Part 1. Overview Information

Key Dates

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

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

It is critical that applicants follow the instructions in the Research (R) Instructions in the 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.

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Key Terms, Definitions, and Uses in this NOFO

• CTS: Clinical and translational science
• CTSA Program: A national network of more than 50 medical research institutions / academic health centers and their partners and collaborators working together to speed translation of research discoveries into improved patient care by tackling system-wide problems in clinical and translational research that no single team can overcome.
• CTSA Trial Innovation Network (TIN): The TIN is a collaborative initiative within the CTSA Program that was established to address critical roadblocks in clinical trials and to accelerate the translation of novel interventions into life-saving therapies. The TIN focuses on operational innovation, operational excellence, and collaboration and leverages the expertise and resources of the CTSA Program. The goal of the TIN is not only to execute trials better, faster, and more cost-efficiently but also to be a national laboratory to study, understand, and innovate the process of conducting clinical trials. The TIN is composed two Trial Innovation Centers (TICs), One Recruitment Innovation Center (RIC), and the CTSA Program institutions. The TICs were established to provide resources to enhance efficiency, improve trial start-up, speed recruitment, and harmonize processes across the CTSA Program for multi-site clinical studies. The RIC was established to develop innovative solutions and demonstrate how these can be successfully applied to accelerate research participant recruitment and, over time, establish best practices that can be generalized to a broad range of research studies across the CTSA Program.
• Hub: Medical research institutions / academic health centers with CTSA hub awards maintain an integrated research and training environment for CTS. Hubs play a central role in their local environments where they coordinate and collaborate with multiple “spokes” such as affiliated hospitals, clinics, and community health centers.
• Innovative Solutions: For purposes of this NOFO, innovative solutions are defined broadly to include, but not limited to, new approaches, methodologies, platforms, technologies, resources, devices, or models. An innovative project could: (1) develop an innovative new solution, or (2) adapt, disseminate, and implement an existing solution in an innovative manner to advance translation.
• Partner/Partnering Institution(s): Must be effectively integrated into the proposed activities of the CTSA UM1 / UL1 hub and are necessary for attaining its strategic goals and research priorities. A Partnering Institution may be included as a partner to only one CTSA hub. For purposes of this NOFO, CTSA partnering institutions are eligible to apply.  
• Stakeholder: Includes individuals and/or organizations representing community members or advocacy groups; health care providers and health care systems; research participants; and patients.
• Translation: Defined by NCATS as the process of turning observations in the laboratory, clinic and community into interventions that improve the health of individuals and communities – from diagnostics, preventions, and treatments to medical procedures and behavioral changes.
• Translational Research (TR): Defined by NCATS as the endeavor to traverse a particular step of the translational process for a particular target or disease.
• Translational Science (TS): Translational science is the field that addresses longstanding scientific and operational challenges along the translational science spectrum through innovations that transform the way research is conducted, making it faster, more efficient, and more impactful.
• Translational scientists. Multi-disciplinary academic and non-academic (e.g., community researchers, patient investigators) researchers that specialize in translation science and possess the skills and fundamental characteristics including domain expert, boundary crosser, team player, process innovator, skilled communicator, systems thinker, and rigorous researcher.

Purpose

The CTSA Collaborative and Innovative Acceleration Award (CCIA) aims to accelerate the pace of translational research by supporting the collaborative development, dissemination, and sustainable implementation of innovative solutions across the CTSA Program Consortium and beyond.

This limited competition Notice of Funding Opportunity (NOFO) invites investigator-initiated applications to develop, demonstrate, and disseminate innovative new approaches, technologies, resources, or models that increase the impact of research across diseases, transform the field of translational science, and bring more treatments for all people more quickly.

Background

The development and implementation of clinical interventions is a complex, iterative, and time-consuming process that takes years before discoveries in biomedical research result in health benefits for patients and communities. The National Center for Advancing Translational Sciences (NCATS) has the unique charge of examining the translational research ecosystem at a systems level to determine where common pitfalls exist in the translational process and developing innovative solutions that will ultimately benefit research across a range of diseases and conditions. This disease-agnostic approach to enhancing the efficiency and effectiveness of all translational research is known as translational science, which focuses on building the evidence base for effective scientific and operational approaches in translational research. NCATS conducts and supports research in the science of translation to discover the scientific, mechanistic, and operational principles of the intervention development and dissemination processes, thereby providing the scientific foundation for improvements in translational efficiency that will accelerate the realization of interventions that improve human health.

To do this, NCATS relies on the power of data, bold new methods, technologies, boundary-crossing partnerships, community and stakeholder engagement, and multi-disciplinary team science to develop, demonstrate, disseminate and sustainably implement innovative healthcare solutions to make biomedical research advancements more impactful for patients and communities. 

CTSA Program

The CTSA Program is one component of the NCATS’ Strategic Plan to advance CTS; it is designed to develop and implement innovative solutions that will improve the efficiency, quality, and impact of the process for turning observations in the laboratory, clinic, and community into interventions that improve the health of individuals and communities. The expertise, resources, and infrastructure of the CTSA Program facilitate innovation and provide support for all scientific/medical communities engaged in CTS research, including disease and condition-specific research supported by NIH Institutes and Centers. As one of the largest NIH clinical and translational science programs and an exemplar of team science, NCATS envisions the CTSA Program progressing toward a standards-based, interoperable network in a cloud environment where informatics assets (e.g., data, software, and algorithms) can be co-developed and shared across the CTSA consortium in a common repository. The CTSA Program goals are to:

1. Advance CTS: develop, demonstrate, and disseminate scientific and operational innovations that improve the efficiency and effectiveness of clinical translation from identification to first-in-human studies to medical practice implementation to community health dissemination.
2. Promote partnerships and collaborations to facilitate and accelerate translational research projects locally, regionally, and nationally.
3. Create, provide, and disseminate innovative research programs and partnerships across institutions and communities to address health disparities and deliver the benefits of translational science to all.
4. Create and implement scientific and operational innovations that increase the quality, safety, efficiency, effectiveness, and informativeness of clinical research.
5. Provide a national resource for the rapid response to urgent public health needs.
6. Create, provide, and disseminate CTS training programs for clinical research professionals of all disciplines on the research team.
7. Create, provide, and disseminate CTS training and career support programs for translational scientists.
8. Foster the development of the emerging field of translational science.

