EXPIRED
National Institutes of Health (NIH)
Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
National Heart, Lung, and Blood Institute (NHLBI)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
February 6, 2024 - Participation Added (NOT-AR-24-012) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)
National Cancer Institute (NCI)
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.
Office of Dietary Supplements (ODS)
Sexual and Gender Minority Research Office (SGMRO)
Office of Research on Women's Health (ORWH)
The purpose of this NOFO is to support projects to test prospective multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities. These research projects will be part of the Multi-Sectoral Preventive Interventions (MSPI) Research Network, which will also include a Coordinating Center (RFA-OD-24-006). Funded under a cooperative agreement, projects participating in the MSPI Research Network will collaborate to share approaches, methods, and data, working closely with NIH Institutes, Offices and Centers. Applicants applying to this NOFO are encouraged to review the Coordinating Center NOFO to fully understand the MSPI Research Network structure and activities.
This NOFO solicits bi-phasic research projects proposed in UG3/UH3 Phased Innovation Awards Cooperative Agreement applications. Funding for the UG3 phase (phase I) will be used to demonstrate sufficient preparation, feasibility and capacity to meet foundational milestone targets specific to the work proposed. A UG3 project that meets its milestones will be administratively considered by NIH and prioritized for transition to the UH3 award (phase II). Applicants responding to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases.
July 5, 2024
Application Due Dates | Review and Award Cycles | ||||
---|---|---|---|---|---|
New | Renewal / Resubmission / Revision (as allowed) | AIDS - New/Renewal/Resubmission/Revision, as allowed | Scientific Merit Review | Advisory Council Review | Earliest Start Date |
August 05, 2024 | Not Applicable | Not Applicable | November 2024 | January 2025 | April 2025 |
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 How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).
Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.
Applications that do not comply with these instructions may be delayed or not accepted for review.
Purpose
The purpose of this NOFO is to support projects to test prospective multi-sectoral preventive interventions that address social determinants of health in populations that experience health disparities. These research projects will be part of the Multi-Sectoral Preventive Interventions (MSPI) Research Network, which will also include a Coordinating Center (RFA-OD-24-006). Funded under a cooperative agreement, projects participating in the MSPI Research Network will collaborate to share approaches, data, and methods, working closely with NIH Institutes, Offices and Centers. Applicants applying to this NOFO are encouraged to review the Coordinating Center NOFO to fully understand the MSPI Research Network structure and activities.
Key Definitions for this NOFO
Preventive intervention: For the purposes of this NOFO, preventive interventions include both primary and secondary prevention. Primary prevention involves interventions or policies designed to prevent or reduce risk factors for developing a new health condition before health effects occur. Secondary prevention involves interventions or policies designed to prevent the recurrence of a health condition or progression of an early-stage health condition. Preventive interventions are inclusive of interventions to prevent or reduce risk factors, screen for risk factors or signs of early disease, or provide referrals or brief treatment to prevent disease onset or progression of early-stage conditions. Projects developing technologies, such as devices and algorithms, as part of risk factor screening or preventive interventions also fall within this definition.
Populations that experience health disparities (HD Populations): Populations defined in section 464z-3(d)(1) of the Public Health Service Act, 42 U.S.C. 285t(d)(1) as health disparity populations based on higher overall rates of disease incidence, prevalence, morbidity, mortality, or survival rates in the population as compared to the health status of the general population. NIH-designated U.S. health disparity populations currently include Black Americans/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians/Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minorities, and people living with disabilities.
Social determinants of health (SDOH): The conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of structural factors shaping the conditions of daily life. These structural factors include social, economic, and legal forces, systems, and policies that determine opportunities and access to high quality jobs, education, housing, transportation, built environment, information and communication infrastructure, food, and health care; the social environment; and other conditions of daily life. See https://www.ninr.nih.gov/researchandfunding/nih-sdohrcc for additional detail on the NIH SDOH Conceptualization.
