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)

Funding Opportunity Title

Exploratory Research for Technology Development (R21)

Activity Code

R21 Exploratory/Developmental Research Grant

Announcement Type

New

Related Notices
  • April 12, 2019 - This PA has been reissued as PAR-19-254.
  • April 3, 2019 - Notice of Change to Science Supported by PAR-17-046. See Notice NOT-GM-19-035.
  • December 20, 2018 - Notice of Consolidation and Additional Clarifications of Applications Relevant to PAR-17-046. See Notice NOT-GM-19-010.
  • November 26, 2018 - NIH & AHRQ Announce Upcoming Updates to Application Instructions and Review Criteria for Research Grant Applications. See Notice NOT-OD-18-228.
  • January 12, 2018 - Notice of Clarification of Applications Relevant to PAR-17-046. See Notice NOT-GM-18-014.
  • NOT-OD-18-009 - Reminder: FORMS-E Grant Application Forms and Instructions Must be Used for Due Dates On or After January 25, 2018.
  • September 20, 2017 - Updates to Active Funding Opportunity Announcements to Prepare for Policy Changes Impacting Due Dates On or After January 25, 2018. See NOT-OD-17-114.
  • May 10, 2017 - New NIH "FORMS-E" Grant Application Forms and Instructions Coming for Due Dates On or After January 25, 2018. See NOT-OD-17-062.
  • May 02, 2017 - Notice of Change in PAR-17-046. See Notice NOT-GM-17-008.
Funding Opportunity Announcement (FOA) Number

PAR-17-046

Companion Funding Opportunity

PAR-17-045, R01 Research Project Grant

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.859

Funding Opportunity Purpose

This initiative will support exploratory research leading to the development of innovative technologies for biomedical research. The program will recognize and reward high risk approaches with potential for significant impact. Projects will entail a high degree of risk or novelty, which will be offset by a correspondingly high potential impact. However, the possible impact is likely to be far off. Application of the proposed technology to specific biomedical questions is considered beyond the scope of the program, and should not be included. Preliminary data demonstrating feasibility of the proposed approach indicates that the project is beyond the scope of this program and therefore unsuitable for this funding opportunity.

Key Dates

Posted Date

November 1, 2016

Open Date (Earliest Submission Date)

January 16, 2017

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

Standard dates apply, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

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.

AIDS Application Due Date(s)

Standard AIDS dates apply, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

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.

Scientific Merit Review
Advisory Council Review
Earliest Start Date
Expiration Date

New Date April 12, 2019 per issuance of PAR-19-254. (Original Expiration Date: May 8, 2019)

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research Instructions for the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the 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.


Table of Contents

Part 1. Overview Information
Part 2. Full Text of the 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

Biomedical research is enabled and accelerated by the development of advanced technologies. Technology enables science by providing new ways to answer questions, and more importantly, allowing new types of questions to be asked 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 virtuous cycle that drives science forward.

A study by NIGMS staff in 2015, which included substantial, detailed input from the biomedical research community in response to a Request for Information (NOT-GM-15-118), concluded that there is a significant unmet need for explicit support of early stage technology development, prior to the application of nascent tools to actual biomedical research problems. Early stage technology development can be described in two phases: (I) exploratory proof-of-principle research to determine the best approach for a technology development project, and (II) the subsequent research and development that focuses exclusively on creating a working technology before application to biomedical problems is possible.

To address the immediate need for programs that support early stage technology development, NIGMS has chosen to develop new programs focusing specifically on the first two phases described above. This FOA invites projects in Stage I of the Technology Development process. A companion FOA, PAR-17-045 "Focused Technology Research and Development" supports projects in Stage II. As these programs develop, the need for additional FOAs for later stage technology development will be considered.

Defining Characteristics of Exploratory Research for Technology Development:

  • Projects should be justified on the basis of a strong potential to advance biomedical research if successful. This rationale should justify the investment of resources in the proposed technology in terms of its potential as an enabling tool for research. The rationale should be broad. Technologies specific to a single organism, system, or disease are not appropriate for this FOA.
  • Project aims should focus on either: (a) exploratory research to differentiate possible technical approaches to determine the one most likely to be successful, or (b) demonstrating feasibility of a specific proposed approach.
  • Projects should have a high risk of failure. Feasibility of a project should not be supported by preliminary data. Projects with preliminary data should be submitted under the Focused Technology Research and Development program (see below).
  • Projects should be focused on technical questions regarding the development of a novel research tool. Projects sufficiently mature to include application to biomedical research problems are inappropriate for this program and should be submitted under the Parent R01 FOA (see below).

