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 Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Purpose

This funding opportunity announcement (FOA) solicits applications for Technology Research and Development Centers (TRDCs) for the Point of Care Technology Research Network (POCTRN). POCTRN’s purpose is to drive the development and application of innovative point of care, home-based, improved clinical laboratory tests and testing technologies. The POCTRN TRDCs will merge scientific and technological capabilities with unmet clinical needs in the areas of testing, monitoring, and treatment.

The network of POCTRN TRDCs will have broad expertise across many research areas and will cover multiple levels of technology readiness from proof of feasibility through products and procedures used in clinical practice.

Through this reissuance, NIH seeks to continue supporting the development of POC devices while building upon the advances in POC and home-based testing technologies achieved over the course of the COVID-19 pandemic. By integrating into POCTRN TRDCs the best practices in accelerating technology development, NIH intends to support a new paradigm by which the agency catalyzes medical device innovation.

Background:

The COVID-19 pandemic has had a tremendous impact on the development and implementation of medical devices, particularly diagnostics, and has precipitated what may be a foundational shift in the approach nations and their health systems take in detecting and diagnosing diseases and conditions, especially infectious diseases. The pre-pandemic model relied largely upon complex, centralized, laboratory-based testing of patient samples collected by a trained healthcare provider or technician in a qualified healthcare setting. The pandemic necessitated a change to this historical model and accelerated a shift to a hybrid approach that includes analysis of patient samples collected in distributed settings, such as at the point-of-care and in workplaces, schools, and community centers. Perhaps the most radical change in response to the pandemic was the large-scale production and distribution of over-the-counter SARS-CoV-2 testing technologies that could be purchased without a prescription and then administered and interpreted by an individual in a home setting.

This revolution in point-of-care technologies and home-based testing was partly driven by NIH’s Rapid Acceleration of Diagnostics Technology (RADx Tech) Program, which is a fast-track technology development program led by the National Institute of Biomedical Imaging and Bioengineering (NIBIB). RADx Tech leverages the POCTRN to speed innovation in the development, commercialization, and implementation of technologies for COVID-19 testing. NIBIB established POCTRN in 2007, with Centers added in 2011 and 2017, to facilitate the development of a pipeline of point-of-care technologies with commercialization potential, utilizing a Center structure that enables incorporation of clinical and user needs in the development process and provides expertise and resources to address early barriers to commercialization and implementation. Information about the existing program can be found at www.poctrn.org.

POCTRN initially sought to contribute to the evolution of the U.S. healthcare system by supporting the development of affordable, easy-to-use, and accurate medical devices, as well as appropriate means for information sharing, to provide timely and actionable health status information at the point-of-care. New healthcare delivery models being implemented in the U.S. and elsewhere envision an empowered patient engaged in informed decision-making and care management alongside the traditional roles of physicians, nurses, and health care practitioners in patient care. This expanded scope of healthcare delivery requires innovation in medical device technologies that bridge the location and timing gaps between the centralized, lab-based approaches and the patient-to-provider interaction that occurs at the point-of-care. Examples of POC devices that can bridge those gaps include diagnostic tools for the evaluation of patient samples such as blood, saliva and urine in non-laboratory settings, low-cost imaging technologies such as ultrasound for use in low-resource settings, monitoring devices for home-based management of chronic conditions, and communications technologies that enable data sharing and team-based care approaches across settings. These devices can expand the capabilities of primary care physicians, nurses, pharmacists, and other health care practitioners, as well as patients themselves, to rapidly determine and deliver the appropriate treatments and prevention strategies. POC technologies also provide an opportunity to deliver healthcare in low-resource settings, such as in low- and middle-income countries or disaster environments, where there is often a lack of diagnostic and monitoring tools.

In this issuance of the POCTRN funding opportunity, NIH seeks to continue supporting the development of POC devices and build upon the advances in POC and home-based testing technologies accelerated by RADx Tech. By integrating into POCTRN the best practices in accelerating technology development learned throughout the course of the COVID-19 pandemic, NIH intends to support a new paradigm by which the agency catalyzes medical device innovation.

