EXPIRED
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
U24 Resource-Related Research Projects Cooperative Agreements
November 18, 2022 - Notice RFA-DK-22-015 "Chronic Kidney Disease in Children Central Biochemistry Laboratory (U24 Clinical Trial Not Allowed)" Is Being Reissued. See Notice NOT-DK-23-002.
The Interventions that Address Structural Racism to Reduce Kidney Health Disparities Consortium aims to foster community-engaged intervention research to address structural racism to reduce health disparities among individuals living with kidney disease. The Consortium will consist of one Research Coordinating Center and multiple Intervention Sites (see RFA-DK-22-014) that will work collaboratively to develop, implement and evaluate meaningful interventions that aim to dismantle or mitigate the effects of structural racism to reduce kidney health disparities.
This Funding Opportunity Announcement (FOA) invites applications for the Research Coordinating Center (RCC) that will lead, manage, and harmonize efforts for the Consortium. The specific activities of the RCC will include: 1) providing organization, management, and administrative support of Consortium activities; 2) providing research coordination, data management and data analyses for Consortium studies; and 3) fostering research collaborations and helping to build a community of investigators with skills to develop, implement, and disseminate effective, scalable, and sustainable interventions that address the structural drivers of kidney health disparities.
October 17, 2022
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
November 17, 2022 | Not Applicable | Not Applicable | March 2023 | May 2023 | July 2023 |
All applications are due by 5:00 PM local time of applicant organization.
Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.
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.
The purpose of The Interventions that Address Structural Racism to Reduce Kidney Health Disparities Funding Opportunity Announcement (FOA) is to support a Research Coordinating Center (RCC) that will work collaboratively with Intervention Sites in a Consortium to develop and test meaningful interventions that aim to dismantle or mitigate the effects of structural racism to reduce kidney health disparities.
Background
Dismantling structural racism and mitigating its harmful social consequences are essential to achieve health equity for people with kidney disease. Structural racism is widely and increasingly recognized as a fundamental cause of the stark racial and ethnic disparities in health outcomes for individuals with chronic kidney disease (CKD) and end-stage renal disease (ESRD) in the United States. Specifically, Blacks/African Americans, Native and Hispanic Americans, as well as Native Hawaiian and Pacific Islanders, experience a disproportionate burden of CKD and ESRD, including more rapid progression from CKD to ESRD, higher incidence and prevalence of ESRD, and lower rates of home dialysis and transplantation.
Structural racism is embedded in societal, institutional, organizational, and governmental systems through formal and informal processes, procedures, and practices, limiting opportunities and resources to marginalized racial and ethnic communities. As a result, these marginalized racial and ethnic groups experience greater exposure to adverse social determinants of health (SDOH). SDOH, defined by the World Health Organization as the conditions in which people are born, grow, work, live, and age, span multiple domains, including economic stability, education access and quality, healthcare access and quality, neighborhood and built environment, and social and community context (https://health.gov/healthypeople/priority-areas/social-determinants-health). Adverse SDOH, or social risks, lead to poor outcomes in CKD (and other disease areas) by reducing access to health promoting resources and increasing risk of detrimental exposures. Specific social risks of interest in CKD and ESRD include, but are not limited to, residential segregation, housing insecurity and inadequacy, food insecurity, inadequate health care, limited access to transportation, and financial resource deprivation, among many others.
Research is urgently needed to develop, implement, and evaluate interventions that address social risks and the upstream unjust systems, policies, and laws that generate and perpetuate social and health inequities in marginalized racial and ethnic populations with CKD and ESRD. Because structural racism operates across multiple socioecological levels (e.g., individual, interpersonal, community, societal) and impacts multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, health system), interventions must be designed and implemented across multiple socioecological domains and levels of influence to mitigate structural racism and the social and health inequities it perpetuates.
Additionally, authentic engagement and meaningful partnership with communities who experience structural racism are essential to effective health equity interventions. Failing to ensure research is founded on the wishes and realities of the people who will be most affected by the intervention(s) may ultimately produce more harm than benefit. In addition, community engaged research brings to bear the lived experience and expertise of the affected communities, which may yield interventions that are more likely to be appropriate, acceptable, and feasible.
