Required Application Instructions

It is critical that applicants follow the instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Supporting fundamental research by funding individual projects has a number of consequences for the efficiency and effectiveness of the biomedical research enterprise in the U.S. To address these issues and increase the efficiency and efficacy of its funding mechanisms, NIGMS launched a pilot program that awards a single grant to provide support for the research in an investigator's laboratory that is related to the mission of NIGMS (See: MIRA web page). It is anticipated that this new funding mechanism 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 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; and
• Enable investigators to devote more time and energy to mentoring junior scientists in a more stable research environment.

In developing the Maximizing Investigator's Research Award (MIRA), 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, regional and institutional distribution, and scientific workforce. Such diversity will optimize returns on the Institute’s investments by maximizing the ideas explored and the chances for important breakthroughs. Because MIRA involves reprogramming of money already awarded to NIGMS investigators, it is expected to be neutral with respect to the investigator-initiated, research project grant budget.

The NIGMS MIRA program is similar to other NIH R35 awards, in that it supports the work of a single investigator's laboratory in the mission of the institute; however, it differs from the NCI Outstanding Investigator Award, and others, in that it is eventually intended to support most NIGMS investigators.

Overview of the MIRA

An NIGMS MIRA grant is intended to provide support for the NIGMS-related research in an investigator’s laboratory. Research areas supported by NIGMS are outlined on the NIGMS website. Within these bounds, investigators will have the freedom to explore new avenues of inquiry that arise during the course of their research. Work involving the addition of human subjects, vertebrate animals, stem cells, select agents, or a new foreign component would require prior approval of NIH staff according to existing policies and procedures. Research that involves a major change in scientific focus or that migrates away from the mission of NIGMS and/or into an area of major interest of one of the other NIH Institutes or Centers warrants a discussion with NIGMS program staff.

MIRA may not be the best mechanism to support all kinds of research, even though it is within the NIGMS mission. For example, clinical research, requiring highly detailed human subjects protocols and milestones, may be more appropriately supported by other mechanisms. In addition, since the flexibility of MIRA allows for work in any area of the NIGMS mission, it may not be the best mechanism to support laboratories that are fully committed to research on HIV/AIDS, which is supported with funds from the Office of AIDS Research, NIH. Confer with NIGMS program staff (or the Scientific/Research staff indicated in Section VII. Agency Contacts of this FOA) before applying for research in these areas.

Because the MIRA grant is to provide support for the research in an investigator's lab related to the mission of NIGMS, the investigator is required to devote at least 51% of his/her research effort, which does not include effort expended toward teaching, administration and/or clinical duties. Because most institutions expect some commitment from investigators to administrative, teaching and/or clinical duties, any salary support for the PD/PI requested on the grant should generally be less than 51% of total professional effort and should in no case be more than the actual effort the PD/PI will devote to the grant.

Investigators receiving a MIRA award are required to relinquish their other NIGMS research grants. NIGMS will negotiate an orderly process for this transition to occur. Details of how this will be accomplished are covered in Frequently Asked Questions on the MIRA web page.

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 grants to support their parts of the team s research. Because the MIRA is expected to support the research program of an individual independent investigator’s laboratory, PDs/PIs may find other support mechanisms better suited to research requiring financial support of many collaborators and subcontractors.

The amount of a MIRA award will be determined by NIGMS staff, based on the recommendations of the initial review group and the National Advisory General Medical Sciences Council, and staff evaluation of the needs, expected productivity, and impact of the program of research. NIGMS will continue to use its $750,000 total direct cost Special Council Review policy in considering all sources of investigator support. It is anticipated that, in general, the amount of a MIRA award will be somewhat less than the sum of all recent concurrent NIGMS support. Investigators should balance a reduction in funding against the benefits of the award when deciding to apply. Benefits include:

• MIRA awards will be for 5 years instead of the current NIGMS average of 4 years;
• Separate applications to continue support for individually funded projects ending during the MIRA grant period or currently in no cost extension will be unnecessary;
• 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;
• A reduction in administrative burden associated with managing multiple grants; and
• A reduction in required application writing.

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

• Grants supporting research resources;
• Contracts and selected cooperative agreements;
• Grants supporting training, workforce development or diversity building;
• Funding for clinical trials;
• SBIR/STTR grants;
• Conference grants;
• Grants supported through NIGMS HIV/AIDS-related FOAs;
• Grants managed by NIGMS but supported through Common Fund resources.

Renewals: NIGMS plans for MIRA grants to be renewable. Because there will be fewer applications as a result of the consolidation of separate research projects, NIGMS anticipates a higher success rate than is the case for current research project grants. If an application for renewal of the MIRA award is unsuccessful, the grant will terminate at the end of its approved project period. However, NIGMS anticipates that it will provide a ramp down of funding rather than terminate support immediately in most instances.

