Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization.

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

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

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

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

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



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

The NIGMS Maximizing Investigators' Research Award (MIRA) provides support for the NIGMS-relevant program of research in an investigator's laboratory. For this NOFO, the "program of research" is defined as a collection of projects in an investigator's laboratory that are within the mission of NIGMS. This NOFO allows applications from eligible Program Directors/Principal Investigators (PDs/PIs) who are NIH-defined Early Stage Investigators (ESIs) at the time of submission.

It is anticipated that MIRA will achieve the following:

• Enable investigators to apply earlier in their independent research careers, allowing them to secure grant funding that will launch and sustain productive research careers.
• Enhance investigators' ability to move into research areas that are distinct from those of their postdoctoral mentors by not requiring or expecting preliminary data, which could lead to new scientific discoveries.
• Larger award amount than the current average NIGMS R01 award to ESIs.
• 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 adapt to 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.
• Enable investigators to devote more time and energy to mentoring trainees in a more stable research environment.

NIGMS will also work to ensure that it maintains a broad research portfolio in terms of scientific areas, approaches, regions, institutions, and individuals. Such breadth will optimize returns on the Institute's investments by maximizing the ideas explored and the chances for important breakthroughs.

The NIGMS MIRA differs from other institutes' R35 awards in that MIRA is not a grant designed to support a small number of investigators; instead, the Institute intends to have at least 60% of the R01-equivalent pool eventually be MIRAs as stated in the Institute's strategic plan.

NIGMS recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a broad scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see Section IV.2 SF424(R&R) Other Project Information. Other Attachments). For further information on the PEDP, please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples.

Examples of structures that promote diverse perspectives include but are not limited to:

• Trans-disciplinary research projects and collaborations among investigators from different fields
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Participation of individuals from diverse backgrounds, including groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

Overview of the ESI MIRA

An NIGMS ESI MIRA is intended to provide support for the NIGMS-related research program in an ESI's laboratory. NIGMS supports research on basic biological processes as well as translational and clinical research in certain areas. In addition to research designed to answer scientific questions and generate new ideas and hypotheses, the development of technology and computational approaches are supported. Within the scope of the MIRA, investigators will have the freedom to explore new avenues of inquiry that arise during the course of their research, as long as they remain within the mission of NIGMS.

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

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

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

Overlap During Peer Review

A PD/PI may submit a research project grant application (i.e., R01) and an ESI MIRA application for the same council round. Submission of other research grant applications (e.g., R15, R16, R21) within NIGMS mission is not allowed while an ESI MIRA application is pending review* at the same time, with the following exceptions:

• Grants supporting resources for the research community (e.g., R24);
• Collaborative Program Grant for Multidisciplinary Teams grants**;
• Biomedical Technology Optimization and Dissemination Center (BTOD) grants***;
• Grants supporting training, workforce development, or diversity building;
• Grants supporting multi-site clinical research, both clinical trials and observational studies, with costs for patient recruitment, protocol-related expenses, and/or community resource activities (e.g., specimen banking, dissemination);
• INBRE, COBRE, IDeA-CTRs, SEPA, or NARCH;
• SBIR/STTR grants;
• Conference grants;
• Contracts.

Applicants who receive funding as the PD/PI of an R01, RM1, SC1, DP1, DP2, or any other type of disqualifying award, including certain ones listed above, prior to issuance of the ESI MIRA become ineligible to receive the award. Refer to NIH's Early Stage Investigator policies for information about what awards impact ESI status.

Notes:

*Applications are defined as pending review until a summary statement is issued.

** MIRA applicants and recipients can participate as a PD/PI on a Collaborative Program Grant for Multidisciplinary Teams (RM1) as part of the 51% effort required by the MIRA but may not receive additional funds from this RM1.

*** For the BTOD grants, the PD/PI must maintain 51% research effort toward their MIRA, and 3 person months' effort toward the BTOD. The BTOD award can only provide support in a MIRA PD/PI's laboratory for late-stage technology development and dissemination efforts.

Resolving Overlap with Other NIGMS Research Grants During the Award Process

All current NIGMS research grants except those listed in the bulleted list in the "Overlap During Peer Review" section above will be terminated upon the issuance of a new MIRA grant. Investigators who receive funds as project leaders on multi-component NIGMS grants (i.e., P50 or RM1) will have their MIRA award level adjusted to remove any overlap between their MIRA and their multi-component grant. The MIRA PD/PI will be required to relinquish their involvement in the multi-component grant at the end of its competitive segment. Investigators with K awards from NIGMS will be required to relinquish the K award prior to the start date of the MIRA. Investigators with K awards from another NIH institute may receive an NIGMS MIRA but will be required to adjust their person-months effort on those awards to be smaller than the person-months effort committed to MIRA.

