National Institutes of Health (NIH)
R01 Research Project Grant
- November 14, 2024 - This PAR has been reissued as PAR-25-203.
- 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.
See Notices of Special Interest associated with this funding opportunity
This Funding Opportunity Announcement (FOA) supports projects relevant to the NIGMS mission or those of other NIH institutes or Centers (ICs) participating in the FOA that focus solely on the development of technologies with the potential to enable acquisition of biomedical knowledge. Projects should be justified in terms of technical innovation and utility of such technical innovation for impacting future biomedical research. Outcomes or products of the proposed project should significantly advance the current state of the art and be sufficiently characterized for application in addressing a broad range of biomedical research questions. These outcomes may include, but are not limited to:
- laboratory instruments and other devices,
- algorithms and software,
- 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 the development of technologies with demonstrated proof-of-concept that have remaining significant technical challenges to full implementation and broad utility. As such, applications should not propose to test specific biological questions. Applications proposing to test specific biological questions are not responsive to this FOA and will be administratively withdrawn without review. Applications with a focus on optimization, hardening, or obvious extrapolations of established technology will be a lower priority for funding.
Not Applicable
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| June 05, 2022 * | July 05, 2022 * | September 07, 2022 * | November 2022 | January 2023 | April 2023 |
| October 05, 2022 * | November 05, 2022 * | January 07, 2023 * | March 2023 | May 2023 | July 2023 |
| February 05, 2023 * | March 05, 2023 * | May 07, 2023 * | July 2023 | October 2023 | December 2023 |
| June 05, 2023 * | July 05, 2023 * | September 07, 2023 * | November 2023 | January 2024 | April 2024 |
| October 05, 2023 * | November 05, 2023 * | January 07, 2024 * | March 2024 | May 2024 | July 2024 |
| February 05, 2024 * | March 05, 2024 * | May 07, 2024 * | July 2024 | October 2024 | December 2024 |
| June 05, 2024 * | July 05, 2024 * | September 07, 2024 * | November 2024 | January 2025 | April 2025 |
| October 05, 2024 * | November 05, 2024 * | January 07, 2025 * | March 2025 | May 2025 | July 2025 |
| February 05, 2025 * | March 05, 2025 * | May 07, 2025 * | July 2025 | October 2025 | December 2025 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
Not Applicable
It is critical that applicants follow the instructions in the Research (R) Instructions in the 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.
Support for Early-Stage Technology Development is Critical to Advance Biomedical Research
Technological advances are crucial for accelerating biomedical research. Technology enables science by providing novel 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. This FOA invites research applications with a focus on early stage technology development and validation before the technologies are ready for application to untested biological questions and wide dissemination. 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 questions is possible. This FOA invites projects in Stage II research and development of a working prototype. A companion FOA, PAR-22-126 "Technology Development Research for Establishing Feasibility and Proof of Concept (R21 Clinical Trial Not Allowed)" supports projects in Stage I (evaluation of an untested concept). Applications that include technology development projects to address specific biological questions are not responsive to the goals of this 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 development of technologies that are already supported by proof-of-concept and preliminary data. The project focus should be on advancing the technology to a stage that demonstrates its potential for broad utility in biomedical research.
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 those of the other ICs participating in this FOA including, but not limited to:
- laboratory instruments and other devices,
- algorithms and software,
- 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, focused technology development predicated on a broad need or challenge in biomedical research that is beyond the current technological capability. The state-of-the-art technological performance defines a measurable starting point. Comparison of the proposed improvement in technical performance to the state of the art provides 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.
Responsiveness Criteria
Working Prototypes: The proposed project objective should be development of a working prototype for a technology that, while supported by preliminary data demonstrating proof of principle, still has significant fundamental technical challenges. These challenges should be substantial enough to require focused effort over a three-to-nine-year period. Since this FOA is designed for highly innovative concepts, the prototype should represent a significant advance over the state of the art. Projects supported by this program should not be incremental improvements to established technologies.
Validation: Applications of the technology in the project period should be limited to test systems chosen to facilitate development. The aims of the project should be focused entirely on the development of the technology. The products of this research will be functioning prototype instruments, methods, synthetic approaches, etc., adequately characterized to be ready for first application to the type of biomedical research questions that provided the rationale for their 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.
