PAR-26-121-Revised-Full-Announcement.html

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

Maximizing Investigators' Research Award (MIRA) (R35 - Clinical Trial Optional)

Activity Code

R35 Outstanding Investigator Award

Announcement Type

Reissue of

PAR-22-180

Related Notices

Check for any recent Notices of NIH Policy Changes that may impact application requirements.

Funding Opportunity Number (FON)

PAR-26-121

Companion Funding Opportunity

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Assistance Listing Number(s)

93.859

Funding Opportunity Purpose

The Maximizing Investigators' Research Award (MIRA) provides support to individual investigators for research within the scientific mission of NIGMS via a single grant to achieve the following:

This NOFO invites applications from eligible NIGMS-funded investigators and from New Investigators proposing research that is aligned with NIGMS' scientific mission. The NOFO also allows renewal applications from all current MIRA grantees (including those previously funded as Early-Stage Investigators). Current Early-Stage Investigators (ESIs) should apply through the ESI MIRA NOFO, not this NOFO.

Funding Opportunity Goal(s)

The National Institute of General Medical Sciences (NIGMS) supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS also supports research in specific clinical areas that affect multiple organ systems: anesthesiology and peri-operative pain; clinical pharmacology common to multiple drugs and treatments; and injury, critical illness, sepsis, and wound healing. 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. Additionally, to ensure the vitality and continued productivity of the research enterprise, NIGMS provides leadership in supporting the training of future scientists and developing research capacity throughout the country.

Key Dates

Posted Date

Open Date (Earliest Submission Date)

December 27, 2025

January 27, 2026

January 27, 2026

Not Applicable

December 2026

May 27, 2026

May 27, 2026

Not Applicable

April 2027

January 27, 2027

January 27, 2027

Not Applicable

December 2027

May 27, 2027

May 27, 2027

Not Applicable

April 2028

January 27, 2028

January 27, 2028

Not Applicable

December 2028

May 26, 2028

May 26, 2028

Not Applicable

April 2029

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.

Expiration Date

May 27, 2028

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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 Key Dates Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II. Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V. Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose To enhance grant funding efficiency and efficacy, the NIGMS established the Maximizing Investigators' Research Award (MIRA), a single grant that provides support for an investigator's NIGMS-aligned research program, encompassing all projects within their laboratory that align with the scientific mission of NIGMS.

It is anticipated that MIRA will achieve the following:

This NOFO invites new applications from eligible investigators as defined in the eligibility section (Section III. 1) and renewals from all current MIRA recipients. Early-Stage Investigators (ESIs) should apply through the ESI MIRA NOFO, not this NOFO.

The NIGMS MIRA differs from other institutes' R35 awards in that the MIRA is not a grant designed to only support a small number of investigators; instead, as described in the Institute's 2021-2025 strategic plan, MIRAs represent over 60% of NIGMS' R01-equivalent awards.

NIGMS will ensure a broad research portfolio, encompassing varied scientific disciplines, methodologies, geographic regions, institutions, and investigators. This approach maximizes the exploration of innovative ideas and enhances the potential for high impact scientific breakthroughs.

Overview of the MIRA The NIGMS MIRA is intended to provide support for the NIGMS-mission aligned research program in an investigator’s laboratory. NIGMS supports basic research on biological processes as well as translational and clinical research in specific areas. In addition to investigating scientific questions, MIRA can support technology development and computational approaches, either as sole research program interests or as components of a broader research program. MIRA investigators have the flexibility to explore new ideas, techniques, and approaches, provided the research remains within the scientific mission of NIGMS. Research involving human subjects, vertebrate animals, stem cells, select agents, or foreign components requires prior approval by NIGMS staff per existing policies and procedures.

Compared to traditional R01 funding, the MIRA offers distinct advantages:

Although mutually beneficial collaborations are encouraged during the course of a MIRA, the MIRA is designed to support the NIGMS-aligned research of an independent investigator's laboratory. For research requiring financial support of collaborators and subcontractors, other funding mechanisms may be more appropriate.