Applying for Subsequent Awards after Receiving a MIRA

NIGMS will not accept applications from MIRA recipients for awards that would begin prior to the original project period end date of the MIRA, with the exceptions in the bulleted list above in the "Overlap During Peer Review" section.

Additionally, NIGMS will not accept assignment of an NIH Director’s Transformative Research Award (TRA) R01 or NIH Director’s Pioneer Award (DP1) application if the PD/PI has a MIRA. By virtue of assignment to NIGMS, the proposed research falls within the mission of NIGMS and would overlap with the MIRA.

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

Renewals: ESI MIRA recipients will be eligible to renew their MIRAs through MIRA NOFOs not limited to ESIs, e.g., through PAR-22-180 and reissuances of it. If an application for renewal of the MIRA is unsuccessful, the grant will terminate at the end of its approved project period.

Resubmissions: Although a resubmission will not be accepted, a PD/PI may submit a new MIRA application as long as the PD/PI remains eligible as an ESI. After the PD/PI's ESI eligibility has expired, they may be eligible to apply to the MIRA for Established and New Investigators as a new investigator. PD/PIs are encouraged to contact the scientific contact listed in this NOFO to discuss this option.

Prior Consultation with IC staff

NIGMS strongly encourages potential applicants to confer with the program officer managing awards in their specific research area at least 6 weeks prior to submission for advice on the suitability of the proposed research for NIGMS. If there are further questions, applicants should consult with the NIGMS Scientific/Research staff (listed in Section VII. Agency Contacts of this NOFO) before submitting an ESI MIRA application.

Applications that are determined to be outside of the NIGMS mission will not be accepted for review. Note that NIGMS routinely withdraws ESI MIRA applications before review when the research proposed falls outside the NIGMS mission.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

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

Other

• Independent School Districts
• Public Housing Authorities/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 SF424 (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.

• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

For this NOFO, eligibility is limited to NIH-defined Early Stage Investigators. ESI eligibility is determined at the time the application is submitted. Any individual with the skills, knowledge, and resources necessary to carry out the proposed research as the PD/PI is invited to work with their organization to develop an application for support. Women, individuals from underrepresented racial and ethnic groups, from disadvantaged backgrounds, or with disabilities (NOT-OD-22-019) are always encouraged to apply for NIH support.

Applications from investigators who are not eligible to receive the award will be administratively withdrawn without review. Note that ESI status can be extended beyond the normal 10-year window after completion of the terminal research degree or medical residency for certain life or career events, as described in NOT-OD-19-125 and on the NIH website. This NOFO does not allow resubmissions, although a new application can be submitted after an unsuccessful attempt as long as the PD/PI remains eligible, as defined above.

PDs/PIs who are currently New Investigators proposing research within the scientific mission of NIGMS are not eligible for this NOFO and should apply instead through PAR-22-180 or its subsequent reissuance.

The PD/PI is required to devote at least 51% of their total research effort to this award. The total research effort should include the PD/PI's combined research effort at all institutions where the PD/PI holds an appointment, should be expressed in person-months, and should not include time expended toward teaching or administration not directly related to the PD's/PI's research, and/or clinical duties. NIGMS staff will verify that the MIRA research effort requirement is met by using the Other support documentation and will exclude support for which the purpose is education, training or enhancing workforce diversity.

Only single PD/PI applications are allowed. Applications with multiple PDs/PIs will not be accepted.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

A PD/PI may submit an R01 application and a MIRA application within the same council round. If both applications are deemed meritorious enough for funding, NIGMS will only award one of the two grants and applicants will be required to withdraw the other.

PDs/PIs who submitted a MIRA application in previous years and are still eligible for this NOFO (i.e., retain their ESI status) are welcome to apply, but must submit a New application because Resubmission applications are not allowed.

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Page Limitations

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

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

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

Other Attachments: The application must include the following attachment.

Plan for Enhancing Diverse Perspectives (PEDP) (1-page maximum): All applications must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for diverse junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented backgrounds.

For further information on the PEDP, please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples.

This attachment should be titled Plan for Enhancing Diverse Perspectives.

SF424(R&R) Senior/Key Person Profile

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

Biographical Sketches: A biosketch should only be provided for the PD/PI and, in rare cases, for collaborator(s) receiving financial support from the MIRA. Applicants are encouraged to use scieENcv to prepare their biosketches in order to reduce burden and simplify the process.

Personal Statement: The Personal Statement should be tailored to the unique attributes and requirements of MIRA. Include descriptions of significant service to the scientific community that are beyond normal mentoring and committee duties expected at the PD's/PI's institution. List ongoing and completed research projects with funding sources from the past three years, and briefly indicate the overall goals of the projects and your responsibilities. Do not include the number of person months or direct costs.

Contributions to Science: This section of the biosketch should emphasize contributions over the past five years.

Include a link to your My Bibliography complete list of publications and be sure the data are complete and up to date.