2. Objectives

The overall objective of the Point-of-Care Technologies Research Network (POCTRN) is to support the rapid development, commercialization, and implementation of innovative point-of-care and home-based diagnostic technologies. As a national resource, the Network model creates a multidisciplinary coalition of knowledge and capabilities that can be leveraged to accelerate technology development, with the fundamental goal of broadly enhancing access to diagnostic technologies. The Network will consist of multiple Technology Research and Development Centers (TRDCs), each with expertise in specific technical and/or clinical areas and each covering multiple levels of technology readiness (See individual NIH Institute/Center Statements of Interest below), which will collaborate through a Coordination and Technology Support Center (CTSC). The TRDCs will engage government, industry, or other organizations, including various departments from academic institutions, that can partner to provide synergistic resources to support the development of new technologies and solutions.

The general scope of work covered within each TRDC and across the Network will include, but is not limited to:

• Conducting Needs Assessments to identify unmet clinical needs in point-of-care and home-based testing
• Developing solicitation topics to address the unmet clinical needs in point-of-care and home-based testing
• Awarding and managing sub-project awards to support point-of-care and home-based technology development activities led by investigators outside the TRDCs
• Collaborating with physical scientists, computational scientists, and engineers (as well as researchers from other relevant disciplines, as appropriate) on technology development projects
• Developing external partnerships (e.g., technology, clinical, industry, and regulatory) necessary to move enabling technologies toward clinical applications
• Conducting and/or providing access to validation and clinical testing of prototype point-of-care and home-based devices
• Creating training opportunities for technology developers and other stakeholders related to the development of point-of-care and home-based devices.

3. Organizational Structure

The Point of Care Technology Research Network (POCTRN) will be comprised of multiple TRDCs, as well as a Coordination and Technology Support Center (CTSC). The CTSC will be established through a separate funding mechanism to provide centralized support services for the Network. Resources provided to the TRDCs by the CTSC will optimize the efficiency of the Network. The PD/PIs from the TRDCs will form a Network Steering Committee to facilitate governance and decision-making for overall Network activities.

The structure of a POCTRN TRDC will consist of in-house scientific and point-of-care technological expertise and the clinical partnerships necessary to facilitate the identification and integration of enabling technologies into devices that address defined clinical needs. Each POCTRN TRDC will be comprised of four Core Components: (1) Administrative Core (2) Technology Core (3) Clinical Core (4) Dissemination Core.

1)Administrative Core

The appropriate leadership and administrative structure to manage the many facets of these large and complex TRDCs will be a key component in establishing a successful TRDC. The Administrative Core serves as the managing component that is charged with effectively leading the organization and governance of the TRDC, and collaboration within the Network and with the CTSC. The TRDC is responsible for establishing an External Advisory Committee (EAC). The EAC is appointed by the TRDC Program Director/Principal Investigator (PD/PI) and provides recommendations to the PD/PI on future directions. EAC members should not be named, contacted, or appointed prior to the submission of the application, however characteristics of EAC members should be included in the Administrative Core component of the application. EAC members will need NIH programmatic approval prior to confirmation.

2) Technology Core

The Technology Core identifies, evaluates, and supports technology development/refinement in-house and external to the TDRC. TRDCs will appoint a program manager to serve as a point of contact to engage with the CTSC. The program manager will receive training from the CTSC and will guide and support the sub-project solicitation, review, selection, and management process for their respective TRDC. The Technology Core will coordinate with the Dissemination Core to conduct regular needs assessments during the grant period and draft annual funding solicitations to address unmet clinical needs. In collaboration with the CTSC, solicitations will be finalized, posted, and advertised. The TRDC program managers will be responsible for coordinating several review-related activities, including recruitment of reviewers, convening review meetings, and garnering TDRC input at review decision points. The CTSC will work with the TRDC program managers to consolidate reviewer feedback from all phases of evaluation and deliver reports to the TRDCs to support funding consideration. The Technology Core will be responsible for preparing final funding recommendations for NIH approval.

For projects approved for funding, the TRDC program manager will work with the CTSC to establish a project management team and negotiate final development milestones for the sub-project awards. It is expected that the project period for sub-project awards will be 6 to 12 months to allow for technologies to be validated and moved into the next stage of clinical testing. Although budgets vary from year to year roughly 50-60% of the total budgets are expected to go to sub-project awards. There is flexibility in the support amount and time periods of the sub-project awards, 6-month awards at $50,000 or 1 year at $100,000 can be used for budgeting purposes. The number of awards would depend on the number of meritorious applications and the TDRC's goals and budget. It is anticipated that each TRDC would manage no more than ten sub-projects per year. The first round of sub-project awards is to be made in Year One of the grant project period.