Research involving human subjects is permitted in the MIRA program. Clinical research must be completely within the context of the research areas supported by NIGMS, which include several specific clinical areas: anesthesiology, perioperative pain, clinical pharmacology, sepsis, injury and critical illness, wound healing, innate immunity and inflammation. Clinical research that involves recruitment of human subjects at more than one site or the substantial financial support of multiple collaborators and subcontractors is not allowed, because these fixed commitments are not consistent with the highly flexible nature of the MIRA program. Mechanistic clinical trials are permitted in MIRA when the mechanistic study is an essential part of the research program. Clinical trials that are designed to test safety and efficacy of interventions (Phase I, Phase II, Phase III) for the purpose of future clinical treatment and/or regulatory approval are not permitted in MIRA. Studies that propose clinical dissemination and implementation research, comparative effectiveness research, and/or pragmatic clinical trials are also not permitted.

Potential applicants are strongly encouraged to confer with the NIGMS program official managing their qualifying award(s) or relevant research portfolio(s), or for additional questions, the Scientific/Research Contacts listed in this NOFO (in Section VII. Agency Contacts) before submitting a MIRA application. NIGMS will not fund applications containing research projects that align with the missions of other NIH Institutes and Centers or federal agencies.

Overlap During Peer Review Since a MIRA is designed to provide support for a PD's/PI's entire NIGMS-mission-aligned research program, it will overlap with most other NIGMS research grant applications. Therefore, a PD/PI may not have a MIRA application and another NIGMS research project grant application (e.g., R01, R15, R21, and R37) pending review at the same time. An application is pending review until its summary statement is issued. The following NIGMS applications are exempted from this policy:

Resolving Overlap with Other NIGMS Research Grants During the Award Process A PD/PI awarded a MIRA must discontinue funding from other NIGMS research grants, except in specific situations as noted below. The following scenarios provide examples of how funding overlaps are addressed:

NIGMS will facilitate an orderly process to transition to MIRA funding when reductions in other commitments are required. Specific details will be provided by NIGMS staff on a case by case basis.

The MIRA budget will be determined by NIGMS staff, based upon the PD's/PI's prior NIGMS funding history, recommendations from the peer review group and the National Advisory General Medical Sciences Council, and the expected productivity and impact of the proposed research program. MIRA applications from PDs/PIs whose total research support from all sources exceeds $1,500,000 in annual total costs are subjected to NIGMS' Special Council Review policy.

A PD/PI with more than $400,000 in direct costs from NIGMS research grants will generally receive a MIRA budget that is approximately 12% lower than the PD's/PI's average NIGMS research funding levels over recent years (as determined by NIGMS staff). MIRA budgets for New Investigators will generally be $275,000 in annual direct costs.

Budgets for MIRA renewals are determined independently based on a variety of considerations, including peer review outcomes, the PD's/PI’s other support and commitments, NIGMS' scientific priorities, and available budget. Overall, most MIRA renewal budgets are expected to be comparable to prior funding periods, though some may increase or decrease. For more information, see this Feedback Loop Post.

Applying for Subsequent Awards after Receiving a MIRA NIGMS will not accept assignment of an NIH Director's Transformative Research Award (TRA) R01 or NIH Director's Pioneer Award (DP1) application if the PD/PI has a MIRA, since by virtue of assignment to NIGMS, the proposed research falls within the mission of NIGMS and would by definition overlap with the MIRA.

Supplements to MIRAs:

MIRA grants are eligible for administrative supplements offered by NIGMS, depending on the specific supplement program's intent and constraints.

Renewals:

MIRA renewals are expected to have higher success rates compared to R01s due to the Institute's commitment to the program as well as the consolidation of separate research projects, which will result in fewer applications. If a MIRA renewal application is unsuccessful, the grant will terminate at the end of its approved project period. A resubmission (A1) application is not allowed; however, a PD/PI may submit a new MIRA application as long as they are eligible.

