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 (R35 - Clinical Trial Optional)
Activity Code
R35 Outstanding Investigator Award
Announcement Type

Reissue of PAR-17-094

Related Notices

NOT-GM-19-006

NOT-OD-19-128 Changes to NIH Requirements Regarding Proposed Human Fetal Tissue Research

NOT-OD-19-137 Clarifying Competing Application Instructions and Notice of Publication of Frequently Asked Questions (FAQs) Regarding Proposed Human Fetal Tissue Research

Funding Opportunity Announcement (FOA) Number
PAR-19-367
Companion Funding Opportunity

None

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

93.859

Funding Opportunity Purpose

The Maximizing Investigators' Research Award (MIRA) provides support for the program of research in an investigator's laboratory that is within the mission of NIGMS. The goal of MIRA is to increase the efficiency and efficacy of NIGMS funding. It is anticipated that this program will:

  • Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively;
  • Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies;
  • More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs;
  • Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research;
  • Enable investigators to devote more time and energy to mentoring trainees in a more stable research environment.
This FOA allows both new applications from eligible NIGMS-funded investigators and renewal applications from current established and early-stage MIRA grantees.

Key Dates

Posted Date

September 9, 2019

Open Date (Earliest Submission Date)
December 17, 2019
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

January 17, 2020; May 18, 2020; January 19, 2021; May 17, 2021; January 18, 2022, May 17, 2022

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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)

Not Applicable

Scientific Merit Review

June/July 2020; October/November 2020; June/July 2021; October/November 2021; June/July 2022; October/November 2022

Advisory Council Review

October 2020; January 2021; October 2021; January 2022; October 2022; January 2023

Earliest Start Date

January 2021; April 2021; January 2022; April 2022; January 2023; April 2023

Expiration Date
May 18, 2022
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 SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts ).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.
  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

Supporting fundamental research by funding individual projects has a number of consequences that reduce the efficiency and effectiveness of the biomedical research enterprise in the U.S. To address these issues and increase the efficiency and efficacy of grant funding, the NIGMS Maximizing Investigators' Research Award (MIRA) is a single grant to provide support for the NIGMS-relevant program of research in an investigator's laboratory. For this FOA, the "program of research" is defined as a collection of projects in an investigator's lab that are within the mission of NIGMS.

It is anticipated that this award will achieve the following:

  • Increase the stability of funding for NIGMS-supported investigators, which could enhance their ability to take on ambitious scientific projects and approach problems more creatively;
  • Increase flexibility for investigators to follow important new research directions within the NIGMS mission as opportunities arise, rather than being bound to specific aims proposed in advance of the studies;
  • More widely distribute funding among the nation's highly talented and promising investigators to increase overall scientific productivity and the chances for important breakthroughs;
  • Reduce the time spent by researchers writing and reviewing grant applications, allowing them to spend more time conducting research;
  • Reduce the administrative burden associated with a PD/PI managing multiple NIGMS research grants; and
  • Enable PD(s)/PI(s) to devote more time and energy to mentoring junior scientists in a more stable research environment.

This FOA allows new applications from eligible PDs/PIs and renewals of both established investigator (EI) and early-stage investigator (ESI) MIRA grants.

In developing the MIRA program, NIGMS is committed to maintaining support for at least the current total number of NIGMS-funded investigators and their associated programs of research. The Institute will also work to ensure that it maintains a broad and diverse research portfolio in terms of scientific areas, approaches, regions, institutions, and individuals. Such diversity will optimize returns on the Institute’s investments by maximizing the ideas explored and the chances for important breakthroughs.

The NIGMS MIRA differs from other institutes' R35 awards in that MIRA is not a grant designed to support a small number of outstanding investigators; instead it could potentially support most NIGMS investigators.

Overview of the MIRA

An NIGMS MIRA is intended to provide support for the NIGMS-related research program in an investigator’s laboratory. NIGMS supports research on basic biological processes as well as translational and clinical research in certain areas. In addition to research designed to answer scientific questions and generate new ideas and hypotheses, the development of technology and computational approaches are supported. Within the scope of the MIRA, investigators will have the freedom to explore new avenues of inquiry that arise during the course of their research, as long as they remain within the mission of NIGMS. Work involving the addition of human subjects, vertebrate animals, stem cells, select agents, or a new foreign component would require prior approval by NIGMS staff according to existing policies and procedures.

