PAR-27-032-Full-Announcement.pdf

Notice of Funding Opportunity

Application due

October 2, 2026, February 3, 2027, October 4, 2027, February 3, 2028, October 3, 2028, February 6, 2029

National Institute of General Medical Sciences (NIGMS)

Maximizing Investigators Research Award (MIRA) for Early Stage Investigators (ESI) (R35 - Clinical Trial Optional) Opportunity number: PAR-27-032

Contents Step 1: Review the Opportunity 4

Basic information 5

Eligibility 7

Program description 10

Step 2: Get Ready to Apply 17

Find the application package 18

Get registered 18

Help applying 19

Step 3: Build Your Application 20

Application checklist 21

Application contents and format 22

Step 4: Understand Review, Selection, and Award 30

Initial review 31

Peer review 31

Award notices 41

Step 5: Submit Your Application 42

Submission requirements and deadlines 43

Step 6: Learn What Happens After Award 45

Post-award requirements and administration 46

Contacts and Support 52

Contents 2

Before you begin If you believe you are a good candidate for this funding opportunity, secure your

SAM.gov, Grants.gov, and eRA Commons registrations now. If you are already registered, make sure your registrations are active and up-to-date.

SAM.gov registration (this can take several weeks)

You must have an active account with SAM.gov. This includes having a Unique Entity

Identifier (UEI).

See Step 2: Get Ready to Apply

Grants.gov registration (this can take several days)

You must have an active Grants.gov registration. Doing so requires a Login.gov registration as well.

See Step 2: Get Ready to Apply eRA Commons registration

Once an organization has established its unique organization identifier, organizations can register with eRA Commons in tandem with completing Grants.gov registration. You must have all registrations in place at the 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.

See Step 2: Get Ready to Apply

Apply by the application due date

Applications are due by 5:00 p.m. local time on October 2, 2026, February 3, 2027, October 4, 2027, February 3, 2028, October 3, 2028, February 6, 2029.

To help you find what you need, this NOFO uses internal links. In Adobe Reader, you can go back to where you were by pressing Alt + Left Arrow (Windows) or Command

+ Left Arrow (Mac) on your keyboard.

Before you begin 3 https://sam.gov/ https://grants.gov/ https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123 https://grants.nih.gov/grants/guide/url_redirect.htm?id=11123

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1:

Review the Opportunity

In this step

Basic information 5

Eligibility 7

Program description 10

Basic information National Institutes of Health (NIH)

National Institute of General Medical Sciences (NIGMS)

Empowering promising Early Stage Investigators (ESIs) to pursue bold, impactful science.

Have questions?

Go to Contacts and

Support.

Key dates

Application due dates:

2026: October 2

2027:

February 3, October 4

2028:

February 3, October 3

2029: February 6

See all important dates.

Key facts

Opportunity name:

Maximizing Investigators

Research Award (MIRA) for

Early Stage Investigators

(ESI) (R35 - Clinical Trial

Optional)

Opportunity number:

PAR-27-032

Assistance listing: 93.859

Activity Code: R35

Outstanding Investigator

Award

Announcement type:

Reissue

Companion funding opportunity: PAR-26-121

NOFO version: Original

Summary The Maximizing Investigators’ Research Award (MIRA) for Early Stage Investigators (ESIs) provides support for ESIs with a research program that aligns with the NIGMS mission.

MIRA distributes funding among promising investigators across the country. The goal is to boost scientific productivity and the chances for important breakthroughs.

Through this program, investigators can:

• Receive independent research funding early to start and sustain strong research careers.

• Explore new, unique research areas in the NIGMS mission.

• Take on ambitious, creative projects.

• Shift focus to include emerging techniques and technologies as needed.

• Devote more time to mentoring trainees in a stable research environment.

Funding details Funding type: Grant

Expected awards: The number of awards is subject to available funds and program priorities.

Project period: Up to five years in 12-month budget periods.

Application type: New, Revision

Clinical Trial?: Optional. We accept applications that either propose or do not propose clinical trials. (Need help determining whether you are doing a clinical trial?)

Expected total program funding over the performance period: N/A

Maximum budget per year: $275,000 in direct costs

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 5 https://grants.nih.gov/grants/funding/ac_search_results.htm?text_curr=r35&Search.x=0&Search.y=0&sort=ac&Search_Type=Activity&text_prev= https://grants.nih.gov/funding/find-a-fit-for-your-research/nih-institutes-centers-offices#nigms https://grants.nih.gov/grants/glossary.htm#NewApplication(award,grant) https://grants.nih.gov/grants/glossary.htm#Revision https://grants.nih.gov/grants/guide/url_redirect.php?id=82370

Important dates NOFO posting date: May 12, 2026

Open Date (Earliest Submission Date): September 2, 2026

Expiration date: February 7, 2029

Application due date Scientific merit review Advisory council review Earliest start date

October 2, 2026 March 2027 May 2027 July 2027

February 3, 2027 July 2027 October 2027 December 2027

October 4, 2027 March 2028 May 2028 July 2028

February 3, 2028 July 2028 October 2028 December 2028

October 3, 2028 March 2029 May 2029 July 2029

February 6, 2029 July 2029 October 2029 December 2029

Step 1: Review the Opportunity 6

Eligibility Eligible applicants Only these types of organizations may apply:

Higher education institutions

• Public/state-controlled institutions of higher education.

