Part 1. Overview Information

Key Dates

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

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

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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

The NIH established the Research Centers in Minority Institutions (RCMI) program in 1985 in response to Congressional interest in expanding the national capacity for research in the health sciences by providing support to institutions that offer doctorate degrees in the health professions or health-related sciences and have a historical and current commitment to educating underrepresented students, and for institutions that provide health care services to medically underserved communities. NIMHD recognizes the important role such institutions play in supporting scientific research and providing health care in underserved communities. These institutions are uniquely positioned to engage minority populations in research and in the translation of research advances into culturally competent, measurable and sustained improvements in health outcomes.

NIMHD Interest in Diversity

The NIMHD's mission is to conduct and support research, training, health information dissemination, and other programs with respect to minority health and health disparities. This funding opportunity seeks to facilitate enhancement of research capacity and faculty development in diverse institutions to pursue basic biomedical, behavioral, and/or clinical research, particularly on diseases that disproportionately impact racial/ethnic minorities and other populations that experience health disparities.

Every facet of the United States' scientific research enterprise—from basic laboratory research to clinical and translational research to policy formation–requires intellect, creativity and a wide range of skill sets and viewpoints. NIH's ability to help ensure that the nation remains a global leader in scientific discovery and innovation is dependent upon a pool of highly talented scientists from diverse backgrounds who will help to further NIH's mission. See NOT-OD-20-031.

Programmatic Objectives

The RCMI Coordinating Center (CC) will serve as a national resource to help RCMI U54 centers achieve their primary goals to: (1) enhance institutional research capacity within the areas of basic biomedical, behavioral, and/or clinical research; (2) enable all levels of investigators to become more successful in obtaining competitive extramural support, especially from NIH, particularly on diseases that disproportionately impact minority and other health disparity populations; (3) foster environments conducive to career enhancement with a special emphasis on development of diverse early career investigators; (4) enhance the quality of all scientific inquiry and promote research on minority health and health disparities; and (5) establish sustainable relationships with community-based organizations that partner with RCMI centers. The RCMI CC will collectively advance the science of minority health and health disparities through intellectual exchange and collaborative interactions that enhance research capacity and competitiveness at participating institutions. Supporting information exchange, sharing of scientific expertise and best practices, leveraging of research resources, and scientific dissemination across RCMI sites are considered essential to the success of the RCMI CC program.

In addition, the RCMI CC is expected to help RCMI investigators take advantage of research and career development opportunities and address research needs as they arise in priority areas of basic biomedical, clinical, and behavioral and social sciences. This can include promoting submission of applications by RCMI investigators to relevant NIH funding opportunity announcements, as well as ongoing NIH programs to support the development of early-career scientists, such as Research Supplements to Promote Diversity in Health-Related Research and educational programs like the NIMHD Health Disparities Research Institute.

The RCMI CC will also assist efforts to build capacity in RCMI U54 centers to not only engage communities in research as partners and participants but also to effectively communicate and disseminate their research findings that advance scientific knowledge at all levels to their communities. Specific discoveries that are useful to the community and have the potential to benefit health and well-being at the neighborhood, community and population levels can be promoted.

RCMI CC activities are expected to align with and support the objectives of the RCMI U54 centers in four key domains: (1) project administration and coordination among sites, (2) research resources to support scientific projects, (3) early-stage investigator development and mentoring, and (4) community engagement. Toward that end, the RCMI CC must have the following essential functions:

