Department of Health
and Human Services (HHS)
and Human Services (HHS)
EXPIRED
National Institutes of Health (NIH)
National Institute on Minority Health and Health Disparities (NIMHD)
U24 Resource-Related Research Projects – Cooperative Agreements
None
Only one application per institution, as defined in Section III. 3. Additional Information on Eligibility.
NIMHD invites applications from eligible institutions to establish a Research Coordinating Center (RCC) to support NIMHD P50 comprehensive research centers on prevention, treatment, and management of comorbid chronic diseases associated with health disparities authorized in Public Law 116-260, the Consolidated Appropriations Act of 2021. The RCC will coordinate activities across all of the chronic disease centers, including data collection; promoting collaboration and communication among investigators and the broader research community; promoting skills development of early stage investigators; coordinating and managing in-person and/or virtual meetings; and facilitating community engagement efforts.
May 11, 2021
| Application Due Dates | Review and Award Cycles | ||||
|---|---|---|---|---|---|
| New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
| June 11, 2021 | Not Applicable | Not Applicable | July 2021 | August 2021 | December 2021 |
All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
No late applications will be accepted for this funding opportunity announcement.
Not Applicable
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.
Purpose
The purpose of this initiative is to establish a research coordinating center (RCC) to support 8-9 NIMHD P50 comprehensive research centers on the prevention, treatment, and management of comorbid chronic diseases associated with health disparities authorized by Public Law 116-260, the Consolidated Appropriations Act of 2021. The RCC will coordinate activities across all of these P50 multiple chronic disease (MCD) Centers, including data collection; promoting collaboration and communication among investigators and the broader research community; promoting skills development of early-stage investigators; coordinating and managing in-person and/or virtual meetings; and facilitating community engagement efforts.
Background
As the Nation’s steward of biomedical and behavioral research, NIH has devoted considerable resources to characterize the root causes of health disparities, uncovering complex webs of interconnected factors (e.g., behavioral, biological, social and environmental factors) acting at multiple levels across the life course. Despite this knowledge, insufficient progress has been made in reducing health disparities in morbidity and mortality related to chronic diseases. Tackling the complex drivers of health disparities requires a transdisciplinary framework that cuts across scientific and organizational silos to integrate multiple disciplines–behavioral, biological, and social sciences, epidemiology, data science, public health, health care delivery, economics, environmental science, public policy, and clinical research. It also requires strong collaborations between researchers, community organizations, health service providers, public health agencies, policymakers and other stakeholders to ensure that relevant, contextually appropriate research is conducted and, more importantly, that findings can be translated into sustainable community and system-level changes that promote health equity. In addition, research conducted at the regional level provides the opportunity to develop local coalitions of relevant stakeholders to address place-based determinants of health that may be specific to a region.
To pursue these objectives, NIMHD is supporting P50 research centers on health disparities in chronic diseases to leverage regional coalitions of research institutions and consortium partners focused on testing interventions implemented in real-world settings to reduce chronic disease disparities (see RFA-MD-21-007 for information on the scope of MCD Center activities). A Multiple Chronic Disease Research Coordinating Center (MCD-RCC) will be responsible for: 1) enabling collaboration and communication among investigators and the broader research community; 2) harmonizing research projects conducted across awardees including common data elements and data sharing; and 3) facilitating network outreach. Specific activities of the MCD-RCC will include, but are not limited to:
Scope of Activities for the Research Coordinating Center
Organization and Management
Research Coordination and Data Analysis
Research Skills Development
Community Engagement
Technical Assistance Webinar
NIMHD will conduct a technical assistance webinar for prospective applicants on May 4, 2021, 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 MCD-RCC 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(s).
To Join the Webinar, interested persons can use the WebEx meeting link or other connection information, as follows:
|
NIMHD Multiple Chronic Disease Centers Research Coordinating Center Technical Assistance Webinar |
|||||||||||||||
|
Tuesday, May 4, 2021 |
|||||||||||||||
|
3:00 PM Eastern Time (US & Canada) 2 hrs |
|||||||||||||||
|
Meeting number (access code): 182 943 8108 |
|||||||||||||||
|
Host key: 328674 |
|||||||||||||||
|
Meeting password: MCDRCC |
|||||||||||||||
|
|||||||||||||||
See Section VIII. Other Information for award authorities and regulations.