In comparison to R01 funding of NIGMS investigators, MIRA benefits include:

  • A longer grant period - five-year awards rather than the current NIGMS median of 4 years;
  • More flexibility to pursue new ideas and opportunities as they arise during the course of research because the award is not tied to specific aims or predicated on completing specific, pre-defined projects;
  • Increased stability of funding through longer-term commitments of support, improved success rates, and more graduated, rather than all-or-none, funding decisions for R35 renewals;
  • A reduction in administrative burden associated with managing multiple grants;
  • A reduction in required application writing.

MIRA may not be the best mechanism to support all kinds of research, even though the research may be within the NIGMS mission. Because the MIRA is expected to support the research program of an independent investigator’s laboratory, PDs/PIs may find other grant programs better suited to research requiring financial support of collaborators and subcontractors.

Research involving human subjects is permitted in the MIRA program. Clinical research must be completely within the context of the NIGMS clinical areas (anesthesiology, clinical pharmacology, sepsis, injury and critical illness). Mechanistic clinical trials are permitted in MIRA when the mechanistic study is an essential part of the research program. 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. 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. Potential applicants are encouraged to confer with the program director managing their qualifying award(s), and if there are further questions, with the NIGMS Scientific/Research staff (in Section VII. Agency Contacts of this FOA) before submitting a MIRA application that includes clinical research. NIGMS does not intend to fund applications that contain clinical research within the missions of other Institutes and Centers at NIH or other federal agencies.

Because the MIRA is intended to support a significant and ambitious program of research, the PD/PI is required to devote at least 51% of his/her total research effort to this award. See Section III.1 Eligible Individuals for more information about this requirement.

Investigators receiving a MIRA will be required to relinquish their other NIGMS research grants, except for award mechanisms mentioned below. Investigators who receive support from the NIGMS research grants of other investigators as collaborators and subcontractors on R01s will not be permitted to receive funds from those sources.Investigators who receive funds as project leaders on multi-component grants (i.e. P01, P50 or RM1) will have their MIRA award level adjusted to remove any overlap between their MIRA and their multi-component grant. The MIRA Principal Investigator will be required to relinquish their involvement in the multi-component grant at the end of its competitive segment. NIGMS continues to encourage collaborative and interdisciplinary research when it is appropriate, and individual MIRA grantees are free to collaborate with one another or with other investigators using funds from their individual MIRA to support their contributions to the team's research. Investigators with K awards from another institute of the NIH may receive an NIGMS MIRA but will be required to adjust their person-months effort on those awards to be smaller than the person-months effort committed to MIRA. NIGMS will establish an orderly process to MIRA funding when reductions in other commitments are required. Details of how these changes may be accomplished are covered in Frequently Asked Questions on the MIRA web page.

The budget of a MIRA will be determined by NIGMS staff, based upon the funding history of the PD/PI, the recommendations of the initial review group and the National Advisory General Medical Sciences Council, and the expected productivity and impact of the program of research. NIGMS' Special Council Review policy for applications that result in over $750,000 total annual direct costs from all sources of research support being awarded to a PD/PI will apply to MIRAs. Although well-funded grantees (having more than $400,000 in direct costs from NIGMS research grants) applying for new EI MIRAs will generally receive budgets about 12% lower than their previous average NIGMS research funding levels (as determined by NIGMS staff), the Institute does not intend to use a similar blanket policy when setting budgets for MIRA renewals. Instead, the funding levels for each MIRA renewal will be independently determined based on a variety of considerations, including the results of peer review, the PD's/PI’s other support and commitments, and the Institute’s scientific priorities and available budget. Overall, we expect most budgets for MIRA renewals to be similar to what they were in the previous funding period, although some grants will have increased or decreased budgets based on the factors described above.

A researcher funded by a MIRA will not subsequently be awarded any other sources of NIGMS funding with the following exceptions:

  • Grants supporting resources for the research community (e.g. P30, P41, R24);
  • Contracts;
  • Grants supporting training, workforce development or diversity building;
  • Funding for clinical trials;
  • INBRE (P20), COBRE (P20/P30) or IDeA-CTRs (U54);
  • SBIR/STTR grants;
  • Conference grants.

NIGMS will not accept applications from MIRA grantees for awards not on the above list that would begin prior to the end date of the MIRA.