• Private institutions of higher education.

Nonprofits other than institutions of higher education

• Nonprofits with 501(c)(3) IRS status.

• Nonprofits without 501(c)(3) IRS status.

For-profit organizations

• Small businesses.

• For-profit organizations (other than small businesses).

Local governments

• State governments.

• County governments.

• City or township governments.

• Special district governments.

• Indian/Native American tribal governments (federally recognized).

• Indian/Native American tribal governments (other than federally recognized).

Federal governments

• Eligible agencies of the federal government.

• U.S. territory or possession.

Other

• Independent school districts.

• Public housing authorities and Indian housing authorities.

• Native American tribal organizations (other than federally recognized tribal governments).

• Faith-based or community-based organizations.

• Regional organizations.

Step 1: Review the Opportunity 7

Foreign institutions

• Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

These types of organizations are not eligible to apply:

Foreign institutions

• Non-domestic (non-U.S.) entities (foreign institutions).

• Non-domestic (non-U.S.) components of U.S. organizations.

Eligible program directors and principal investigators

Qualifications

For this Notice of Funding Opportunity (NOFO), we limit eligibility to NIH-defined Early

Stage Investigators (ESIs). We confirm ESI eligibility after you submit your application.

For certain life or career events, you can request to extend your ESI status. See the policy on the Early Stage Investigator Extensions.

Total research effort

The Program Director/Principal Investigator (PD/PI) must devote at least 51% of their total research effort to this award. The total research effort should:

• Include the PD’s/PI’s combined research effort at all institutions where they hold an appointment.

• Be expressed in person-months.

• Not include time spent on teaching or administration that is not directly related to the PD’s/PI’s research or clinical duties.

We will verify that the PD/PI meets the MIRA research effort requirement by using the

Other Support documentation. Do not submit Other Support documentation with your application. We will collect this information as needed after review.

Number of PDs/PIs

We allow only single PD/PI applications. We will not accept applications with multiple PDs/PIs.

Ineligible PDs/PIs

PDs/PIs who are not ESIs are not eligible for this NOFO. A PD/PI who is a New Investigator but not an ESI should apply instead through PAR-26-121 or its equivalent.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 8 https://grants.nih.gov/grants/guide/url_redirect.php?id=11118 https://grants.nih.gov/policy-and-compliance/policy-topics/early-stage-investigators https://grants.nih.gov/policy-and-compliance/policy-topics/early-stage-investigators https://grants.nih.gov/policy-and-compliance/policy-topics/early-stage-investigators/extensions https://grants.nih.gov/grants/forms/othersupport.htm https://grants.nih.gov/policy/early-stage/index.htm

We will withdraw, without review, applications from investigators who are not eligible to receive the award.

Unsuccessful applications

This NOFO does not allow resubmissions. A PD/PI may submit a new application to this

NOFO after an unsuccessful attempt as long as the PD/PI remains eligible as an ESI and the summary statement from the prior application has been issued.

Responsiveness criteria We will review your application to make sure it meets the standard NIH requirements and the following NOFO-specific requirements.

We won’t accept an application that:

• Proposes a program of research with projects that are not within the NIGMS mission.

◦ Note: Studies aimed at specific diseases, organ systems, stages of life, or populations may be more appropriate for NIH Institutes and Centers focused on those missions.

• Is from a PD/PI who is not an ESI at the time of submission.

• Is from multiple PDs/PIs.

• Is from a foreign organization.

• Includes a specific aims page.

• Uses specific aims or similar designation, including “aims”, in the application (for example, using this language in the abstract or research strategy sections).

• Overlaps with an NIGMS research grant application under review. (Exceptions noted in Overlap During Peer Review).

• Is incomplete. For example, we will not accept an application missing the required

Institutional Commitment Letter of Support from the chair or dean.

Applications deemed to be non-responsive will not proceed to review and will be withdrawn.

Cost sharing and matching funds This program does not have a cost-sharing requirement, meaning you do not need to contribute to the costs of this project.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 9 https://grants.nih.gov/funding/find-a-fit-for-your-research/nih-institutes-centers-offices#nigms https://grants.nih.gov/grants/guide/url_redirect.php?id=11126

Post-award requirements

Before you apply, make sure you understand the requirements that come with an award.

See Step 6: Learn What Happens After Award for information on regulations that apply, reporting, and more.