Key Definitions for the FOA
Structural Racism refers to the Totality of ways in which societies foster racial discrimination, through mutually reinforcing inequitable systems (in housing, education, employment, earnings, benefits, credit, media, health care, criminal justice, and so on) that in turn reinforce discriminatory beliefs, values, and distribution of resources, which together affect the risk of adverse health outcomes . (Bailey ZD et al, Lancet. 2017; 389:1453-1463)
NIH-designated Racial/Ethnic Groups who experience Health Disparities include American Indians/Alaska Natives, Asian Americans, Blacks/African Americans, Hispanics/Latinos, and Native Hawaiians and Pacific Islanders (see https://www.nimhd.nih.gov/about/overview/).
Multi-level refers to the multi-dimensional framework of determinants relevant to understand minority health and address health disparities. This concept is further described under the National Institute of Minority Health and Health Disparities Research Framework (https://www.nimhd.nih.gov/about/overview/research-framework/).
Intervention refers to a manipulation of the subject or subject's environment for the purpose of modifying one or more health-related biomedical or behavioral processes and/or endpoints. (https://grants.nih.gov/policy/clinical-trials/glossary-ct.htm#I)
Scope of Activities for Research Coordinating Center
The Interventions that Address Structural Racism to Reduce Kidney Health Disparities FOA invites applications for a Research Coordinating Center (RCC) that will work collaboratively with Intervention Sites in a Consortium. The Consortium will support community-engaged clinical trials to test novel interventions that dismantle or mitigate the effects of structural determinants that perpetuate inequities in the care and outcomes of people living with kidney disease. Studies proposed by the successful applicants may be substantially revised by the Steering Committee prior to being undertaken by the Consortium, including the potential of harmonizing intervention components and data collection measures across Intervention Sites. The final interventions undertaken by the Consortium may include none, some, or all the interventions proposed by grant applicants. The Consortium also will help to foster collaborations between investigators with expertise in kidney health disparities and health equity research and patients, community members, community-based organizations, and other key stakeholders.
This FOA is intended to support one RCC to facilitate collaboration and communication between Intervention Sites supported under the companion RFA [RFA-DK-22-014]. The specific activities of the RCC will include, but are not limited to:
Applications should include a multi-PD/PI structure and multidisciplinary research team with diverse perspectives and backgrounds (https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp) and with relevant complementary and integrated expertise, which may include nephrologists, social scientists, behavioral medicine experts, healthy equity researchers, public health practitioners, biostatisticians, ethicists, clinical trialists, people with kidney disease, and community-based organization representatives. At least one Principal Investigator (PI) named on the grant should have substantial experience in community-engaged health equity research.
Applications must include a Plan for Enhancing Diverse Perspectives (PEDP) submitted as Other Project Information as an attachment (see Section IV). The PEDP will be assessed as part of the scientific and technical peer review evaluation, as well as considered among programmatic matters with respect to funding decisions (https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp).
Please refer to NIDDK’s Policies for Clinical Researchers (https://www.niddk.nih.gov/research-funding/human-subjects-research/policies-clinical-researchers) for additional guidance regarding the roles/responsibilities for Research and Data Coordination Centers for clinical cooperative agreements.
Consortium Structure
The Intervention Site and RCC investigators will work closely together to achieve the goals of the Consortium, including the design, planning, execution, and analysis of one or more interventions. Studies proposed by the successful applicants may be substantially revised prior to being implemented regarding the research project(s) to be undertaken by the Consortium, including the potential of harmonizing intervention components and data collection measures, or developing a unifying study across Intervention Sites. Patient, community, and/or other key stakeholders at the local and national level will be involved in the planning and execution of studies. The final study protocol(s) will be designed by the Intervention Sites and RCC Principal Investigators and approved by the Steering Committee, then the DSMB and the NIDDK, and then submitted for IRB review and approval.
Intervention Sites
The responsibilities of each Intervention Site are: recruitment of participants for the intervention study or studies; engagement of patient, community members and other relevant stakeholders in all aspects of the research process; local institutional review board (IRB) review and approval (or single IRB approval/reliance as appropriate) of final study protocol(s)); collection of data according to the approved protocol(s), initial quality control of data, timely transmission of data to the RCC (where not otherwise prohibited such as by Tribal sovereignty); analysis, interpretation and publication of study data; and participation in Steering Committee meetings and meetings with the Data Safety and Monitoring Board (DSMB) and the NIDDK.
