PAR-22-126: Technology Development Research for Establishing Feasibility and Proof of Concept

PAR-22-126: Technology Development Research for Establishing Feasibility and Proof of Concept is sponsored by National Institute on Aging (NIA). Supports development of innovative technologies for research relevant to NIA’s mission.

Expired PAR-22-126: Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed) This notice has expired. Check the NIH Guide for active opportunities and notices. 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 General Medical Sciences ( NIGMS ) National Cancer Institute ( NCI ) Funding Opportunity Title Technology Development Research for Establishing Feasibility and Proof of Concept (R21 - Clinical Trial Not Allowed) R21 Exploratory/Developmental Research Grant Notices of Special Interest associated with this funding opportunity November 14, 2024 - This PAR has been reissued as PAR-25-202 .

NOT-OD-23-012 Reminder: FORMS-H Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2023 - New Grant Application Instructions Now Available NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022 April 11, 2022 - Notice of Informational Webinar on NIGMS Technology Development Program Funding Opportunity Announcements (PAR 22-126 and PAR 22-127).

See Notice NOT-GM-22-034 . Funding Opportunity Announcement (FOA) Number Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) supports exploratory research leading to the development of innovative technologies for biomedical research that is relevant to the NIGMS mission or that of other NIH Institutes or Centers (ICs) participating in this FOA.

Projects should entail a high degree of risk and/or novelty, which will be offset by a high future potential impact in biomedical research.

Outcomes or products of the proposed project, which should significantly advance the current state of the art, may include, but are not limited to: laboratory instruments and other devices, chemical reagents and processes, biological molecules or systems that have been modified by human intervention to become research tools.

The goal of this FOA is to support proof of concept, high-risk and potentially high-reward studies for feasibility and exploratory technology development. Due to the constraints that would be imposed on broad utility, this FOA does not support technology development that is narrowly focused on addressing specific biological questions.

Rather, applications should propose development of innovative tools that can potentially benefit a broad spectrum of biomedical research. Moreover, feasibility of the proposed technology must not have already been established in the literature or with preliminary data.

Applications that are focused on technology development to address specific biological questions and/or include unpublished or published data that provide proof of concept are not responsive to this FOA and will be administratively withdrawn without review. Open Date (Earliest Submission Date) Letter of Intent Due Date(s) The following table includes NIH standard due dates marked with an asterisk.

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. New Date November 14, 2024 per issuance of PAR-25-202 .

(Original Expiration Date: May 08, 2025 ) Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide , except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the FOA) 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.

Part 1. Overview Information Part 2. Full Text of Announcement Section I.

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.

Funding Opportunity Description Support for Early-Stage Technology Development Is Critical to Advancing Biomedical Research Technological advances are crucial for accelerating biomedical research. Technology enables science by providing new ways to address questions, and more importantly, by allowing researchers to pose new questions that could not be anticipated in the absence of the enabling technology.

New knowledge drives the imperative for new tools, and those tools open new questions, in a mutually reinforcing positive feedback loop that drives science forward.

Early technology development can be described in two stages: (I) exploratory proof-of-concept research to determine the feasibility and best approach(es) for a technology development project, and (II) the subsequent research and development that focuses exclusively on creating and validating a working prototype technology before application to untested biomedical problems is possible.

This FOA invites projects in Stage I evaluation of an untested concept. A companion FOA, PAR-22-127 Focused Technology Research and Development (R01- Clinical Trial Not Allowed) supports projects in Stage II - research and development of a working prototype.

Applications that include technology development projects to address specific biological questions are not responsive to the goals of these FOA but may be submitted through the Parent R01 funding announcement or other FOAs (e.g., NIGMS' Maximizing Investigators' Research Awards).

Applications to this FOA should propose technology development at a conceptual stage , not yet supported by any proof-of-concept-data, in order to demonsetrate feasibility of the proposed technology and/or establish the most likely path to successful development.

When compared to current state-of-the-art technology, the proposed concept should lead to a technological breakthrough, or a significant advance in current biomedical research or approaches. The project’s starting point should be the current state of knowledge and concepts must not have been tested for feasibility.

Project aims should focus on either: (a) exploratory research to identify, among several possibilities, the approach with the highest likelihood of success, or (b) demonstrating feasibility of a specific novel approach.

For this FOA, technology refers to tools, methods and techniques that enable a broad spectrum of biomedical research that falls within the NIGMS mission or in that of the ICs participating in this FOA including, but not limited to: laboratory instruments and other devices, chemical reagents and processes, biological molecules or systems that have been modified by human intervention to become research tools.

Further, this FOA calls for innovative exploratory technology development predicated on an explicitly described broad need or challenge in biomedical research. This need should exceed current technological capability, with the state-of-the-art technological performance defining the starting point.