Program description Purpose The NIGMS Maximizing Investigators’ Research Award (MIRA) for Early Stage Investigators

(ESIs) provides support for a program of research in an ESI’s laboratory. For this NOFO, we define the “program of research” as a collection of projects in an investigator’s laboratory that are within the NIGMS mission.

Under a MIRA, investigators can explore new avenues of inquiry if the work stays within the NIGMS mission.

NIGMS strives to maintain a broad research portfolio that spans various scientific areas, approaches, regions, institutions, and individuals. This approach can increase the range of ideas explored and maximize the chances for important breakthroughs.

The NIGMS MIRA supports a majority of NIGMS R01-equivalent awards.

Overview NIGMS supports basic research on biological processes as well as translational and clinical research in specific areas. MIRA investigators have the flexibility to explore new ideas, techniques, and approaches that remain within NIGMS’ scientific mission.

Although we encourage mutually beneficial collaborations, the MIRA supports the research of an independent investigator’s laboratory. The MIRA’s intent is to support a significant and ambitious program of research.

Expected MIRA for ESIs achievements

We expect that a MIRA for ESIs award will:

• Enable investigators to apply early in their independent research careers. Doing so allows them to secure grant funding to launch and sustain productive research careers.

• Allow investigators to move into research areas that are distinct from those of their postdoctoral mentors.

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Step 1: Review the Opportunity 10 https://grants.nih.gov/grants/glossary.htm#EarlyStageInvestigator(ESI) https://grants.nih.gov/grants/glossary.htm#EarlyStageInvestigator(ESI) https://grants.nih.gov/funding/find-a-fit-for-your-research/nih-institutes-centers-offices

• Provide sufficient funding to encourage a robust research program.

• Increase funding stability for NIGMS-supported investigators.

• Encourage investigators to take on ambitious scientific projects and approach problems creatively.

• Increase flexibility for investigators to adapt to important new research directions, instead of being bound to specific aims proposed in advance.

• Widely distribute funding among the nation’s talented and promising investigators to increase scientific productivity and the chances for important breakthroughs.

• Reduce the time spent by researchers writing grant applications. The goal is to allow them to spend more time conducting research.

• Enable investigators to devote more time to mentoring trainees in a stable research environment.

Allowable and unallowable activities

For this NOFO, we allow:

• Research within the mission of NIGMS, including programs that focus, solely or in part, on technology development and computational approaches.

• Research that involves human subjects.

• Clinical research within the context of the NIGMS clinical areas:

◦ Anesthesiology and perioperative pain.

◦ Clinical pharmacology.

◦ Sepsis.

◦ Injury and critical illness.

◦ Wound healing.

◦ Systemic immune/inflammatory responses.

• Mechanistic NIH-defined clinical trials that are essential parts of the research program.

• Foreign Components, as defined in the NIH Grants Policy Statement, if the foreign component does not require NIH funding. We encourage you to consult NIGMS before proposing a foreign component.

For this NOFO, we do not allow:

• Support for domestic or foreign subawards.

• Clinical trials designed to test safety and efficacy of interventions (Phase I, II, III) for future clinical treatment or regulatory approval.

• Studies that propose:

◦ Clinical dissemination and implementation research.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 11 https://grants.nih.gov/grants/glossary.htm#MechanisticStudy https://grants.nih.gov/grants/glossary.htm#ClinicalTrial https://grants.nih.gov/grants/guide/url_redirect.php?id=11118

◦ Comparative effectiveness research.

◦ Pragmatic clinical trials.

Prior consultation with IC staff We encourage you to contact an NIGMS program officer before submission to help you determine if your project is suitable for NIGMS. To find a point of contact, you may consider using the Matchmaker tool that is part of the NIH RePORTER. Provide as complete a summary of your research program as you can to achieve the best results.

This tool uses data from current and past NIH awards to identify similar projects and relevant program officials. The tool provides a range of possibilities and does not provide a precise match to an NIH Institute or Center. Keep in mind that funding priorities of NIH

Institutes and Centers change over time.

Select one NIGMS program officer whose interests best align with your research and contact that person by email, providing a one-page summary of the proposed MIRA research program. Please do not contact multiple staff members at the same time, as this can cause confusion. We recommend contacting a program officer at least six weeks before the application due date.

If your research includes clinical trials, you should also visit the Research Methods

Resources website for information about developing statistical methods and study designs.

We will not accept applications that we determine to be outside of the NIGMS mission.

Research with the overall goal to gain knowledge about a specific organ or organ system or the pathophysiology, treatment, or cure of a specific disease or condition will, in most cases, be more appropriate for another Institute or Center. We routinely withdraw applications before review when the proposed research falls outside the NIGMS mission.

Overlap during peer review An application is under review from the time of submission until NIH issues the summary statement from that review. We limit the types of applications you may have as a PD/PI under concurrent review with a MIRA for ESIs.

• You may not have other research grants being considered by NIGMS (such as R15, R16, R21, DP2, or additional MIRA applications) under review concurrently, regardless of which application was submitted first.

