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 is launching a pilot program that will award a single grant to provide support for all of the research in an investigator's laboratory that is related to the mission of NIGMS. 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 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, investigator career stages, and investigator backgrounds. Such diversity will optimize returns on the Institute’s investments by maximizing the ideas explored and the chances for important breakthroughs.

In July, 2014 NIGMS issued a Request for Information (RFI): Soliciting Comments on a Potential New Program for Research Funding by the National Institute of General Medical Sciences (NOT-GM-14-122) to seek community input on its ideas. Responses were overwhelmingly positive as described to the National Advisory General Medical Sciences Council at its meeting on September 19, 2014.

An NIGMS MIRA grant is intended to provide support for all of the NIGMS-related research in an investigator’s laboratory. Within the scope of the MIRA grant, 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 would warrant a discussion with NIGMS program staff.

Investigators receiving a MIRA award are required to relinquish their other NIGMS research funding with the exception of Mentored Career Development (K) awards, and the excepted award mechanisms mentioned below. Investigators with funding from NIGMS program project or center grants will be required to relinquish this funding and conduct their portion of the project using MIRA funds. 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 grant is to support a broad and ambitious program of research, the investigator is required to devote at least 51% of his/her research effort, not including effort expended toward teaching, administration and/or clinical duties. Effort already committed to research by investigators who are supported by Mentored Career Development (K) awards will be considered to meet the requirement for effort on a MIRA award.

The amount of a MIRA award will be determined by NIGMS staff, depending on the recommendations of the study section 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 the amount of a MIRA award to a new investigator will be somewhat larger than the current average NIGMS R01 award to new investigators, while the project period will be similar to the current average NIGMS R01 award to new investigators.

MIRA is expected to provide the following benefits to new investigators:

• More flexibility to pursue new ideas and opportunities that are within scope 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 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 be provided 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, including individual career development mechanisms;
• Funding for clinical trials;
• SBIR/STTR grants;
• Conference grants

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. NIGMS also anticipates there will be opportunities for increases in the budget of MIRA awards to New PDs/PIs and ESIs upon renewal. 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 their existing resources (e.g., addition of human subjects); however generally, applicants will be expected to reallocate existing resources within the MIRA project period to accommodate new research directions.

Implementation Plan and Pilot Testing: The first test of the MIRA concept, PAR-16-002, Maximizing Investigators' Research Award (R35), was issued on January 27, 2015 for established investigators. First applications will be received May 20, 2015 with start dates anticipated in April, 2016. The immediate goal of the current FOA is to test the MIRA concept for new investigators on a small scale. The number of applications and phase-in of the MIRA program must be carefully managed and assessed. The FOA is intended for junior investigators in their first independent faculty position. For that reason, eligibility is limited to early stage investigators and new investigators who are at the assistant professor rank or hold the equivalent entry level independent investigator position defined by their institution.

Evaluation

NIGMS intends to evaluate the MIRA program as it is implemented and periodically thereafter. Both the process and the outcomes of the awards will be monitored relative to the intent of the MIRA program and the NIGMS mission. Particular attention will be paid to maintaining and improving the diversity of the NIGMS portfolio along all dimensions of diversity, including race/ethnicity, gender, career stage, geography, institutional setting, and areas of scientific research.

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)

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 Director/Principal Investigator (PD/PI)

All PD/PI must have an eRA Commons account. PD/PI 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.

Individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) are 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.

This FOA targets investigators who are beginning their independent research careers. Applications will be accepted from: a) NIH defined Early Stage Investigators; and b) NIH defined New Investigators who are at the assistant professor rank or hold the equivalent entry level independent investigator position defined by their institution. Postdoctoral fellows, including those on K99 awards, who have not established an independent laboratory are not eligible to apply. Individuals who have transitioned from the K99 phase to the R00 phase of a NIH Pathway to Independence Award are eligible to apply for a MIRA. PDs/PIs of Mentored Career Development (K) awards are eligible to apply for a MIRA award.

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

PD/PI must be able to devote 51% of their research effort to the MIRA, not including effort expended toward teaching, administration and/or clinical duties. Effort already committed to research by investigators who are supported by Mentored Career Development (K) awards will be considered to meet the requirement for effort on a MIRA award.

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).

NIGMS will only accept one MIRA application from a given PD/PI. For this FOA, the PD/PI will no longer be able to receive support for his/her laboratory from NIGMS grants of other PD(s)/PI(s). A MIRA PD/PI may choose to serve as senior/key personnel on another PD/PI's MIRA grant but support for that effort should come from one's own MIRA award.

Applicants must download 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: [email protected]

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

• For this specific FOA, the Research Strategy section is limited to 6 pages.

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.

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

Biographical Sketch: The PD/PI should use the Biosketch to address MIRA specific elements of the Investigator Review Criterion. Indicate training experiences that are relevant to the proposed program of research. Explicitly address intellectual and technical contributions to any publications with former mentors and highlight contributions since becoming an independent investigator. Include experience as a mentor of undergraduate and graduate students, postdoctoral associates.

Other independent investigators may be included as senior/key personnel on the project, but not if they are also applying for a MIRA in response to this or other FOAs. Include biosketches for senior/key personnel and for any subcontracted independent investigators.

Current & Pending Support: Use the SF424 R&R Current and Pending Support instructions and attach this information to the Senior/Key Personnel Form. List NIGMS grants first, followed by other NIH grants, followed by other sources of support.