Do not present or include figures or preliminary data.

R&R Budget

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

Itemized budget information is not required and will not be accepted. Instead, a total requested direct cost amount for each budget period, including requests for equipment purchase, is required. Do not include annual inflationary increases. Applications may request up to $250,000 direct costs per year including equipment and consortium direct costs.
All instructions in the SF424 (R&R) Application Guide must be followed except as detailed below. While a 10-year R&R Detailed Budget form is provided in the application package, applicants may not request more than 5 years of support.

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

1. For Budget Type select Project. A separate budget form for any Subaward/Consortium is not required for this NOFO.
2. Provide the Budget Period Start Date and End Date.
3. In Section A: Senior/Key Persons, provide an entry for the PD/PI, including the appropriate level of effort, and enter $0 for Requested Salary and $0 for Fringe Benefits. Entering $0 does not imply that the PD/PI will not receive any salary or fringe benefit support from the grant.
4. In Section C: Equipment Description, enter budget request for equipment. Provide complete justification using the Budget Justification.
5. In Section F: Other Direct Costs, add a line item titled Requested Direct Costs and provide the total request for that budget period (up to $250,000). If equipment is requested in Section C, do not add the equipment budget in Section F. If subaward/consortium costs are requested, the subaward/consortium direct costs (not including consortium F&A) should be included in the "Requested Direct Costs."
6. In Section H: Indirect Costs, enter your institutional "indirect cost type," "indirect cost rate," "indirect cost base" and "funds requested."

Budget Justification: The following budget categories must be justified, where applicable: equipment and subaward/consortium costs.
Use the Budget Justification to provide the additional information requested in each budget category identified above only. Equipment quote(s) may be included here.
Consortium Justification: Consortium/Contractual Arrangements are not anticipated in most cases and must be extremely well justified. A letter from the subcontract PD/PI should be included making it clear why 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 only provide funding for a foreign consortium arrangement when the collaboration is essential to the PD's/PI's research program and represents a unique scientific opportunity that cannot be supported by the collaborator without MIRA funds. List the individuals/organizations with whom consortium or contractual arrangements have been made and indicate whether the collaborating institution is foreign or domestic. Provide the total consortium/subaward costs for each budget period listing the total direct costs and indirect (F&A) costs separately.
F&A base: Also use the Budget Justification to explain any exclusions applied to the F&A base calculation.

R&R Subaward Budget

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

Do not complete a separate R&R Budget form for the Budget Type Subaward/Consortium or the R&R Subaward Budget Attachment form. All budget information should be provided on the R&R Budget form for Budget Type Project.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

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

Research Strategy: MIRA applications should not use the typical Research Strategy 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, to give context for the overview of future research. This may include development of technical expertise and administrative skills such as mentoring. Do not repeat material adequately covered in the Biosketch. 3) Overview of Future Research Plans. This should be a description of the key questions or challenges the PD/PI plans to address and the general strategies that might be used to approach them. The focus should be on the importance of the questions or challenges. A detailed experimental plan should not be provided.

Note that preliminary data are neither expected nor required, and PDs/PIs may wish to indicate this prominently in the Research Strategy. In lieu of preliminary data from the PD/PI's independent lab, feasibility of the program may be demonstrated through literature citation, data from other sources, or data generated by the applicant as a graduate student or postdoctoral fellow. 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 as long as they remain within the NIGMS mission.

Given that the MIRA is meant to provide support for a research program within the NIGMS mission in a PD s/PI’s laboratory, and may include multiple projects on disparate topics, there is no obligation for the PD/PI to present a single unifying theme. Applicants should directly address the rationale, underlying the balance of effort and the resources dedicated to each activity, and how the activities are distinct or complementary.

The research strategy should address the requirements of the NIH policy on rigor in research as well as requirements related to sex as a biological variable as detailed in the SF424 (R&R) Application Guide..

Letters of Support: A letter of support must be included from the department chair, dean, or other academic unit leader that describes institutional commitment to the development of the investigator and any other pertinent information. If this letter is not included, the application will be considered incomplete and will not be reviewed.This information could include start-up packages and other institutional research support, space available to the PD/PI, salary support commitment for the PD/PI, skills and career development opportunities for the PD/PI, mentoring during the promotion and tenure process, and career advancement prospects for non-tenure track applicants.

Letters from former mentors are not required, nor encouraged, except in the case of continuing collaborations.

Letters of support from collaborators must be limited to 1 page each, must not include attached Biographical Sketches, and should 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.

Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

For this NOFO, do not suggest a Scientific Review Group because applications will be reviewed by MIRA-specific study sections or special emphasis panels.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

For this NOFO:

• A permanent change of PD/PI will not be allowed under the MIRA. A temporary change may be allowed with NIGMS' prior approval under circumstances such as sabbatical leave, medical conditions, disability, or personal or family situations. In case of changes in employment of the PD/PI (e.g., accepting an appointment at another institution, while retaining an appointment at the institution which received the MIRA award), the PD/PI is required to maintain their commitment to MIRA as originally reviewed and approved. The situation will be evaluated on a case-by-case basis and the MIRA could be terminated if continued support is not warranted.
• Transfer of a MIRA to a foreign institution will not be allowed. Addition of a foreign component requires NIGMS' prior approval.
• The MIRA will replace all current NIGMS research funding of the laboratory of the PD/ PI with the exception of those listed in Section I under Overlap during peer review . Institutions will be required to relinquish their interests in current NIGMS-funded research grants and withdraw pending applications where the MIRA investigator is listed as the PD/PI or multi-PD/PI.
• NIGMS will not consider funding future individual PD/PI or multiple PD/PI research grant applications on which a MIRA PD/PI is listed as the PD/PI or MPI during the MIRA funded project period, except for of those in the bulleted list in Section I under Overlap during peer review. Thus, NIGMS will not accept applications for grants not on the list of exempted awards from MIRA PDs/PIs unless the earliest start date of the grant is after the end date of the MIRA grant.
• Because most institutions expect some commitment from investigators to administrative, teaching, and/or clinical duties, any salary support for the PD/PI charged to the grant should generally be less than 51% of the PD/PI's annual salary and should in no case be more than the actual research effort the PD/PI will devote to the grant.

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the 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 the National Institute of General Medical Sciences. Applications that are incomplete or non-compliant, or that do not fall within the NIGMS mission, will not be reviewed.

Applications must include a PEDP submitted as an Other Attachment on the SF424(R&R) Other Project Information form and an institutional letter of commitment submitted as a Letter of Support on the PHS 398 Research Plan form. Applications that fail to include a PEDP and an institutional letter of commitment will be considered incomplete and will be withdrawn without review.

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

For this particular announcement, note the following:

• The goal of this MIRA program is to provide support for an ESI’s research program that is within the NIGMS mission, to offer an opportunity for these ESIs to receive support as early as possible in their careers, to give them relative freedom in pursuing their research goals, and to encourage them to move into research areas that are distinct from those of their postdoctoral mentors.
• Applicants are expected to provide an overview of the research program/scientific questions they plan to address and a general description of possible strategies; experimental details are not expected. Given that the MIRA is meant to provide support for a research program within the NIGMS mission in a PD s/PI’s laboratory, and may include multiple projects on disparate topics, there is no obligation for the PD/PI to present a single unifying theme.
• Reviewers should evaluate the likelihood that the proposed research will launch and sustain a successful independent research program.
• Preliminary data are not required and justification for the proposed work may be provided through literature citations, data from other sources, or data generated by the applicant as a graduate student or postdoctoral fellow. Similarly, early career stage applicants may not have yet published independently as senior or corresponding authors, and the absence of these publications should not be viewed as a weakness.

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

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 program proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit, however, individual review criterion scores will not be assigned. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a program that by its nature is not innovative may be essential to advance a field.

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

As applicable for the proposed research program, 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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit will be discussed and assigned an overall impact score.

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

The following will be considered in making funding decisions:

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

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement. Additionally, a signed letter from the institution's Authorized Organizational Representative (AOR) stipulating to the following points will be required as just-in-time information after review for applications being considering for funding:

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

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

Recipients must comply with any funding restrictions described in Section IV.6. 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 NOFO 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. After the award, research involving the addition of human subjects, vertebrate animals, stem cells, select agents, or a new foreign component would require prior approval by NIGMS staff according to existing policies and procedures.

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

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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 NOFO.

• For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

Awardees will provide updates at least annually on implementation of the PEDP.

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

a) Under Section B.1 What are the major goals of the research? 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 explain how the research continues to fit within NIGMS mission interests.

b) Under Section B.4, Opportunities for Training and Professional Development, indicate if individual development plans have been used for any graduate students and/or post-doctoral fellows supported by this award.

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

In carrying out stewardship of grant programs, NIGMS will periodically evaluate the MIRA program, employing the representative measures identified below. In assessing the effectiveness of research project grant investments, NIGMS may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes. The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

• Characteristics of the applicant and awardee pool for the program, such as:
  • Number of ESI PD/PIs who apply for MIRA instead of R01s
  • Geographic distribution of Investigator demographics
  • Institution types
  • Scientific topics of supported research
  • Renewal rates
• Indicators of scientific accomplishments / productivity, such as:
  • Peer-reviewed research publications and citations
  • Patent activity among grantees

Section VII. Agency Contacts

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

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Michelle R. Bond, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Marc Rigas, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Maqsood Wani, Ph.D.
Center for Scientific Review (CSR)
Email: [email protected]

Jessica Dean
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Leslie Nichols
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

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 and 2 CFR Part 200.