• These application types are permitted under concurrent review with a MIRA for ESIs:

◦ An application that is being considered for funding by another NIH Institute or Center.

◦ An R01 application being considered by NIGMS.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 12 https://reporter.nih.gov/matchmaker https://researchmethodsresources.nih.gov/ https://researchmethodsresources.nih.gov/

• The following grant applications are not primarily research focused and constitute an exception list that may be under concurrent review with a MIRA for ESIs. You may also receive funds from these awards if a MIRA is awarded (see Resolving overlap with other NIGMS research grants):

◦ Grants that support research community resources, such as the NIGMS

National and Regional Resources program.

◦ Collaborative Program Grant for Multidisciplinary Teams.

▪ You may be a PD/PI as part of your required 51% MIRA research effort.

▪ You may not receive additional funds from the Collaborative Program

Grant for Multidisciplinary Teams award.

◦ Biomedical Technology Optimization and Dissemination Center (BTOD) grants.

▪ You must maintain the 51% research effort toward MIRA, and 3 person months on the BTOD.

◦ Training or workforce development grants, such as Institutional National

Research Service Awards (T32 and T34) and Science Education Partnership

Awards (SEPA).

◦ Grants for multi-site clinical research, (clinical trials and observational studies), with costs for patient recruitment, protocol-related expenses, or community resource activities like specimen banking and dissemination.

◦ Capacity building programs such as:

▪ Institutional Development Award (IDeA) centers to build research capacity

(for example, Centers of Biomedical Research Excellence (COBRE), IDeA

Networks of Biomedical Research Excellence (INBRE)).

◦ Health Research Programs for Federally recognized Tribes or Tribal Entities (for example, Native American Research Centers for Health (NARCH)).

◦ Small Business Innovation Research (SBIR) and Small Business Technology

Transfer (STTR) grants.

◦ Conference grants.

◦ Contracts.

Disqualifying awards

If you receive an award that removes your ESI status before we fund a MIRA for ESIs, you will no longer be eligible to receive a MIRA for ESIs. This includes awards such as R01, RM1, DP1, and DP2.

Check the NIH’s Early Stage Investigator policies to see which awards affect your

ESI status.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 13 https://www.nigms.nih.gov/Research/clinicaltrials/pages/investigatorapps.aspx https://grants.nih.gov/policy/early-investigators/index.htm

Resolving overlap with other NIGMS research grants If you receive a MIRA for ESIs, you may not receive funds from other NIGMS research awards (exceptions listed under ‘overlap during peer review’). If you are already supported by NIGMS funding when you receive a MIRA, we will facilitate an orderly process to transition to MIRA funding. We will provide specific details on a case-by-case basis. These scenarios provide some examples of how we address funding overlaps:

• If you are the single PD/PI for an NIGMS research grant, funding for that award will be discontinued.

• If you are a subawardee or paid collaborator on an NIGMS research grant or if you are a PD/PI on a Multiple Principal Investigator (MPI) research grant from NIGMS, you may continue to work on that grant, but funding for the work must be supported by your MIRA.

• If you receive funds as a project leader on an NIGMS multi-component grant, your

MIRA funding level will be adjusted to remove any overlap with the multi-component grant. You will be required to relinquish your funding from the multi-component grant at the end of its current competitive segment.

• If you have a K award from NIGMS, you must discontinue the K award before the

MIRA start date.

• If you have a K award from another NIH Institute or Center, you must adjust your effort on that award so that you can commit the required effort to your MIRA.

Applying for awards after receiving a MIRA We 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. If assigned to NIGMS, the proposed research would fall within the mission of NIGMS and would overlap with the MIRA.

Supplements to MIRAs

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

Renewals

MIRA for ESIs recipients will be eligible to renew their award through PAR-26-121 and reissuances of it. If a MIRA renewal application is unsuccessful, the grant will terminate when the project period ends.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 14 https://commonfund.nih.gov/tra https://commonfund.nih.gov/tra https://commonfund.nih.gov/pioneer

After ESI eligibility ends

After a PD/PI’s ESI eligibility expires, they may be eligible to apply to the MIRA for

Established and New Investigators as a New Investigator (PAR-26-121 and subsequent reissuances). We encourage you to discuss this option with the NOFO’s scientific/ research contact.

Funding policies and limitations

Changes in HHS regulations

As of October 1, 2024, HHS adopted 2 CFR 200, with some exceptions included in 2 CFR

300. These regulations replace those in 45 CFR 75. See NOT-OD-25-059 “NIH

Implementation of Uniform Administrative Requirements for Federal Financial

Assistance.”

General guidance

• You may use funds only for reasonable program purposes consistent with the award, its terms and conditions, and federal laws and regulations that apply.

• All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

• We allow pre-award costs only as described in the NIH Grants Policy Statement.

• Support beyond the first budget year will depend on:

◦ Appropriation of funds.