Provide a list of all current and pending support for the PD/PI (even if they receive no salary support from the project(s)) for ongoing projects and pending applications. Show the total award amount for the entire award period (including indirect costs) as well as the number of person-months per year to be devoted to the project by the senior/key person, regardless of source of support. Concurrent submission of an application to other organizations that are not components of NIH or the Public Health Service will not prejudice its review.

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. Holders of Mentored Career Development (K) awards may receive salary from a MIRA only in the last two years of their K award period.

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 of collaboration 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 that purpose.

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 containing the following information: 1) Background on the area(s) of research and key gaps in our understanding or important challenges to be addressed; 2) Description of recent progress by the PD/PI. 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 program. 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 that are within the scope of the grant, the PD/PI will have the flexibility to change course and pursue them.

Letters of Support: The application should include letters of support from collaborators and subcontractors. The application must include a letter from the institution’s Authorized Organizational Representative (AOR) indicating that they are aware of and accept the condition that other NIGMS research support must be relinquished as a condition of receiving a MIRA award, that the PD/PI will not be able to apply for additional NIGMS awards, except as provided in Section I, and provide 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. In addition a letter of support should be included from the department chair, dean, or other academic unit leader testifying to the institutional commitment to development of the investigator, junior faculty mentoring plans, and any other pertinent information.

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.

Part I. Overview Information contains information about Key Dates. 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.

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. If a Changed/Corrected application is submitted after the deadline, the application will be considered late.

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 for this purpose.
• It is expected that the MIRA will replace all current NIGMS research funding of the laboratory, with the exceptions noted in Section I. Institutions will be required to relinquish current NIGMS-funded research grants where the applicant investigator is listed as the PD/PI. The PD/PI will no longer be able to receive support for his/her laboratory from NIGMS grants of other PD(s)/PI(s). The initial budget period of the MIRA and timing of the award will be negotiated so that a smooth transition of support takes place.
• PDs/PIs of Mentored Career Development (K) awards will be permitted to receive salary from a MIRA only during the last two years of the K award period. Research expenses provided through the K award will be relinquished and replaced by research support through the MIRA.
• 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 applications from a MIRA investigator during the MIRA award project period, except for applications included under the list of exempted awards in Section I. Applications for awards to begin after the MIRA project period ends would be accepted but it is anticipated that most investigators would submit an application for continuation of the MIRA instead.

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.

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. Applicants are discouraged from including in a MIRA application 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 entire 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.

Reviewers will be asked to emphasize the training, record of past contributions, and potential of the investigator to establish a strong independent research program and the investigator's vision for how the program will evolve over their early career to have a significant impact in their chosen area of science.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

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, research 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? If the overall goals of the research program are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will obtaining answers to the scientific questions posed change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

For this FOA: Is the proposed research program substantive in scope and appropriate for long-term pursuit? Is the proposed research program adequately broad and ambitious? Will the proposed research program permit the investigator to establish a uniquely independent place in the field of research?

Are the PD/PI, collaborators, and other researchers well suited to the research program? Do they have appropriate experience and training? 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: Is the PD/PI's training appropriate for conducting the proposed research program?

Does the PD/PI have a record of productivity and scientific impact? Has the PD/PI shown evidence of being creative and adaptable, able to recognize new opportunities and to explore new areas of scientific inquiry, and openness to the use of new systems and strategies? Does the PD/PI have a record of conducting rigorous, reproducible, careful research? Does the PD/PI have strong potential to establish a successful independent program of research in his/her own laboratory? Does the PD/PI show promise as a mentor of undergraduate and graduate students, and postdoctoral associates, and the potential to establish a record of professional service?

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: Is there evidence that creative strategies will 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? If the research program is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed?

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 effort? Is there evidence that the research program will evolve appropriately as the work is performed? Is the research likely to be performed rigorously and the results interpreted carefully? Do the plans reflect sensitivity to the need for cost effectiveness in research?

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

For this FOA: What is the evidence that the PD/PI has an independent research position in which he/she can set the scientific goals and the strategies to achieve them? What is the evidence that the environment will be conducive to the development of the ESI or New PD/PI and will facilitate his/her advancement as an established investigator whose laboratory will have a sustained impact on science? What is the evidence of institutional support and mentoring?

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

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

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. 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 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 Wide Association Studies (GWAS) /Genomic Data Sharing Plan.

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 special emphasis panel Scientific Review Groups convened by the Center for Scientific Review, specifically for the purpose of reviewing applications only in response to this FOA, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to the 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.

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

Applications will be assigned to the National Institute of General Medical Sciences. 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.

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.

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.

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.

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

• Number of ESIs and New PIs who apply for MIRAs instead of R01s.
• Publication rate of NIGMS MIRA grantees vs. traditionally funded NIGMS grantees.
• Citation rate of NIGMS MIRA grantees vs. traditionally funded NIGMS grantees.
• Changes in NIGMS funding distribution and number of investigators supported by the Institute.
• Changes in the diversity of NIGMS supported investigators and the portfolio of research they undertake.
• 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)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)
Finding Help Online: http://grants.nih.gov/support/index.html
Email: [email protected]

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: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (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: [email protected]

Maqsood Wani, Ph.D.
NIH Center for Scientific Review (CSR)
Telephone: 301-435-2270
Email: [email protected]

Lisa Moeller
National Institute of General Medical Sciences (NIGMS)
Telephone: 301-594-3914
Email: [email protected]

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.