Program Goal and Scope

The CTSA Collaborative and Innovative Acceleration Award (CCIA) aims to accelerate the pace of translational research by supporting the collaborative development, dissemination, and sustainable implementation of innovative solutions across the CTSA Program Consortium and beyond. CCIA projects should:

• Build upon the unique and innovative activities, resources, expertise, and strengths of individual CTSA hubs
• Leverage existing or new partnerships to sustainably implement an innovative solution across multiple CTSA hubs, partners, collaborators, and/or other external stakeholders in a manner that no single organization can accomplish alone
• Demonstrate feasibility, in one or more use cases, for an innovative solution utilizing clear and meaningful metrics and outcomes
• Have a plan for the long-term adoption, implementation, and maintenance/sustainment of the innovative solution across the CTSA institutions, external stakeholders, and/or communities and patients, as appropriate

NIH Institute-, Center-, and Office-Specific Research Interests

Applications should be relevant to the purpose of this NOFO and to at least one of the NIH Institutes’, Centers’ and Offices' research interests outlined below. 

U.S. Food and Drug Administration (FDA)

The U.S. Food and Drug Administration (FDA) hosts the Centers of Excellence in Regulatory Science and Innovation (CERSI) Program to foster robust and innovative approaches to advance regulatory science. The goal of the CERSI Program led by the Office of Regulatory and Emerging Science (ORES), is to advance regulatory science individually and synergistically through collaborative interactions with FDA scientific experts and funding offices. The FDA invites multi-site research projects from the collaborating CTSA Program and CERSI Program eligible organizations to advance the field of regulatory science by applying the NCATS’ translational science principles and the FDA’s regulatory science framework.

The Areas of Research Interest and Priority Include:

Area 1 - Modernize Product Development, Evaluation, and Surveillance Methodologies
Appropriate topics include, but are not limited to, the following:

• Strengthen surveillance and risk communication to patients and consumers
• Consider diverse populations in the process of product development evaluation
• Explore potential alternative methods to support product development and assessment

Area 2 - Community Engagement to Promote Public Health Preparedness for FDA, Patients and Consumers
Appropriate topics include, but are not limited to, the following:

• Enhance FDA's ability and capacity to respond to public health threats engaging diverse populations
• Utilize novel approaches to minimize misinformation/disinformation for patients and consumers

Area 3 - Data Science and Digital Health Technology
Appropriate topics include, but are not limited to, the following:

• Utilize AI and real-world data for enhanced product evaluation and surveillance
• Explore innovative tools to support regulatory decision-making and adoption.

Area 4 - Workforce Development and Regulatory Science Training.
A comprehensive approach to advancing Regulatory Science involves focusing on training and education, promoting collaboration, and establishing a robust Regulatory Science network.
Appropriate topics include, but are not limited to, the following:

• Adoption of regulatory science core competencies and curricular guidelines
• Dissemination of best practices to improve regulatory processes to enhance product safety and public health

National Center for Advancing Translational Sciences (NCATS)

Translational science projects that utilize boundary-crossing partnerships and cross-disciplinary team science to collaboratively develop, adapt, demonstrate, disseminate and sustainably implement innovative solutions that enhance the efficiency and speed of translational research. These include but are not limited to:

1.Topics of high priority

• Creation of infrastructure and processes to allow for rapid, robust, and ongoing evaluation and validation of emerging artificial intelligence/machine learning enabled tools in the biomedical and healthcare space, ensuring that such tools perform to known and acceptable levels across health systems and allowing for rapid dissemination of “learning by doing” in safe, secure, ethical, and equitable ways in the health AI sector
• The development of a “Data-Science Innovation Program” for the dissemination and sustainable implementation across the CTSA consortium and beyond. A Data-Science Innovation Program would accelerate TR/TS through multidisciplinary teams and networks that engage data scientists through: (1) the development and dissemination of resources and expertise to facilitate rigorous and innovative integration of cutting-edge data science across the CTSA consortium, and/or (2) practical consultations and partnerships to comprehensively and effectively integrate innovative data science into wide-ranging TR/TS CTSA activities. Responsive applications could contain elements such as, but are not limited to:

1. Education and/or practical instruction from and for multidisciplinary teams that engage data scientists, highlighting whether, when and how data science can be incorporated into clinical and TS workflows, 
2. Innovative methods and processes that integrate disparate data-based resources to increase the quality and efficiency of TR,
3. Innovative programs that leverage disparate data-based resources to increase the quality, safety, efficiency, effectiveness and informativeness of clinical and translational research, and/or
4. Development, dissemination, and sustainable implementation of data-science-based consultative service models.

Projects should engage data scientists as full scientific partners in every phase of the TR process. As one conceptual example of how the different parts of a comprehensive program might work together, see NCATS’ Trial Innovation Network.

2. Community and multi-sectoral partnerships:

• Leverage innovative translational science approaches in community-led and community-driven approaches to address and overcome systemic health inequities, rural-urban, health disparities, systemic racism.
• Leverage use of large health data sets including those of state and local entities to create health solutions that are meaningful for communities.
• Creation of a health equity dashboard that leverages the strengths of the CTSA community engaged research efforts to share best practices, strategies and resources that demonstrate the impact of CTSA community-driven and community-engaged research efforts.
• Leverage community health analytic tools and methods including geocoding and appropriate collection of race and ethnicity data to address social determinants of health and health inequities.
• Community engagement methods and technologies that increase the efficiency and effectiveness of intervention development and deployment, and measurement of their effects on improving health outcomes. Community engagement should be defined broadly to include local and distributed, physical and virtual communities.

3. Response to urgent public health need:

• Rapid response to urgent public health crises (e.g., opioid epidemic, COVID-19 pandemic, maternal mortality, health disparities).
• Improve the infrastructure and capability to conduct decentralized clinical research.
• Leverage of Veterans Health Administration for system-wide implementation of new and disruptive approaches to address the health burdens of veterans and improve veteran’s health.

4. Transformative technologies:

• Technologies (such as digital health, telehealth, artificial intelligence) to increase efficiency during implementation of clinical research studies or clinical trials (e.g., study site selection and activation, recruitment and retention, patient reported outcomes, biomarker identification and validation, data collection and analysis, risk communication, clinical monitoring, data and safety monitoring, interoperability of electronic health record systems and clinical research data management systems).
• Strategies leveraging real world evidence (RWE)/real world data (RWD) collection to identify and test new uses of off-patent drugs that are marketed in the U.S. for a different indication (Please see Envisioning an actionable research agenda to facilitate repurposing of off-patent drugs).
• Innovative applications and integration of data science, informatics tools and/or artificial intelligence/machine learning to make data more meaningful, open and accessible for the scientific community (predictive modeling, algorithms, simulation technologies, creation and dissemination of knowledge networks).

5. Innovations in Advancing Recruitment through the Trial Innovation Network (AR-TIN)

Innovations that are scientifically sound and use the latest evidence-based recommendations and guidelines that address critical barriers that hinder increasing the number of participant recruitment in clinical trials. This includes tools and resources that: (1) transform, increase, and improve the recruitment of participants in clinical trials and (2) improve the use of participant-based information that will inform safety and efficacy for improving participant recruitment in clinical trials. Examples include:

• Methods to improve disease progression modeling to advance the use of participant-based information that will inform safety and efficacy,
• Transformative tools and resources, such as but not limited to the use of artificial intelligence, that advance the digitalization of clinical trial activities,
• Innovative ways to incorporate clinical and demographic characteristics of intended populations in the absence of self-identification,
• Improving rural inclusion in centralized and decentralized clinical trials,
• User-friendly dynamic model on the inclusion/exclusion criteria and its impact on participant recruitment in clinical trials.
• Strategies to improve the recruitment, retention, and safety of under recruited and/or under reported populations in clinical trials (e.g., women, rural, disabled, racial, and ethnic populations).