Multi-sectoral intervention: An intervention involving two or more service sectors (e.g., health, public health, education, housing, labor, social services, child welfare, transportation, parks and recreation, commerce, justice, environmental protection, etc.). These sectors may include neighborhood, city, county, regional, state, national, or tribal governmental or non-governmental organizations. For the purposes of this NOFO, research teams from academic institutions or research organizations are not considered as a service sector. However, institutions of higher learning would be considered as a service sector for multi-sectoral interventions directed towards students of those institutions.
Level of Influence: The socio-ecological levels (e.g., individual, interpersonal, organizational, community, or societal) at which specific determinants operate to influence risk factors and subsequent health outcomes (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants at different levels of influence). To constitute an intervention at the interpersonal, organizational, community, or societal level, the intervention must directly alter determinants at that level, not just be delivered in a setting at that level or help individuals manage the consequences of determinants at that level. For example, an intervention to promote better nutrition among school-aged children by adjusting available food options in the school cafeterias would be an organizational-level intervention; an intervention providing nutrition information to students within schools would be an individual-level intervention.
Background
The NIH Office of Disease Prevention (ODP) within the Office of the Director, Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) is coordinating the new trans-NIH research effort, ADVANCE: Advancing Prevention Research for Health Equity, which grew out of the ODP’s portfolio analysis of NIH research. In an examination of NIH-funded grants and cooperative agreements between fiscal years 2012 and 2017, the ODP found that only 8.5% of all projects focused on preventing the leading risk factors or causes of death and disability (e.g., poor nutrition, low physical activity, smoking), falling well below their burden on the nation’s health. An additional analysis of the NIH research portfolio showed that between fiscal years 2016 and 2019, only 3.6% of NIH-funded prevention projects included a randomized intervention to address a leading risk factor in populations that experience health disparities.
To address this research gap, this ADVANCE initiative will support research projects to test preventive interventions addressing risk factors for chronic or acute health conditions in populations that experience health disparities. Prevention or reduction of leading risk factors in HD populations requires moving beyond addressing knowledge, attitudes, and behaviors of individuals to intervene upon social determinants of health (SDOH) that drive inequities, such as limited access to healthy food options, limited opportunities for physical activity, lack of access to healthcare, and exposure to stigma, discrimination, and violence. Multi-sectoral collaborations that span multiple service sectors and community-based organizations have great potential to develop, implement, and sustain preventive interventions that address SDOH and promote health equity. Projects will be part of a research network to share approaches, data, and methods to facilitate the generation of research evidence about the prevention of common risk factors for multiple health conditions across different populations.
Research Objectives
Proposed intervention projects are expected to have the following features:
Study designs are expected to include the following features:
MSPI Research Network Structure
The MSPI Research Network will consist of the awarded UG3/UH3 Research Projects and a Coordinating Center (CC) (see RFA-OD-24-006). The CC and each of the Research Projects will also work collaboratively with one or more Project Scientists and Program Officers from NIH institutes, centers, and offices (ICOs).
The MSPI Research Network priorities and activities will be governed by a Steering Committee (SC) which at a minimum will include at least two representatives from each Research Project (e.g., research and community organizational MPI or key personnel), the CC, and at least one NIH representative. The MSPI Research Network Steering Committee will meet at least monthly and be chaired by personnel from the CC. Based on the priorities set by the Steering Committee, relevant workgroups will be established to carry out cross-project activities or consultation. For example, NIH anticipates there will be at least three workgroups: methodology and data analysis, data harmonization, and dissemination.
UG3/UH3 Phased Innovation Awards
This UG3/UH3 Phased Innovation Award supports bi-phasic projects for up to seven years. The UG3 (Phase 1) will be a two-year award for a milestone-driven developmental/exploratory study that can demonstrate sufficient preparation, feasibility, capacity and leveraging of foundational activities needed for the implementation studies planned in Phase 2 (UH3). Phase 1 includes scientific, operational and collaborative planning activities as well as tangible deliverables/preliminary findings that could be informative to the field as appropriate.