◦ Satisfactory progress in meeting your program’s objectives.

◦ A decision that continued funding is in the government’s best interest.

See also program-specific limitations.

For guidance on some types of costs that we restrict or do not allow, see 2 CFR 200.420, Considerations for Selected Items of Cost.

Program-specific limitations

Change of PD/PI

NIGMS will review these situations on a case-by-case basis. If you cannot meet the requirements for PD/PI, or if NIGMS otherwise decides continued support is inappropriate, we may end the MIRA.

You cannot make a permanent change of PD/PI on a MIRA grant.

We may allow a temporary change with NIGMS’ prior approval in cases such as:

• Sabbatical leave.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 15 https://grants.nih.gov/policy-and-compliance/policy-topics/early-stage-investigators https://www.ecfr.gov/current/title-2/part-200 https://www.ecfr.gov/current/title-2/part-300 https://www.ecfr.gov/current/title-2/part-300 https://grants.nih.gov/grants/guide/notice-files/NOT-OD-25-059.html https://grants.nih.gov/grants/guide/url_redirect.php?id=11120 https://grants.nih.gov/grants/guide/url_redirect.php?id=11143 https://www.ecfr.gov/current/title-2/section-200.420

• Medical conditions.

• Disability.

• Personal family situations.

If your employment changes, you must maintain the approved commitment level to the MIRA.

Foreign institutions and components

We will not allow transfer of a MIRA to a foreign institution. Please refer to the Grants

Policy Statement for requirements associated with foreign components.

Other awards

The MIRA will replace all current NIGMS research funding in the PD’s/PI’s laboratory

(exceptions listed under ‘overlap during peer review’). We will require institutions to discontinue their interests in current NIGMS-funded research grants and withdraw pending applications where the MIRA investigator is listed as the PD/PI or MPI.

NIGMS will not consider funding future research grant applications where a MIRA PD/PI is listed as the PD/PI or MPI during the MIRA-funded project period (exceptions listed under ‘overlap during peer review’). NIGMS will not accept applications for grants from

MIRA PDs/PIs that are not on the excepted list, unless the new award would begin after the MIRA ends.

Mission relevance

MIRA allows investigators to shift focus to emerging research areas, but the work must remain within the NIGMS mission. Pursuing research that is outside of the NIGMS mission may result in termination of the award.

PD/PI salary charged

Most institutions expect some commitment from investigators for administrative, teaching, and/or clinical duties. As a result, any salary support for the PD/PI charged to the grant should generally be less than 51% of the PD/PI’s annual salary. In no case should it be more than the actual research effort the PD/PI will devote to the grant.

Statutory authority NIH Research Project Grants are authorized under 42 USC 241 and 284 as implemented under 42 CFR Part 52 and 2 CFR Part 200.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 1: Review the Opportunity 16 https://grants.nih.gov/grants/policy/nihgps/HTML5/section_1/1.2_definition_of_terms.htm#foreign_component https://grants.nih.gov/grants/policy/nihgps/HTML5/section_1/1.2_definition_of_terms.htm#foreign_component

Step 2:

Get Ready to Apply

In this step

Find the application package 18

Get registered 18

Help applying 19

Find the application package The online application package has all the forms you need to apply.

Go to Grants Search at Grants.gov and search for this NOFO’s opportunity number. After opening the opportunity, select the “package” tab to see the forms. We recommend that you select the Subscribe button from the View Grant Opportunity page for this NOFO to get updates. The Apply button brings you to the login screen for preparing an application using Grants.gov Workspace. If using Grants.gov Workspace to apply, be sure to track your submitted application status in eRA Commons.

Additional options to submit your application through Grants.gov to NIH:

• Use NIH ASSIST to prepare, submit, and track your application. Enter the opportunity number in the ASSIST system to initiate an application and the application package will automatically load for you.

• Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Consult with your administrative office for instructions.

Get registered Organizations must be registered in SAM.gov, Grants.gov, and eRA Commons to apply.

You can review the requirements and get started on developing your application before your registrations are complete.

SAM.gov Before registering in Grants.gov or eRA Commons, organizations must have an active account with SAM.gov to apply. SAM.gov registration can take six weeks or more. Begin that process today.

To register:

• Go to SAM.gov Entity Registration and select Get Started. From the same page, you can also select the Entity Registration Checklist for the information needed to register.

• Organizations must agree to the financial assistance general certifications and representations specifically. Those for contracts are different.

Upon registration, organizations will receive a Unique Entity Identifier (UEI).

After registration:

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 18 https://public.era.nih.gov/commonsplus/publhttps://grants.nih.gov/grants/guide/url_redirect.htm?id=11123ic/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fcommons%2F https://public.era.nih.gov/assist/public/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fassist%2F https://public.era.nih.gov/commonsplus/publhttps://grants.nih.gov/grants/guide/url_redirect.htm?id=11123ic/login.era?TARGET=https%3A%2F%2Fpublic.era.nih.gov%3A443%2Fcommons%2F https://sam.gov/content/entity-registration https://www.hhs.gov/sites/default/files/financial-assistance-general-certification-representations.pdf https://www.hhs.gov/sites/default/files/financial-assistance-general-certification-representations.pdf

• Organizations will have to maintain an active registration throughout the life of any award.