Any MIRA application submitted after a prior renewal's pending review must be a new application. However, if a renewal application is withdrawn prior to peer review, another renewal can be submitted in its place.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

Funding Instrument

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

Application Types Allowed

New

Renewal

Revision

The OER Glossary and the How to Apply - Application Guide provide details on these application types. Only those application types listed here are allowed for this NOFO.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIGMS appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Applications from investigators with existing NIGMS research grants may request up to $750,000 direct costs per year. Investigators should request well-justified costs that are aligned with their proposed research program, noting that efficient use of funds is an expectation of the MIRA program. Budget justification is considered during the review process and in making funding decisions. Generally, awards will be commensurate with the PD's/PI’s average total NIGMS research funding over the past few years.

For new applications from PDs/PIs previously funded through NIGMS R01-equivalents other than MIRAs, well-justified budget increases may be considered for PDs/PIs previously supported by budgets below $275,000 in annual direct costs, while modest reductions of approximately 12% on average, are expected for PDs/PIs with $400,000 or more in annual direct costs from NIGMS. The MIRA budget will typically be lower than an NIH Transformative Research Award and will be significantly reduced from an NIH Director's Pioneer Award (DP1).

MIRA budgets for New Investigators are typically set at $275,000 in annual direct costs, not including equipment.

For MIRA renewal applications, NIGMS expects that the award level may vary based on the justification and available funds. Meritorious renewal applications that are not prioritized for full funding may receive reduced budgets.

Equipment should be requested in Year 1 only. Unless equipment costs are requested, annual direct costs will remain constant throughout the award period.

Award Project Period

Applications may request a maximum project period of five years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Nonprofits Other Than Institutions of Higher Education

For-Profit Organizations

Local Governments

Federal Governments

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 Organizations/Foreign Collaborations

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations. This new requirement was effective, May 1, 2025.

Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding. This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors.

Required Registrations

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply - Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.

Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.

eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.

Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Subject to the eligibility criteria below, any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) is invited to work with their organization to develop an application for support.

PDs/PIs whose only NIGMS research grant(s) is a multi-PD/PI grant(s) are not eligible to apply for a MIRA.

PDs/PIs with a funded NIGMS MIRA are eligible to submit a MIRA renewal application before the end of their eligibility time window. Successful renewal applications will generally be awarded in the fiscal year of Council review, with the current MIRA terminated upon the issuance of the MIRA renewal award. Resubmissions are not allowed. If a renewal MIRA application is unsuccessful, a new MIRA application may be submitted as long as the PD/PI remains eligible. The eligibility for investigators funded with a MIRA extends to the end of the second fiscal year following the one in which the funded MIRA was originally set to expire. For example, if the current MIRA expires in fiscal year 2025 (October 1, 2024 to September 30, 2025), a renewal MIRA application needs to be submitted before September 30, 2027.

PDs/PIs with at least one NIGMS single-PD/PI R01-equivalent award (defined here as R01, R37, DP1, DP2, and SC1) are eligible to submit a new MIRA application before the end of their eligibility time window. Successful MIRA applications will generally be awarded in the fiscal year of Council review. If a pending MIRA application is unsuccessful, a new MIRA application may be submitted as long as the PD/PI remains eligible. Resubmissions are not allowed. The eligibility for investigators funded with at least one single-PD/PI NIGMS R01 or equivalent award extends to the end of the fiscal year following the one in which the funded single-PD/PI R01 or equivalent award was originally set to expire. For example, if the qualifying R01-equivalent award ends in fiscal year 2025 (October 1, 2024 to September 30, 2025), a MIRA application needs to be submitted before September 30, 2026.

No-cost extensions (NCEs) cannot be used to extend the eligibility time window. NIGMS will consider requests to extend the eligibility time window to apply for a MIRA for life events (e.g., childbirth or adoption, military service, health-related issues, natural disasters) that impact research progress during the eligibility time window, as well as unanticipated administrative issues. Applicants seeking an extension of their eligibility status must contact a Scientific/Research Contact listed in this NOFO (in Section VII. Agency Contacts) at least 8 weeks before submitting the application.