Supplements to MIRAs: MIRAs will be eligible for Research Supplements to Promote Diversity in Health-Related Research, for Research Supplement to Promote Re-Entry into Biomedical and Behavioral Research Careers, and for Administrative Supplements for Equipment Purchases. Other supplements offered by NIGMS may also be made available to MIRA grantees, depending on the intention and constraints of the particular supplement program.

Renewals: Because of the Institute's commitment to the MIRA program and the fact that there will be fewer applications as a result of the consolidation of separate research projects, NIGMS anticipates a higher success rate for R35 renewal applications than is the case for R01s. If an application for renewal of the MIRA is unsuccessful, the grant will terminate at the end of its approved project period. Although a Resubmission will not be accepted, a PD/PI may submit a new MIRA application in the next two fiscal years after the original project period expiration date. PDs/PIs may alternatively choose to submit a new R01 grant application to resume support of their laboratory through individual project funding.

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
Renewal

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

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 NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Applications may request no more than $750,000 direct costs per year. Investigators are encouraged to request well-justified actual costs for their research program and to recognize that efficient use of funds is an expectation of the MIRA program and is considered during the review process and in making funding decisions. In general, awards will be commensurate with the investigator’s average total NIGMS research funding over the past few years.

For new applications from PDs/PIs previously funded through NIGMS R01-equivalents, well-justified increases over previous funding levels will be considered for PDs/PIs previously supported by modest budgets (~$250,000 in annual direct costs or less), while modest reductions should be anticipated for well-funded PDs/PIs ($400,000 or more in annual direct costs from NIGMS). The MIRA budget will generally not be at the level of an NIH Transformative Research Award and will be significantly reduced from NIH Director's Pioneer Award (DP1) level.

For MIRA renewal applications, NIGMS expects that, on average, budgets will be similar to what they were in the previous award period. However, well-justified requests for increases will be considered and it is expected that some budgets will be increased or decreased based on the outcomes of peer review and assessments by NIGMS staff.

Other than years when equipment is requested, it is expected that the annual direct costs will remain constant in all years of an 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 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:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

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)
  • 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.

  • 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) – 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration , but 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 DUNS number and 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, 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. Women, individuals from underrepresented racial and ethnic groups, from disadvantaged backgrounds, or with disabilities are always encouraged to apply for NIH support.

For this FOA, PDs/PIs with a previously funded ESI or EI NIGMS R35 or at least one NIGMS single-PD/PI R01-equivalent award (defined here as R01, R37, DP1, DP2, and SC1 awards) are eligible to apply. Renewal MIRA applications need to be submitted no later than the end of the second NIH fiscal year following the original project period expiration date of the qualifying R35. An early renewal application can be submitted in any of the budget periods of a funded R35 if a PD/PI considers significant progress has been made to warrant a successful scientific review. Successful Renewal applications will be awarded in the fiscal year of Council review, and the current MIRA will be terminated upon the issuance of the new MIRA award. Thus, early Renewal applications may truncate the current project period. If a Renewal MIRA application is unsuccessful, a new MIRA application may be submitted if the PD/PI remains eligible.

For new MIRA applications from PDs/PIs with qualifying single-PD/PI R01-equivalent NIGMS award(s), the application may be submitted at any time prior to the original project period end date, but no later than the end of the fiscal year following the original project period expiration date of the qualifying award. Successful MIRA applications will be awarded in the fiscal year of Council review. All current NIGMS research grants will be terminated upon the issuance of the new MIRA grant. Investigators who receive funds as project leaders on multi-component grants (i.e., P01, P50 or RM1) will have their MIRA award level adjusted to remove any overlap between their MIRA and their multi-component grant. The MIRA Principal Investigator will be required to relinquish their involvement in the multi-component grant at the end of its competitive segment. A PD/PI with an unsuccessful MIRA application may apply again to this FOA if he/she remains eligible, but must submit a New Application, rather than a Resubmission which is not allowed for this FOA.

NIH will consider requests to extend the eligibility 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 window. Applicants seeking an extension of their eligibility status must contact a Scientific/Research Contact at least 8 weeks before submitting the application.

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

The PD/PI is required to devote at least 51% of his/her total research effort to this award. The total research effort should include his/her combined research effort at all institutions where the PD/PI holds an appointment, should be expressed in person-months, and should not include time expended toward teaching, administration not directly related to the PD's/PI's research, and/or clinical duties.