Appropriateness for this Program:

For the purpose of this FOA, technology refers to tools that enable research. This includes laboratory instruments and other devices, algorithms and software, chemical reagents and processes by which biomedically related molecules are produced and modified, and the manipulation of biological systems to produce or become research tools.

This FOA calls for exploratory technology development predicated on a broad need or challenge in biomedical research that can be described explicitly. This need should be beyond the ability of the current technology development regime to meet. It should be clear that something fundamentally different is needed. The proposed technology should have the potential to address basic biomedical research needs or technical problems that occur broadly across multiple systems or diseases. Specific examples may be cited. Exploratory research into technologies specific to only one disease or system are not appropriate for this FOA.

No Preliminary Data: Availability of preliminary data is an indication that the proposed project has advanced beyond the exploratory stage defined by this program, and will make the application unsuitable for this funding opportunity. Consideration should be given to submitting such projects to the companion R01 program (PAR-17-045).

High-Risk Exploratory Research: Applications through this FOA for exploratory research projects may propose a single specific solution to a broadly stated biomedical research need, with the goal of determining the feasibility of that approach. Alternatively, a proposed project may take a broader approach that will explore several possible solutions, leading to an improved understanding of the best technical avenues to pursue in order to create a new capability. This less directed approach may lead to a better understanding of the relative merits or likelihood of success of multiple potential approaches to be pursued in developing a technology.

This program will support proof-of-principle research leading to advances in technology. Because new ideas are essential to this process, the projects will entail a high degree of risk or novelty, which will be offset by a correspondingly high potential impact. However, the possible impact is unlikely to be immediate. Substantial additional development of the technology after completion of the project is likely to be necessary. The program will recognize and reward high risk approaches with the potential for significant impact.

No Biological Aims: Biomedical relevance is an essential element of NIH research. However, the exploratory stage of technology development should not include immediate short-term application of nascent technologies to challenging biomedical research questions because an insistence on explicit linkage to a specific research problem and the immediate demonstration of an immature technology's effectiveness in that context can distort the technology development process. It can also diminish focus on development of genuinely innovative technology in favor of incremental improvements to existing technologies. In the early stages of technology development, insistence on biomedical applications is counterproductive. Therefore, in this program, application to specific biomedical questions in the timeframe of the proposed project is considered beyond the scope of the program, and should not be included.

Milestones: A milestone is a defined event, achievement, or important stage that is used to indicate the progress of a project. Milestones should be descriptive of what will be done and when it will be completed.

The expected results from projects funded under this announcement will be the demonstration of feasibility, including (a) proof of principle, or (b) preliminary data that indicates a promising avenue for future development.

For purposes of this FOA, the following are not considered to be early

  • pursuit of a biological hypothesis
  • biomarker discovery or validation
  • development of drugs or therapies
  • new uses of existing technologies that may be ready for advanced development and validation without substantial further development efforts.

Applications proposing projects with these goals are not appropriate for this program and should be submitted elsewhere.

Choosing the Appropriate NIGMS Biomedical Technology Development Program

NIGMS Biomedical Technology Research and Development programs are defined by specific criteria that differentiate each stage of technology development. The process of Technology Research and Development can be divided into four domains. The appropriate Funding Opportunity Announcement in each area for NIGMS applicants is listed. Further information is available at the NIGMS website (http://www.nigms.nih.gov/technologydevelopment).

(I) Exploratory Research for Technology Development: High risk exploration of possible approaches to development of a potential biomedical technology. This is preliminary research that, if successful, should lead to proof-of-concept: a preliminary demonstration of feasibility. These projects are characterized by a high degree of uncertainty regarding the appropriateness and performance characteristics of the technology in question, with no supporting preliminary data. The project should be responsive to an unmet need or emerging opportunity in biomedical research. This is a broad rationale justifying the investment in technology development, not a description of a specific biomedical driving project.