6. Rare disease:

• Clinical, genetic or machine-learning approaches that speed the identification or accurate diagnosis of rare disease patients to shorten the diagnostic odyssey encountered by rare disease patients.
• Approaches that more rapidly identify the molecular underpinnings of rare genetic diseases and potential targets for therapeutics development, such as computationally assisted modeling.
• Development and use of master protocols, such as basket, umbrella or platform trials, that include “many-diseases-at-a-time” approaches for rare disease therapeutics development.
• Clinical trial readiness strategies, such as adapting and validating clinical outcome assessment tools, e.g., patient-, observer- or clinician-reported outcomes or assessment tools or scales, for rare disease-specific indications.
• Novel approaches to increasing the efficiency of pre-clinical studies and/or clinical trials of “N-of-1" genetic therapies, e.g., antisense oligonucleotides.

7. Opportunities for Academic Learning Health Systems.

Including innovative solutions for integrating the full life cycle of translational research from hypothesis testing to implementation. Examples include:

• Innovative organizational approaches to improve patient care.
• Innovation tools or approaches to engage communities and mitigate health disparities.

8. Education and training:

• Artificial Intelligence in Healthcare
• Establishing and developing an entrepreneurial training center that applies translational science principles to catalyze the commercial development of innovative biomedical services or products.
• Good Algorithm Practices (GAPs) which includes model validation, data integrity, and generalizability.
• Customized training modalities targeting the needs of academic and non-academic clinical researchers (e.g., study coordinators, research pharmacists, patient investigators, community health workers, doulas, physician assistants, nurse practitioners, midwives).

National Human Genome Research Institute (NHGRI)

NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.

For this NOFO, NHGRI intends to support the development of tools and resources that foster the use of genomics in clinical trials. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices:

• Division of Genome Sciences: https://www.genome.gov/about-nhgri/Division-of-Genome-Sciences 
• Division of Genomic Medicine: https://www.genome.gov/about-nhgri/Division-of-Genomic-Medicine 
• Ethical, Legal, and Social Implications Research Program: https://www.genome.gov/Funded-Programs-Projects/ELSI-Research-Program-ethical-legal-social-implications 
• Office of Genomic Data Science: https://www.genome.gov/about-nhgri/Office-of-the-Director/Office-of-Genomic-Data-Science 
• Training, Diversity and Health Equity Office: https://www.genome.gov/about-nhgri/Office-of-the-Director/Training-Diversity-and-Health-Equity-Office 

Applications for clinical trial tools and resources relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center. Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI.

National Institute of Allergy and Infectious Disease (NIAID)

The mission of the National Institute of Allergy and Infectious Diseases (NIAID) is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. Under the Chemical Countermeasures Research Program (CCRP), the NIAID supports projects across the NIH that focus on the research and early-stage development of medical countermeasures (MCMs) for situations of high consequence public health chemical emergencies. The civilian chemical threat spectrum includes chemical warfare agents as well as various toxic industrial chemicals and materials that the U.S. Department of Homeland Security has identified as Chemicals of Concern (CoCs). These CoCs can have a variety of toxic effects or toxidrome(s), including:

• Pulmonary, irritant, and corrosive agents that target the respiratory tract and may induce edema and/or other long-term pathologies, e.g., chlorine, phosgene, and oleum.
• Pharmaceutical-based agents, such as incapacitating compounds to include e.g., fentanyl, carfentanil, and nitazenes.
• Vesicating agents that may cause dermal and ocular pathologies, e.g., sulfur mustard and nitrogen mustard.
• Cellular respiration inhibitors, such as blood, hemolytic, and metabolic agents, e.g., cyanide and hydrogen sulfide.
• Cholinergic, convulsant, encephalopathic, and sympathomimetic/stimulant agents that target the nervous system inducing seizure and and/or neurodegeneration, e.g., organophosphorus pesticides and warfare agents
• Other agents such as those that induce coagulopathy, e.g., brodifacoum

Only preclinical research will be supported. Prospective applicants are strongly encouraged to contact the NIAID or NCATS Scientific Officials listed below to confirm eligibility to apply under this solicitation and/or to ensure the proposed research is within scope of the CCRP mission.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this NOFO, the NIAMS is interested in research from collaborative research teams focused on innovative solutions designed to accelerate the translation of scientific knowledge to interventions that improve the treatment of NIAMS mission relevant diseases. 

National Institute of Dental and Craniofacial Research (NIDCR)

The NIDCR is interested in research from collaborative research teams focused on accelerating the translation of scientific knowledge about dental, oral, and craniofacial diseases and conditions into prevention, early detection, and/or treatment strategies to improve dental, oral, and craniofacial health across the lifespan. For applications submitted to this NOFO, the contact PD(s)/PI(s) must have a primary appointment as a faculty member of a dental school in the United States.

National Institute of General Medical Sciences (NIGMS)

The NIH/NIGMS Institutional Development Award (IDeA) is a congressionally mandated program that builds research capacity in states that historically have had low levels of NIH funding. It supports competitive basic, clinical, and translational research, career development, and infrastructure improvements.

One IDeA component is the IDeA Clinical and Translational Research (IDeA-CTR) Program, which supports clinical and translational research through programs that develop research infrastructure and human resources, enhance the ability of investigators and institutions to develop competitive clinical and translational research programs, and strengthen collaborative research that addresses the broad spectrum of health conditions prevalent in IDeA states. Organizations holding active CTR-Network (CTR-N, P50) awards, its predecessor IDeA-CTR (U54) awards, and its companion CTR-Development (CTR-D, P20) awards are eligible to serve as CCIA partners; see the IDeA CTR Dashboard for a list of eligible award recipient.

National Institute of Minority Health and Health Disparities (NIMHD)

The NIMHD mission is to lead scientific research to improve minority health and reduce health disparities in populations that experience disparities. Projects must include a focus on one or more of the following NIH-designated populations that experience health disparities in the United States: racial and/or ethnic minority populations, less privileged socioeconomic status (SES), underserved rural populations, persons with disabilities, and sexual and gender minority (SGM) groups. Projects focused on rural populations, SGM groups, and people with disabilities are encouraged to examine intersections with race and/or ethnicity, and/or SES.