Only single PD/PI applications are allowed. Applications with multiple PD(s)/PI(s) will not be accepted.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

 

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.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101)
 

Because MIRAs are designed to provide support for a laboratory's research relevant to the mission of NIGMS, it is deemed to have overlap with any other pending research grant applications assigned to NIGMS. Therefore, NIGMS will not accept a MIRA application from an investigator who is the PD/PI of another NIGMS application under review, except as mentioned under Section I. Conversely, NIGMS will not accept any other applications from an investigator who has a MIRA application under 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 FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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.

Project Summary/Abstract:

For this FOA, use the abstract to provide an overview of research in the laboratory, the goals for the next five years, and the overall vision of the research program. Do not include specific aims or use any similar designation in the abstract. This abstract should serve both the needs of the public and the needs of the reviewers for an introduction to the research plan.

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

Biographical Sketches: A biosketch should only be provided for the PD/PI and in rare cases, for collaborator(s) receiving financial support from the MIRA.

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

Contributions to Science: This section of the biosketch should emphasize contributions over the past five years. Because this FOA is for PDs/PIs with funded R35 or R01-equivalent research funding from NIGMS, applicants are encouraged to clearly state contributions that are within the scientific mission of NIGMS and have resulted from NIGMS support. Cite all sources of support as originally acknowledged in the publications for each paper listed.

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

Research Support: List ongoing and completed research projects from the past three years that you want to draw attention to. Briefly indicate the overall goals of the projects and your responsibilities. Do not include the number of person months or direct costs.

Do not present include figures or preliminary data.

Current & Pending Support: This attachment is required. For the PD/PI only, use the SF424 R&R Current and Pending Support instructions as modified here. To minimize redundancy, grants and other support reported in the Current and Pending Support section can be simply listed by grant numbers or other relevant identifiers (for other types of support). Do not list Total Costs for the Entire Project Period; instead list Annual Direct Costs allocated to the MIRA PD's/PI's laboratory, only. List the PD's/PI's effort on each support mechanism in person-months.

All sources of support including foreign support should be reported. List NIGMS grants first, followed by other NIH grants, followed by other sources of support.

 

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

Itemized budget information is not required and will not be accepted. Instead, a total requested direct cost amount for each budget period, including requests for equipment purchase, is required. Other than years when equipment is requested, it is expected that the annual direct costs will remain constant in all years.

All instructions in the SF424 (R&R) Application Guide must be followed except as detailed below. While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 5 years of support.

In order to allow submission of a budget request without filling out detailed yearly budgets, some basic information must be completed in order for NIH to successfully process the budget form. For each budget period:

1. Select the appropriate Budget Type.

2. Provide the Budget Period Start Date and End Date.

3. Section A: Senior/Key Persons 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 imply that the PD/PI will not receive any salary or fringe benefit support from the grant.

4. In Section C: Enter budget request for equipment. Provide complete justification using the Budget Justification.

5. In Section F: Other Direct Costs add a line item titled ‘Requested Direct Costs’ and provide the total request for that budget period (up to $750,000). If equipment is requested in Section C, do not add the equipment budget in Section F. Other than when equipment is requested it is expected that the total annual direct costs requested will remain constant in future years.

Budget Justification: The following budget categories must be justified, where applicable: equipment, and consortium/subaward costs. For MIRA Renewal applications, justify any increase in funding requested over the previous project period. For applications for new MIRA grants, justify any requested increase in support relative to NIGMS research support over the previous three years.

Use the Budget Justification to provide the additional information requested in each budget category identified above only. Equipment quote(s) may be included here.

Consortium Justification: Consortium/Contractual Arrangements are not anticipated in most cases and must be extremely well justified. A letter from the subcontract PD/PI should be included making it clear why he/she cannot participate in collaborative research with the PD/PI without support from the MIRA. NIGMS will accept MIRA applications with foreign collaborations but will only provide funding for a foreign consortium arrangement when the collaboration is essential to the PD's/PI's research program and represents a unique scientific opportunity that cannot be supported by the collaborator without MIRA funds.

Provide an estimate of total consortium/subaward costs (direct costs plus indirect [F&A] costs) for each budget period, rounded to the nearest $1,000.

List the individuals/organizations with whom consortium or contractual arrangements have been made and indicate whether the collaborating institution is foreign or domestic.

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

R&R Subaward Budget

Do not complete the R&R Subaward form. All budget information should be provided on the R&R Budget form.

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:

Specific Aims: Do not submit a Specific Aims page or identify specific aims or use any similar designation in the Research Strategy.