Cooperative Agreement: A support mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities. See Section VI.2 for additional information about the substantial involvement for this FOA.
The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.
Not Allowed: Only accepting applications that do not propose clinical trials.
Need help determining whether you are doing a clinical trial?
NIMHD intends to commit $4,500,000 in FY 2021 to fund one award.
Application budgets are limited to $3,000,000 in direct costs annually.
The scope of the project should determine the project period. The maximum project period is 5 years.
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Local Governments
Federal Governments
Other
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.
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.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
Number of Applications
Only one application per institution (normally identified by having a unique DUNS number or NIH IPF number) is allowed.
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.
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:
The letter of intent should be sent to:
Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: [email protected]
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.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
The MCD-RCC will be responsible for organizing and attending annual meetings meant to facilitate coordination among MCD Centers and any subcommittees in which they participate. The MCD-RCC application budget should include funds for organizing the annual meeting and for travel of the MCD-RCC PD(s)/PI(s) and other key personnel to the meeting. The MCD-RCC is not responsible for the travel of participants from individual MCD Centers.
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 the organizational plan and management structure for providing leadership and administrative support for MCD-RCC activities and interactions with the MCD Centers and NIMHD. Applicants should consult RFA-MD-21-007 for information concerning the scope of the MCD Centers. 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.
Describe how the MCD-RCC will work in close collaboration with the MCD Centers to facilitate and coordinate program activities nationally. Include plans for fostering communication and collaborative research arrangements between the MCD Centers, such as through arranging and hosting monthly PD/PI conference calls as well as similar calls and support for the various MCD Center Cores as needed, as well as providing logistical support to the MCD Centers and NIMHD staff to arrange a yearly MCD Center grantee meeting. Include plans and mechanisms for maintaining active involvement of all MCD Centers in all aspects of the program.
Describe plans and mechanisms for providing methodological consultation to MCD Center investigators on study design, regulatory compliance, biostatistics and other technical areas to augment expertise and research resources at individual MCD Centers.
Describe plans for developing and maintaining a secure Data hub to warehouse deidentified data, collect information on scientific advances from full research projects and pilot projects, as well as career development of pilot award recipients in MCD Centers. Include plans for working with MCD Centers to develop, adapt or use an existing set of minimum common structured data elements and performance metrics to assess progress on achieving programmatic objectives.
Describe how the MCD-RCC will support MCD Center 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 research skills development of investigators from diverse backgrounds, including investigators from groups underrepresented in the biomedical research workforce (see Notice of NIH’s Interest in Diversity, https://grants.nih.gov/grants/guide/notice-files/NOT-OD-20-031.html) . Highlight how the relevant expertise of the MCD-RCC team will support these activities.
Describe plans to assist community engagement efforts at MCD Centers 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 MCD-RCC will function to serve as the MCD initiative’s point-of-contact for linking the MCD 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 MCD Center investigators and affiliated scientists to the broader research community, policymakers, and other relevant stakeholders. Include plans for maintaining an up-to-date MCD-RCC website with links to each MCD Center and the NIMHD.
Applications must include a plan for evaluating all activities supported by the MCD-RCC, in line with the broader MCD Centers initiative program goals. The evaluation plan must specify baseline metrics to be included for the participating MCD 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 MCD-RCC in achieving its objectives.
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:
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.
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.
See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.
Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.
Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.
Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.
Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants Policy Statement.
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.
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.
Does the proposed MCD-RCC address the needs of the MCD Centers that it will coordinate? Is the scope of activities proposed for the MCD-RCC appropriate to meet those needs? Will successful completion of the aims bring unique advantages or capabilities to the MCD centers?
To what extent are the proposed activities of the MCD-RCC likely to help MCD Centers achieve their primary goals and collectively advance the science of multiple chronic disease disparities nationally?