The UH3 phase will provide support for five additional years to conduct the implementation phase of research that will advance knowledge of multi-sectoral preventive interventions with HD populations. The UH3 phase award will support the implementation and evaluation of the interventions or strategies planned or developed in the UG3 phase. UG3 projects that have met the milestones for the first phase (e.g., scientific, operational, collaborative) will be programmatically considered and prioritized for transition to the UH3 phase.
Funding of the UG3 (Phase 1) does not guarantee support of the UH3 (Phase 2) award for research implementation, and all funded UG3 projects may not transition to the UH3 phase. Transition to the UH3 phase will be determined by the availability of funds and the outcome of a programmatic evaluation at NIH that is based on 1) appropriate sustainability plans with successful engagement of local collaborating agencies and partners and 2) Go/No-Go Transition Milestone accomplishment specific to the project being proposed [e.g.; establishment of relevant collaborations with community and other sector partners needed to advance achievement of the research objectives as demonstrated by the execution of necessary agreements with these agencies for committed financial and/or human resources, data sharing, etc.; demonstrated ability to recruit appropriate individual and/or organizational population samples, conduct data collection, access to data for appropriate data linkages, etc.]. Continued programmatic priorities and availability of funds will impact the decision to transition to the UH3 award. Appeals of the transition decision will not be accepted.
Applications Not Responsive to the NOFO
Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.
Pre-application technical assistance
Information regarding a pre-application webinar and frequently asked questions (FAQs) will be provided in a forthcoming Notice published in the NIH Guide.
Areas of Research Interest:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Musculoskeletal diseases are the leading cause of disability and health care expenditures in the United States. NIAMS is interested in receiving research applications that design, adapt, test and/or implement culturally appropriate, multi-sectoral interventions for the primary and secondary prevention of arthritic, other rheumatic, musculoskeletal, and skin diseases, among populations experiencing health disparities. Applications centered on improving access to evidence-based interventions and strategies and with a focus on sustainability are encouraged. Applicants are strongly encouraged to discuss their proposed research interest with NIAMS program staff.
National Cancer Institute (NCI)
In the US, there are approximately 18 million cancer survivors, which includes individuals diagnosed with cancer from the time of diagnosis until the end of life. Cancer survivors from racial and ethnic minority groups and other medically underserved populations are more likely to experience cancer recurrence, secondary malignancies, multiple chronic comorbidities, physical and psychological side effects, poorer health-related quality of life and health behaviors, and higher financial toxicity than other cancer survivors. The cases of disparities in cancer prevention, screening, and management of onset of other health conditions, reoccurrence, and secondary malignancies can be attributable to factors beyond the healthcare system into other SDOH. For example, the neighborhood built and social environments shape how communities are connected via public transportation that enables timely access to healthcare, affect the walkability, safety, availability of green space or gardens, fast food density, and access to full-service grocery stores that promote physical activity and healthy eating; and determine the availability of quality healthcare services, providers, and resources. SDOH can, directly and indirectly, impact the ability of cancer survivors to engage in positive health behaviors (e.g., walking, eating healthy, survivorship care visits) to reduce their risk through various mechanistic pathways at multiple levels of influence. These direct, indirect, and synergistic interactions cause health disparities and require the collaboration of multiple sectors, including health, public health, social services, transportation, parks and recreation, environmental protection, and community-based organizations, to address and alter SDOH.
NCI invites research applications that design and test cancer preventive and survivorship interventions to address the mechanistic pathways by which SDOH impact modifiable risk factors, thereby increasing the risk for multiple chronic comorbidities or health conditions and poor health-related quality of life. Interventions must be multilevel and use the Socioecological Framework to target SDOH that indirectly, directly, and synergistically lead to poor health outcomes at two or more levels of influence (e.g., interpersonal, organizational, community, or societal). Research studies that integrate trans-disciplinary expertise are of particular interest.