• If an organization has multiple UEIs, use the one associated with your physical location.

Grants.gov Organizations must also have an active account with Grants.gov. You can see step-by step instructions at the Grants.gov Quick Start Guide for Applicants.

eRA Commons

Register your organization

• Organizations must be registered in eRA Commons.

• Begin at least 4 weeks before the application deadline.

Register key people

The PD/PI, senior/key personnel, other significant contributors, and other individuals named on the R&R Senior/Key Personnel form require eRA Commons IDs which must be provided in the Credential field of the form.

Need help? See Contacts and Support.

Help applying For help with the application process and tips for preparing your application, see How to

Apply – Application Guide on our website.

If any instructions differ from those in this NOFO, follow the instructions in this NOFO.

For other questions, see Contacts and Support.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 2: Get Ready to Apply 19 https://grants.gov/applicants/applicant-registration http://www.grants.gov/quick-start-guide/applicants https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400

Step 3:

Build Your Application

In this step

Application checklist 21

Application contents and format 22

Application checklist You must follow the research instructions to complete your application. In this section, we also provide NOFO-specific guidance for some forms.

Make sure that you have everything you need to apply:

Form Required for

SF424 (R&R) All applications.

PHS 398 Cover Page Supplement form All applications.

SF424 (R&R) Other Project Information All applications.

SF424 (R&R) Project/Performance Site Locations All applications.

SF424 (R&R) Senior/Key Person Profile All applications.

R&R Budget form All applications.

PHS 398 Research Plan form All applications.

PHS Human Subjects and Clinical Trials Information All applications.

PHS Assignment Request form Optional.

See submission requirements and deadlines to see if there are other requirements beyond the application itself.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 21

Application contents and format You must follow the research instructions in the How to Apply – Application Guide. We strictly enforce these requirements. If you do not follow them, we may delay or not accept your application for review.

When the NOFO-specific instructions deviate from those in the Application Guide, follow the NOFO-specific instructions.

Check the policy notices

Recently issued NIH-wide policy changes may affect your application submission. You may also review complete and updated information on NIH Policy & Compliance.

NIH requires the use of NOT-OD-26-018: NIHs Implementation of Common Forms for

Biographical Sketch and Current and Pending (Other) Support for Due Dates on or after

January 25, 2026.

Page limits You must follow all page limitations described in the How to Apply – Application Guide and the Table of Page Limits.

SF424 (R&R)

All instructions in the How to Apply – Application Guide must be followed.

PHS 398 Cover Page Supplement form All instructions in the How to Apply – Application Guide must be followed.

SF424 (R&R) Other Project Information form All instructions in the How to Apply – Application Guide must be followed.

Project summary/abstract

Use the abstract to provide an overview of research in your laboratory relevant to the

MIRA, the goals for the next five years, and an overall vision of the research program.

This attachment should serve both the needs of the public and the reviewers for an introduction to the research plan.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 22 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 http://grants.nih.gov/grants/guide/url_redirect.htm?id=11163 https://grants.nih.gov/policy-and-compliance https://grants.nih.gov/grants/guide/notice-files/NOT-OD-26-018.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-26-018.html https://grants.nih.gov/grants/guide/notice-files/NOT-OD-26-018.html https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.php?id=11133 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400

Do not include specific aims or use any similar designation, including “aims”, in the abstract. If you submit an application using this language, we will withdraw it prior to review.

SF424 (R&R) Project/Performance Site

Location(s) form All instructions in the How to Apply – Application Guide must be followed.

SF424 (R&R) Senior/Key Person Profile form All instructions in the How to Apply – Application Guide must be followed.

Biographical sketch

Only provide a Biographical Sketch for the PD/PI.

We require the use of SciENcv to prepare the Common Forms for the Biographical Sketch and the NIH Biographical Sketch Supplement.

Personal statement

Tailor the personal statement to the unique attributes and requirements of MIRA. Include descriptions of notable contributions to mentoring and significant service to the scientific community beyond duties expected at your institution.

If you list ongoing and completed research projects, do not include the number of person months or direct costs.

Contributions to science

Emphasize your contributions to science over the past five years. Do not present or include figures or preliminary data.

R&R Budget form All instructions in the How to Apply – Application Guide must be followed.

We do not require itemized budget information. Instead, we require a total requested direct cost amount for each budget period, including requests for equipment purchase in

Year 1.

Applications may request up to $275,000 direct costs per year. Do not request equipment except for Year 1. Do not include annual inflationary increases in out years. The direct costs requested in Year 1 cannot be higher than $275,000, inclusive of any equipment request.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 23 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://www.ncbi.nlm.nih.gov/sciencv/

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

While the application package provides a 10-year R&R Budget form, applicants may not request more than 5 years of support.

