National Institute of
General Medical Sciences

Applications to NIGMS Technology Development Programs propose projects that focus on technology development without inclusion of biomedical aims or tests of biological hypotheses. These applications contrast with typical NIH proposals that address biological questions. In fact, technology development applications with biomedical aims or untested biological hypotheses will be administratively withdrawn without review.

These Notice of Funding Opportunities (NOFOs) support exploratory and/or focused research and development of innovative technologies for biomedical research that is relevant to the NIGMS mission.

• Applications to the NOFO should focus on advancing technology and may not include biological questions or untested biomedical aims.
• Projects may entail a high degree of risk and/or novelty, which will be offset by a high future potential impact in biomedical research.
• Projects should be justified in terms of technical innovation and their potential broad utility in biomedical research.
• Outcomes or products of the proposed project should significantly advance the current state of the art.
• Outcomes or products of Focused Technology Research and Development R01 should also be sufficiently characterized and have demonstrated usefulness in addressing a broad range of biomedical research questions.

NIGMS supports research for understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. Research within the mission of NIGMS may utilize specific cells or organ systems if they serve as models for understanding general principles. Research with the overall goal to gain knowledge about a specific organ or organ system or the pathophysiology, treatment, or cure of a specific disease or condition will, in most cases, be more appropriate for other disease-oriented Institutes or Centers (ICs).

Many NIH ICs provide funds to support biomedical research. You can refer to this link to learn more about the mission(s) of each IC.

In order for your technology application to NIGMS-Technology-Development-Programs-R21-and-R01 to be eligible, the utility of the technology should enable future biological questions, basic or clinical, that are within the mission of NIGMS. Technology development R21 and R01 notice of funding opportunities (NOFOs) encourage evaluation of technological innovations to overcome current technical limitations in biomedical research. Therefore, you may not include untested biological questions in your application.

• The R21 supports novel concepts that have not yet been tested for feasibility. Thus, unpublished or any data that support feasibility or proof of concept are not allowed. Because proof of concept must not already be developed, NIGMS expects the projects to be high-risk. Unpublished experiments are not allowed whether they support the premise of the project, the expertise of the investigators, or establish feasibility by mitigating high risk bottlenecks. Applications that include such data will be administratively withdrawn without review.
• The R01 is for technologies that have demonstrated feasibility but need further technical work to produce a useful prototype. Applicants 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. Technology Development R01 awards can only be renewed once.

For more information on stages of technology development supported by NIGMS, please see, Funding Announcements for Three Technology Development Stages.

Please note that NIGMS is not the only Institute participating in the NIGMS Technology Development NOFOs. National Institute on Aging (NIA) and National Cancer Institute (NCI) also participate in these NOFOs; therefore, your application could be assigned to NIA or NCI by the Division of Receipt and Referral within the Center for Scientific Review. NIH also has several technology specific NOFOs such as exploratory bioengineering research grants (EBRG) and bioengineering research grants (BRG) in which several NIH Institutes and Centers (ICs) participate. The list of participating ICs can be found under Part 1. Overview Information, Components of Participating Organizations.

Yes, but the research must focus on technology development. No untested biomedical research aims are allowed for NIGMS Technology Development NOFOs. Applications submitted to technology development programs using hypothesis-driven framework have been successful, though, particular attention must be given to address the additional instructions for application preparation and program specific review criteria.

While investigators may be comfortable writing applications using hypothesis-driven research framework to address biological questions and untested biomedical research aims, for the R21 and R01 Technology Development programs in particular, biomedical research aims, or objectives are not allowed. Rather, technology development beyond the current state-of-the-art should be the focus of the research project, and only synthetic models or well-characterized biological systems may be used to assess performance.

Engineering design provides a framework that, although less familiar to investigators, in many ways aligns with expectations of the technology development programs. We introduce the major elements of engineering design below and relate these elements to the additional instructions and review criteria of the technology development programs.

• Needs identification. Identify the unmet need or emerging research opportunity. A well-articulated need will be compelling and may be used to motivate in the Specific Aims, Significance, and Innovation sections of the application.
• Problem statement. Identify the barriers or obstacles to addressing the unmet need or to advancing the emerging research opportunity. A well-constructed problem statement may not only outline project aims to overcome these barriers or obstacles but also identify areas of uncertainty and risk that need to be managed.
• Design specifications. From the needs and problem statement, design specifications of the technology to be developed may be formulated that are measurable and are characteristics or properties of the developed technology necessary to meet the identified need(s) or advance an emerging research opportunity. Design specifications may not only be thought of as end-point objectives but may also be developed as intermediate milestones and guideposts in developing the new technology. Well-constructed specifications may also guide a realistic timetable for development of different aspects of the new technology.
• Verification is the set of criteria used to determine whether design specifications have been met. The criteria describe quantifiable measurements and tests, thresholds, tolerances, for example, that must be achieved to meet project milestones and objectives. In practice, well-designed verification criteria demonstrate rigor within the research approach and may be used to help manage risk. The key is that verification uses measurable quantities and, therefore, objective measures of progress.
• Validation is the set of criteria used to determine whether the new technology has met the need(s) identified or realized the emerging research opportunity. These criteria may be quantitative as well as qualitative. Validation criteria may also include tests or measurements on well-characterized model systems to demonstrate feasibility or readiness for biomedical application. From a research design perspective, well-designed validation criteria focus the research strategy end-point objectives on need(s) identified or emerging research opportunity and help prevent mission creep.

