint. nih.

gov/neurotherapeutics/blueprint-medtech Review the relevant institute interest statements for your proposed submission and contact the program staff listed in the link to discuss your proposal, clinical study requirements, and additional budget considerations prior to submission. https://neuroscienceblueprint. nih.

gov/neurotherapeutics/blueprint-medtech/blueprint-medtech-ics-and-contacts Funding Opportunity Goal(s) To support extramural research funded by the National Institute of Neurological Disorders and Stroke (NINDS) including: basic research that explores the fundamental structure and function of the brain and the nervous system; research to understand the causes and origins of pathological conditions of the nervous system with the goal of preventing these disorders; research on the natural course of neurological disorders; improved methods of disease prevention; new methods of diagnosis and treatment; drug development; development of neural devices; clinical trials; and research training in basic, translational and clinical neuroscience.

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 The NIH Blueprint for Neuroscience Research is a collaborative framework through which 12 NIH Institutes, Centers and Offices jointly support neuroscience-related research, with the aim of accelerating discoveries and reducing the burden of nervous system disorders (for further information, see http://neuroscienceblueprint.

nih. gov/ ). Innovators developing groundbreaking medical device technologies face several challenges along the translational path from bench to bedside.

The Blueprint MedTech program aims to address such challenges and support the innovators by accelerating the development of medical devices to prevent, monitor, diagnose, and treat disorders within the missions of the participating NIH institutes and centers, as well as the HEAL and BRAIN Initiatives.

The mission of the program is to catalyze the translation of novel technologies from early-stage development towards first-in-human clinical studies.

The program will provide: (a) non-dilutive funds to support medical device development activities led by investigators, and (b) additional resources and support services including, but not limited to: Planning resources to support concept development, team building, needs assessment, and other early translational activities.

Streamlined access to NIH-funded translational services and contract research organizations (e.g., design and prototyping, bench testing, large animal testing, biocompatibility assessment, manufacturing, medical monitoring, clinical trials). Assistance from NIH-funded service providers (e.g., on regulatory, reimbursement, intellectual property, commercialization, and strategic partnership issues).

Advice from industry experts (e.g. mentors, meetings with an external oversight committee). The overarching goal of the Blueprint MedTech program is to accelerate patient access to groundbreaking, safe, and effective medical devices. The program will provide support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.

The purpose of this Notice of Funding Opportunity (NOFO) is to support investigators in pursuing translational activities and clinical studies to advance the development of therapeutic and diagnostic devices for disorders within the missions of the participating NIH institutes and centers, as well as the HEAL and BRAIN Initiatives.

Activities supported by this NOFO include implementation of clinical prototype devices, non-clinical safety and effectiveness testing, design verification and validation activities.

Additional activities include obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as support for subsequent clinical study, feasibility, or pivotal clinical trial as appropriate.

The clinical study is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. Check the relevant institute interest statements and websites for additional limitations on clinical study requirements and limitations.

All projects must have two phases: UG3 and UH3. The UG3 phase will support translational device activities to obtain an IDE and IRB approval for an SR clinical study, or to obtain IRB approval for an NSR clinical study. All projects will start with a UG3 phase.

The duration of the UG3 phase will depend on the maturity of the project at entry, and the specific indication, and can range from one to four years. Only those UG3 phase projects that have met specific criteria (see below) will be eligible for transition to the UH3 phase after NIH administrative review. The UH3 phase will support a clinical study and can last up to four years.

The total proposed project period (including both the UG3 and UH3 phases) may be up to five years. This NOFO utilizes a UG3/UH3 cooperative agreement funding mechanism. As a cooperative agreement, this NOFO supports milestone-driven projects and involves NIH program staff’s participation in negotiating project and milestone plan before award, monitoring the research progress, and making go/no-go decisions.