• Organize and convene an annual grantees meeting bringing together RCMI U54 PDs/PIs and other senior scientists from each site, research project leaders, pilot project awardees, key community partners, and NIH staff to exchange information and discuss opportunities for collaboration and strategies for solving shared challenges in each of the four key domains noted above.
• Monitor the extent to which investigator development activities at the RCMI U54 sites, including but not limited to pilot project programs, lead to impactful scientific publications and to extramural research grant awards from NIH and other sources to RCMI investigators.
• Monitor the extent to which community engagement activities at RCMI U54 sites foster sustainable relationships with community-based organizations, enhance minority participation in research, and promote dissemination of research findings to communities to address their health-related concerns.
• Serve as a resource for connecting RCMI U54 sites and investigators to a broader spectrum of scientists and community partners to promote research collaborations and the development and adoption of best practices to improve minority health and address health disparities. The RCMI CC will foster linkages with other NIH programs such as NIMHD Centers of Excellence on Minority Health and Health Disparities; NCATS Clinical and Translational Science Awards (CTSA); NIGMS Institutional Development Award (IDeA) program centers and networks; NIA Resource Centers for Minority Aging Research (RCMAR), Alzheimer's Disease Research Centers, and the NIA Research Center Collaborative Network; NIAID Centers for AIDS Research (CFAR); NIDDK Network of Minority Health Research Investigators (NMRI); NHLBI minority cohort studies (e.g., Jackson Heart Study, Hispanic Community Health Study[HCHS]/Study of Latinos [SOL], Multi-Ethnic Study of Atherosclerosis [MESA]); NCI Comprehensive Cancer Centers; the Adolescent Brain Cognitive Development (ABCD) Study; the All of Us Research Program, and others.
• Facilitate research collaboration across RCMI sites through periodic web-based and face-to-face meetings inclusive of the three broad RCMI program research themes of basic biomedical research, behavioral and social science, and clinical/health services research, as well as cross-cutting themes and specific scientific topics of shared interest.
• Convene periodic meetings of RCMI U54 core directors and staff to discuss administrative issues, core facility management, opportunities for sharing access to specialized equipment and other technical resources, mentoring strategies and resources, best practices for community engagement, and program evaluation.
• Facilitate broad access to research mentors and other resources, including the NIH-funded National Research Mentoring Network, that can enhance career development, particularly for diverse early-stage RCMI investigators and more-established RCMI investigators seeking to expand their skill sets.
• Provide methodological consultation to RCMI investigators on study design, regulatory compliance, biostatistics, bioinformatics and computational biology, data science, data management and analysis including but not limited to analysis of multi-omic datasets and other high-dimensional data, geographic information systems, health economics, or other technical areas.
• Work with RCMI U54 centers to develop common data elements and performance metrics for project evaluation in each of the four key domains noted above that can provide information to assist an external RCMI national program evaluation.
• Maintain a centralized database through which RCMI sites and NIMHD can track recruitment and retention of diverse investigators and their career trajectories, along with outcomes of RCMI-supported projects such as peer-reviewed publications and grant awards to RCMI investigators. These data should be collected and maintained in standardized, structured formats that are easily analyzable and shareable in order to better evaluate the progress and successes of the RCMI program. The RCMI CC will use this information to prepare annual reports for NIMHD highlighting significant program developments by individual RCMI U54 centers and collectively across the RCMI program.
• Facilitate RCMI collaborations with other academic institutions, community-based organizations, federal/state/local agencies or programs, and industry partners engaged in research, training and educational activities focused on reducing health disparities and improving the health of underserved populations.
• Coordinate and enhance communication, marketing and outreach of RCMI activities and research findings nationwide through a public website, newsletters, and social media. The RCMI CC will maintain an active RCMI program website with links to each RCMI U54 site and the NIMHD. The website will serve as the source of information dissemination to scientific and lay audiences and will be accessible and readily identifiable.

Additional activities may be proposed to promote collaboration among RCMI sites, contribute to the professional development of RCMI investigators, encourage interactions between the RCMI program and other NIMHD- and NIH-supported resources, and enhance the value, visibility and scientific impact of the RCMI program. Examples include but are not limited to:

• Providing visiting scientist opportunities across RCMI U54 centers for pilot project recipients to foster collaboration and career development, and for senior investigators to promote mentorship and scientific exchange.
• Coordinating submission of peer-reviewed manuscripts by RCMI investigators for publication in thematic special issues of scholarly journals.
• Fostering new or existing partnerships with local, county, or state health departments and small, for-profit businesses to address community health concerns.
• Assist efforts of RCMI U54 centers to assess or characterize improvements, relative to established baselines, in health-related knowledge and health outcomes at the community/neighborhood and higher levels resulting from dissemination of research advances.