NIMHD seeks to support collaborative research that accelerates the translation and implementation of scientific findings to improve health outcomes and decrease health disparities in the above populations. Translational research studies that consider the multiple levels and domains of influence that are relevant to understanding and addressing minority health and health disparities (See NIMHD Research Framework) are of particular interest. 

Areas of specific interest to NIMHD include but are not limited to studies that:

• Accelerate translation of research findings to develop and implement interventions in behavioral, clinical, and health services in conditions disproportionately affecting populations that experience health disparities.
• Develop innovative strategies to promote academic-community partnerships to increase the implementation and dissemination of evidence-based interventions that reduce health disparities.
• Identify and address multilevel barriers to the translation and implementation of evidence-based scientific findings that improve health outcomes and reduce health disparities

Office of Disease Prevention (ODP)

The Office of Disease Prevention (ODP) is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 Institutes and Centers of NIH, ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. In general, ODP provides co-funding support for research that has strong implications for disease and injury prevention, health equity, and research that includes innovative and appropriate research design, measurements, and analysis methods.

Within ODP, the Tobacco Regulatory Science Program (TRSP) is an interagency partnership between NIH and the Center for Tobacco Products at the Food and Drug Administration (FDA), which fosters research in tobacco regulatory science. As the tobacco-focused program within ODP, TRSP also monitors NIH investment in tobacco prevention and facilitates collaboration across NIH Institutes and Centers (ICs) for ODP-led opportunities to address research gaps in tobacco prevention that complement the FDA-supported program of tobacco regulatory research.

Office of Disease Prevention (ODP) and Tobacco Regulatory Science Program (TRSP) Areas of Research Interest

Develop, demonstrate, and disseminate innovative new approaches, technologies, resources, or models that advance the following scientific domains:

• Product design. Understanding tobacco product composition and design
• Toxicity. Approaches that test the toxicity of non-cigarette tobacco smoke, aerosol, or specific constituents
• Addiction. Effects of tobacco product characteristics on addiction and abuse liability
• Health Effects. Short- and long- term health effects of tobacco products
• Behavior. Understanding of knowledge, attitudes and behaviors related to tobacco product use
• Communications. Understanding how to effectively communicate the health effects of tobacco products
• Marketing Influences. Influences of tobacco marketing
• Prevention and Treatment. Prevention and/or treatment for tobacco product use and addiction particularly in populations that experience tobacco-related disparities

For additional information about ODP’s research priorities and interests, please refer to the ODP Strategic Plan or visit www.prevention.nih.gov.    

Office of Research on Women’s Health (ORWH)

The Office of Research on Women’s Health (ORWH) is part of the NIH Office of the Director, and works in partnership with the 27 NIH Institutes, Centers, and Offices (ICOs) to ensure that women's health research is part of the NIH scientific framework and supported throughout the biomedical research enterprise. ORWH uses a multidimensional framework to represent the intersection of factors that underlie patterns of disease and social determinants of health outcomes in diverse populations.

ORWH recognizes the need of collaborative and interdisciplinary research teams to accelerate the translation of knowledge to address disease and  health conditions  that predominantly affect women (e.g., autoimmune diseases; depressive disorders, Alzheimer’s disease (AD) and Alzheimer’s disease-related dementias (ADRD), gender-based-violence), present and progress differently in women (e.g., cardiovascular disease; HIV; reproductive aging and its implications), or are female-specific (e.g., uterine fibroids; endometriosis; menopause). There is an urgent need to address sex and gender influences in basic, translational, interdisciplinary, behavioral, clinical, and/or health services research relevant to women's health, and, where appropriate, include both sexes to better understand the influence of sex as a biological variable (SABV) on health and disease. Integrating the purposeful accounting for SABV in biomedical research, from the most basic to the clinical and applied efforts, will fill gaps in our knowledge, and will inform more effective and personalized approaches for women and men. Applications seeking ORWH co-funding support in response to this NOFO, should ensure that their grant application is responsive to at least one of objectives as outlined in the 2024-2028 NIH-Wide Strategic Plan for Research on the Health of Women.  

Applications Not Responsive to this NOFO

The following types of studies are not responsive to this NOFO. Applications proposing such studies will be considered non-responsive and will not be reviewed or considered for funding:

• Applications that do not include at least three currently active, eligible organizations as of the due date of the application (see Section III.1. Organizational Eligibility below)
• Applications that do not include a letter of support from each collaborating organization.
• Applications that do not include a Milestone Plan attachment as described below.
• Applications that do not include a Sustainability Plan attachment as described below. 
• Applications that do not include a signed Eligibility Statement attachment as described below. 
• Applications that do not include a Data Management and Sharing (DMS) Plan (see the NIH Data Management and Sharing Policy). Please note the difference between a DMS Plan and a Resource Sharing Plan. See here to determine which sharing policies apply to the planned research.
• Applications that propose to use funds to support any clinical trial beyond Phase IIB except for Phase III clinical trials for treatment of rare diseases. Projects that do not meet these clinical trial limitations will not be reviewed. See NOT-TR-18-025.
• Applications in response to the NICDR research priority statement that do not include PD(s)/PI(s) affiliated with one or more US dental schools.

Funding Mechanism

This NOFO will use the UG3/UH3 Cooperative Agreement mechanism. This funding mechanism involves two phases. Both phases are required in the application. Delineation of scientific and/or operational milestones is a key characteristic of this NOFO. Each application must provide a fully developed research plan and budget for both UG3 and UH3 phases at the time of submission, with distinct Aims for each phase.

The UG3 Phase:

The UG3 Phase will support the development, adaptation, and/or demonstration of an innovative solution that accelerates the translational research process. A feasibility assessment should be conducted in the UG3 Phase to ensure that an innovative solution can be successfully disseminated and implemented during the UH3 Phase of the award.

The UH3 Phase:

The UH3 Phase will support the dissemination, implementation, and evaluation of the innovative solution that was developed during the UG3 Phase by all collaborating organizations for dissemination across multiple CTSA hubs and/or other stakeholders outside the Consortium.

Transition from the UG3 to the UH3 Phase:

Milestones provide quantifiable measures of success and are a key characteristic for this bi-phasic mechanism. A milestone is defined as a finding or set of findings that signal the achievement of a Specific Aim in your research plan. Milestones should be comprised of three basic components: (1) a desired goal, (2) a timeline or decision point by which the goal must be accomplished, and (3) evidence that the goal has been accomplished based upon quantitative criteria. For evaluative purposes, each application must include a Milestone Plan as a separate attachment (see Other Attachments below). The Milestone plan should include three separate components:

1. A distinct set of annual milestones for both the UG3 and UH3 Phases related to assessing progress on each Aim of your project. 
2. A set of quantitative, transitional milestones that will be used to evaluate overall progress made during the UG3 phase of the award and justify the transition into the UH3 phase of the award (i.e., go/no go criteria), and
3. A Timetable (e.g., Gantt Chart) identifying when each of the key milestones will be met. The timeline of UG3 activities should not extend into the UH3 Phase of the award as each Phase of the award should contain a distinct project.