Research Coordinating Center (RCC)
The RCC will be responsible for the overall organization, research coordination, data management (including quality assurance and quality control), and data analyses for the Consortium. The RCC will have a lead role in collaborative efforts to develop and refine the final study design(s) and protocol(s) for the Consortium projects, which may include the potential of harmonizing intervention components and data collection measures to be implemented at each of the Intervention Sites or developing a unifying study across all Intervention Sites; and obtaining single IRB approval/reliance, as appropriate, of final study protocol(s). The RCC applicants should have well-documented experience in managing multi-center, multi-institutional clinical trials and should include research and training expertise in interventional research, implementation science, community-engagement, health equity research, and kidney research.
Administration and Meetings
Data Safety and Monitoring Board (DSMB)
A DSMB will be appointed by the NIDDK at the beginning of the funding period, to provide input on the study design(s) and protocol(s) prior to their implementation. The DSMB will monitor the research efforts and the safety and progress of the studies. The DSMB will advise primarily the NIDDK as well as the Consortium investigators. The DSMB will include experts from multiple disciplines with relevant expertise, which may include health equity and disparities researchers, biostatisticians, nephrologists, primary care clinicians, social scientists, behavioral medicine experts, ethicists, people with kidney disease, and/or others with relevant expertise. The DSMB will review study protocols prior to implementation and will monitor study progress and safety of the participants in the studies (including quality assurance/quality control metrics, recruitment, study feasibility, and stopping criteria).
Steering Committee (SC)
The SC will consist of Program Directors/Principal Investigators (PDs/PIs) from each of the sites and the NIH Project Scientists, as well as at least one patient participant representative appointed by NIDDK. The SC will hold regular meetings as determined by needs of the Consortium. It will designate subgroups and working groups and all PDs/PIs are expected to participate actively in these groups. The Steering Committee will serve as the governing body of the Consortium and decisions will be determined by majority vote, including decisions to accept the final protocols and other actions pertaining to the governance, design and implementation of matters pertaining to the Consortium and the successful achievement of the goals of the FOA (see section VI, #2, Cooperative Agreement Terms and Conditions of Award Areas of Joint responsibility). SC responsibilities include providing input on and approval of all studies developed by Consortium members prior to study implementation; review and approval of all data analyses, public presentations and publications of research conducted within the Consortium; and development of policies and procedures for submission and approval of research applications using Consortium resources. The NIDDK may select a chair of the SC [Steering Committee Chair (SCC)] either from the PDs/PIs of the Intervention Site s, or outside the study group.
Community Advisory Committee (CAC)
The Intervention Sites and RCC will each identify at least two representatives of the population most affected by the interventions to serve on a CAC, which will provide feedback to the Consortium regarding the design and conduct of the studies. At least one NIDDK and one RCC member will staff the CAC.
Executive Committee (EC)
An EC will be comprised of the Steering Committee Chair, RCC PDs/PIs, NIH Program Staff, and a patient representative. Additional Project site investigators and other support personnel may participate in the EC as needed. The Executive Committee will make operational decisions for the Consortium between SC meetings by means of weekly conference calls.
Awardees will meet to finalize the Consortium study protocol(s). Both Intervention Sites and RCC awardees and Community Advisory Council should be prepared to participate in conference calls immediately after funding and should plan to attend the first Steering Committee meeting in the Bethesda, Maryland / Washington DC area or virtually, if necessary, in July/August 2023.
Subsequent 1-2 day in-person or virtual SC meetings will be conducted every 3-4 months for the first year and twice yearly or more often as needed thereafter in the Bethesda MD / Washington DC area or virtually. Applicants should budget accordingly.
Awardees must agree to abide by the Network Duality of Interests Policy and Procedures and may need to develop procedures to require study investigators and others associated with the study to identify financial and other conflicts of interest on a routine basis, at least annually, and to share this information with the NIDDK Program staff.