Program Evaluation by NIMHD

NIMHD will evaluate the effectiveness of the RCMI CC program in five years to determine whether to (a) continue the program as currently configured; or (b) continue the program with modifications, or (c) discontinue the program. Appropriate metrics will be developed to assess the following program outputs and outcomes:

• Increased programmatic coordination and scientific collaboration across RCMI centers;
• Increased RCMI scientific collaborations with other NIH-funded centers and consortia nationwide;
• Increased institutional capacity and readiness to support collaborative multi-disciplinary research teams and leverage existing resources available through other NIH-funded programs;
• Enhanced engagement of a diverse group of scientists in basic biomedical, behavioral and clinical research, including but not limited to individuals from underrepresented backgrounds (racial and ethnic minorities, persons with disabilities, or persons from disadvantaged backgrounds), women, early-stage investigators and experienced investigators with a track record of funding, and scientists from various disciplines and specialties.
• Increased access to research mentors and other available resources, such as expert consultation on study design and other technical areas, that can enhance the competitiveness and career development of diverse early-stage RCMI investigators;
• Enhanced or expanded partnerships with community-based organizations and members of underserved communities to increase minority participation in research and promote effective dissemination of research findings to address community partners’ health-related concerns;
• Increased dissemination and marketing of RCMI program activities, research resources, and research advances nationwide to increase the visibility and scientific impact of RCMI institutions and investigators.

Technical Assistance Webinar

NIMHD will conduct a Technical Assistance webinar for prospective applicants on Thursday, March 26, 2020, at 3:00 PM Eastern Time. The Webinar connections will open 15 minutes in advance of the start time. NIMHD staff members involved in this FOA will provide orientation and technical assistance to potential applicants by explaining the goals and objectives of the NIMHD RCMI Cooridinating Center initiative and answering questions from attendees. . Prospective applicants are encouraged to send questions, preferably at least 24 hours prior to the webinar, to the Scientific/Research Contact, Dr. Derrick Tabor, at tabord@mail.nih.gov.

To Join the Webinar, interested persons can use the Webex meeting link or other connection information, as follows:

Join Webex meeting
Meeting number (access code): 625 216 570 Meeting password: RCMICC300

Join from a video system or application
Dial 625216570@nih.webex.com">625216570@nih.webex.com
You can also dial 173.243.2.68 and enter your meeting number.

Join by phone
Tap to call in from a mobile device (attendees only)
1-650-479-3208 Call-in toll number (US/Canada)
Global call-in numbers

Join using Microsoft Lync or Microsoft Skype for Business

Dial 625216570.nih@lync.webex.com

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

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 FOA.

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)

To be eligible for this FOA, the applicant institution must be a domestic institution located in the United States and its territories which:

• Has received an average of less than $50 million per year of NIH support for the past three fiscal years;
• Awards doctorate degrees in the health professions or the sciences related to health; and
• Has a historical and current mission to educate students from any of the populations that have been identified as underrepresented in biomedical research as defined by the National Science Foundation NSF, see http://www.nsf.gov/statistics/wmpd/) (i.e., African Americans or Blacks, Hispanic or Latino Americans, American Indians, Alaska Natives, Native Hawaiians, U.S. Pacific Islanders, and persons with disabilities) or has a documented record of: (1) recruiting, training and/or educating, and graduating underrepresented students as defined by NSF (see above), which has resulted in increasing the institution's contribution to the national pool of graduates from underrepresented backgrounds who pursue biomedical research careers and, (2) for institutions that deliver health care services, providing clinical services to medically underserved communities.

Eligible applicant institutions for this FOA are limited to recipients of RCMI awards through RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012 or PAR-11-132.

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 not 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) – 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 to register in eRA Commons.Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

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

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

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

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications  

Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.

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)

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guideexcept 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.

Letter of Intent  

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:

Maryline Laude-Sharp, Ph.D.
Telephone: 301-451-9536
Fax: 301-451-4484
Email: mlaudesharp@mail.nih.gov

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed. All instructions in the SF424 (R&R) Application Guide must be followed.

The PD/PI of the RCMI CC must be the lead Director of theCC and is the person responsible for the overall management of the CC; if there are multiple PDs/PIs of the CC, the MPIs will serve as co-Directors. The relationship between the RCMI CC and the RCMI U54 centersshould be one of equal and substantial partners in all joint activities.