Areas of research interest include, but are not limited to:
National Center for Complementary and Integrative Health (NCCIH)
The mission of NCCIH is to determine, through rigorous scientific investigation, the fundamental science, usefulness, and safety of complementary and integrative health approaches and their roles in improving health and health care. Examples of complementary and integrative health approaches include those with physical and/or psychological therapeutic inputs, often called mind and body interventions (e.g., acupuncture, yoga, tai chi, qi gong, meditation/mindfulness, hypnosis, music therapy, art therapy, and massage), and approaches with dietary or nutritional therapeutic inputs (e.g., special diets). Applications will not be considered by NCCIH if they propose trials of regulated products (e.g., dietary supplements, devices, or biologics) for indications that have not been approved or cleared by the U.S. Food and Drug Administration. NCCIH will only accept assignment of applications that include complementary and integrative health approaches. As discussed in NCCIH’s Strategic Plan, expanding the portfolio of research on complementary and integrative health approaches to address and eliminate health disparities across the lifespan is a high priority.
Under this PAR, NCCIH is interested in supporting studies that develop, adapt, test, and/or implement culturally appropriate, multi-sectoral prevention interventions with a complementary and integrative health component in diverse settings (e.g., schools, Federally Qualified Health Centers, child welfare and juvenile justice systems, correctional and detention systems, etc.) and among populations experiencing health disparities. Research involving interventions with a high potential for sustainability and/or examinations of implementation strategies to facilitate sustainability are encouraged. In addition, a central focus of NCCIH’s Strategic Plan is whole person health, which emphasizes that health exists across multiple interconnected body systems and domains, including biological, behavioral, social, and environmental. Multi-sectoral prevention interventions that intervene on social determinants of health to reduce risk and/or enhance protective factors across multiple levels of influence are aligned with a whole person health framework. Accordingly, under this PAR, research involving multicomponent behavioral or systems-level interventions that aim to improve health and prevent disease in multiple interconnected therapeutic modalities and/or pathways are encouraged.
Investigators are encouraged to review the NCCIH Clinical Research Toolbox to learn more about NCCIH's requirements, policies, guidelines, and required templates for clinical trials. Applicants are strongly encouraged to discuss their proposed research interest with the designated NCCIH Scientific/Research Contact listed below to confirm its relevance to the NCCIH mission areas.
National Heart, Lung, and Blood Institute (NHLBI)
The NHLBI is interested in supporting multisectoral interventions that focus on heart, lung, blood, and/or sleep (HLBS) risk factors, diseases, and conditions. NHLBI has a strong interest in dissemination and implementation science studies that aim to utilize evidence-based interventions and strategies that:
Investigators planning to submit an application are strongly encouraged to consult with the NHLBI Scientific Contact listed in Section VII of this NOFO.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
The Surgeon General’s Report on Alcohol, Drugs, and Health published in 2016 calls for a public health model for addressing substance misuse and related consequences. This report identified risk and protective factors at the individual, family, school, and community levels, provided a list of evidence-based prevention programs and policies, and highlighted evidence-based community coalition-based prevention models, such as the Communities That Care and the Communities Mobilizing for Change on Alcohol. NIAAA-developed Alcohol Screening and Brief Intervention for Youth: A Practitioner’s Guide provides a tool and resources for identifying youth at risk for alcohol-related problems. CollegeAIM provides intervention matrices for addressing alcohol issues in college, and some interventions are relevant to young adults who are not in college. The Healthcare Professional’s Core Resource on Alcohol provides evidence-based context to help healthcare professionals to overcome barriers to care for patients with alcohol-related concerns. The Alcohol Policy Information System (APIS) supported by NIAAA provides detailed information on alcohol-related and recreational cannabis policies at both State and Federal levels. The Community Preventive Services Task Force reviewed and recommended numerous interventions to reduce excessive alcohol consumption in communities. Countermeasures That Work by the National Highway Traffic Safety Administration provides evidence-based interventions and policies for alcohol-impaired driving. The Sequential Intercept Model by the Substance Abuse and Mental Health Services Administration (SAMHSA) is a tool that helps communities develop strategies to divert people with substance use disorders away from the justice system into treatment. SAMHSA’s Evidence-Based Practices Resource Center provides a collection of scientifically based tools for the public to quickly identify approaches for their needs. A wide variety of resources are available, but much more needs to be done to test or implement prevention interventions and policies in the context of SDOH and assess outcomes in HD populations.