The TRDC program manager will oversee the portfolio of sub-projects supported by their TRDC and will directly engage with the project management teams to provide direction to funded projects. Quarterly reviews will be coordinated with the CTSC to assess sub-project progress against milestones, and TRDCs will be responsible for making milestone-based go/no-go decisions on sub-projects. Projects that continue to meet or exceed milestones may be eligible for additional support at the discretion of each TRDC; the TRDC may terminate projects that fail to meet milestones and reallocate resources accordingly.

The budget requested by applicants to this FOA should reflect this scale of activity. Award recipients from this FOA should plan to issue a solicitation for sub-projects soon after receiving a Notice of Award from NIH. After the TRDC evaluates proposals in collaboration with the CTSC, and after NIH case-by-case approval, the TRDC will make sub-project awards for meritorious sub-projects. The details of the full governance structure are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award . Although TRDC institutions may receive funding for collaborative sub-project awards,it is expected that the majority of funds will be used to fund sub-project awards outside of the U54 awardee institution.

3) Clinical Core

Clinical validation, usability, and feasibility testing are necessary to ensure that the technology prototypes supported under this program will have a reasonable rate of success for public uptake. To provide continuity of support for rapid technology development, the Clinical Core will direct technical and clinical validation services aimed at assessing analytical performance and optimizing designs and prototypes. The Clinical Core may accept or solicit proposals on a rolling basis to evaluate for access to validation services and resources. Sub-projects that successfully achieve milestones within the Technology Core will be eligible to receive validation services, and TRDC program managers will work closely with the Clinical Core to request access. TRDC recommendations to provide clinical validation services will need NIH Program Officer approval prior to initiating any activities.

TRDCs are expected to validate the performance of prototypes and undertake rigorous feasibility and adoption testing for the point-of-care and home-based devices in both clinical and real-world settings. Examples of intended-use settings include, but are not limited to, the integration of the point-of-care technologies into clinical workflow (private offices and academic practices), implementation within low-resource settings and among the intended users and/or caregivers, or deployment for home-based use. An important characteristic of funded TRDCs is therefore the ability to collaborate effectively with entities that possess the Examples of resources to support clinical validation, usability and feasibility testing would include access to facilities, biospecimens, funding etc. for clinical translation of prototype devices developed through TRDC activities. Knowledge of Food and Drug Administration (FDA) regulatory guidance for the diagnostic industry is a critical component to establishing protocols for device testing. Typical protocols might include limit of detection (LOD) studies, sensitivity and specificity analysis, cross-reactivity panels, human factors and usability, and engineering design. Support for clinical translation can also be in the form of sub-project awards, tools, and/or other resources such as biorepositories and biospecimens.

4) Dissemination Core

The Dissemination Core provides training activities for point-of-care and home-based technology stakeholders such as scientists, engineers, clinicians and other medical professionals, patients, policy makers, and investors. Training activities can include but are not limited to webinars, workshops, hackathons, etc. The Dissemination Core will also conduct assessments (minimum of 3) of clinical and user needs to inform device design and further define and disseminate publicly available clinical needs information. A needs assessment may take the form of a questionnaire, survey, focus group, or consultation with persons with specific knowledge to identify needs or "gaps" in the research focus area of the TRDC. Findings from the needs assessments will provide useful information for the TRDCs to develop the solicitations for sub-project awards, and engagement with the Technology Core will be imperative.

Additional details regarding each core component and the information required for submission can be found Section IV, "Research Plan".

Coordination and Technology Support Center (CTSC)

The CTSC will work with the TRDCs to develop and deploy standard operating procedures covering various Network activities: clinical needs assessments; solicitation development; proposal management, review and selection; project management; milestone development and evaluation; project risk assessments; and commercialization resource allocation. Open and frequent communication is critical to the success of the Network model. The CTSC will facilitate information sharing and interactions between and among the TRDCs, convening regular Network meetings to enable cooperative and coordinated activities among the TRDCs. To ensure consistency and efficiency, the CTSC will implement standardized workflows for the solicitation development process, the proposal evaluation process, the project management and milestone evaluation process, and the allocation of commercialization resources for all TRDCs. Through the systemic integration of best practices, the CTSC will enhance Network capabilities by allowing TRDCs to focus time and resources most prudently.

The collaborative foundation of the Network model will be a web-based platform for soliciting, receiving, evaluating, and tracking proposals for technology research and development. This centralized proposal management platform will be hosted by the CTSC and offer streamlined data management, communication, and reporting. TRDCs will utilize the platform throughout the solicitation, review, and selection process. The platform will also enable milestone-tracking of funded projects to simplify project management and progress evaluation.