The RCMI CC team is expected to have significant experience and knowledge in (1) priority areas of basic biomedical research, behavioral and social sciences, and clinical research, including research on minority health and health disparities; (2) in program management and coordination; and (3) in support of activities to promote diversity in the scientific research workforce.

R&R Budget  

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

The RCMI CC will be responsible for organizing and attending annual face-to-face meetings meantto facilitate coordination among RCMI U54 centersand any subcommittees in which they participate. The RCMI CC application budget should include funds for organizing the annual meeting and for travel of the RCMI CC PD(s)/PI(s) and other keypersonnel to the meeting. The RCMI CC is not responsible for the travel of participants from individual RCMI U54sites.

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:

Research Strategy

Describe how the RCMI CC will work in close collaboration with approximately 18-20 RCMI U54 centers to facilitate and coordinate RCMI program activities nationally. Include plans for fostering communication and collaborative research arrangements between the U54 centers, such as through arranging and hosting monthly PD/PI conference calls as well as similar calls and support for the various U54 Cores as needed, as well as providing logistical support to the U54 centers and NIMHD staff to arrange a yearly RCMI grantee meeting. Include plans and mechanisms for maintaining active involvement of all U54 sites in all aspects of the program.

Describe plans and mechanisms for providing methodological consultation to RCMI investigators on study design, regulatory compliance, biostatistics and other technical areas to augment expertise and research resources at individual U54 sites.

Describe plans for developing and maintaining a secure database to collect information from RCMI U54 centers on scientific advances from full research projects and pilot projects, as well as career development of pilot award recipients. Include plans for working with U54 centers to develop, adapt or use existing common structured data elements and performance metrics to assess progress on achieving programmatic objectives.

Describe how the RCMI CC will support RCMI activities aimed at diversifying the scientific workforce in basic biomedical research, behavioral and social sciences, and clinical research. Include plans and mechanisms to facilitate broad access to research mentors and other resources that can enhance the competitiveness and career development of diverse investigators. Highlight how the relevant expertise of the RCMI CC team will support these activities.

Describe plans to assist community engagement efforts at RCMI U54 sites to (1) develop/maintain strong working relationships with community partners, (2) increase minority participation in health-related research, and (3) promote timely dissemination of research findings to communities to help address their health-related concerns.

Describe how the RCMI CC will function to serve as the RCMI program’s point-of-contact for linking the U54 centers with other NIMHD-funded centers, other major NIH extramural programs, and the broader scientific community to promote collaborations in priority areas of basic biomedical research, behavioral and social sciences, and clinical research, especially in topics related to minority health and health disparities.

Describe plans and mechanisms for informing and making visible scientific advances of RCMI investigators and affiliated scientists to the broader research community, policymakers, and other relevant stakeholders. Include plans for maintaining an up-to-date RCMI website with links to each RCMI U54 site and the NIMHD.

Describe the organizational plan and management structure for providing leadership and administrative support for RCMI CC activities and interactions with the U54 centers and NIMHD. Delineate the roles and responsibilities among key personnel at participating organizations. Include plans for ensuring accountability for achieving program objectives. Describe how the Steering Committee and any other advisory group(s) will be used to ensure successful completion of the stated aims. Applicants should avoid naming potential members of an advisory group, unless such persons have been consulted or contacted.

Applications must include a plan for evaluating all activities supported by the RCMI CC, in line with the broader RCMI program goals. The evaluation plan must specify baseline metrics to be included for the participating RCMI U54 centers, e.g., numbers of research grant applications submitted and funded, research publications and other forms of scientific dissemination, scientific collaborations and partnerships, utilization/expansion of shared research resources and databases, as well as measures to gauge the short- and long-term success of the RCMI CC in achieving its objectives

Letters of Support: Applicants must provide letter(s) from the appropriate high-ranking institutional officials that:

• Indicate the commitment of the institution(s) to the RCMI CC goals and how its activities will be integral to the broad institutional vision for biomedical, behavioral, and/or clinical research.
• Specify any institutional support, for example financial support, dedicated space, salary support for professional or administrative staff, interface with other grants, centers, and initiatives, etc.
• Indicate the commitment of the institution(s) to participate in the RCMI program nationally and other national consortia working towards developing, adopting and implementing best practices in basic biomedical, behavioral, and/or clinical research and training.