Research Strategy: 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 contain the following information: 1) Background on the area(s) of research and key gaps in our understanding or important challenges to be addressed. 2) Recent Progress by the PD/PI which focuses on the past five years. Do not repeat material adequately covered in the Biosketch. 3) Overview of Future Research Plans. This should be a description of the key questions or challenges the PD/PI plans to address and the general strategies that might be used to approach them. The focus should be mainly on the importance of the questions or challenges. A detailed experimental plan should not be provided. Although the proposed direction of the PD's/PI’s scientific program will be considered in review, if new opportunities or directions within the mission of NIGMS arise during the course of the research, the PD/PI will have the flexibility to change course and pursue them.

Given that the MIRA is intended to enable consolidation of NIGMS support for multiple projects that may be disparate, there is no obligation to develop a single unifying theme. Applicants should directly address the rationale underlying the balance of effort and the resources dedicated to each activity, and how the activities are distinct or complementary.

The research strategy should address the requirements of the NIH policy on rigor and transparency in research as detailed in NOT-OD-18-228. This section should also address requirements related to sex as a biological variable as detailed in NOT-OD-15-102.

Progress Report Publication List: For renewal MIRA applications, follow the instructions in the SF424 Application Guide to prepare the progress report publication list. In addition, for each publication identify all funding sources acknowledged, and for those publications with multiple funding sources, identify which aspects were supported by the MIRA.

Letters of Support: Letters of support from collaborators should be limited to 1-2 pages, may not include attached Biographical Sketches, and must not circumvent page limitations by including figures and data.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should include both a Resource and a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
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 SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

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.

For this FOA:

  • A permanent change of PD/PI will not be allowed under the MIRA. A temporary change may be allowed with NIGMS' prior approval under circumstances such as sabbatical leave, medical conditions, disability, or personal or family situations. In case of changes in employment of the PD/PI (e.g., accepting an appointment at another institution, while retaining an appointment at the institution which received the MIRA award), the PD/PI is required to maintain his/her commitment to MIRA as originally reviewed and approved. The situation will be evaluated on a case by case basis and the MIRA could be terminated if continued support is not warranted.
  • Transfer of a MIRA to a foreign institution will not be allowed. Addition of a foreign component, including a significant new foreign collaboration, requires NIGMS' prior approval; however, MIRA funds may be used to support a subcontract at a foreign institution, but only if the collaboration is essential to the PD's/PI's research program, represents a unique scientific opportunity and cannot be supported by the collaborator without MIRA funds.
  • The MIRA will replace all current NIGMS research funding of the laboratory. Institutions will be required to relinquish their interests in current NIGMS-funded research grants and withdraw pending applications where the MIRA investigator is listed as the PD/PI or multi-PD/PI.
  • The PD/PI of a MIRA cannot receive funds from other NIGMS grants (e.g., as a sub-project leader or as the recipient of a sub-contract), excepting those listed in Section I.
  • NIGMS will not consider funding future individual PD/PI or multiple PD/PI research grant applications from a MIRA investigator during the MIRA funded project period, except for applications included under the list of exempted awards in Section I. Thus, NIGMS will not accept applications for grants not on the list of exempted awards from MIRA PDs/PIs unless the earliest start date of the grant is after the end date of the MIRA grant.
  • Because most institutions expect some commitment from investigators to administrative, teaching and/or clinical duties, any salary support for the PD/PI charged to the grant should generally be less than 51% of the PD/PI's annual salary and should in no case be more than the actual research effort the PD/PI will devote to the grant.

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 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 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 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.

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.

For this particular announcement, note the following:

The goal of the MIRA program is to provide support for a laboratory’s research program that is within the NIGMS mission, and to give investigators relative freedom in pursuing their research goals. For this FOA, applicants are expected to provide an overview of the research program/scientific questions they currently plan to address and a general description of possible strategies. Experimental details are not expected. Given that a MIRA is intended to administratively consolidate projects that may be scientifically disparate, there is no obligation for the PD/PI to present a single unifying theme.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the program 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 proposed program).

Review Criteria

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. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a research program that by its nature is not innovative may be essential to advance a field.

 

Does the research program address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the goals of the research are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the research change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

For this FOA: Are the theme and/or topics of the research program substantive and appropriate for long-term pursuit? Is the proposed research program appropriate in scope and ambition to address the scientific questions posed?

In addition, for applications involving clinical trials: Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?