Alignment with NIDDK Strategic Plan and Priorities
This FOA aligns with the Mission and Vision of the NIDDK Strategic Plan for Research, including the theme of empowering a multidisciplinary workforce, engaging diverse stakeholders, and pursuing pathways to health for all. Specifically, this FOA aligns with the Scientific goals 2, 3, and 4 and Cross-cutting topics of reducing health disparities and increasing health equity among racial and ethnic minority populations and others who are underserved and strengthening research workforce diversity and training.
The NIDDK strongly encourages Research on Sex/Gender Differences, Sexual and Gender Minority-Related Research and Race/Ethnic Diversity (see NOT-DK-22-003).
Technical Assistance Webinar
NIDDK will conduct a Technical Assistance webinar for prospective applicants; details are forthcoming through a future guide notice.
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.
NIDDK, NIMH, NINR and ODP intend to commit 4.85 million in FY 2023 to support RFA-DK-22-014 and RFA-DK-22-015. We anticipate funding up to 6 Intervention Sites and 1 Research Coordinating Center.
The direct costs for the Research Coordinating Center U24 award are expected to be $500,000 direct costs per year (excluding opportunity pool). Applicants may ask for $100,000 or more per year for the opportunity pool. All Opportunity Pool costs are inclusive of any F&A for the Research Coordinating Center and the subawardees. As such, the Research Coordinating Center should not calculate F&A on the Opportunity Pool set aside.
Application budgets are not limited but should reflect the actual needs of the proposed project.
The scope of the proposed 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.
1. Eligible Applicants
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 diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.
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.
Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
The NIH will not accept duplicate or highly overlapping applications under review at the same time, per 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:
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 Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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:
John F. Connaughton, Ph.D.
Chief, Scientific Review Branch
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-7797
Email: NIDDKLetterofIntent@mail.nih.gov
Page Limitations
All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.
Instructions for Application Submission
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.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Other Attachments:
Plan for Enhancing Diverse Perspectives (PEDP): The filename Plan for Enhancing Diverse Perspectives.pdf should be used.
In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured. The PEDP may be no more than 2-pages in length and should include a timeline and milestones for relevant components that will be considered as part of the review. Examples of items that advance inclusivity in research and may be part of the PEDP can include, but are not limited to:
For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp. Applications lacking the Plan for Enhancing Diverse Perspectives are incomplete and will not be reviewed.
Clinical Trials Research Experience: The filename "Clinical Trial Research Experience.pdf" should be used.
Applicants must provide a detailed table listing the characteristics of trials they have been involved in that demonstrate experience in trial coordination in the last 5 years. The table must be provided as an "Other Attachmentment" entitled "Clinical Trial Research Experience" and may not exceed 3 pages. The table columns should include:
Applications that lack the Clinical Trials Research Experience Table are considered incomplete and will not be peer reviewed.
SF424(R&R) Senior/Key Person Profile
All instructions in the SF424 (R&R) Application Guide must be followed.
The Multiple PD/PI plan, if applicable, may include nephrologists, social scientists, behavioral medicine experts, healthy equity and disparities researchers, public health practitioners, biostatisticians, and/or clinical trialists.
R&R Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
Applicants should also include:
R&R Subaward Budget
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Cover Page Supplement
All instructions in the SF424 (R&R) Application Guide must be followed.
PHS 398 Research Plan
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
Research Strategy:
Application for the RCC should include the following:
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:
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information
When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:
If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.
Study Record: PHS Human Subjects and Clinical Trials Information
All instructions in the SF424 (R&R) Application Guide must be followed.
Delayed Onset Study
Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.
PHS Assignment Request Form
All instructions in the SF424 (R&R) Application Guide must be followed.
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 form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by NIDDK. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Use of Common Data Elements in NIH-funded Research
NIDDK encourages the use of common data elements (CDEs) in basic, clinical, and applied research, patient registries, and other human subject research to facilitate broader and more effective use of data and advance research across studies. CDEs are data elements that have been identified and defined for use in multiple data sets across different studies. Use of CDEs can facilitate data sharing and standardization to improve data quality and enable data integration from multiple studies and sources, including electronic health records. NIH ICs have identified CDEs for many clinical domains (e.g., neurological disease), types of studies (e.g., genome-wide association studies (GWAS)), types of outcomes (e.g., patient-reported outcomes), and patient registries (e.g., the Global Rare Diseases Patient Registry and Data Repository). NIH has established a Common Data Element (CDE) Resource Portal" (https://cde.nlm.nih.gov/home) to assist investigators in identifying NIH-supported CDEs when developing protocols, case report forms, and other instruments for data collection. The Portal provides guidance about and access to NIH-supported CDE initiatives and other tools and resources for the appropriate use of CDEs and data standards in NIH-funded research. Investigators are encouraged to consult the Portal and describe in their applications any use they will make of NIH-supported CDEs in their projects.