New Investigators proposing NIGMS mission-aligned research programs are eligible to apply for a MIRA if the PD/PI is not a project leader on any NIH multi-component awards from NIH, except for Research Project Leaders and Pilot Project Leaders of COBRE, IDeA-CTR or NARCH awards. Potential applicants are strongly encouraged to contact NIGMS program staff to discuss the possible alignment of their proposed research program to the NIGMS mission before applying. Applications that fall outside the NIGMS scientific mission will be withdrawn prior to peer review.

ESIs should apply for a MIRA through the ESI MIRA NOFO, not this NOFO.

The PD/PI is required to devote at least 45% of their total research effort to the MIRA. Total research effort includes the PD's/PI's combined research effort across all institutions where they hold an appointment, expressed in person-months, and excludes time spent on teaching and on administration unrelated to the PD's/PI's research or clinical duties. NIGMS staff will verify compliance with the MIRA research effort requirement using the Just-in-Time (JIT) Other Support documentation.

All current NIGMS research grants except those listed in Section I will be terminated upon issuance of the MIRA grant. MIRA PDs/PIs receiving funds as Project Leaders on NIGMS multi-component grants (i.e., P50) or a Collaborative Program Grant for Multidisciplinary Teams (RM1) will have their MIRA budget adjusted to eliminate overlap, and they must discontinue their involvement in the multi-component grant at the end of its competitive segment.

2. Cost Sharing This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

Since a MIRA is designed to provide support for a PD's/PI's entire NIGMS-mission aligned research program, it will overlap with most other NIGMS research grant applications (e.g., R01, R15, and R21). Therefore, NIGMS will not accept a MIRA application from a PD/PI who is the PD/PI of another NIGMS research grant application pending review (as defined above), except as mentioned under Section I. Conversely, NIGMS will not accept any other applications from a PD/PI who has a MIRA application pending review, except as mentioned under Section I.

Section IV. Application and Submission Information

1. Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise (in this NOFO, in a policy notice, or other notice from NIH Guide for Grants and Contracts). Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

SF424(R&R) Other Project Information

Project Summary/Abstract: The abstract should provide an overview of the research in the laboratory, goals for the next five years, and the overall vision of the research program. Specific aims or any similar designation, including “aims”, must not be included in the abstract as they are antithetical to MIRA's flexibility in allowing research to easily change directions. Doing so will lead to administrative withdrawal of the application prior to peer review.

SF424(R&R) Senior/Key Person Profile

Biographical Sketches: A biosketch is required only for the PD/PI and, if included, for any collaborator(s) receiving financial support from the MIRA. As noted in the R&R Budget section below, consortia/subawards are not allowed.

Personal Statement: The Personal Statement should be tailored to the unique attributes and requirements of the MIRA, including descriptions of significant service to the scientific community that are beyond the mentoring and committee duties expected at the PD's/PI's institution.

Contributions to Science: This section should highlight contributions over the past five years. Since this NOFO targets PDs/PIs with funded NIGMS R35 or R01-equivalent awards or New Investigators seeking NIGMS funding, applicants should emphasize contributions within NIGMS' scientific mission, noting those supported by NIGMS whenever applicable. All sources of funding support, as acknowledged in publications, should be listed for each publication cited.

Applicants may include a link to their My Bibliography for a complete list of publications.

Figures or preliminary data must not be included in this section.

R&R Budget

Itemized budget information is not required. Instead, a total requested direct cost amount for each budget period, including requests for equipment, is required. Unless equipment is requested in Year 1, annual direct costs are expected to remain constant throughout the award period. Do not request equipment in years 2-5 and do not include expected inflationary adjustments in out years.

Consortia/subawards are not allowed and should not be included in the budget.

All instructions in the SF424 (R&R) Application Guide must be followed except as detailed below. While the application package includes a 10-year R&R Detailed Budget form, applicants may request no more than 5 years of support.