Comparison of the proposed technical performance improvement to the state of the art will provide the rationale for developing a fundamentally different technology. Specific well-characterized test systems may be used for validation, but applications should highlight the broad utility of the technology for biomedical research.

Applications that include investigation of specific biological questions in the time frame of the proposed project are considered nonresponsive to this FOA and will be administratively withdrawn without review.

Proof of Concept: This FOA supports proof-of-concept studies to develop prototypes and exploratory technology that do not have demonstrated feasibility in the literature, are not based on preliminary data, and are not obvious extensions of the current state of the art. The expected project outcome should be a clear test of concept, either positive or negative.

The proposed concept should be innovative, represent a significant advance over the state of the art, and address current obstacles to advancing biomedical research. Validation: Application to synthetic models or well-characterized biological systems to assess performance can be included at this stage.

To be considered for funding, applications of the technology must be limited to test systems chosen to facilitate technology development rather than to immediately address biological questions. The project aims must be focused entirely on the technology development.

Non-Responsiveness Criteria Biological Questions: Applications that include aims that address specific biological questions are not responsive to the goals of this FOA and will be administratively withdrawn without review. However, validation of a technology against known standards is encouraged.

Although biomedical relevance is an essential element of NIH research, this stage of technology development should not include immediate short-term application of nascent technologies to challenging biomedical research questions.

Information that establishes feasibility or proof of concept: Applications that include published or unpublished results that support the feasibility of the Specific Aims, forecast the project objectives, develop proof of concept or mitigate risk are not responsive to the goals of the FOA and will be administratively withdrawn.

Relevance of Research Topics for this FOA Prospective applicants are strongly advised to consult with the relevant Scientific/Research Contact(s) listed in this FOA for guidance on assessing the application's relevance for this FOA. Final determination of application eligibility for this FOA will be based on NIH Staff assessment of the full application after submission.

Applications that are determined to be non-responsive to this FOA, or that propose research topics that are not appropriate for the participating NIH institutes, will be administratively withdrawn.

Participating NIH Institute Missions NIGMS: The mission of NIGMS is to support basic research that increases our understanding of biological processes and lays the foundation for future advances in disease diagnosis, treatment, and prevention. NIGMS-funded scientists investigate how living systems work at a range of levels - from molecules and cells to tissues and organs - in research organisms, humans, and populations.

The institute’s research mission is aimed at understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. NIGMS also supports the development of fundamental methods and new technologies to achieve its mission. Supported research may utilize specific cells or organ systems if they serve as models for understanding general principles.

research and technology development that is aimed at understanding general principles, mechanisms, and processes through Scientific Divisions with diverse interests, research in specific clinical areas that affect multiple organ systems such as anesthesiology and peri-operative pain, sepsis, clinical pharmacology that is common to multiple drugs and treatments, trauma, burn injury, and wound healing.

research focused on single classes of cells, tissues, organs, or diseases unless they are used as models for elucidating basic principles, technology development for a specific disease and/or organ system beyond the specific ones listed above, HIV/AIDS-related applications. Prospective applicants are encouraged to visit NIGMS Technology Development Programs (R21 and R01) for more details.

NIA: The mission of NIA is conducting and supporting research on aging and the health and well-being of older people. NIA supports technologies which will increase the understanding of the nature of aging and the aging process, and diseases and conditions associated with growing older, in order to extend the healthy, active years of life.

NCI: The mission of NCI is to lead, conduct, and support cancer research across the nation to advance scientific knowledge and help all people live longer, healthier lives. NCI is interested in technology development projects which can ultimately enable novel and improved cancer diagnostic capabilities and treatment strategies.

Examples of focused research areas include, but are not limited to: Synthetic biology devices to advance understanding of cancer biology with a goal of improving cancer diagnosis and treatment, Nanotechnologies capable of biological discovery, Tools to enable deep tissue ex vivo and in vivo imaging and integration, Next-generation non-invasive cancer molecular diagnostics platforms beyond tissue biopsies, In vitro imaging diagnostic technologies, Liquid biopsy technologies with the goal of improving cancer diagnosis and treatment, Technologies for the detection and evaluation of cancer of unknown primary (CUP), Technologies for neoantigen identification, including dendritic cell-displayed antigens and neoantigens.

Note: Applications that propose technology development with the following characteristics will be of low funding priority: incremental advance of technology, obvious substitution of one known element for another, technology that will only lead to an incremental advance in biomedical research, combinations of prior elements with additive utility, technologies that are ready for advanced development and validation. See Section VIII.

Other Information for award authorities and regulations. Section II. Award Information Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA. Not Allowed: Only accepting applications that do not propose clinical trials.

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 limited to a total of $275,000 Direct Costs over the two-year project period.

No more than $200,000 Direct Costs may be requested in any single year. (Direct cost limits exclude consortium F&A costs.) The budget must be well justified and reflect the actual needs of the proposed project.