To allow submission of a budget request without filling out detailed yearly budgets, you must complete some basic information for NIH to successfully process the budget form.

Use the following instructions for each budget period:

Budget type

For Budget Type, select Project.

Budget period

Provide the budget period start date and end date.

Section A: Senior/key person

Provide an entry for the PD/PI, including the appropriate level of effort, and enter $0 for requested salary and $0 for fringe benefits. Entering $0 does not mean that the PD/PI will not receive any salary or fringe benefit support from the grant. Do not include other personnel.

Section C: Equipment description

Enter budget request for equipment in Year 1.

Section F: Other direct costs

Add a line item titled “Requested Direct Costs” and provide the total request for that budget period (up to $275,000).

If you request equipment in Section C, do not add the equipment budget in Section F.

Section H: Indirect costs

Enter your institutional “indirect cost type,” “indirect cost rate,” “indirect cost base” and

“funds requested.”

Section L: Budget justification

When applicable, use Section L to justify equipment costs, data management and sharing costs, and any exclusions applied to the F&A base calculation.

Equipment

Justify your equipment costs. You may also include equipment quote(s) in your justification.

Step 3: Build Your Application 24

Data management and sharing costs

NIGMS expects that most grantees will incur minimal, if any, additional costs for data management and sharing. Label the justification for data management and sharing costs 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 How to Apply –

Application Guide instructions for the Data Management and Sharing Justification.

F&A base

Also use the Budget Justification to explain any exclusions applied to the F&A base calculation.

R&R Subaward Budget form Do not complete the R&R Subaward form.

PHS 398 Research Plan form Use the PHS 398 Research Plan form to complete your research plan. You will upload each of the following parts of the form as a separate attachment.

We may not require some parts for your application.

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

• Follow all instructions outlined in the research instructions under the “R.400 - PHS

398 Research Plan Form” section. We note additional instructions here.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 25 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants-process/write-application/forms-directory/public-health-service-grant-application https://grants.nih.gov/grants-process/write-application/forms-directory/public-health-service-grant-application

Research plan section

The parts for this section include:

Parts Required for Page limit

Specific aims Do not submit this page. N/A

Research strategy All applications. 6

Progress report publication list Renewal applications only. N/A

Specific aims

Do not submit a specific aims page. Do not identify specific aims or use any similar designation, including “aims”. If you submit an application including this section or using this language, we will withdraw it prior to review.

Research strategy

Do not identify specific aims or use any similar designation in the Research Strategy, including “aims”. If you submit an application using this language, we will withdraw it prior to review.

Do not use the standard Research Strategy headings of Significance, Innovation, and

Approach. Instead, include:

• Background on the area(s) of research.

• Key gaps in our understanding or important challenges the research program will address.

• Recent progress by the PD/PI, focusing on the past five years, to give context for the overview of future research. This may include the development of technical expertise and administrative skills such as mentoring. Do not repeat material adequately covered in the Biographical sketch.

• Overview of future research plans. Include a description of the key questions or challenges you plan to address and the general strategies you might use. Focus on the importance of the questions or challenges. Do not provide a detailed experimental plan. Do not use specific aims or any similar designation, including “aims”.

We do not expect or require preliminary data. If you include it, you may wish to clearly indicate it in the research strategy section.

You can show feasibility of your program through preliminary data from your independent lab, literature citation, data from other sources, or data you generated as a graduate student or postdoctoral fellow.

Step 3: Build Your Application 26

Because the MIRA supports a research program within the NIGMS mission and may include multiple projects on different topics, you do not need to present a single unifying theme. Explain the balance of effort and the resources for each activity, and how the activities are distinct or complementary.

If you receive a MIRA and new opportunities or directions arise during the research, you can change course and pursue them. These new directions must remain within the

NIGMS mission.

The Research Strategy should address the requirements of the NIH policy on rigor and reproducibility in research as well as requirements related to sex as a biological variable as detailed in the How to Apply – Application Guide.

Other research plan section

To complete this section, use the instructions outlined under the “Other research plan section” section as detailed in the How to Apply – Application Guide. The parts for this section include:

Parts Required for Page limit

Vertebrate animals If you answer “Yes” to the question “Are vertebrate animals used?” on the R&R Other Project Information

Form.

None

Select agent research If your proposed activities involve the use of select agents at any time during the proposed project period.

None

Multiple PD/PI leadership plan Do not include. Not permitted. N/A

Consortium and contractual arrangements

Do not include. Consortia/contracts not permitted. N/A

Letters of support All applications. Required institutional commitment letter:

None

Other optional letters: 1 page

Resource sharing plans If model organisms or research tools will be generated. None

Other plans All applications (i.e. Data Management and Sharing

Plan).