While TRDCs will be responsible for clinical needs assessments and drafting solicitations, they will be able to leverage the expertise of the CTSC to refine solicitations consistent with Network standards. The CTSC will post solicitations on a central Network website, as well as coordinate outreach and advertising activities. The CTSC will provide supervision of the proposal review process, which has been optimized through the RADx -Tech program. During the multi-phase review, the CTSC will provide support for the recruitment and training of reviewers, convening the review meetings, standardizing review templates and scoring frameworks, and communicating review outcomes. The TRDCs will confer with the CTSC at each phase of review to provide TRDC decisional approval on review recommendations and ultimately to ensure that their stated solicitation objectives are being met through the coordinated process.

Upon completion of a review cycle, the CTSC will consolidate reviewer feedback from all phases of evaluation and deliver reports to the TRDCs for funding consideration. The TRDCs will be responsible for preparing final funding recommendations for NIH approval. For proposals that are selected and approved for funding, the CTSC will help establish a project management team to work in concert with the TDRC to support the milestone-driven objectives of each project. Milestones will have been developed during the review process and will be used to continually assess progress throughout the project. Based on risk assessments completed during review, the CTSC can also facilitate access to commercialization consultants and services that help mitigate the risks identified for each project. Experts and services provided by the CTSC may cover design and prototyping, usability, intellectual property, manufacturing, quality systems, regulatory, reimbursement, finance, legal, operational, and marketing. The CTSC will support the TRDCs in completing quarterly reviews of funded projects. The TRDC evaluation of progress against established milestones will inform the TRDCs in making go/no-go decisions for supported projects. Projects that continue to meet or exceed milestones may be eligible for additional support, while the TRDC may terminate projects that fail to meet milestones and reallocate resources accordingly. NIH staff approval is required for all decisional actions related to allocating funding and/or resources. Additionally, the CTSC will assist TRDCs in developing processes and policies for sub-award management that comply with NIH grants management policy.

All Applications to this FOA must include the following

Applications that omit any of this information will be withdrawn and not undergo peer review:

• Descriptions of all required Cores;
• Plans to ramp up each Core within the first year, including a specific timeline describing when each capability is anticipated to be available;
• A preliminary needs assessment to identify areas for targeted solicitation;
• A draft of the TRDC’s first solicitation.

Non-responsive activities

Applications that include efforts to develop animal models will be considered non-responsive and will be withdrawn and not reviewed.

NIH Participating Institute and Center Statements of Interest:

National Institute of Biomedical Imaging and Bioengineering

The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to transform through engineering the understanding of disease and its prevention, detection, diagnosis, and treatment. NIBIB supports new tools and technologies to improve human health within its internal laboratories and through grants, collaborations, and training. In the area of POC technologies, the NIBIB supports research that enables patient-centered health care through the development and application of point-of-care and home-based technologies. The NIBIB will support point-of-care and home-based technologies to detect, measure, and analyze biological information including molecular, genomic, cellular, clinical, behavioral, physiological, and environmental parameters at the site of patient care or within the home to assist prevention, diagnosis, treatment, and management of diseases. NIBIB is interested in supporting Research Center(s) that are structured around emerging technologies, clinical needs and opportunities in the following example areas, but not limited to:

• Primary Care
• Emergency Preparedness
• Emerging Infectious Diseases
• Low-Resource Settings
• Ambulatory Care

The above suggestions are intended to be exemplary rather than exhaustive or prescriptive. Previously funded POCTRN TRDCs supported by NIBIB can be found on the current NIBIB POCTRN website (https://www.nibib.nih.gov/research-funding/point-care-technologies-research-network).

National Heart, Lung and Blood Institute

The NHLBI supports development of technologies to detect, prevent, or treat heart, lung, blood and sleep (HLBS) disorders. It also supports research on the clinical use of blood and all aspects of the management and safety of blood resources.

The NHLBI is interested in sponsoring a Center to facilitate clinical validation and adoption studies for technologies that can be deployed in low-resource settings. The NHLBI Center will support clinical validation of POC technologies by serving as a clinical laboratory for innovators. To facilitate clinical validation of a technology, the NHLBI Center will provide appropriate clinical samples, test integration into clinical workflow and electronic health records, and optimize user interfaces. Additionally, the Center will support feasibility and demonstration studies to test how these technologies could be used in low-resource settings, and whether these technologies could improve the quality of life, quality of care, and reduce health care costs. The NHLBI Center will also conduct needs assessment to understand the critical unmet needs within these communities (including needs of healthcare providers and end users) and identify specific technologies, along with requirements for these technologies to be acceptable and usable in low resource communities. The NHLBI Center’s annual solicitation will require applicants to address implementation outcomes to close the know-do gap, such as accessibility, feasibility, costs, penetration and sustainability, because implementation science outcomes need to be considered at the beginning of the design and research of POC technologies for low-resource settings.