The maximum project period is 2 years. NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education: Hispanic-serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISIs) Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (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 Institutions) 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 SF 424 (R&R) 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. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

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.

SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application. Dun and Bradstreet Universal Numbering System (DUNS) Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM.

By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and 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 his/her organization to develop an application for support.

Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH 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 SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement. 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 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 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 FOA. 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 SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement 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 SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing (DMS) Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages.

For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages. The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the SF424 (R&R) Application Guide must be followed. SF424(R&R) Senior/Key Person Profile All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. PHS 398 Cover Page Supplement All instructions in the SF424 (R&R) Application Guide must be followed.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H and subsequent application forms packages. For due dates on or before January 24, 2023, the Data Sharing Plan and Genomic Data Sharing Plan GDS) will continue to be attached in the Resource Sharing Plan attachment in FORMS-G application forms packages.

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.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: Specific Aims: Specific Aims should propose to advance the technical knowledge required to investigate or manipulate biological systems in the service of furthering basic biomedical research that is supported by the participating NIH institutes.

Technical advances should be novel, inventive entities or methods that have future utility to broadly advance biomedical research. Examples would include instruments, devices, processes, algorithms, software, chemicals, biomolecules, or cells that have potential value for enabling new biomedical research.

In addition to the topics outlined in the SF424 (R&R) Application Guide, describe the potential impact of the tool that will be developed. Describe the proposed technical advance over the state of the art and the future biological applications that would be enabled by the new technology. Limitations of the state of the art provide the rationale for developing a fundamentally different technology.

Because this is very early-stage exploratory technology development, the impact is not likely to be immediate. Nonetheless, the possible future impact of the proposed technology must be compelling and clearly articulated. In addition to the topics outlined in the SF424 (R&R) Application Guide, outline the unique nature of the technical opportunity that will be exploited in the project.

The technology concept should be novel, inventive entities or methods with potential broad utility for biomedical research. Innovation could be evaluated by the amount of technical advance over the state of the art and/or the potential advance enabled in current biomedical research or approaches.

In addition to the topics outlined in the SF424 (R&R) Application Guide, describe those aspects of the experimental approach that are specific to exploratory technology development. These include the uncertainties underlying the proposed technology research and development, including the risk of failure. Provide the rationale for the approach or approaches to be explored in the project.

Describe how feasibility or proof of concept for the technology will be established. Outline how data will be obtained, analyzed, and interpreted with sufficient rigor to quantitatively assess project outcomes. Identify the project performance that would be required to achieve high reward in the objectives and milestones.

While inclusion of untested biological questions will not be funded, validation of the nascent technology with well-characterized models or gold standard biological samples is encouraged. Project objectives should be novel and not obvious compared to the current state of the art, as evidence that the concept is achievable would demonstrate positive proof of concept which is not allowed in this FOA.

To ensure that feasibility or proof of concept has not been evaluated, do not include or refer to unpublished and/or preliminary data, results, or conclusions, since these forecast an increased likelihood of success.

Published data for establishing the state of the art and/or justifying the proposed work can be provided through literature citations, published data from other sources including preprints with a DOI number, or theoretical principles. Any published data that forecast the success of the project objectives or develop proof of concept are not responsive to the FOA.

Objectives and Milestones: Describe the desired characteristics of the technology at the conclusion of the project as end-point objectives, and present intermediate milestones towards that goal. Direct the milestones toward addressing the fundamental questions regarding the selection of an appropriate path forward for continued development of the technology once the project is completed.

The milestones and objectives are measurable project performance criteria that, if achieved, would be a significant increment of technical advance over the state of the art. Describe how experimental results from the exploratory project will serve as a foundation for next phase development efforts such as R01, small business grants, or equivalent.

For exploratory research, high risk is expected, and milestones might not be reached on a predictable timetable. Nonetheless, define measurable milestones and state whether intermediate or end-point project performance would be adequate for further technical development of working prototypes. For exploratory research, it is expected that further technical improvement would be necessary to achieve biomedical research utility.

Describe the desired performance characteristics of the proposed technology and specific measures that will be used to evaluate progress toward achieving those goals. Limit applications of the technology to validation against synthetic models or well-characterized biological systems.

Explain the rationale for the selection of test systems in terms of the desired technology performance and how a test system will facilitate technology development. Resource Sharing Plan : Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply: All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan. Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) 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 SF424 (R&R) Application Guide must be followed. PHS Assignment Request Form All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM) See Part 1. 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.

Overview Information 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 Policy on Late Application Submission.

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 SF424 (R&R) Application Guide. 5.

Intergovernmental Review (E. O. 12372) This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement . Pre-award costs are allowable only as described in the NIH Grants Policy Statement . 7.

Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the SF424 (R&R) 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 . All PD(s)/PI(s) must include their eRA Commons ID in the Credential fieldof 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 FOA for information on registration requirements. The applicant