None

Authentication of key biological and/or chemical resources

If applicable to the proposed science. None

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Step 3: Build Your Application 27

Letters of support

You must include a letter of support from your department chair, dean, or other academic unit leader. This letter should describe the institutional commitment to your development as an investigator and any other relevant information.

If you do not include this letter, we will consider the application incomplete and will withdraw it.

The letter could include:

• Start-up packages and other institutional research support.

• Space available to the PD/PI.

• Salary support commitment for the PD/PI.

• Skills and career development opportunities for the PD/PI.

• Mentoring during the promotion and tenure process.

• Career advancement prospects for non-tenure track applicants.

We do not require or encourage letters from former mentors, except in the case of continuing collaborations.

Letters of support from collaborators may not exceed one page each.

Do not circumvent page limitations by including figures and data.

Resource sharing plan

You must comply with the instructions for the Resource Sharing Plans as indicated in the

How to Apply – Application Guide.

Other plan(s)

You must follow all instructions in the How to Apply – Application Guide, 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 must comply with the instructions for and include the Data Management and Sharing Plan. Applicants must submit the

DMS Plan at the time of application using the NIH DMS Plan Format Page. The DMS

Plan must address the elements in the structured format should not exceed two (2) pages. Where the DMS Plan Format Page requires a “Yes or No” response, no additional narrative is allowed.

Appendix

We only allow limited appendix materials. Follow all the instructions for the Appendix in the How to Apply – Application Guide.

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Step 3: Build Your Application 28 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400

Do not include publications or other material, except for blank questionnaires or blank surveys, in the Appendix.

PHS human subjects and clinical trials information Follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply – Application Guide when involving any of the following:

• Human subjects research.

• Clinical research.

• NIH-defined clinical trials (and when applicable, clinical trials research experience).

Also use 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

You must follow all instructions in the How to Apply – Application Guide.

Delayed onset study

Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start). You must follow all instructions in the How to Apply –

Application Guide.

PHS assignment request form You must follow all instructions in the How to Apply – Application Guide.

For this NOFO, do not suggest a Scientific Review Group. MIRA-specific study sections or special emphasis panels review applications.

Pre-award requirements You must follow the instructions for post-submission materials, as described in the policy.

1. Review 2. Get Ready 3. Build 4. Understand 5. Submit 6. Award Contacts

Step 3: Build Your Application 29 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/glossary.htm#DelayedOnsetStudy https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.htm?id=82400 https://grants.nih.gov/grants/guide/url_redirect.php?id=82299

Step 4:

Understand Review, Selection, and Award

In this step

Initial review 31

Peer review 31

Award notices 41

Initial review The Center for Scientific Review and the National Institute of General Medical Sciences will evaluate applications for completeness and compliance with application instructions.

We will also review your application to make sure that it meets the responsiveness criteria. If your application does not meet these criteria, is incomplete, or is non-compliant, we will withdraw it and not move it to the peer review phase.

Peer review Reviewers evaluate applications for scientific and technical merit through the NIH peer review system. Reviewers consider only the review criteria described below in the review process.

You can find information about the disposition of applications in the

NIH Grants Policy Statement.

Process The Center of Scientific Review convenes Scientific Review Groups to evaluate applications for scientific and technical merit. Your application will be assigned to an appropriate Scientific Review Group. The panel will review your application according to

NIH peer review policy and procedures and use the stated review criteria. eRA Commons will show the Scientific Review Group assignment.

Written critiques As part of the scientific peer review, there is a written critique (Summary Statement) for all applications.

After peer review of the application is complete, the PD/PI will be able to access their

Summary Statement in the eRA Commons.

See important dates for dates for peer review, advisory council review, and earliest start date.

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Step 4: Understand Review, Selection, and Award 31 https://grants.nih.gov/grants/guide/url_redirect.php?id=11120 https://grants.nih.gov/grants/guide/url_redirect.php?id=11154 https://grants.nih.gov/grants/guide/url_redirect.php?id=11123

Context for reviewers For this announcement:

Goal

The goal of the MIRA for ESIs program is to support an ESI’s research program within the

NIGMS mission and:

• Offer an opportunity for ESIs to receive support as early as possible in their independent careers.

• Encourage ESIs to move into research areas that are distinct from those of their postdoctoral mentors.

• Give investigators relative freedom in pursuing their NIGMS-mission relevant research goals.

Overview vs. details

We expect applicants to provide an overview of the research program/scientific questions they plan to address and a general description of possible strategies. We do not expect experimental details.

MIRA provides support for a single PD’s/PI’s NIGMS mission-aligned research program.

The application may include multiple projects on different topics and does not need to present a single unifying theme.

Preliminary data and publications expectations

We do not require preliminary data in MIRA for ESIs applications.

Applicants may provide justification for the proposed work through preliminary data from their independent laboratory, literature citations, data from other sources, or data generated by the applicant as a graduate student or postdoctoral fellow.

Simi…