Relevance of Research Topics for this FOA
Prospective applicants are strongly advised to consult with the relevent 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.
NIGMS supports:
- 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.
NIGMS does not support:
- 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.
See Section VIII. Other Information for award authorities and regulations.
Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.
Renewal
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.
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 must reflect the actual needs of the proposed project. Applications proposing projects that have early feasibility data but significant risk due to their early stage of development may request reduced budgets or a reduced duration in their applications. Applications proposing projects that are well supported by feasibility studies and are ready to develop into fully functional prototypes might require higher budgets for up to a four-year duration (five years for Early- Stage- Investigators).
The scope of the proposed project should determine the project period. The maximum project period is 5 years, although investigators supported by NIGMS who are not ESIs will generally receive no more than four years of support in a project period. The grant may be renewed only one time.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
1. Eligible Applicants
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
- Small Businesses
- For-Profit Organizations (Other than Small Businesses)
Local Governments
- State Governments
- County Governments
- City or Township Governments
- Special District Governments
- Indian/Native American Tribal Governments (Federally Recognized)
- Indian/Native American Tribal Governments (Other than Federally Recognized)
Federal Government
- Eligible Agencies of the Federal Government
- U.S. Territory or Possession
Other
- Independent School Districts
- Public Housing Authorities/Indian Housing Authorities
- Native American Tribal Organizations (other than Federally recognized tribal governments)
- Faith-based or Community-based Organizations
- Regional Organizations
Non-domestic (non-U.S.) Entities (Foreign 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
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.
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.
2. Cost Sharing
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
3. Additional Information on Eligibility
Number of Applications
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 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).
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.
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.
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.
R&R or Modular Budget
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.
Other Plan(s):
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.
Research Strategy:
Significance
In addition to the topics outlined in the SF424 (R&R) Application Guide, explain the potential impact of the technology for biomedical research. Describe the rationale for the proposed technology development and incorporate discussion of the broad opportunity or need that the new technology will address.
Innovation
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.
Approach
In addition to the topics outlined in the SF424 (R&R) Application Guide, describe those aspects of the experimental approach that are specific to focused technology development. These include the uncertainties underlying the proposed technology research and development, including the risk of failure.
Design the Approach to establish a working prototype with substantially improved technical capacities not provided by current tools. For technologies with insufficient feasibility studies, describe how feasibility will be rapidly evaluated prior to advancing to prototype development. 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.
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. The milestones and objectives are measurable project performance criteria that, if achieved, would provide a significant technical advance over the state of the art. Describe how experimental results from this project will provide an adequate foundation for the next phase of development efforts, such as a future R01 project or equivalent. For focused research, 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 working prototypes to have utility for addressing novel biological questions. Describe the desired performance characteristics of the proposed technology and specific measures that will be used to evaluate progress toward achieving those goals. Limit the technology application to test systems and explain the rationale for the choice of test systems in terms of the desired technology performance and how a test system will facilitate the 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.
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.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
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.
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.
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.
Important reminders:
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 organization must ensure that the unique entity identifier (DUNS number or UEI as required) provided on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness, compliance with application instructions and responsiveness to the FOA by the Center for Scientific Review and the participating ICs. Applications that are incomplete, non-compliant or non-responsive will not be reviewed.
Requests of $500,000 or more for direct costs in any year
Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.
Applicants are required to follow the instructions for post-submission materials, as described in the policy.
1. Criteria
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.
For this particular announcement, note the following:
The intent of this FOA is to support high risk projects that are not ready for testing biological hypotheses. As such, the objectives should not address untested biological questions or gain new biological knowledge. Applications should be innovative, include measurable end-point objectives and intermediate milestones, and describe risk management. Preliminary data, theoretical evaluation, alternative approaches, and well-described criteria for success and failure can mitigate risk. Projects appropriate for a four- or five-year R01 should include evidence that the outcome is feasible. The R01 objectives should include functioning prototypes or evaluation of working technology that may not be as efficient, robust, or versatile as the final version, but should demonstrate utility to resolve a significant biomedical problem. The specific aims should include validation of technology against known standards such as synthetic models and characterized, gold-standard, biological systems. Projects that are at an intermediate stage, with incomplete preliminary data, but with substantial remaining risk, may request reduced budgets or a shorter project duration.