Inclusion of Letters of Support in the application should adhere to the SF424 instructions and be combined into a single file attachment. The Letters of Support attachment should begin with a table of letter authors, their institutions, and the type of each letter (institutional commitment or resources; collaboration or role in the project; potential or current user of a resource or service provided in the application). Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

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

Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide. When involving human subjects research, clinical research, and/or NIH-definedclinical 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.

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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

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, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance  

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

To what extent are the proposed activities of the RCMI CC likely to help RCMI U54 centers achieve their primary goals and collectively advance the science of minority health and health disparities nationally?

Investigator(s)  

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

To what extent is the proposed governance structure for the RCMI CC likely to ensure clear understanding of roles and responsibilities among key personnel and participating organizations, as well as accountability for achieving program objectives?

Is the plan for a Steering Committee and any other advisory group(s) indicative that RCMI CC leadership will actively solicit and be responsive to constructive feedback from stakeholders to help ensure successful performance of RCMI CC’s essential functions and other proposed activities?

Innovation  

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?

Approach  

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

To what extent are the proposed activities likely to foster programmatic coordination and scientific collaborations among RCMI U54 centers and between RCMI-funded institutions and other research organizations? Are plans for periodic RCMI grantee meetings (face-to-face and/or web-based) adequately described and justified, and are those meetings likely to foster productive relationships between participating institutions to help achieve RCMI program goals?

To what extent are the proposed activities likely to enhance basic biomedical, behavioral and clinical research capacity across RCMI-funded institutions and help all levels of investigators at those institutions become more successful in obtaining competitive extramural support, particularly on diseases that disproportionately impact minority populations and other populations that experience health disparities?

To what extent are the proposed activities likely to enhance the career development and competitiveness of diverse investigators in basic biomedical, behavioral and/or clinical sciences, particularly early-stage investigators?

Is there a well-formulated plan for supporting timely communication across RCMI U54 centers as well as outreach to the broader research community and public, including an RCMI CC website? Are proposed outreach plans likely to increase awareness of and interest in the RCMI program and participation in RCMI CC-supported activities?

To what extent are the proposed activities likely to help RCMI-funded institutions establish and/or enhance sustainable working relationships with underserved communities and community-based organizations to enhance participation in research and the timely dissemination of research findings?

Are plans for maintaining a centralized database through which RCMI sites and NIMHD can track recruitment and retention of diverse investigators and their career trajectories, along with outcomes of RCMI-supported projects, adequately described and likely to be effective? Will data be collected in standardized, structured formats that are easily analyzable and shareable with authorized users? Are adequate safeguards in place to ensure data security?

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

Environment  

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

To what extent do the institutional letters of support indicate that the applicant institution (and consortium site(s), as applicable) is fully committed to achieving the goals and objectives of the proposed RCMI CC, and that the RCMI CC will be integral to achieving the broad institutional vision for minority heath and health disparities research?

Are plans to support technical consultation (e.g., study design, biostatistics, bioinformatics, data management and analyses, regulatory compliance) to investigators at RCMI-funded institutions adequately described and likely to be effective? Are there unique strengths or special expertise to enhance collaborative research efforts across RCMI sites?

Protections for Human Subjects  

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan  

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

Vertebrate Animals  

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards  

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.

Resubmissions  

Not Applicable.

Renewals  

Not Applicable.

Revisions  

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.

Applications from Foreign Organizations  

Not Applicable.

Select Agent Research  

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).

Resource Sharing Plans  

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:  

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support  

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

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

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

• Will receive a written critique.

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 on Minority Health and Health Disparities (NIMHD). 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 Council on Minority Health and Health Disparities. 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.

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.

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.

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research.

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

For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-individuals/section-1557/index.htmlhttps://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.htmlor call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

The following special terms of award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 45 CFR Part 75, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardee is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipient’s activities by involvement in and otherwise working jointly with the award recipient in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardee for the project as a whole, although specific tasks and activities may be shared among the awardee and the NIH as defined below.