The NHLBI POCTRN Research Center will not support early stage development of prototypes, but will support refinement of prototypes based on clinical validation results and user feedback. NHLBI supports early state prototype development work through the Catalyze Program. Functional prototypes that have been validated in animal models, when applicable, will be candidates for clinical validation studies within the Center. Services provided by the Center include, but are not limited to, the following aspects:

• Provide clinical samples to validate analytic performance
• Help to identify data management and integration issues and strategies
• Provide access to clinical testing lab to identify issues and strategies in quality control, workflow integration, and unanticipated human factors
• Provide feedback on user interface optimization and user acceptance
• Provide initial data on device/technology usability in a real-world clinical setting
• Provide statistical consultations

Technologies that are already on the market but need additional demonstration studies for low resource settings will be candidates for additional clinical adoption support, which include but are not limited to the following examples:

• POC technologies that can detect acute condition or deterioration of chronic diseases and facilitate clinical decisions, such as bleeding, thrombosis, pulmonary embolism, and heart failure decompensation
• POC technologies that will enable continuous monitoring and management of chronic diseases at home, such as heart failure, chronic obstructive lung disease, asthma, and sickle cell disease
• Integrated devices that can monitor multiple parameters, such as heart rate, respiratory rate, temperature, asthma status, blood pressure and sleep quality
• Enabling, minimally invasive, biomarker detection technologies for early identification of HLBS diseases and disorders
• Mobile applications and POC technologies for improving patient self-management, communications with health care providers, and adherence to treatment
• Mobile applications and POC technologies that can monitor patients response to treatment and allow for clinical decisions via telehealth

The NHLBI Center is anticipated to have the capacity to cover four main programmatic areas: heart, lung, blood, and sleep disorders. The applicant is encouraged to have co-investigators or collaborators with expertise in all four programmatic areas and should demonstrate the following in the application:

1. Adequate clinical capacities to validate POC technologies, such as number of clinics, ability to conduct clinical research within the center, biospecimen banks, etc.
2. Description of POC technologies that can be validated in the center at the onset of the award.
3. Supporting letters from ongoing clinical trials or observational studies with the types of POC technologies that can be validated in the study.
4. Plan for identifying and selecting POC technologies to be validated in the center.
5. Have a strong partnership with under-served communities that have high burden of HLBS diseases. See, NIH definitions, https://www.nimhd.nih.gov/about/strategic-plan/nih-strategic-plan-definitions-and-parameters.html#:~:text=NIH%20defines%20health%20disparity%20populations,or%20more%20of%20these%20descriptions
6. Capability to address social determinants of health (diverse and inclusive study populations) and strive for health equity.

National Cancer Institute (NCI)

The focus of the NCI in this initiative is to support the transition of scientific discoveries and engineering advances into tools to address clinical cancer research for assessment of cancer risk, cancer screening, early detection, prevention, diagnosis, treatment, treatment monitoring and/or disease management.

The NCI is interested in funding one center for the development, validation and/or adoption of point of care technologies in clinical and other settings where the point-of-care device and assays will be deployed.

The cancer POCTRN center is envisioned to incentivize the development of POC technologies for cancer care continuum, including technologies explicitly designed to address challenges and barriers associated with cancer health disparities and low resource settings. For this purpose, the center will encourage the engagement of racial and ethnic minorities during technology optimization and validation to better serve’s minority health and NIH-designated populations that experience health disparities. See, NIH definitions, https://www.nimhd.nih.gov/about/strategic-plan/nih-strategic-plan-definitions-and-parameters.html#:~:text=NIH%20defines%20health%20disparity%20populations,or%20more%20of%20these%20descriptions.

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Examples of POC technologies supported by the NCI include, but are not limited to:

POC technologies that work with non-invasive or minimally invasive samples

POCTs for in vitro and in vivo imaging

Portable platforms for near patient use

Paper based POC platforms

Printed sensor/electrode based POC platforms

Smartphone-based platforms (beyond cell phone apps)

Technologies that enable processing of complex samples, such as samples obtained by self-sampling, in the POC and point-of-need settings to quickly deliver results

National Institute of Allergy and Infectious Diseases (NIAID)
Statement of Interest

NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world. NIAID advances the understanding, diagnosis, and treatment of many of the world’s most intractable and widespread diseases.