Overall Impact
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Scored Review Criteria
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Specific to this FOA: Does the proposed technology development have the potential to address an important unmet need in biomedical research or open considerable new avenues for investigation? Does the technology overcome the limitations of the current state of the art? Is the potential effect of the technology on biomedical research appropriately broad? Regardless of the inherent risk of the project, assuming that continued development of the technology is successful, would its availability enable new research or appreciably facilitate current research? Is the technology likely to have a practical utility for the research community?
Investigator(s)
Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Innovation
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Specific to this FOA: Does the proposed research test an innovative concept for development of an unproven technology? Is the proposed technology fundamentally new? If it is not new, does it solve a longstanding technical problem in an established technology area? Does the project involve an appropriately high level of uncertainty or risk? Is the potential impact commensurate with the level of risk?
Approach
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
Specific to this FOA: Upon its completion, will the project establish the readiness of the proposed technology for subsequent application to biomedical research problems? Will the project objectives lead to a working prototype of the technology? If projects are at an intermediate stage with insufficient feasibility studies, is the approach for rapidly evaluating feasibility of the proposed technology reasonable? Will the data collection and analysis process enable quantitative assessment of the project outcomes and milestones? Does the research plan adequately address technical challenges?
Are intermediate and end-point objectives or milestones well defined? Would experimental results from this project provide an adequate foundation for the next phase of development efforts, such as a future R01 project or equivalent?
Environment
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
Additional Review Criteria
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
Inclusion of Women, Minorities, and Individuals Across the Lifespan
When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable
Renewals
For Renewals, the committee will consider the progress made in the last funding period and whether a renewal would likely lead to completion of the technology development project Only one renewal is allowed for this program.
Revisions
Not Applicable
Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) as part of the Resource Sharing Plan will not be evaluated at time of review.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Applications from Foreign Organizations
Not Applicable
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
Authentication of Key Biological and/or Chemical Resources:
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications . Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
- Scientific and technical merit of the proposed project as determined by scientific peer review,
- Availability of funds,
- Relevance of the proposed project to program priorities,
- Institute portfolio diversity.
3. Anticipated Announcement and Award Dates
After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
1. Award Notices
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
2. Administrative and National Policy Requirements
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
- Federalwide Research Terms and Conditions
- Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
- Acknowledgment of Federal Funding
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.
- Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
- For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
- HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
- For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.
Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.
In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
Not Applicable
Data Management and Sharing
Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.
Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
As part of the RPPR, grantees are expected to report any accomplishments of the award leading but not limited to:
- Grant applications to programs such as the SBIR/STTR
- Dissemination of tools and technologies to other research laboratories or as commercialized products
- Patent applications and awards
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.
4. Evaluation
To evaluate the success of the NIGMS Technology Development R01 Program, NIGMS may request information essential to an assessment of the program effectiveness from databases and participants themselves. After the award ends, participants may be contacted for periodic updates on their publication activities, support from additional research grants or contracts, and other information helpful in evaluating the program's impact. Within ten years of making awards under this program, NIGMS will assess the program’s overall outcomes, gauge its effectiveness in encouraging technological innovations to further biomedical research, and consider a continued need for the program. Upon completion of this evaluation, NIGMS will determine whether to (a) continue the program as currently configured, (b) continue the program with modifications, or (c) discontinue the program.
Overall program evaluation will be based on metrics that will include, but are not limited to, the following:
- Aggregate number and demographic characteristics of applicants and awardees including applicant’s home department, institution, and/or career progression,
- Grant applications to programs such as the SBIR/STTR or other independent research funding programs,
- Dissemination of tools and technologies to other research laboratories or as commercialized products,
- Patent applications.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]
Alvin Yeh, Ph.D.
Division of Biophysics, Biomedical Technology and Computational Biosciences
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]
Kadir Aslan, Ph.D.
Division of Pharmacology, Physiology, and Biological Chemistry
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]
Leonid Tsap, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-402-7747
Email: [email protected]
Piotr Grodzinski, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-781-3305
Email: [email protected]
For question on cancer in-vitro imaging and molecular diagnosis
Miguel R. Ossandon, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-5714
Email: [email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Jennifer Billington
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]
Jessi Perez
National Institute on Aging (NIA)
Telephone: 301-402-7739
Email: [email protected]
Shane Woodward
National Cancer Institute (NCI)
Telephone: 240-276-6303
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.
and Human Services (HHS)