In the event of an award, NCATS staff will work the PI(s)/PD(s) to negotiate any changes to the annual milestones each year based on progress. Final negotiated milestones will be included in the Notice of Award.

At the end of the UG3 Phase, NCATS will conduct an administrative review of projects at the end of the UG3 phase to determine the readiness to transition into the UH3 phase. An evaluation will be made based upon successful completion of quantitative transitional milestones (go/no-go criteria) and availability of funds. Award recipients should note that UG3 funding does not guarantee subsequent UH3 funding.

Applications submitted without a Milestone Plan will be considered incomplete and will not be reviewed.

UG3/UH3 Project Period

The total project period for the UG3/UH3 Cooperative Agreement mechanism cannot exceed 5 years. Flexibility is allowed for the UG3 Phase (1 - 3 years) and the UH3 Phase (2 - 4 years). Examples include:

• UG3/UH3 (up to 5 years): UG3 (1 year) / UH3 (4 years)
• UG3/UH3 (up to 5 years): UG3 (2 years) / UH3 (3 years)
• UG3/UH3 (up to 5 years): UG3 (3 years) / UH3 (2 years)

UG3 Phase and UH3 Phase will generally not be awarded in the same NIH fiscal year. For example, applications proposing partial years are not allowed (e.g., UG3 - 1.5 years / UH3 - 3.5 years).

Pre-Application Consultation:

Potential applicants are highly encouraged to contact the NCATS Scientific/Research Contacts listed in this NOFO to discuss the scope of the project, required materials, responsiveness, and clinical trials status designation prior to submission of an application. Please contact NCATS at: [email protected]

Please see the CCIA webpage and CTSA Applicant Information for more information.

Resources Provided by NCATS

Specified support services will be provided through grants, contracts, and/or NCATS for certain CTSA consortium activities, e.g., use of a specified NCATS vendor for organization of workshops or provision of certain UM1-related data. Specific requirements for UM1 recipients are described in the Terms and Conditions of Award.

In support of the NCATS goal of promoting and facilitating the development and dissemination of interoperable assets, such as algorithms and software, the NCATS Information Resources Technology Branch (ITRB) may provide access to various public cloud services and high-performance computing services for the needs of the recipients. This enables the recipients to offer their systems, projects, and research in a secure environment with simplified implementation, deployment and operational reliability. Through these services, NCATS ITRB will enable the recipients to gain a self-service capability. NCATS ITRB may provide the following, pending consultation with the recipient and the NCATS Project Collaborator:

• Infrastructure as a Service (IaaS) on any of the major public cloud providers via NCATS' Federated Authorization Service.
• Access to NCATS' Federated Authorization Software as a Service (SaaS) to any of the CTSA recipients’ systems and applications, various Common Cloud Engineering and Support Services

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

A CTSA Program hub includes the prime recipient organization of the CTSA Program hub UL1 or UM1 award, as well as any organizations listed as partners in the CTSA Program hub UL1 or UM1 awards. Only organizations with currently active CTSA Hub prime awards or named UM1/UL1 award partnering organizations are eligible to apply. (see CTSA Hub Directory)

A hub that is in a no-cost extension (NCE) status as of the due date of the application is not considered to be currently active and therefore is ineligible to apply.  

Number of Eligible Organizations

To create boundary-crossing partnerships and enable team science in that way that enhances the efficiency and speed of translational research, applications must include collaborations with at least 3 eligible organizations for both the UG3 and UH3 award phases, selecting from one of the following options:

Option 1 – Investigators from at least three different currently active CTSA Program hubs/partners as of the due date of the application,

OR

Option 2 – Investigators from at least two different CTSA hubs/partners + one non-CTSA eligible organization, as listed below. For example: (1) CTSA hub “A” + (2) CTSA hub “B” + (3) NIH ICO or FDA CERSI award recipient from the non-CTSA eligible organization section below would be eligible to apply. All institutions must be active as of the due date of the application.  

Notes on eligibility:

• The contact PD/PI named on the application must be from a currently active CTSA prime or partnering organization as of the due date of the application.
• CTSA hub and partner. A collaboration including a CTSA hub and its partner institution are considered one eligible organization. For example, CTSA hub award recipient “A” and its listed hub partner – Hospital System “B” would be considered a single eligible organization and at least two additional eligible organizations would be needed to apply.
• CTSA hub and eligible participating / participating component organization. A collaboration including a CTSA hub and an eligible institution from one of the eligible participating / participating component organizations outlined below – even though they are at the same institution – would be considered to be two separate organizations for the purpose of meeting the minimum number of eligible organizations. Only one additional CTSA hub prime or partner would be needed to apply. 
• Interested applicants must ensure all collaborating organizations will have an active funding status as of the due date of the application. Applications that do not include at least three active collaborating organizations as of the due date of the application will be considered non-responsive will not be reviewed.

Non-CTSA eligible organizations are as follows:

U.S. Food and Drug Administration:

• Centers of Excellence in Regulatory Science and Innovation  (award recipients funded under RFA-FD-23-004 and subsequent reissues)

NCATS:

• Rare Diseases Clinical Research Network Centers  (award recipients funded under RFA-TR-18-020, RFA-TR-18-021 and subsequent reissues)

NIAMS:

• Core Centers for Clinical Research  (award recipients funded under RFA-AR-24-003, RFA-AR-22-002 and subsequent reissues)
• Centers of Research Translation  (award recipients funded under RFA-AR-22-001 and subsequent reissues)

NIDCR:

• National Dental Practice-Based Research Network  (award recipients funded under RFA-DE-19-001, RFA-DE-19-002, RFA-DE-19-006, PAR-20-306 and subsequent reissues)
• Practice-Based Research Integrating Multidisciplinary Experiences in Dental Schools (PRIMED) (award recipients funded under RFA-DE-23-012 and subsequent reissues)
• FaceBase (award recipients funded under PAR-23-237 and subsequent reissues) 

NIGMS:

• IDeA Clinical & Translational Research Development (CTR-D)  (award recipients funded under PAR-23-257 and subsequent reissues)
• IDeA Clinical & Translational Research Network (CTR-N)  (award recipients funded under PAR-23-241, PAR-20-175, PAR-18-265 and subsequent reissues) 

NIMHD:

• Research Centers in Minority Institutions Program  (award recipients funded under RFA-MD-17-003, RFA-MD-17-006, RFA-MD-18-012, RFA-MD-20-006, RFA-MD-22-002 and subsequent reissues). The purpose of the Research Centers in Minority Institutions (RCMI) Program is to expand the national capacity for research in health sciences by providing cooperative agreement support to institutions that officer doctorate degrees in the health professions or in a health-related science and have a documented historical and current commitment to educating underrepresented students, and for institutions that provide clinical services to medically underserved communities.  
• Centers for Multiple Chronic Disease Associated with Health Disparities  (award recipients funded under RFA-MD-21-007 and subsequent reissues). The purpose of the Centers for Multiple Chronic Disease Associated with Health Disparities initiative is to support regional comprehensive research centers on the prevention, treatment, and management of chronic disease associated with health disparities.  Each center addresses two or more chronic conditions that commonly co-occur and/or share common social context, etiological pathways, or risk factors and share some similar management strategies.  
• Environmental Health Disparities Centers (award recipients funded under RFA-MD-20-001 and subsequent reissues). The purpose of the Environmental Health Disparities Centers is for specialized center grants to support multidisciplinary research, research capacity building, and community-engaged research activities focused on understanding and reducing or eliminating environmental health disparities, defined as inequities in population health mediated by disproportionate adverse exposures associated with the physical, chemical, social and built environments. 