To submit a budget request without detailed yearly budgets, the following information must be completed. For each budget period:

Data Management and Sharing Costs: NIGMS expects that most grantees will incur minimal, if any, additional costs for data management and sharing, as significant changes to existing practices are not expected. The justification for Data Management and Sharing costs should be clearly labeled as “Data Management and Sharing Justification” and include any requested direct costs. If no costs are requested, state $0 for the requested amount. Follow the SF424 Application Guide instructions for the Data Management and Sharing Justification.

Budget Justification: The following budget categories must be justified, where applicable: equipment costs, data management and sharing costs, and any exclusions applied to the F&A base calculation. For MIRA renewal applications, justify any requested increase in funding compared to the previous project period. For new MIRA applications, justify any requested increase in support relative to the average NIGMS research support received over the previous three years. New Investigators should request a maximum of $275,000 in direct costs, excluding equipment costs.

The Budget Justification should include only the information requested for the budget categories listed above. Equipment quote(s), if applicable, may be included in this section.

R&R Subaward Budget

Do not complete the R&R Subaward form.

PHS 398 Cover Page Supplement

PHS 398 Research Plan All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

Specific Aims: This application must not include a Specific Aims attachment; inclusion of this page will lead to administrative withdrawal of the application prior to peer review.

Research Strategy: The Research Strategy must not contain specific aims or use any similar designation, including “aims.” Upload the Research Strategy as a single attachment. MIRA applications should not use the typical R01 application headings of Significance, Innovation, and Approach. This section should include the following information:

Keep in mind that although the proposed research direction(s) of the PD's/PI’s scientific program will be evaluated during review, the PD/PI will have the flexibility to pursue new opportunities or directions that arise within NIGMS's scientific mission over the course of the award period.

Since the MIRA enables consolidation of NIGMS funding support for potentially disparate projects, a single unifying theme is neither expected nor required. Applicants should justify the balance of effort and resources across activities, explaining how they are distinct or complementary.

The research strategy should address NIH policies on rigor and transparency in research (NOT-OD-18-228) and, if applicable, the consideration of sex as a biological variable (NOT-OD-15-102).

Progress Report Publication List: For MIRA renewal applications, follow the instructions in the SF424 Application Guide to prepare the progress report publication list. For each publication, list all funding sources acknowledged in the publication. If multiple funding sources are cited, clearly and concisely indicate which specific aspects of the work were supported by the MIRA.

Letters of Support: Letters of support from collaborators should be limited to one page, must not include attached Biographical Sketches, and must not circumvent page limitations by including figures and data. Letters of support from foreign collaborators may be subject to NOT-OD-25-098 and require a Foreign Justification.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

Other Plan(s):

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

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.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

PHS Human Subjects and Clinical Trials Information When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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

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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

3. Unique Entity Identifier and System for Award Management (SAM) See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information Applications must be submitted electronically following the instructions described in the How to Apply - 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 field of 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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.

Mandatory Disclosure

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at grantdisclosures@oig.hhs.gov.

Post Submission Materials Applicants are required to follow the instructions for post-submission materials, as described in the policy

Section V. Application Review Information

1. Criteria 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 NOFO, note the following:

The goal of the MIRA program is to provide support to individual investigators for research that is within the NIGMS scientific mission, and to provide PDs/PIs flexibility in pursuing their research goals, provided they remain in NIGMS's scientific mission. For this NOFO, applicants should provide an overview of their research program and the key questions or challenges they currently plan to address, along with a general description of possible strategies. Detailed experimental details are neither required nor expected. The MIRA is intended to consolidate support for projects that may address different research areas within the NIGMS's scientific mission, so there is no expectation or requirement for the PD/PI to propose a single unifying theme.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

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

Specific to this NOFO: Review criteria are not scored individually.

Reviewers will consider each of the review criteria below in the determination of scientific merit but will not provide a separate score for individual criterion.