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?
Are the PD(s)/PI(s) and other personnel well suited to their roles in the MCD-RCC? Do they have appropriate experience and training, and have they demonstrated experience and an ongoing record of accomplishments in managing human subjects research? Do the investigators demonstrate significant experience with coordinating collaborative research? If the Center is multi-PD/PI, do the investigators have complementary and integrated expertise and skills; are their leadership, approach, governance, plans for conflict resolution, and organizational structure appropriate for the MCD-RCC? Does the applicant have experience overseeing selection and management of subawards, if needed?
Does the application propose novel organizational concepts and management strategies in coordinating the projects the MCD-RCC will serve? Are the concepts and strategies novel to one type of research program or applicable in a broad sense? Is a refinement, improvement, or new application of organizational concepts and management strategies proposed?
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the projects the MCD-RCC will serve? Will the investigators promote strategies to ensure a robust and unbiased scientific approach across the projects, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the program is in the early stages of operation, does the proposed strategy adequately establish feasibility and manage the risks associated with the activities of the program? Are an appropriate plan for work-flow and a well-established timeline proposed? Have the investigators presented adequate plans to ensure consideration of relevant biological variables, such as sex, for studies of vertebrate animals or human subjects?
If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
To what extent are the proposed activities likely to foster programmatic coordination and scientific collaborations among MCD Centers and between MCD Centers and other research organizations? Are plans for periodic MCD Center 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 MCD Center program goals?
To what extent are the proposed activities likely to enhance basic biomedical, behavioral and clinical research capacity across MCD Center institutions and help all levels of investigators at those institutions become more successful in obtaining competitive extramural support, particularly on chronic diseases that disproportionately impact populations that experience health disparities?
To what extent are the proposed activities likely to enhance the research skills and competitiveness of investigators from diverse backgrounds, including investigators from groups underrepresented in basic biomedical, behavioral and/or clinical sciences, particularly early-stage investigators?
Is there a well-formulated plan for supporting timely communication across MCD Centers as well as outreach to the broader research community and public, including an MCD-RCC website? Are proposed outreach plans likely to increase awareness of and interest in the MCD Centers program and participation in MCD-RCC-supported activities?
To what extent are the proposed activities likely to assist MCD Center institutions in establishing and/or enhancing sustainable working relationships with underserved communities and community-based organizations to foster and increase participation in research and the timely dissemination of research findings?
Will the institutional environment in which the MCD-RCC will operate contribute to the probability of success in facilitating the research program it serves? Are the institutional support, equipment and other physical resources available to the investigators adequate for the MCD-RCC proposed? Will the MCD-RCC benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Are plans to support technical consultation (e.g., study design, biostatistics, bioinformatics, data management and analyses, regulatory compliance) to investigators at MCD Centers adequately described and likely to be effective? Are there unique strengths or special expertise to enhance collaborative research efforts across MCD sites?
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
Protections for Human Subjects
For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.
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).
Data Sharing Plan: Are plans for developing and maintaining a Data hub to warehouse deidentified data collected using a minimum set of common data elements from the MDC Centers adequately described and likely to be effective? Are plans for maintaining a centralized database, through which MCD Center sites and NIMHD can track recruitment and retention of investigators from diverse backgrounds, including investigators from groups underrepresented in the biomedical research workforce and their productivity, along with outcomes of MCD Center-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?
Authentication of Key Biological and/or Chemical Resources:
For Centers 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.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMHD, 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 (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.
Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council on Minority Health and Health Disparities. The following will be considered in making funding decisions:
Information regarding the disposition of applications is available in the NIH Grants Policy Statement.
If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.
A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient'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: Recipient 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.
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. 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 laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 FOA.
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 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.
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:
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 and Project Scientist(s) to the MCD-RCC.
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:
Additionally, an NIMHD Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice. The Program Official will:
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:
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.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.
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: 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: [email protected] (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: [email protected]
Nathan Stinson, Jr, PhD, MD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8704
Email: [email protected]
Yujing Liu, MD, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-7815
Email: [email protected]
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.