ODP:

• Tobacco Centers of Regulatory Science (TCORS) for Research Relevant to the Family Smoking Prevention and Tobacco Control Act (award recipients funded under RFA-OD-22-004 and subsequent reissues)
• Center for Coordination of Analysis, Science, Enhancement, and Logistics (CASEL) in Tobacco Regulatory Science (award recipients funded under RFA-OD-22-003 and subsequent reissues)
• Center for Rapid Surveillance of Tobacco (CRST) to Assess Changes in Use Behaviors, Product Marketing, and the Marketplace (award recipients funded under RFA-OD-22-002 and subsequent reissues)

ORWH:

• Specialized Centers of Research Excellence (SCORE) on Sex Differences (award recipients funded under RFA-OD-22-014, RFA-OD-19-013 and subsequent reissues). 

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 How to Apply- 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 the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

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

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

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

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 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 How to Apply-Application Guide.

Early-stage Investigators (ESIs). ESIs, or those in the early stages of independent careers, must propose to serve as an MPI with an investigator(s) who have previously received substantial independent research funding from NIH.

Multiple Principal Investigators (MPIs). NCATS encourages applicants to utilize the multiple PDs/PIs (MPIs) option, particularly when each investigator brings diverse perspectives and complementary expertise to the project from different institutions. Applicants are further encouraged to propose projects with an MPI at each Project/Performance Site.

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.

Contact PD/PI. The contact PD/PI must be an investigator from a CTSA prime or partnering organization that is active as of the due date of the application. 

2. Cost Sharing

This NOFO does not require cost sharing as defined in the 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:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the 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.

Letter of Intent

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

NCATS Letters of Intent
Telephone: 301-827-9549
Email: [email protected] 

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 How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed, with the following additional information:

All instructions in the SF424 (R&R) Application Guide must be followed except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts).

Other Attachments

The following "Other Attachments" must be included to aid in review:

1. Milestone Plan (use filename “Milestone Plan”, limited to 3 pages):

A description of the proposed Milestone Plan must be included in a single attachment. Milestones provide quantifiable measures of success and are a key characteristic of this bi-phasic UG3/UH3 mechanism. A milestone is defined as a finding or set of findings that signal the achievement of a Specific Aim in your research plan. Milestones should be composed of three basic components: (1) a desired goal, (2) a timeline or decision point by which the goal must be accomplished, and (3) evidence that the goal has been accomplished based upon quantitative criteria. The Milestone plan should include three key components:

a) A distinct set of annual milestones for both the UG3 and UH3 Phases related to assessing progress on each Aim of your project.

b) A set of quantitative, transitional milestones that will be used to evaluate overall progress made during the UG3 phase of the award and justify the transition into the UH3 phase of the award (i.e., justifiable go/no go criteria).

c) A timetable (e.g., Gantt Chart) identifying when each of the key milestones will be met. The timeline of UG3 activities should not extend into the UH3 Phase of the award as each Phase of the award should contain a distinct project.

In the event of an award, NCATS staff will work the PI(s)/PD(s) to negotiate any changes to the annual milestones each year based on progress. Final negotiated milestones will be included in the Notice of Award. 

NCATS will conduct an administrative review of projects at the end of the UG3 phase to determine the readiness to transition into the UH3 phase. An evaluation will be made based upon successful completion of quantitative transitional milestones (go/no go criteria) and availability of funds. Award recipients should note that UG3 funding does not guarantee subsequent UH3 funding.

2. Sustainability Plan (use filename “Sustainability Plan”, limited to 3 pages):

The CCIA awards are not renewable. As such, a sustainability plan is a key component of a CCIA project and should be an extension of the research strategy. The application must include an attachment titled “Sustainability Plan” that outlines a plan to broadly disseminate and sustainably implement the innovative solution across additional CTSA hubs and/or external stakeholders beyond the UG3/UH3 grant periods. The Sustainability Plan should include at least three components including a plan for:

a) Collaborations. A plan for establishing collaborations with additional CTSA hubs and/or external stakeholders, including for example, federal agencies, local government, industry, small businesses, non-profits organizations, higher education institutions, advocacy groups, health care providers and health care systems, research participants, communities and patients, as appropriate.

b) Financial sustainability. A plan for creating or obtaining additional external resources for the sustainable implementation of innovative solutions.

c) Sustainable implementation. A plan for the sustainable adoption and consistent implementation of innovative solutions to reach the intended individual users and/or communities. This could include elements such as presentations, meetings, training programs, websites, consultative services, open-source resources, etc.

3. Signed Eligibility Statement (use filename “Eligibility Statement”, limited to 1 page)

Each application must include at least one PD/PI or co-Investigator with expertise in translational science to collaborate with the project investigators in developing, adapting, demonstrating, disseminating, implementing, and evaluating innovative solutions to accelerate the translational research process. Translational science expertise is defined as having at least one year of affiliation in a CTSA program role such as an investigator directly supported by a currently active CTSA Hub UL1, UM1, or RC2 program as of the due date of the application as well as alumni from a currently active CTSA Hub KL2/K12, TL1/T32 or Diversity and Re-entry program as of the due date of the application. Current trainees and scholars affiliated with CTSA Hub KL2/K12 and TL1/T32 programs as well as current trainees and alumni from the short-term CTSA Hub TL1 and R25 programs will not be considered to have translational science expertise.

Applications must include an Eligibility Statement signed by the CTSA affiliated program contact PD/PI that provides a description of the translational science expertise and outline the role and period of affiliation on the applicable CTSA hub program.

Exception: An Eligibility Statement is not required if the application includes a PD(s)/PI(s) or Co-Investigator who currently serves or has previously served as the PD/PI or MPI of CTSA hub UL1/ UM1, KL2/K12 or TL1/T32 award.

Applications submitted without a Milestone Plan, Sustainability Plan, and signed Eligibility Statement will be considered incomplete and will not be reviewed.