Post Submission Materials
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.
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 are asked to especially consider the justification of the following:
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 Research Coordinating Center?
Specific to this FOA:
Are the PD(s)/PI(s) and other personnel well suited to their roles in the Research Coordinating Center? Does the applicant have experience overseeing selection and management of subawards, if needed?
Specific to this FOA:
Does the application propose novel proposed?
Specific to this FOA:
Are the overall strategy, operational plan, and organizational structure well-reasoned and appropriate to accomplish the goals of the research consortium? 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?
Specific to this FOA:
Will the institutional environment in which the Research Coordinating Center benefit from unique features of the institutional environment, infrastructure, or personnel? Are resources available within the scientific environment to support electronic information handling?
Specific to this FOA:
As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.
For research that involves human subjects but does not involve one of the 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.
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.
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
As applicable for the 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.
Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).
For consortia involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
2. Review and Selection Process
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIDDK, 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 Diabetes and Digestive and Kidney Diseases Advisory Council. The following will be considered in making funding decisions:
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.
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 recipient's business official.
Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.
Any application awarded in response to this 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.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
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 recipient 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: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:
If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.
Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS 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 (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html
HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this 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 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.
The following special terms of the 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, 2 CFR 200, 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 recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients 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 recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.
The Program Director(s)/Principal Investigator(s) will have the primary responsibility for:
1. Developing the research design and study protocol, including the definition of objectives and approaches, sample size and power calculations, and establishing procedures for participant recruitment and follow-up, data collection, quality control, interim data and safety monitoring, final data analysis and interpretation, and publication of results.
2. Establishing a Steering Committee to implement, coordinate and manage the project(s). Recipient(s) will name investigators to serve as members on a Steering Committee and other subcommittees, as appropriate, meeting periodically. Recipients will be required to accept and implement the common protocol(s) and procedures approved by the Steering Committee.
3. Designating Protocol Chairs. The Program Directors/Principal Investigators (for studies involving multiple protocols) shall designate a single Protocol Chairperson (if the Program Director/Principal Investigator does not assume this role) for each protocol to be carried out by the study group. The Protocol Chairperson shall function as the scientific coordinator for the protocol and shall assume responsibility for obtaining approval to implement the protocol from the Steering Committee and for developing and monitoring the protocol. Significant modifications to approved protocols must be approved by the Steering Committee.
4. Implementing collection of data specified by the study protocol. For a multi-center study, each recipient/site is required to ensure that data will be submitted expeditiously to the Data Coordinating Center. Additionally, individual investigators/sites must demonstrate the ability to implement the strategy specifically designed for their individual study population.
5. Establishing procedures for data quality, completeness, and security. Recipients are responsible for ensuring accurate and timely assessment of the progress of each study, including the development of procedures to ensure that data collection and management are: (1) adequate for quality control and analysis; (2) for clinical trials, as simple as appropriate in order to facilitate cooperation/referral of study participants by physicians to avoid unnecessary expense; and (3) sufficiently staffed across the participating institutions. For research involving multiple sites, a plan for analysis of pooled data will be developed by the Steering Committee.
6. Submitting interim progress reports, when requested or agreed upon by both parties, to the NIDDK Program Official including as a minimum, summary data on protocol performance. For coordinated multiple awards or a multi-site single award, the NIDDK Program Official may require additional information from individual recipients/sites. Such reports are in addition to the required annual noncompeting continuation progress report.
7. Reporting of the study findings. Recipients 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. The recipient must also be adherent to the Study Publication and Presentation Policy. The NIDDK will have access to and may periodically review all data generated under an award. NIH staff may co-author publications of findings with recipients consistent with NIH and study policies.