PAR-17-046: Exploratory Research for Technology Development (this FOA)

(II) Focused Technology Research and Development: These projects focus on the development of a technology with potential to enable biomedical research. Projects are characterized by innovative research and development, focused on addressing technical challenges that stand in the way of creating an effective research tool. Projects are supported by preliminary data demonstrating feasibility of the approach. The challenge in these projects lies in how the technical challenges will be addressed more than whether the approach is possible. These projects stop short of the application of the emerging technology to specific biomedical research problems.

PAR-17-045: Focused Technology Research and Development

(III) Iterative Technology Research and Development: These projects are characterized primarily by the close coupling of technology development with the application of emerging technologies to biomedical projects that serve as test-beds. This pattern is commonly supported through conventional R01 grants that combine aims in technology development with challenging research projects positioned to benefit significantly from access to the technology as it matures. In these cases, technology developers benefit significantly from the opportunity to use those research projects as a proving ground that exposes areas for continued development of technologies.

PA-16-160: NIH Research Project Grant (Parent R01)

(IV) Research and Development for Technology Optimization: Refinement of fragile, unreliable technologies with strong potential for biomedical impact, in order to make them transferrable to other laboratories. This work can sometimes be completed concurrently with prior stages of technology development.

As technology development programs mature, NIGMS will determine whether there is a need for specific support in this area.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Clinical Trial?

Clinical Trials Not Allowed for due dates on or after January 25, 2018: 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.

Award Budget

Application budgets are limited to a total of $275,000 Direct Costs over the two-year project period. No more than $200,000 may be requested in any single year. The budget must be well justified and reflect the actual needs of the proposed project.

Award Project Period

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 in response to this FOA.

Section III. Eligibility Information
1. Eligible Applicants
Eligible Organizations

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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)
  • 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
Foreign Institutions

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.

Required Registrations

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.

Program Directors/Principal Investigators (PD(s)/PI(s))

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. 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.
  • System for Award Management (SAM) (formerly CCR) 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.
  • eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

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. 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 NOT-OD-11-101).
Section IV. Application and Submission Information
1. Requesting an Application Package

Buttons to access the online ASSIST system or to download application forms 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 Instructions for the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

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.

SF424(R&R) Cover

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.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

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.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Research Strategy:

Significance

In addition to the topics outlined in the SF424 (R&R) Application Guide, the application should describe the potential impact of the tool that will be developed. Because this is very early stage exploratory technology development, the impact is not likely to be immediate. The possible future impact of the proposed technology must be compelling and clearly articulated.

Proposed technologies should offer the potential for substantially improved research capabilities not provided by current tools. Clearly define the unmet need or emerging research opportunity that will be addressed by the proposed technology and describe its anticipated use. The application should explain the potential impact of the technology in the context of biomedical research. The proposed technology should have the potential to address basic biomedical research needs or technical problems that occur broadly across multiple systems or diseases.

Innovation

In addition to the topics outlined in the SF424 (R&R) Application Guide, the application should describe the nature of the technical opportunity to be exploited and obstacles to be overcome. If the relative merits of multiple technological pathways will be explored, provide the rationale for why that broad approach is likely to lead to an innovative solution. If one specific approach is to be explored, explain the rationale for the proposed solution.

Describe the desired performance characteristics of the proposed technology and specific measures that will be used to evaluate progress toward achieving those goals. Goals and measures need to be commensurate with the stage of development of the technology, and may be very general early in the process.

Approach

In addition to the topics outlined in the SF424 (R&R) Application Guide, the application should describe those aspects of the experimental approach that are specific to exploratory technology development. This includes the uncertainties underlying the proposed technology research and development, including the risk of failure. A high degree of uncertainty and risk are appropriate in exploratory technology development, and should be described realistically. Avoid unrealistic, overly optimistic descriptions of the possible outcomes. Straightforward discussion of the challenges and risks inherent in the research plan is encouraged.

The rationale for the proposed technology development must be explained, and should incorporate discussion of the broad opportunity or need that the new technology will address, as well as a discussion of why the approach or approaches to be explored have been selected. However, for this program, preliminary data demonstrating feasibility of the proposed approach is not necessary, and should not be included.

This program is intended to support exploratory research, the outcome of which will be preliminary data that may provide the rationale for continued development of the subject technology. The research plan should describe the manner in which these preliminary data will be obtained and analyzed. The rationale for the experimental approach should be explained. The proposed exploratory research plan should have a high risk of failure. If feasibility has been demonstrated, the project is outside the scope of this program.