NO for Technology Development R21. Applications with preliminary data that support proof-of-concept or feasibility will be considered non-responsive and withdrawn without review.

YES for Technology Development R01. The proposed project objective should be prototype development for a technology supported by preliminary data demonstrating proof of principle. The technology should still have significant fundamental technical challenges to developing and validating a working prototype.

**Can I include links to data or figures that are in my laboratory website? Data available solely in abstracts or on personal or institutional webpages without DOIs are not allowed (see NOT-OD-17-050).

NO. Only new applications will be accepted and evaluated based on their current merit for current NOFOs. Resubmission applications in response to the previous FOAs (PAR-22-126 and PAR-22-127, expired) should submit the revised applications as NEW applications to the reissued FOAs (PAR-25-202 and PAR-25-203).

No. Applications that include biological aims are not responsive to the goals of NIGMS Technology Development program and will be administratively withdrawn without review. However, validation against known standards is encouraged to justify the relevance of the proposed technology for addressing a broad range of biomedical research questions.

A technology research and development project in which an untested biomedical question serves as a testbed for demonstration of the technology's impact is beyond the scope of NIGMS Technology Development program and is more appropriate for a conventional R01 application to the Parent R01 program.

Known standards or well-characterized model systems may be used to test the new technology against a set of well-defined criteria that demonstrate success, including both qualitative and quantitative measures. From a research design perspective, well-designed criteria of success focus the research strategy end-point objectives and help prevent mission drift.

For R21, a high degree of uncertainty and risk are appropriate and should be described realistically. A straightforward discussion of the challenges and risks inherent in the research plan is encouraged. Theoretical evaluation, alternative approaches, and well-described criteria for success and failure can mitigate or manage risk.

For R01, 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. Projects that are at an intermediate stage, with incomplete preliminary data, but with substantial remaining risk, may be narrower in scope with reduced budgets or a shorter project duration.

Well-defined, measurable characteristics or properties of the proposed technology are very helpful when managing risk with criteria for success and failure. Criteria for success and failure can then be described by quantifiable measurements and tests, thresholds, tolerances, for example, that must be achieved to meet project milestones and objectives. In practice, well-designed criteria demonstrate rigor within the research approach and may be developed as objective measures of project progress. Well-constructed milestones and end-point objectives may also guide a realistic timetable for development of different aspects of the new technology.

Milestones and project outcomes are objective measures of progress of the proposed technology toward the desired characteristics of the technology at conclusion of the project. Milestones and outcomes are measurable project performance criteria, and project outcomes should be specified to provide a significant technical advance over the state-of-the-art.

Scientific rigor is the strict application of the scientific method to ensure unbiased and well-controlled experimental design, methodology, analysis, interpretation and reporting of results. Please see, Enhancing Reproducibility through Rigor and Transparency, for more information.

There are four key areas of rigor that need to be addressed in your grant application: Rigor of prior research, Scientific rigor, Biological variables, and Authentication. More information may be found, Guidance: Rigor and Reproducibility in Grant Applications.

No. As stated in the NOFOs, "The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications."

All Technology Development applications are reviewed in relevant study sections in the Center for Scientific Review (CSR).

Tech Dev program officers foster and maintain communications with CSR Scientific Review Officers (SROs) who organize review of applications submitted through Tech Dev R01 and R21 mechanisms. The SROs give instructions to reviewers on the Tech Dev program purpose and special review criteria.

NIGMS does not have a "payline" or strict cutoff in scores that it will fund. The Institute strives to support a broad and diverse portfolio of research grants of high scientific and technical merit, as determined by peer review, in its mission areas. Towards this end, NIGMS staff also considers other factors, including,

• the breadth and diversity of the Institute's research portfolio, approaches, and investigators
• the total amount of funding available to the PI's laboratory
• the priority of the research area for the Institute's mission
• and whether the PI would have more than 2 NIGMS funded R01s.

For more information, please see NIGMS Funding Policies.

NIGMS strives to support a broad and diverse portfolio of research grants of high scientific and technical merit, as determined by peer review, in its mission areas. NIGMS will consider awarding five-year R01 grants to most ESIs in order to provide extra time for getting their projects under way.

ESIs are also encouraged to consider applying to NIGMS Maximizing Investigators' Research Awards (R35) Program which provides five years of funding. For more information on ESI MIRA, please see PAR-23-145.

NIH definition of ESI and NI can be found at Early Stage Investigator Policies.

For investigators with at least one single-PI R01-equivalent award, please see PAR-19-367. The R21 is not an R01-equivalent award.

Early-stage investigators (ESI), please see PAR-23-145.