Supplements to MIRA grant awards: MIRA awards will be eligible for Research Supplements to Promote Diversity in Health-Related Research and other types of administrative supplements, including equipment supplements that may be offered by NIGMS through FOAs in the NIH Guide. NIGMS anticipates publishing an FOA for Competitive Supplemental Applications (Revisions) to support increases in scope beyond the ability of the investigator to accommodate through reprioritization of existing resources (e.g., addition of human subjects); however, generally, applicants will be expected to reallocate existing resources to accommodate new research directions.

Implementation Plan and Pilot Testing: NIGMS tested the MIRA concept on a small scale using RFA-GM-16-002 to enable the number of applications and phase-in of the MIRA program to be carefully managed and assessed. Because the MIRA program is still considered a pilot and enlisting well-funded laboratories in the program as well as limiting the total number of applications continue to be useful implementation strategies, eligibility for this FOA is again restricted. See Section III. Eligibility. NIGMS anticipates broadening the MIRA program to all NIGMS-funded investigators in the near future. A separate FOA, RFA-GM-16-003, tested the MIRA concept for applications from New and Early Stage Investigators. This FOA may be reissued pending evaluation of the first announcement.

NIGMS investigators with additional NIH support from other ICs may apply, but are prohibited from requesting funds for similar work as part of an NIGMS MIRA application. Investigators are free to submit regular R01 grant applications in accordance with NIH policy to continue support for these projects in the usual manner.

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

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)
• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

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) (formerly CCR) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

Eligibility is restricted to investigators who received either two or more R01 equivalent awards (defined here as R01, R37 awards), or a single award of greater than $400,000 direct costs, from NIGMS in FY2014 or 2015 and with one or more of their awards expiring in FY2017, FY2018, or FY2019. Other investigators are ineligible.

PD/PIs who submitted a response to RFA-GM-16-002 and remain eligible for this FOA are welcome to apply but must submit a New Application, rather than a Resubmission.

PD/PIs must be able to devote 51% of their research effort to the MIRA, not including effort expended toward teaching, administration and/or clinical duties.

NIGMS anticipates issuing additional FOAs that will broaden eligibility if the initial tests are successful.

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

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Because MIRA is designed to provide support for the NIGMS mission-related research in the laboratory, a MIRA application is deemed to have overlap with any other pending applications assigned to NIGMS. Therefore, NIGMS will not accept a MIRA application on May 20, 2016 from an investigator who is the PD/PI of another NIGMS application submitted for the October, 2016, January 2017, or May 2017 Council rounds, except as mentioned under Section I. Conversely, NIGMS will not accept any other applications for these Council rounds from an investigator who submits a MIRA application, except as mentioned under Section I.

Applicants must obtain the SF424 (R&R) application package associated with this funding opportunity using the Apply for Grant Electronically button in this FOA or following the directions provided at Grants.gov.

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

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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Peter C. Preusch, Ph.D.
Telephone: 301-594-0828
Fax: 301-480-2004
Email: preuschp@nigms.nih.gov

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

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.

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

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

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

Project Summary/Abstract: Use the abstract to provide an overview of research in the laboratory and the goals for the next five years and overall vision of the research program. This document should serve both the needs of the public and the needs of the reviewers for a description of the research program.

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

Biographical Sketch: Use the Personal Statement to address MIRA-specific elements of the Investigator Review Criterion. Include descriptions of significant service and contributions to the scientific community beyond contributions of research results, and including any contributions to enhancing the efficiency and productivity of the research community, as well as any related to the development of the next generation of researchers. Under the section on research contributions, emphasize especially contributions over the past five years. Be sure to include a link to your My Bibliography list of publications and be sure the data are complete and up to date.

Do not use the Biosketch to circumvent page limits of the research plan by including figures or preliminary data.

Include Biosketches for any subcontracted independent investigators and include the same information that is requested for the PD/PI.

Do not include Biosketches for Other Significant Contributors who are not Key Personnel.

Current & Pending Support: Use the SF424 R&R Current and Pending Support instructions as modified here and attach this information to the Senior/Key Personnel Form. Rather than Total Costs for the Entire Project Period, list Annual Direct Costs allocated to the MIRA PD/PI's laboratory, only.

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. 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.

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

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 they cannot participate in collaborative research with the PD/PI without support from the MIRA. NIGMS will accept MIRA applications with foreign collaborations, but will not provide funding for foreign consortium arrangements.

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

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

Specific Aims: Do not submit Specific Aims

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, focusing on the past five years. Do not repeat material adequately covered in the Biosketch. Do NOT include a Publication List. Instead, include references as necessary in the Bibliography & References Cited section in the Other Project Information Form. 3) Overview of Future Research. 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 on the importance of the questions or challenges. A detailed experimental plan is not expected. Although the proposed direction of the PD/PI’s scientific program will be considered in review, if new opportunities or directions 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 consolidate NIGMS support for multiple projects that may be disparate, there is no obligation to develop a single unifying theme. The presentation in this case may be challenging and the abbreviated research strategy section may make it difficult to provide adequate background. At a minimum, 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 rigor and transparency in research and requirements related to sex as a biological variable, an indicated in the SF 424 (R&R) Application Guide.