The expectations of the program are in line with those of industry regarding the advancement of devices through the developmental and translational pipelines. As such, an inherent rate of attrition is possible within this program. Projects must focus on a disease or disorder that falls within the mission of participating Institutes and Centers, as well as the HEAL and BRAIN Initiatives.

It is expected that devices within the scope of this program either: are very close to the 'final system' and manufactured using very close to the same manufacturing process as the device to be marketed or studied in a larger clinical trial following the completion of this project; or have received Pre-Submission feedback from the FDA (see FDA/CDRH Q-Submission website and CDRH-learn website additional resources); or require early feasibility clinical data to inform the final device design or manufacturing processes.

Applicants to the Blueprint MedTech program must include novel medical device technologies in the proposal that will advance patient care towards new or improved therapeutics or diagnostics that are safe and effective. Applicants should clearly define the current state of the art and highlight how their proposed technology will advance patient care.

Responsive applications should propose medical devices, expected to be regulated by the FDA, with first-of-its-kind technologies, new safety questions, and/or new regulatory questions. Responsive applications may also refine existing technologies toward new intended use and/or use in novel settings (e.g., innovating and translating a neuromodulation device approved for healthcare-setting only to home-use).

Proposed medical devices and their indications will likely follow De Novo or Premarket Approval (PMA) regulatory pathways. Medical devices with indications that may fit within an existing 510(k) pathway may also be accepted, as long as the application can demonstrate a clear clinical and technological innovation beyond the state of the art of existing FDA-cleared predicates.

Such devices should be reasonably expected to provide new clinically meaningful diagnostic or therapeutic options or improve the benefit-risk profile of a treatment or diagnostic through substantial safety innovations.

It is recommended that applicants reach out to the NIH program staff listed for this funding opportunity to discuss mission fit with respect to proposed technologies and indications as well as additional IC-specific requirements . https://neuroscienceblueprint. nih.

gov/neurotherapeutics/blueprint-medtech/blueprint-medtech-ics-and-contacts For entry to the program, projects should have: Comprehensive supporting data based on bench, in vitro , and/or in vivo models that are representative of the intended patient population and indication.

Identified one or more clinically meaningful device outcome measures based on input from key stakeholders (e.g., clinicians, patients, and caregivers) as well as supporting literature. A compelling case for a successful IDE submission for an SR study or IRB approval for an NSR study by the end of the UG3 phase. Applicants are encouraged, but not required, to consult with FDA via a Pre-Submission meeting.

Applicants who do not have sufficiently relevant feedback from the FDA regarding all planned activities prior to application for funding will be expected to do so as the first milestone of the award.

Funding may be restricted to a maximum of $100,000 in direct costs until FDA feedback that is consistent with the likely success of the regulatory path to market and overall device development plan outlined in the grant application is received.

In the event that FDA feedback is not consistent with the plans in the grant, program staff will evaluate the concerns and change of scope that would be needed and work with the investigators to determine the most appropriate course of action. Any remaining funds associated with the original award will not be released.

Examples of studies that may be proposed during the UG3 phase include, but are not limited to: Non-Good Laboratory Practice (GLP) animal studies to develop surgical techniques relevant to the device, optimize relevant therapeutic or diagnostic parameters, and refine device design as necessary for subsequent GLP testing or additional clinical studies for regulatory approval.

Bench-top and animal testing to demonstrate compliance with FDA Recognized Standards. GLP compliant large animal model safety and/or testing of an implanted device. Activities to become current Good Manufacturing Practice (cGMP) compliant.

Activities to bring the development process under Design and Quality Systems Control. Studies addressing usability or acceptability. Device, software, firmware, and cybersecurity, design verification and validation activities.

Development of packaging, connectors, and other accessories necessary for the translation of this technology. Regulatory activities, including pre-submission meetings with FDA, IDE submission, or other FDA regulatory submissions (e.g., Humanitarian Device Exemption (HDE), Request for Risk Designation, 513(g) submission, Breakthrough Device Designation). Use of the clinical experience to inform device design decisions.