SDOH can impact the likelihood of alcohol misuse and alcohol use disorder (AUD), such as social and community context (e.g., discrimination, racism, social isolation, growing up in a home with parental AUD), neighborhood and built environment (e.g., alcohol outlet density, exposure to violence, housing affordability), health care access and quality (e.g., receiving evidence-based preventive care), economic stability (e.g., job and food security, income), and education access and quality (e.g., educational opportunities and attainment). Adverse SDOH serve as allostatic loads on the body’s stress systems, increase vulnerability to mental and physical conditions, and contribute to health disparities and inequities. Such stressors can drive alcohol misuse to cope which, in turn, exacerbates the initial problems, further fueling alcohol misuse.
Under this PAR, NIAAA is interested in multilevel and multisectoral preventive interventions that are not feasible to accomplish with the Research Project Grant (R01) mechanism. Study designs are expected to include process evaluation, assessment of barriers and facilitators to implementation and sustainability, and evaluation of any unintended negative effects. Contingent upon funding availability, NIAAA may prioritize applications with scientifically meritorious scores in the following research areas of interest:
Applications submitted to NIAAA are expected to adhere to NIAAA’s expectations for Data Management and Sharing Plans described in NOT-AA-23-001, as appropriate.
National Institute on Drug Abuse (NIDA)
NIDA is interested in research to determine the extent to which interventions at the policy, community, organizational, or individual levels that address SDOH prevent substance use and associated negative outcomes. Applicants may choose to study a single intervention or a combination of interventions that impact substance use. NIDA studies must include a substance use outcome. Specific outcomes of interest include substance use risk, substance use initiation, substance misuse, and escalation from misuse to substance use disorder (SUD). NIDA prioritizes research that examines the mechanisms through which addressing the SDOH will have an impact on substance use outcomes.
Examples of research areas that would be of interest to NIDA include, but are not limited to:
In developing studies that feature collaboration of two or more sectors, applicants are encouraged to engage partners that are positioned to sustain effective strategies after study completion, especially those that use existing funds (e.g., federal block grant, entitlement programs, settlement funds) to address SDOH. To maximize the acceptability, feasibility, scalability, and sustainability of the intervention(s) being studied, applicants should also engage relevant end users in study conceptualization, design, execution, and interpretation. For this NOFO, end user is broadly defined and may include policymakers, state and local level decision makers, practitioners, intervention implementers, families, youth, and community members.
The National Institute of Dental and Craniofacial Research (NIDCR)
NIDCR encourages the submission of applications for multi-sectoral interventions targeting social determinants of health (SDOH) and/or commercial determinants of health (CDOH) to reduce modifiable risk factors shared across multiple chronic diseases and conditions to prevent dental, oral, and craniofacial (DOC) diseases in populations that experience health disparities. Examples include coordinated efforts to implement systematic screening and referral for DOC diseases, or testing combined efforts to reduce common risk factors for preventing occurrence, recurrence, or progression of DOC diseases and comorbid conditions. Investigators planning to submit an application are strongly encouraged to consult with the NIDCR Scientific Contacts listed in Section VII of this NOFO.
National Institute on Minority Health and Health Disparities (NIMHD)
The mission of NIMHD is to lead scientific research to improve minority health and reduce health disparities in populations that experience health disparities. Of specific interest are meritorious applications that focus on racial and ethnic minority populations and/or low socioeconomic status (SES) persons. The intersectionality of race and ethnicity and/or low SES with rural populations, sexual and gender minority (SGM) groups, or individuals with disabilities, as well as any other condition is also a priority.
NIMHD is interested in multisectoral preventive interventions that lead to improved health outcomes and decrease health disparities in the above populations. Interventions of particular interest are: 1) multi-level (e.g., individual, interpersonal, family, peer group, community, societal), 2) culturally appropriate, 3) intentional about which populations, time points in the life course, and risk or protective factors are targeted for reduction of health disparity outcomes, 4) utilize community-engaged approaches, and 5) address risk factors among populations that experience earlier onset of conditions or premature morbidity, and mortality.