8. Any third-party collaboration (including but not limited to interactions with organizations from industry, academia, and nonprofit institutions) should be governed by a research collaboration agreement (e.g., Clinical Trial Agreement, Research Collaborative Agreement, etc.) or any third-party contract mechanism(s) with terms that ensure the collaboration is conducted in accordance with the Cooperative Agreement, applicable NIH/NIDDK policies and procedures, and with written approval from NIDDK Program staff. Any relevant proposed third-party agreements related to the network studies between the recipient and the third-party will be provided to the NIDDK Program staff and NIDDK Technology Advancement Office for review, comment, and approval to assure compliance with NIH/NIDDK policies and network policies. Further, at the request of the NIDDK Program staff, any other network-relevant third-party agreements must be shared with NIDDK. Failure to comply with this term may prompt action in accordance with NIH Grants Policy Statement, Section 8.5 titled: Special Award Conditions and Remedies for Noncompliance (Special Award Conditions and Enforcement Actions , and Section 8.5.2, titled: Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding Support , noncompliance with the terms and conditions of award will be considered by the funding IC for future funding and support decisions and may result in termination of the award.
9. Any involvement of a third-party (including but not limited to industry, academia, and nonprofit institutions) in the study and network activities that includes access to any network-generated resources (i.e., data and biosamples), or study results that are not publicly available, or using the name of the network or study or the name of the NIH or NIDDK, is permitted only after written permission by the NIDDK Program staff who will consult with others at NIH and NIDDK Technology Advancement Office.
10. Study investigators are required to publish and to release publicly and disseminate results and other products of the study, in accordance with study protocols, steering committee policies on publications, and the NIDDK-approved sharing plan.
11. Maintaining confidentiality of information: The recipient(s) will maintain the confidentiality of the information developed by the investigators (i.e., protocols, data analysis, conclusions, etc.) as well as proprietary information of an individual company or other entity collaborating with the study. Any exception requires written approval from NIDDK Program staff.
12. The NIDDK has established a Central Repository to support the receipt, storage, and distribution of data, biosamples, and other resources generated in clinical studies funded by the NIH/NIDDK. When the NIDDK Central Repository is to be utilized, prior to enrolling participants, the PI or his/her designee will coordinate with the NIDDK Program and Central Repository staff to prepare for eventual archiving and distribution of the study-generated resources that are to be maintained in the Central Repository. All resources transferred to the Central Repository will be under the custodianship of the NIDDK. The study’s leadership will have proprietary control of and exclusive access to the resources per the NIDDK-approved sharing plan. Subsequently, these resources will be available to the wider scientific community in accordance with the NIH policy on Data Sharing (http://grants.nih.gov/grants/policy/data_sharing/ and, https://grants.nih.gov/policy/sharing.htm, and http://grants.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm), as well as the NIDDK policy for resource sharing, NIDDK Data Sharing Policy.
13. Study investigators are required to comply with NIH Policy on the Dissemination of NIH Funded Clinical Trial Information as stated at https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm. Per policy, the recipient is responsible for meeting the expectations of this policy. Refer to additional information at https://grants.nih.gov/policy/clinical-trials/reporting/index.htm.
NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below:
An NIH Project Scientist(s) with substantial involvement will:
1. Serve as the contact point for all facets of the scientific interaction with the recipient (s). As required for the coordination of activities and to expedite progress, NIDDK may designate additional NIH staff to provide advice to the recipient on specific scientific and/or analytic issues. Such staff may include another Project Scientist or Project Coordinator, who will provide direct technical assistance to the recipients to optimize the conduct and/or analysis of the study; or who may assist in the coordination of activities across multiple sites.
2. For multi-center studies, participate in the Steering Committee that oversees study conduct. The NIH Project Scientist or Project Coordinator will be a full participant and voting member of the Steering Committee and, if applicable, subcommittees. If there are multiple NIH Project Scientists or Project Coordinators participating on the Steering Committee, one NIDDK Project Scientist will be designated to serve as the voting member of the SC representing the NIH Project Team.
3. Serve as a resource to study investigators with respect to other ongoing NIH activities that may be relevant to the study to facilitate compatibility with the NIDDK missions and avoid unnecessary duplication of effort.