Applications using these attachments to circumvent the NIH standard page limits as described in the general application guide instructions, will be considered non-compliant and will not be reviewed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R Budget

All instructions in the How to Apply- Application Guide must be followed, with the following additional information:

Each application must include a separate budget and budget justification for both the UG3 Phase and UH3 Phase.

Budgeting for Data Management and Sharing. As outlined in the NIH Guide Notice Supplemental Policy Information: Allowable Costs for Data Management and Sharing, NIH recognizes that making data accessible and reusable for other researchers may incur costs. For that reason, investigators may request funds toward data management and sharing in the budget and budget justification sections of their applications.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions:

This funding mechanism involves two phases – a UG3 Phase and a UH3 Phase. To clearly distinguish between the two phases, applicants must specify separate UG3 and UH3 information in each subsection (Specific Aims and Research Strategy) of the PHS 398 Research Plan as appropriate. Activities in both phases will depend on the specific project. In preparing the application, investigators must consider the fact that applications will be assigned a single impact score for both UG3 and UH3 Phases.

Specific Aims:

Specific aims must be scientifically appropriate for the distinct phases of the project. Include separate aims, within the designated page limit, for both the UG3 and UH3 Phases, and clearly label them as UG3 specific aims and UH3 specific aims.

• UG3. A feasibility assessment should be conducted in the UG3 Phase to ensure an innovative solution can be successfully disseminated and implemented during the UH3 Phase of the award.
• UH3. The UH3 Phase will support the dissemination, implementation, and evaluation of the innovative solution developed during the UG3 Phase by all collaborating organizations for sustainable use across multiple CTSA hubs and/or other stakeholders outside the Consortium.

Research Strategy:

Describe the overall strategy and methodology used to accomplish the goals and specific aims of the project. The description should address the following:

Collaboration: List all CTSA Institutions and collaborating institutions. Describe how the project will stimulate complementary and/or synergistic collaborations to build on the strength and resources of each collaborating organization (e.g., CTSA Program hub, eligible participating / participating component organizations, and/or external stakeholders) while generating innovative new approaches, technologies, resources, or models to attain a generally applicable translational science advance that no single organization can accomplish alone. Describe how the project will involve interdisciplinary and/or multi-disciplinary collaboration. Describe the complementary and integrative efforts that each collaborator will contribute to both phases of the project. Describe the plans and timeframe for how multiple collaborators will participate in this research, identify those responsible for various efforts, declare milestones, metrics, individual responsibilities, timelines and plans for dissemination and implementation as well as evaluation.

Innovation: The description must explain how the project is innovative. Provide a description of- and rationale for the proposed innovation. An innovative project could: (1) develop an innovative new solution, or (2) adapt, disseminate and implement an existing solution in an innovative manner. Describe how the innovative solution will be disseminated and implemented in various environments (e.g., academic or community settings, urban and rural settings) and/or populations (e.g., minority, communities with disparate health outcomes). Discuss how the project might open a new avenue of translational research or might be a systematic improvement over the current processes used in translational research. Discuss how the project applies big, bold, paradigm-shifting ideas to advance translational science.

Acceleration: Describe how the project will catalyze a transformation so that research observations and discoveries in the laboratory, clinic, and/or community turn into more treatments that improve health for all people more quickly. Describe how the project will streamline the current timeline of translational research process. Describe how the project will enable stakeholders to perform translational research more efficiently and effectively. Apply the NCATS description of translational science spectrum (i.e., the spectrum is not linear or unidirectional; each translational science stage builds upon and informs the others) to accelerate the translation research process. Describe the evaluation methods to assess the acceleration aspects of the project. Describe how the project will speed the development, demonstration, dissemination and implementation of the innovative solution. Describe the methodologies that will yield the scientific evidence for the innovative solution to accelerate the translational research process relative to current research, clinical, and public health practice paradigms. Describe how the project will apply the innovative solution for a disease to other diseases. Describe how the project will apply the innovative solution for a specific subpopulation to other subpopulations.

Dissemination & Implementation: Describe how the innovative solution will be disseminated and sustainably implemented in a targeted scientific, clinical, community or public health setting. Describe how the collaborators will use strategies to adopt, scale-up and integrate the innovative solution into different environments to improve individual outcomes and benefit population health. Discuss how the project will engage collaborating organizations for the dissemination and implementation of the innovative solution. Highlight how the implementation work proposed here will integrate with the longer-term goals for sustainability (post award) as laid out in the attached Sustainability Plan. 

Evaluation: Describe how the project can leverage the resources and expertise from the evaluation component of the collaborating CTSA Program hubs. Define success for the proposed project and describe how success can be evaluated and quantified.

Risks to the Project / Contingency Plans: Identify any perceived implementation problems or ethical issues during the startup, conduct and closeout of the project. Propose solutions to mitigate or eliminate the foreseeable risks that can jeopardize the completion and success of the project. Describe potential contingency plans and alternative approaches to completing the goals and specific aims of the project. Describe the management plan to address the unforeseeable risks to the project.

Letters of Support:

It is recommended a cover page be included indexing all provided letters of support.

Each application must include letters of support from each collaborating institution including the:

• Contact PD/PI from the CTSA hub prime or partnering organization
• PD(s)/PI(s) from each eligible, collaborating organization, and,
• Collaborators, key personnel, institutions, and/or other significant contributors, as appropriate. 

Each letter of support should detail how the organization will provide support to the project (e.g., shared resources, assistance with dissemination and implementation efforts, etc.).

For multiple investigators from the same CTSA Program hub, one letter of support from the CTSA Program PD/PI is sufficient.

Where relevant, include letters of support or other documentation of collaborative effort with the external stakeholders.

If applicable, for drug or device clinical trials, a letter of support must be included demonstrating that the study drug or device will be available in sufficient quantities to ensure study feasibility.

Applications submitted without the required letters of Support from the contact PD/PI of the CTSA Program hub, contact PD/PI of the participating NIH ICO programs, and the external stakeholder’s institution or organization will be considered incomplete and will not be reviewed.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan. 
• Please note the difference between a DMS Plan and a Resource Sharing Plan. See here to determine which scientific data sharing policies apply to the planned research.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

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

See Part 2. 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. 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.

Applications must be submitted electronically following the instructions described in the How to Apply 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 How to Apply 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 non-responsiveness by NCATS, NIH. Applications that are incomplete or non-responsive will not be reviewed.

In order to expedite review, applicants are requested to notify the NCATS Referral Office by email at [email protected] when the application has been submitted. Please include the NOFO number and title, PD/PI name, and title of the application.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

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

Section V. Application Review Information

1. Criteria

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

This NOFO will use the UG3/UH3 Cooperative Agreement mechanism, involving two distinct phases. The UG3/UH3 bi-phasic activity is a fast-track process that allows applicants to submit two projects (one UG3, one UH3) in a single application, geared to enhance the efficiency and speed of translational research. Both phases are required in one application with distinct Aims for each phase. During both phases of the award, rigorous methods should be applied to evaluate whether the innovative solution can be feasibly developed and sustainably implemented in a way that accelerates the translational research process and improves the efficiency and effectiveness of many aspects of translational research. 