Areas of specific interest to NIMHD include but are not limited to studies that:
National Institute of Nursing Research (NINR)
NINR supports research to solve pressing health challenges and inform practice and policy - optimizing health and advancing health equity into the future. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community.
Office of Disease Prevention (ODP)
The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers (ICs), the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP co-funds research that has strong implications for disease and injury prevention and health equity and that includes innovative and appropriate research design, measurement, and analysis methods. For this NOFO, the ODP has a specific interest in projects that develop and/or test preventive interventions operating at organizational and/or community levels. The ODP does not award grants; therefore, applications must be relevant to the objectives of at least one of the participating NIH ICs listed in this announcement. Please contact the relevant IC Scientific/Research Contact(s) listed for questions regarding IC research priorities and funding. ODP only accepts co-funding requests from NIH ICs. For additional information about ODP, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.
Office of Dietary Supplements (ODS)
ODS advances and disseminates research on dietary supplements to foster knowledge and optimize health across the lifespan. Dietary supplement ingredients are defined as including vitamins, minerals, herbs and other botanicals, amino acids, and other dietary or bioactive substances, consumed as dietary supplements to promote health and prevent disease. For this NOFO, ODS is interested in interventional studies, including those involving nutrition education-related interventions aimed at addressing disparities in health-related behaviors. This includes areas such as infant feeding practices (specifically Vitamin D supplementation needs), as well as supplementation during pregnancy and lactation, among others, and interventions to determine where dietary supplements can meet nutrient gaps for different population groups.
The ODS does not award grants, therefore, applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed in this announcement. Please contact the relevant IC program contacts listed for questions related to funding.
Office of Research on Women’s Health (ORWH)
The Office of Research on Women’s Health (ORWH) is part of the Office of the Director, NIH, and works with the 27 NIH Institutes and Centers to advance rigorous research of relevance to the health of women. ORWH does not award grants but co-funds women’s health-related applications and research projects that have received an award from one of the participating NIH Institutes and Centers (ICs) listed in the announcement. Applications seeking ORWH co-funding, in response to this NOFO, should ensure that the proposed work is aligned with at least one goal and objective outlined in the Trans-NIH Strategic Plan for Women’s Health Research (https://www.nih.gov/women/strategicplan).
For this announcement, ORWH supports research projects that address the social determinants of health and health disparities of women across the lifespan. Projects using interdisciplinary evidence-based interventions to prevent common risk factors for multiple health conditions in women historically understudied, underrepresented, and underreported in biomedical research are of particular interest. Projects considering community-based collaborations are also highly encouraged.
Sexual & Gender Minority Research Office (SGMRO)
The SGMRO coordinates research and activities related to the health and well-being of sexual and gender minority (SGM; defined for NIH research in NOT-OD-19-139) populations by working directly with the NIH Institutes and Centers (ICs) and serves as a liaison for the research community to ensure SGM populations are considered and represented in research activities across the agency. The SGMRO does not have grant-making authority and can only support grants deemed meritorious after review by one of the ICs participating in this announcement and after a co-funding request is initiated through the IC. Please reach out to the relevant Scientific/Research Contact(s) identified in this announcement with any questions about IC-specific research priorities and funding. More SGM- and SGMRO-specific information is available in the NIH Strategic Plan to Advance Research on the Health and Well-being of Sexual and Gender Minorities FY 2021-2025 and on the Office’s Research Resources webpage.
For this NOFO, SGMRO is interested in intervention research across the life course that explores and addresses SGM-relevant and -specific social and structural determinants of health to support the maintenance or improvement of health and health outcomes among SGM communities and SGM people who are members of other populations that experience health disparities and inequities. When appropriate, SGMRO encourages consideration and incorporation of relevant concepts (e.g., minority stress, social safety, intersectionality, stigma), research strategies (e.g., community-led or -engaged research, trauma-informed research, strengths-based approaches), and frameworks (e.g., SGM Health Disparities Research Framework, NIMHD Research Framework).