4. Have substantial involvement assisting in the design and coordination of research activities for recipients as elaborated below:
a. Assisting by providing advice in the management and technical performance of the investigations, coordinating required regulatory clearances for investigational agents used in the study, which are held by NIDDK. The NIDDK may reserve the right to cross file or independently file an Investigational New Drug Application or an Investigational Device Exemption form with the FDA.
b. The NIH Project Scientist(s) or Project Coordinator(s) may coordinate activities among recipients by assisting in the design, development, and coordination of a common research or clinical protocol and statistical evaluations of data; in the preparation of questionnaires and other data recording forms; and in the publication of results.
c. Reviewing procedures for assessing data quality and study performance monitoring.
d. The NIH Project Scientist(s) or Project Coordinator(s) may be co-authors on study publications. In general, to warrant co-authorship, NIH staff must have contributed to the following areas: (a) design of the concepts or experiments being tested; (b) performance of significant portions of the activity; (c) participation in analysis and interpretation of study results and (d) preparation and authorship of pertinent manuscripts.
The NIDDK Program Official identified in the Notice of Award will:
Areas of Joint Responsibility include:
In addition to the interactions defined above, NIH Project Scientist(s) and Recipients shall share responsibility for the following activities:
Steering Committee
A Steering Committee organized by the study investigator(s) will be the main governing body of the study.
The Steering Committee has the primary responsibility to design research activities, establish priorities, develop common protocols and manuals, questionnaires, and other data recording forms, establish and maintain quality control among recipients, review progress, monitor patient accrual, coordinate and standardize data management, and cooperate on the publication of results. Major scientific decisions regarding the core data will be determined by the Steering Committee. The Steering Committee will document progress in written reports to the NIDDK Program Official and will provide periodic supplementary reports upon request.
The Steering Committee will be composed of all Program Director(s)/Principal Investigator(s), (including those of data coordinating /statistical centers, if any) and co-investigators as deemed necessary, the NIH Project Scientist(s), and at least one patient participant representative appointed by NIDDK. The final structure of the Steering Committee and voting procedures will be established at the first meeting. The NIDDK Project Scientist will have voting membership on the Steering Committee, and as appropriate, its subcommittees. The frequency of Steering Committee meetings will be dictated by a vote of the members of the Steering Committee.
A Chairperson will be selected by the Steering Committee. The Chairperson provides leadership to the Committee by conducting the Steering Committee meetings and representing the study group by interacting closely with the recipients during protocol development and implementation. The NIDDK Project Scientist may not serve as Chairperson. The NIDDK Program Official should be consulted regarding the selection of the Chairperson to provide any feedback regarding concerns regarding potential for bias or conflict of interest or lack of required expertise.
Dispute Resolution
Any disagreement that may arise on scientific/programmatic matters (within the scope of the award), between award recipients and the NIDDK may be brought to dispute resolution. A dispute resolution panel will be composed of three members --one selected by the recipient (or the Steering Committee, with the NIDDK member, not voting), a second member selected by NIDDK, and the third member elected by the two prior selected members. These special dispute resolution procedures in no way affect the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations at 42 CFR Part 50, Subpart D, and HHS regulations at 45 CFR Part 16.
3. Reporting
When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.
A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over the threshold. See the NIH Grants Policy Statement for additional information on this reporting requirement.
In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.
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: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-480-7075
Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov
Raquel C. Greer, M.D., M.H.S.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-402-0306
Email: raquel.greer@nih
Jenna Norton, Ph.D, M.P.H.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-451-7314
Email: jenna.norton@nih.gov
Dionne Godette-Greer, PhD
National Institute of Nursing Research (NINR)
Telephone: 301-827-0095
Email: dionne.godette@nih.gov
Vanessa J Marshall, Ph.D.
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: vanessa.marshall@nih.gov
Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email: Jennifer.alvidrez@nih.gov
Michele Barnard, PhD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Telephone: 301-594-8898
Email: michele.barnard@nih.gov
Norma Deguzman
National Institute of Diabetes and Digestive, and Kidney Diseases (NIDDK)
Telephone: 301-480-1810
Email: norma.deguzman@nih.gov
Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@mail.nih.gov
Priscilla Grant, JD.
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-594-8412
E-mail: pg38h@nih.gov
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75 and 2 CFR Part 200.