Letters of Support: The application must include a letter from the institution’s Authorized Organizational Official (AOR) indicating that they are aware of and accept the condition that other NIGMS research awards must be relinquished as a condition of receiving a MIRA award, and providing a statement that if chosen to receive an award, the PD/PI will commit a minimum of 51% of their research efforts to MIRA activities.

Letters of support from collaborators must 1) be no more than 2 pages; 2) not include attached Biographical Sketches; and 3) 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, with the following modification:

• All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.

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

When conducting clinical research, follow all instructions for completing Planned Enrollment Reports as described in the SF424 (R&R) Application Guide.

When conducting clinical research, follow all instructions for completing Cumulative Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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.

This initiative is not subject to intergovernmental review.

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 prior approval under circumstances such as sabbatical leave, medical conditions, disability, or personal or family situations such as child or eldercare.
• Transfer of a MIRA to a foreign institution will not be allowed. Addition of a foreign component, including a significant new foreign collaboration, requires prior approval; however, MIRA grant funds may not be used to support a subcontract at a foreign institution.
• It is expected that the MIRA will replace all current NIGMS funding of the laboratory. Institutions will be required to relinquish their interests in current NIGMS-funded research grants where the applicant investigator is listed as the PD/PI
• It is expected that the PD/PI will renegotiate effort on other grants, if necessary, to permit 51% research effort on the MIRA. A temporary reduction in effort may be approved under circumstances such as medical conditions, disability, or personal or family situations such as child or eldercare.
• NIGMS will not consider funding future individual PD/PI or multiple PD/PI research grants from a MIRA investigator during the MIRA award project period, except for applications included under the list of exempted awards in Section III.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by staff of the NIGMS, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed. All MIRA applications will be administratively reviewed to identify research which is currently funded by and that fits appropriately within the mission of other NIH components.

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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

For this particular announcement, note the following:

The goal of MIRA is to provide support for a laboratory s research program that is related to 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 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.

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

Reviewers will consider each of the review criteria below in the determination of scientific merit, but will assign only a single overall impact score. 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 there a strong scientific premise for the research program? If the aims of the research program 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: Is 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?

Are the PD/PI, collaborators, and other researchers well suited to the research program ? Has the PD/PI demonstrated an ongoing record of accomplishments that have advanced his/her field(s)? If the project is collaborative, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

For this FOA: Does the PD/PI have a consistent and current record of productivity and scientific impact, and is he/she driving the proposed research program for the future? 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, careful and cost-effective research? Does the PD/PI have a record of significant service and contributions to the research community?

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 the overall strategy well-reasoned and appropriate to accomplish the overall goals of the research program? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 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 investigator presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

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

For this FOA: Is there a sound basis for the proposed research program? Is there evidence that the research program will evolve appropriately as the work is performed?

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?

As applicable for the research program proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

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

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

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

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

Not Applicable

Not Applicable

As applicable for the research program 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 research programs 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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Office of Scientific Review, NIGMS, 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:

• Will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. 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 project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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.

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 http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.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

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.

For this FOA, the instructions are hereby modified as follows:

a) Under Section 6.2 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 further contributions to the field, and an explanation of how the research continues to fit within NIGMS mission interests.

b) Under Section B.2, in addition to the instructions, emphasize how the work continues to be innovative and of high impact.

c) Under section D.2.c. additional information, indicate if there have been changes in Other Support. In addition to the revised Other Support page, include an explanation of the relationship of the new awards to the activities supported by the MIRA.

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

In carrying out its stewardship NIGMS will evaluate the MIRA programs, employing the measures identified below. In assessing the effectiveness of its research investments, NIH may request information from databases, PD/PIs, and participants themselves. NIGMS will assess the program s overall outcomes and gauge its effectiveness in increasing the efficiency and efficacy of NIGMS funding. Upon the completion of a program evaluation, NIGMS will determine whether to (a) continue the program as currently configured, (b) continue with modifications, or (c) discontinue the program.

Evaluation Measures:

The overall evaluation of the program will be based on metrics that will include, but are not limited to, the following:

• Number of established investigators volunteering to convert R01s to NIGMS MIRAs.
• Publication rate of NIGMS MIRA grantees vs. traditional NIGMS grantees
• Citation rate of NIGMS MIRA grantees vs. traditional NIGMS grantees
• Level of interest of other NIGMS grantees and applicants in obtaining NIGMS MIRAs.
• Changes in NIGMS funding distribution and number of investigators supported by the Institute.
• Changes in the distribution over time of research topics studied by NIGMS MIRA vs. traditional grantees.
• Rate at which NIGMS MIRA grantees elect to apply to renew their awards vs. re-enter the traditional system.

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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726
Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-710-0267

Peter C. Preusch, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-0828
Email: preuschp@mail.nih.gov

Brian R. Pike, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3907
Email: pikbr@mail.nih.gov

Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: moellerl@nih.gov

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.

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.