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

As applicable for the project proposed, reviewers will consider the following additional items while determining scientific and technical merit, but will not give criterion scores for these items, and should consider them in providing an overall impact score.

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.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NCATS, 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. 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:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 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.

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.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

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.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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

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

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

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

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

2. Administrative and National Policy Requirements

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• 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 Laws and Regulations Enforced by 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.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

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 among the recipients and NIH as defined below.

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

• Defining research objectives and approaches, planning, conducting, analyzing, and publishing results, interpretations, and conclusions of their studies, and providing overall scientific and administrative leadership for the Research Project.
• Overseeing all aspects of the organization and execution of the studies outlined in the application and approved by NCATS after peer review.
• Negotiate and agree on a final set of milestones, the final negotiated and approved milestones will be specified in the Notice of Award.
• Participating in regular (monthly) conference calls with the NIH Project Collaborator.
• Putting all study materials and procedure manuals into the public domain. Recipients are expected to publish and publicly disseminate results, data, and other products of the study, concordant with governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NCATS/NIH.
• Recipients have primary and lead responsibilities for the project, including any modification of study design, the conduct of the study, quality control, data analysis and interpretation, preparation of publications, and collaboration with other investigators unless otherwise provided for in these terms or by the action of the primary leadership committee.
• Make publicly accessible interim presentations of project progress on annual basis and final presentation at the completion of each UG3/UH3 Phase using an online platform and resources provided by NCATS.

Recipients will retain custody of and have primary rights to the intellectual property, data and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.

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

The NIH Project Collaborator will:

• Provide substantial programmatic involvement that is above and beyond the normal stewardship role in awards with substantial involvement in the proposed research project.
• Cooperate, coordinate with, and/or assist recipients in performing project activities, e.g., coordination of research networks; coordinating access to NIH-supported research resources; identifying other researchers/resources for the projects.
• Participate on steering and operations committees or in other functions responsible for helping to guide the course of long-term projects or activities; e.g., annual meetings.
• Provide scientific and technical discussions with recipients, facilitate or expedite interactions between recipients, and/or identify and facilitate access to resources; e.g., organizing and holding meetings of investigators.
• Have access to data generated under this Cooperative Agreement and may periodically review the data. NCATS staff may use information obtained from the data for the preparation of internal reports on the activities of the study. However, recipients will retain custody of and have primary rights to all data developed under these awards, subject to Government rights of access consistent with HHS, PHS, and NIH policies.
• Serve as a resource to provide scientific/programmatic support during the accomplishment of the research by participating in the design of the activities, advising in the selection of sources or resources (e.g., determining where a particular reagent can be found), provision of research resources and reagents available from NCATS award recipients and contractors, or other CTSA Program sites, advising in management and technical performance or participating in the preparation of publications.
• If the award involves a clinical study, oversee the adequacy of adverse event management and reporting, and have regular communications with the PD/PI and study team, which may include attendance at the DSMB and related committee meetings. Review and monitor the progress of inclusion of women and minorities in the clinical trial.
• Review the progress of each participating organization, through consideration of the annual reports, site visits, screening logs, etc.
• Determine whether milestones are appropriate for each stage of the award. Review and approve any milestone changes.
• Monitor study progress; as with any award, continuation, even during the period recommended for support, is contingent upon satisfactory progress. The schedule for these interim reviews will be based on the duration of the award. Continuation of funding will be dependent upon the recipient’s ability to show adequate progress.
• Be responsible for assessing the progress of the project towards the specified milestones, and for recommending if further funds should be released to the project and whether the project should transition to the UH3 Phase.
• Determine continued funding based on the overall robustness of the entire data that adequately allows an interpretation of the results (regardless of being captured in the milestones), overall progress, NIH portfolio balance, and program priorities, competitive landscape, and availability of funds.

Additionally, the Project Collaborator, acting as the NIH Program Official, will be responsible for normal stewardship of the award and will be named in the notice of award. The Project Collaborator may recommend the termination or curtailment of an investigator or project/program (or an individual award) in the event the partnerships fail to evolve within the intent and purpose of this program. 

Areas of Joint Responsibility include:

• Clarifying and negotiating any modifications of the annual milestones and timeline.
• Coordination of meetings, if needed, at critical transition points of the award.

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.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. 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.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

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

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

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

Kristopher Bough, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 240-987-9930
E-mail: [email protected]

Tracy Chen
Office of Regulatory and Emerging Science (ORES)
Office of the Chief Scientist (OCS)
Office of the Commissioner (OC)
U.S. Food and Drug Administration
Phone: 301-796-3597
E-mail: [email protected]

Kay Wanke, PhD, MPH
NIH Office of Disease Prevention (ODP)
Phone: (301) 451-1856
E-mail: [email protected]

Robb Kenneth Rowley
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: (240) 460-0429
E-mail: [email protected]

Dolly Penn White, MD, MSCR
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: (301) 402-1366
E-mail: [email protected]

Dena Fischer, DDS, MSD, MS
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: (301) 594-4876
E-mail: [email protected]

Melissa Parisi, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6880
Email: [email protected]

Mary Garcia-Cazarin, Ph.D.
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS)
Phone: (301) 402-2446
E-mail: [email protected]

Erin Iturriaga, D.N.P., M.S. N., B.S.
NIGMS - NATIONAL INSTITUTE OF GENERAL MEDICAL SCIENCES
E-mail: [email protected]

Rajeev K Agarwal, Ph.D.
ORWH - Office of Research on Women's Health
Phone: 301-451-7058
E-mail: [email protected]

Dave Yeung, PhD
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (301) 761-7237
Email: [email protected]

Lourdes Ponce, Ph.D.
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-435-0810
Email: [email protected]   

Rachel Ratz
National Center for Advancing Translational Sciences (NCATS)
Telephone: 301-451-4765
Email: [email protected] 

Terrin Brown
[email protected]

Deanna L Ingersoll
NHGRI - NATIONAL HUMAN GENOME RESEARCH INSTITUTE
Phone: 301-435-7858
E-mail: [email protected]

Priscilla Grant, JD
NIMHD - NATIONAL INSTITUTE ON MINORITY HEALTH AND HEALTH DISPARITIES
Phone: 301-594-8412
E-mail: [email protected]

Gabriel Hidalgo, MBA
NIDCR - NATIONAL INSTITUTE OF DENTAL & CRANIOFACIAL RESEARCH
Phone: 301-827-4630
E-mail: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Erik Edgerton
NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES (NIAMS)
Phone: 301-594-7760
E-mail: [email protected]

Tamia Carter
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: (240) 669-2982
Email: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.