See Section VIII. Other Information for award authorities and regulations.
Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.
Cooperative Agreement: A financial assistance 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 NOFO.
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 NOFO.
Required: Only accepting applications that propose clinical trial(s).
The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.
Application budgets are limited to $500,000 per year in direct costs for UG3 (phase 1), and $750,000 per year in direct costs for UH3 (phase 2).
The maximum project period is 7 years. This includes 2 years for the UG3 (phase 1) and 5 years for the UH3 (phase 2).
NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this NOFO.
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 Organizations) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
Applicant Organizations
Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information
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 their 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 NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.
3. Additional Information on Eligibility
Number of Applications
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 NIH Grants Policy Statement Section 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 NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution.
2. Content and Form of Application Submission
It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
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:
Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Telephone: 301-827-0071
Email: Jennifer.alvidrez@nih.gov
Page Limitations
All page limitations described in the How to Apply Application Guide and the Table of Page Limits must be followed.
The following section supplements the instructions found in the How to Apply Application Guide and should be used for preparing an application to this NOFO.
SF424(R&R) Cover
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Project/Performance Site Locations
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Other Project Information
All instructions in the SF424 (R&R) Application Guide must be followed.
SF424(R&R) Senior/Key Person Profile
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.
Applicants should budget for at least one in-person meeting in the Bethesda, Maryland area per year.
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:
Specific Aims
Applications must provide the overall goals and hypotheses for the entire project and indicate separate specific aims to be accomplished in both the UG3 phase and the UH3 phase.
Research Strategy
This UG3/UH3 Phased Innovation Award has two phases. The UG3 (Phase 1) will be a two-year award for milestone-driven developmental/exploratory studies to demonstrate sufficient preparation, feasibility, capacity and leveraging of foundational activities needed for the implementation studies planned in Phase 2 (UH3). Phase 1 includes scientific, operational and collaborative planning activities as detailed in the " UG3/UH3 Phased Innovation Awards of the NOFO Background. The UH3 phase award will support the implementation and evaluation of the interventions or strategies planned or developed in the UG3 phase.
Separate sections that describe the research strategy for the UG3 and the UH3 phases are required. Investigators should consider that the application will be assigned a single overall impact score. Thus, clarity and completeness of the application with regard to specific goals, feasibility, approach, and the transition milestones are critical. It is not necessary to repeat information or details that are described in the UG3 section in the UH3 section.
Applications should clearly describe:
Letters of Support:
Provide all appropriate letters of support, including any letters necessary to demonstrate the support of collaborators. If co-funding or in-kind support is planned from non-NIH sources, letter(s) outlining details of the commitment (e.g. type, amount and source of support), signed by a business official on organization letterhead, and must be included in the Letters of Support.
Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.
Other Plan(s): Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.
All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:
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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.
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 How to Apply 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 Section 7.9.1 Selected Items of Cost.
7. Other Submission Requirements and Information
Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide. Paper applications will not be accepted.
Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.
For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.
Important reminders:
All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile form. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this NOFO for information on registration requirements.
The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.
See more tips for avoiding common errors.
Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.
Post Submission Materials
Applicants are required to follow the instructions for post-submission materials, as described 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.
A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.
Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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 project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?
Specific to this NOFO: How well are the health disparity populations of focus specified and justified? How compelling is the rationale provided for the proposed intervention in the population(s) of focus? How complete and appropriate is the conceptual model for the proposed intervention, including the risk factors to be addressed, the health outcomes to be impacted, and the specific type(s) and socioecological level(s) of SDOH being modified? What is the potential sustainability of the intervention after the project is over and the scalability to other settings? ?
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?
With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?
Specific to this NOFO: To what extent are the roles of service sector collaborators clearly defined and appropriate? To what extent does the project team have appropriate experience conducting interventions that involve prospective assignment of groups or clusters (e.g., health clinics, schools, neighborhoods, etc.)?
Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?
Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?