The UH3 phase will support a clinical study that will lead to either: A marketing application if the clinical study is sufficiently powered to demonstrate device safety and effectiveness for regulatory approval; or A larger clinical study that will lead to a marketing application; or Use of the clinical experience to inform device design decisions.

Examples of studies that may be proposed during the UH3 phase include, but are not limited to: Optimization of the device design with respect to the human functional anatomy; Identification of the most simple, reliable, and cost-effective device configuration for more advanced clinical studies and eventual market approval; Studies of the key physiological variables that may impact the function of the device in humans; Initial assessments of device safety are expected, but only in conjunction with obtaining enabling data about device design or function E.

Non-Responsive Activities Applications that include the following activities will be considered non-responsive and will be withdrawn and not reviewed: Animal model development: all in vivo models must be established and characterized, and available to the applicant; Projects focused on technologies for augmentation of healthy individuals; Delayed-onset clinical studies; Device technologies not regulated by the FDA.

Applications that fail to include the following items will be considered non-responsive and will be withdrawn and not reviewed: Specific Aims that cover activities for both UG3 and UH3 phases of the award A delayed-start (not delayed onset) clinical study or trial planned in the UH3 phase, including all required documentation to support the study.

Applications that do not include the following required attachments or are over the specified page limits will also be considered incomplete and/or non-compliant and will be withdrawn and not reviewed: The following other attachments: Needs Assessment (3 pages max), IP Strategy (3 pages max), Gantt Chart (1 page max), Long-term care plan (3 pages max), Resource Checklist (3 pages max) UG3 and UH3 milestone plans Team management plan (2 pages max) Applications that include the following optional attachments, but are over the specified page limits will also be considered non-compliant and will be withdrawn and not reviewed: The following optional other attachments: Schematics (2 pages max), IRB Communications (5 pages max), FDA Communications (10 pages max including summary) Review the relevant institute interest statements for your proposed submission and contact the program staff listed in the link to discuss your proposal, clinical study requirements, and additional budget considerations prior to submission.

https://neuroscienceblueprint. nih. gov/neurotherapeutics/blueprint-medtech/blueprint-medtech-ics-and-contacts Because device development is an inherently risky process, it is anticipated that there may be attrition as projects progress.

As stated by the SF424 (R&R) Application Guide, Specific Aims are goals, specific objectives, and expected outcomes of the proposed research. These Specific Aims are the activities that enable a company to reach a milestone, i.e., important decision points at which significant uncertainty for the project is resolved (go / no-go decision point).

Each Specific Aim in the application should therefore have at least one milestone associated with it. Moreover, each milestone should be tied to tangible deliverables that are specific, measurable, achievable, relevant, and time-bound. Because of the specific requirements of the program, applicants are recommended to include aims, milestones and associated deliverables addressing both technical and commercial feasibility.

Applicants are encouraged to read examples of milestones within IC-specific interest statements ( https://neuroscienceblueprint. nih. gov/neurotherapeutics/blueprint-medtech/blueprint-medtech-ics-and-contacts ).

NIH program staff will contact the applicant to discuss and negotiate the proposed milestones and any changes suggested prior to funding the application. The final agreed upon and approved milestones will be specified in the Notice of Award (NoA). Progress towards achievement of the final set of milestones will be evaluated yearly by NIH program staff.

Program staff may involve independent consultants or subject matter experts with relevant expertise. If justified, future milestones may be revised based on data and information obtained during the previous project period. If, based on the progress report, a funded project does not meet the milestones, funding for the project may be discontinued.

In addition to milestones, the decision regarding continued funding will also be based on the overall robustness of the entire data package that adequately allows an interpretation of the results (regardless if they have been captured in the milestones), overall progress, portfolio balance and program priorities, competitive landscape, and availability of funds.