 

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the research program? Has the PD/PI demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the research is collaborative, do the investigators have complementary and integrated expertise?

For this FOA: Does the PD/PI have a consistent and current record of productivity and scientific impact commensurate with the applicant's current career stage and support level? Is he/she clearly the intellectual driver of the proposed research program? Has the PD/PI shown evidence of being creative and adaptable, able to recognize new opportunities and explore new areas of scientific inquiry, and open to the use of new systems and strategies, as appropriate for the proposed research program? Does the PD/PI have a record of conducting and reporting rigorous, reproducible, transparent, and cost-effective research? Does the PD/PI have a record of significant service to the scientific community?

In addition, for applications involving clinical trials: With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

 

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?

For this FOA: Will creative strategies be employed as needed and appropriate to address the research questions posed? Is there evidence that the freedom and flexibility of the MIRA will lead to innovation?

In addition, for applications involving clinical trials: Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

 

Is the overall strategy well-reasoned and appropriate to accomplish the goals of the research program? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed research? Has the PD/PI 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 research program is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? Has the PD/PI presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

For this FOA: Is there a logical plan for sustained progress across a research program for the award period? Is there evidence that the research program will evolve appropriately as the work is performed? Do the plans reflect sensitivity to the need for cost-effectiveness in research?

In addition, for applications involving clinical trials: Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

 

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 research program proposed? Will the research program benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials: If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria
As applicable for the proposed program, 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.

Study Timeline

Specific to applications involving clinical trials: Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

 

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

 

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.

 

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.

 

Not Applicable

 

For Renewals, the committee will consider the progress made in the last MIRA funding period. For renewals of previous ESI MIRAs, has the PD/PI established a research program with the potential for continued growth and enhanced scientific impact? For renewals of established investigator MIRAs, has the PD/PI maintained a productive research program with strong evidence of impactful contribution to the field and recognition of new opportunities and directions?

 

Not Applicable

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.

 

Not Applicable

 

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).

 

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).

 

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.

 

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research. Reviewers will rate the budget request as either (1) appropriate, or (2) excessive in relation to the scope and predicted impact of proposed research program.

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.

All applications will be assigned to NIGMS. Applications will compete for available funds with all other recommended applications submitted . Following initial peer review, recommended applications will receive a second level of review by the National Advisory General Medical Sciences Council.

The following will be considered in making funding decisions:

  • Scientific and technical merit of the proposed research as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed research to NIGMS' priorities.
  • Contributions to portfolio breadth and diversity as outlined in the NIGMS Strategic Plan.
  • Other funding support to PD/PI.

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 and this FOA. Additionally, a signed letter from the institution's Authorized Organizational Representative (AOR) stipulating to the following points will be required as just-in-time information after review for applications being considering for funding:

  • The PD/PI will devote at least 51% of his/her total research effort to this award, inclusive of his/her combined research effort at all institutions where he/she holds an appointment (including foreign institutions). The total research effort should be determined in person-months and should not include time expended toward teaching, administration not directly related to the PD's/PI's research, and/or clinical duties.
  • The institution and PD/PI are aware of and accept that other NIGMS research awards, except as allowed in Section I, must be relinquished, and pending NIGMS research applications withdrawn, as a condition of receiving a MIRA.

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.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols. Data and Safety

Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

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 https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://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 https://www.hhs.gov/civil-rights/for-individuals/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) Under Section B.1 What are the major goals of the project? Note that the goals of the program of research supported by the MIRA are broader than the specific aims of a single project and should be appropriately described. If the goals of the MIRA have changed, complete section B.1.a. Provide a rationale for the changes in the context of the originally proposed research program and give an explanation of how the research continues to fit within NIGMS mission interests.

b) Under Section B4, Opportunities for Training and Professional Development, indicate if individual development plans have been used for any graduate students and/or post-doctoral fellows supported by this award.

c) Under section D.2.c. Changes in Other Support, indicate if there have been changes in Other Support. In addition to the revised Other Support page, include an explanation of how changes in other support relate to the activities supported by the MIRA.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

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, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Zhongzhen Nie, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: MIRA2019RESEARCH@NIGMS.NIH.GOV

Peer Review Contact(s)

Maqsood Wani, Ph.D.
NIH Center for Scientific Review (CSR)
Email: wanimaqs@csr.nih.gov

Financial/Grants Management Contact(s)

Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Email: MIRA2019FINANCIAL@NIGMS.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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