Specific to this NOFO: To what extent does the proposed intervention include novel multi-sectoral partnerships or approaches to address SDOH?
Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
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?
Does the application adequately address the following, if applicable
Study Design
Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?
Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?
Data Management and Statistical Analysis
Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?
Specific to this NOFO: To what extent are the scientific, operational, and/or collaborative planning activities planned for the UG3 phase clearly defined and appropriate to achieve the stated aims? To what extent are the transition milestones from the UG3 phase to the UH3 phase specific to the project being proposed, discrete, and measurable? How appropriate are the study design and analytic plan to address multi-sectoral or multi-level SDOH, intervention effects, and outcomes?
Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?
If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?
Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?
If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?
If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?
Specific to this NOFO: How clear and appropriate is the plan for participating in MSPI Research Network activities (e.g., participation in workgroups and Steering Committee meetings, data harmonization and sharing, cross-site dissemination products, etc.), including how the project team might work with the MSPI Research Network Coordinating Center?
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.
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?
Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?
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 will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Not Applicable
Not Applicable
Not Applicable
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.
Not Applicable
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.
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 the Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.
As part of the scientific peer review, all applications will receive a written critique.
Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this NOFO. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. 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 Section 2.4.4 Disposition of Applications.
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 NOFO will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.
Awards issued under this NOFO will be excluded from the Streamlined Noncompeting Award Process. NIH Grants Management Officials must review and approved all carryover requests, regardless of the size and/or dollar threshold. No automatic first no-cost extension will be allowed.
Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.
ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain applicable clinical trials on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm
Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the recipient must provide NIH copies of documents related to all major changes in the status of ongoing protocols.
Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).
Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).
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.
If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the HHS Office for Civil Rights website.
HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.
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 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 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 (HHS) grant administration regulations at 2 CFR Part 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 purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the 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 between the recipients and 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:
Areas of Joint Responsibility include:
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between recipients and NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened: 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 recipient. This special dispute resolution procedure does not alter the recipient's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and HHS regulation 45 CFR Part 16.
Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.
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 NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.
The Federal Funding Accountability and Transparency Act of 2006 as amended (FFATA), 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 2 CFR Part 200.113 and Appendix XII to 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 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)
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Kristy Nicks, Ph.D.
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Phone: 301-827-3354
E-mail: kristy.nicks@nih.gov
Jennifer Alvidrez, PhD
Office of Disease Prevention
Telephone: 301-827-0071
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Christopher Barnhart, PhD
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I-Jen Castle, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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Elena K Gorodetsky, MD, PhD
ORWH - Office of Research on Women's Health
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Lorena Baccaglini, DDS, MS, PhD
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
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E-mail: lorena.baccaglini@nih.gov
Hiroko Iida, DDS, MPH
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
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E-mail: hiroko.iida@nih.gov
Sung Sug (Sarah) Yoon, RN, PhD
National Institute of Nursing Research (NINR)
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Email: sungsug.yoon@nih.gov
Nancy L. Jones, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
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nancy.jones@nih.gov
Mary Yaasedegah Masterson, PhD
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Patricia A. Haggerty, Ph.D.
Office of Dietary Supplements
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Jennifer N. Baumgartner, Ph.D.
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Tanya Agurs-Collins, PhD, RD
National Cancer Institute (NCI)
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Shannon Elizabeth Nicks
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
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Center for Scientific Review (CSR)
Katie Joffee
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Email: joffeek@mail.nih.gov
Judy Fox
NIAAA - NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM
Phone: (301) 443-4704
E-mail: jfox@mail.nih.gov
Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: hidalgoge@mail.nih.gov
Ron Wertz
National Institute of Nursing Research (NINR)
Telephone: 301-594-2807
Email: wertzr@mail.nih.gov
Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov
Taryn Cobb
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-827-8025
E-mail: cobbt@mail.nih.gov
Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: debbie.chen@nih.gov
Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: crystal.wolfrey@mail.nih.gov
Pamela G Fleming
NIDA - NATIONAL INSTITUTE ON DRUG ABUSE
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov
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