UG3 phase to UH3 phase transition: An administrative review will be conducted by program staff, with potential input by independent consultants, to decide whether a UG3 phase project will transition to the UH3 phase based on the following: Successful achievement of the defined milestones for the UG3 phase of the project; Programmatic priorities and current portfolio balance (for funded projects, search NIH RePORTER https://projectreporter.

nih. gov/); For significant risk studies, documentation of final or conditional approval of the IDE from the FDA; Submission of the final clinical protocol and supporting documents to NIH for administrative review, and notification of approval by NIH; Agreement on updated timeline, milestones, and budget for the clinical study; and G.

Quality and Compliance Requirement The use of the Design Control and Quality Systems processes ( https://www. fda. gov/regulatory-information/search-fda-guidance-documents/design-control-guidance-medical-device-manufacturers ) to the degree specified by the FDA is required.

Intermediate steps in the Design Control process (e.g., design reviews, design verification, design validation, and design transfer activities) where appropriate, and IDE submission should be represented in the annual milestones. NIH recognizes that the degree to which Design Controls and Quality Systems processes are required by the FDA may vary substantially depending on the specific device.

Investigators are encouraged to discuss these issues with the FDA and regulatory consultants prior to submitting an application so the extent to which these processes are required is clearly defined and verifiable in the application. Applicants should consider the Quality System requirements at the IDE stage (i.e., design controls) when preparing their device development activities.

Applicants should consider Guidelines and Policies for Monitoring Clinical Research in the formation of a plan for data and safety monitoring as required by the appropriate IC. H.

Intellectual Property (IP) Since the ultimate goal of this program is to bring new therapeutic and diagnostic devices to the market, the program strongly encourages the recipients and/or their collaborators to obtain and retain any IP developed around the device during the project period (see instructions on attachment or letters to address IP issues in Section IV).

Recipients of awards are encouraged to identify and foster relationships with potential licensing and commercialization partners early in the device development process.

The PD/PI(s) are expected to work closely with technology transfer officials at their institution to ensure that royalty agreements, patent filings, and all other necessary intellectual property arrangements are completed in a timely manner and that commercialization plans are developed and updated over the course of the project.

For rare or ultra-rare diseases where commercialization may be challenging, applicants are encouraged to discuss alternative strategies with Scientific/Research staff to get further guidance. I. Pre-application Consultation As a UG3/UH3 cooperative agreement, NIH program staff will be involved in the negotiation and execution of the project.

Applicants are strongly encouraged to consult with NIH program when planning an application. Early contact provides an opportunity for staff to provide further guidance on program scope, goals, and developing appropriate milestones. When possible, applicants should contact program staff at least 12 weeks before a receipt date.

J. Institute Statements of Interest Refer to the Blueprint MedTech website for specific IC requirements and interest statements. 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 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 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.

Application budgets are not limited but need to reflect the actual needs of the proposed project. In all cases, applicants should propose a budget that is reasonable and appropriate for completion of the research project. Application budgets should only cover the work that will be performed by the PD/PI and his/her staff.

The NIH will pay Blueprint MedTech contractors and consultants directly for their work; therefore, these expenses should not be included in the budget for this application. It is recommended that applicants reach out to the NIH program staff listed for this funding opportunity to discuss IC-specific award budgets. https://neuroscienceblueprint.

nih. gov/neurotherapeutics/blueprint-medtech/blueprint-medtech-ics-and-contacts The proposed project period for the UG3 phase must not exceed 4 years. The proposed project period for the UH3 phase must not exceed 4 years.

The proposed total duration of the UG3 and UH3 may not exceed 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 Higher Education Institutions - Includes all types Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. 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 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 ). 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. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review. By the date listed in Part 1.

Overview Information , prospective applicants are asked to submit a letter of intent that includes the following information: Descriptive title of proposed activity Name(s), address(es), and telephone number(s) of the PD(s)/PI(s) Names of other key personnel Participating institution(s) Number and title of this funding opportunity The letter of intent should be sent to: 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