The PD(s)/PI(s) will have the primary responsibility for:

• Supporting the essential functions of the RCMI Coordinating Center (RCMI CC);
• Working towards developing, adopting and implementing the agreed-upon policies, procedures, best practices, or other measures;
• Providing information to the NIH Program Official and Project Scientist(s) concerning progress;
• Participating in the overall coordination of NIMHD efforts in minority health and health disparities research; this participation may include collaboration and consultation with other research awardees, and the sharing of information, data and research materials.
• Awardee will retain custody of and have primary rights to the data and software developed under these awards, subject to Government rights of access consistent with current DHHS, PHS, and NIH policies

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:

NIMHD will assign a Program Official, Project Scientist(s), and a Grants Management Specialist to the RCMI CC.

NIH Project Scientist(s) will have substantial scientific involvement during the conduct of this activity, through technical assistance, advice, and coordination. NIH Project Scientists(s) will:

• Review and comment on critical stages in the program implementation;
• Assist in coordinating activities with other ongoing studies supported through statewide, regional, or national programs to avoid duplication of efforts and encourage sharing and collaboration in the development of new research resources and methodologies;
• Assist in the interaction between the awardee and investigators at other institutions to promote collaborations;
• Assist in coordinating access to other research resources available through NIMHD- and NIH-funded extramural programs;
• Retain the option of recommending termination of support if technical performance or implementation falls below acceptable standards, or when specific key resources cannot be effectively implemented in a timely manner;
• Retain the option to recommend additional infrastructure support within the constraints of the approved research and negotiated budget;
• Convene meetings/workshops to address emerging areas of high priority.

An NIH Program Official will be responsible for the normal programmatic stewardship of the award and will be named in the award notice. The Program Official will:

• Assist in enforcing general statutory, regulatory or administrative assistance policy requirements;
• Evaluate progress by reviews of technical or fiscal reports or by site visits to determine that performance is consistent with objectives, terms and conditions of the award;
• Ensure that activities proposed for development or implementation do not overlap or duplicate activities supported by other peer reviewed funding mechanisms;
• Provide assistance in reviewing and commenting on all major transitional changes of RCMI CC activities prior to implementation to ensure consistency with the goals of this FOA;
• Link the approaches developed by the RCMI CC to other NIMHD-supported extramural programs to ensure that information is shared and utilized on the widest basis possible;
• Monitor institutional commitments and resources to ensure that the RCMI CC receives the maximum chance of stabilization and success;
• Assist with financial oversight of the Program.

Additionally, the NIH Program Official may recommend the termination or curtailment of an activity in the event the proposed activities fail to evolve within the intent and purpose of this initiative.

Areas of Joint Responsibility include:

• Establishing a Steering Committee consisting of: (a) the PD(s)/PI(s); (b) up to six other members selected by the PD(s)/PI(s); and (c) the NIH Project Scientist(s). Each committee member will have one vote except for the NIH Project Scientists, who collectively will have one vote. In addition, the NIH Program Official and other NIH staff members may participate in Steering Committee meetings as non-voting members. The award recipient agrees to governance, through voting and decision making, of the RCMI CC through this Steering Committee.

• Identifying and facilitating partnerships between RCMI awardees and other NIMHD award recipients in the respective regions with expertise and/or interest in health disparities or other relevant resources and expertise that could be leveraged to facilitate achievement of RCMI program goals and objectives.

• Organizing and participating in Steering Committee meetings to discuss matters of mutual interest and promote information exchange across RCMI sites. Quarterly meetings of the Steering Committee will be held in the first year of the award, one of which must be an in-person meeting in Bethesda, MD. The frequency and venue(s) of meetings in succeeding years will be decided by the Steering Committee at the beginning of each budget period.

Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel will be convened, composed of three members: a designee of the Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement. A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreementsare required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threatensubmission by the due date, and post-submission issues)

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

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

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

Derrick C. Tabor, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8950
Email: tabord@mail.nih.gov

Maryline Laude-Sharp, Ph.D.
Telephone: 301-451-9536
Fax: 301-451-4484
Email: mlaudesharp@mail.nih.gov

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: grantp@mail.nih.gov

Section VIII. Other Information

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