Milestones: The desired characteristics of the technology at the conclusion of the project should be described, and milestones toward that goal should be presented. The milestones should be directed toward answering the fundamental questions regarding the selection of an appropriate way forward for continued 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.

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Inclusion Enrollment Report

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

PHS Human Subjects and Clinical Trials Information

Form only available in FORMS-E application packages for use with due dates on or after January 25, 2018.

When involving NIH-defined human subjects research, clinical research, and/or clinical trials 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 a 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: 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.

6. Funding Restrictions

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. 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 DUNS number it provides 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 and compliance with application instructions by the Center for Scientific Review, NIH. Applications that are incomplete or non-compliant will not be reviewed.

Post Submission Materials

Applicants are required to follow our Post Submission Application Materials policy.

Section V. Application Review Information

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

1. Criteria

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

The R21 exploratory/developmental grant supports investigation of novel scientific ideas or new model systems, tools, or technologies that have the potential for significant impact on biomedical or biobehavioral research. Accordingly, reviewers will focus their evaluation on the conceptual framework, the level of innovation, and the potential to significantly advance our knowledge or understanding.

The NIGMS Exploratory Research for Technology Development program uses the R21 activity code but is distinguished from the NIH Parent R21 in several important respects. Projects should be justified broadly on the basis of a strong potential to enable biomedical research if successful. However, projects should focus exclusively on technology development. Biomedical research aims are inappropriate for this program. Projects should have a high risk of failure. The project should focus on exploratory research to evaluate the feasibility of one or more technical approaches. Projects with preliminary data are not appropriate for this program. Preliminary data may not be included. Appropriate justification for the proposed work can be provided through literature citations or data from other sources.

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 there a strong scientific premise for the project? 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?

Does the proposed technology development have the potential to address a significant unmet need in biomedical research, or open significant new avenues for investigation? Is the potential significance of the technology for biomedical research appropriately broad, beyond a single organism, system, or disease?

Regardless of the inherent risk of the project, assuming that continued development of the technology is successful, would its availability enable new research or significantly facilitate current research?

If the technology is fully developed subsequently, is it likely to have practical significance for the research community? Does the proposed technology have the potential to be widely adopted by the relevant 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?

Do the investigators have a record of significant technological innovation?

Do the investigators demonstrate a willingness to recognize risks, and take risks to solve challenging problems?

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?

Does the proposed technology offer the potential for clear and significant improvements over currently available tools?

Is the proposed technology fundamentally new? If it is not new, does it solve a longstanding technical problem in an established technology area?

Is the proposal ambitious rather than incremental? Does the proposed project go beyond the current technology development regime in a given area? Will the project take a fundamentally new approach?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed?

Is the research plan focused on demonstrating proof-of-principle for an unproven idea? Does the project involve a high level of uncertainty or risk, consistent with the goals of the program?

Is the application designed to obtain preliminary data and determine feasibility of the proposed technology, rather than presenting previously obtained preliminary data?

Does the application appropriately focus on exploratory research to determine technological feasibility rather than proposing hypothesis-driven, biomedical research?

If the project is intended to select the most appropriate technological approach among multiple alternatives, would completion of the proposed research plan be likely to result in sufficient preliminary data to make that determination? If the project is successful, will the next steps be clear?

If development of a specific technology is proposed, would meeting the proposed milestones be sufficient to establish the feasibility of a subsequent project to develop the proposed technology? Would experimental results from the exploratory project serve as a foundation for next phase development efforts such as a future R01 project or equivalent? If the project is successful, will the proposed technology be ready for the next stage of development?

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 six 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 six 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 Children

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 children 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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

Not Applicable

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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:

  • 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.
  • Will receive a written critique.

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.
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.

Section VI. Award Administration Information
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 grantee's business official.

Awardees 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.

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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person's race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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.

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 "Federal awarding agency review of risk posed by applicants." This provision will apply to all NIH grants and cooperative agreements except fellowships.

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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/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. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final progress report, 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees 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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)

Telephone: 301-710-0267

Scientific/Research Contact(s)

Paul Sammak, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-8494
Email: paul.sammak@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Lori Burge
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-451-3781
Email: burgel@mail.nih.gov

Section VIII. Other Information

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.

Authority and Regulations

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.

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