NIAID is interested in supporting, by intellectual and technical input and guidance, POCTRN TRDC that are structured around emerging technologies, clinical needs and opportunities focused on advancing innovative point-of-care and home-based diagnostic technologies for emerging and re-emerging infectious diseases, sexually transmitted infections, and other research areas within its mission. Technologies to distinguish vaccine induced seropositivity from infections or to allow early detection or characterization of emerging variants conferring resistance to treatment are needed.

National Institute on Drug Abuse (NIDA)

NIDA focus is to support the transition of scientific discoveries and engineering advances into tools to address the clinical and field research in the area of drug detection, screening and quantification with the goal of diagnosis, treatment, treatment monitoring and/or disease management. Additionally, devices aiding the determination of cause of death in cases of suspected drug overdose are of interest.

NIDA is interested in funding one center for the development, validation and/or adoption of point of care (POC) technologies in clinical and other settings where the point-of-need devices and assays will be deployed.

A NIDA POCTRN center is envisioned to incentivize the development of point of care (POC) technologies for substance use disorder (SUD) care continuum, including technologies explicitly designed to address challenges and barriers associated with SUD health disparities and low resource settings. For this purpose, the center will encourage the engagement of minorities, tribes, as well as justice system-involved groups during technology optimization and validation to better serve underserved populations.

Examples of POC technologies supported by NIDA could include, but are not limited to:

POC technologies for drug quantification in blood, saliva, sweat or tissues with minimal or no sample preparation;

POC technologies capable of analyzing 2 or more matrices without change in workflow;

Reusable POC drug panels for rapid toxicology testing;

Low-cost electrochemical, optical or calorimetric-based POC platforms for drug detection;

PON technologies focused on rapid detection of emerging drugs of abuse and/or drug analogs;

Technologies that enable processing of complex samples in point-of-need settings to facilitate the POC use of existing technologies

National Center for Complementary and Integrative Health (NCCIH) Statement of Interest

The NCCIH supports the development and validation of technologies that assess symptoms commonly treated by the public with complementary and integrative health (CIH) approaches or technologies that monitor or enhance these approaches forsymptom management, prevention of diseases, and promotion of well-being. The CIH approaches of interest include natural products, such as herbs, prebiotic, probiotics, and selective medical diets, and mind and body practices including acupuncture, meditation, manual therapies (e.g., spinal manipulation/mobilization), hypnosis, meditative movements (e.g. tai chi, yoga, etc.), and music/art therapies.

NCCIH is particularly interested in the development and validation of technologies that aim to monitor, assess, enhance, or incorporate these CIH approaches into point of care for the following applications:

• Pain and pain management;
• Sleep and sleep disturbances;
• Symptomatic conditions, such as those associated with menopause;
• Management of mental health conditions commonly managed in primary care such as mild to moderate depression, or anxiety;
• Behavior change to promote healthy behaviors such as healthy eating and physical exercise.

The NCCIH is interested in supporting a Center(s) to facilitate the development, clinical validation, and adoption studies for clinic or other health settings where the point of care assessment or treatment will be deployed. For this FOA, NCCIH will not support clinical trials. NCCIH does not need the Investigational Device Exemption (IDE) from the US Food and Drug Administration (FDA) to be in place at the time of application, but an IDE (if needed) must be obtained before an award is made.

Examples of such technologies include, but are not limited to:

• Mobile devices or applications that can monitor the dose, intensity, duration and/or frequency of CIH approaches employed by the patients at POC;
• Technologies that can objectively measure pain or functional limitations due to pain, which would be treated by CIH approaches, at home or in primary care facilities;
• Technologies that can monitor or enhance physiological responses to CIH approaches at POC for the treatment of pain, sleep disorder, mild to moderate depression, anxiety, or other symptomatic conditions;
• Technologies that can objectively assess or monitor stress, pain, sleep dysfunction, depression, or anxiety, which would be treated or managed by CIH approaches, at home or in primary care facilities.

Fogarty International Center

The FIC is interested in facilitating research in a Center on the development, validation, and adoption of technologies to address global health problems. Technologies studied should be specifically suited for low resource settings and applicable to low- and middle-income countries (LMICs; as defined by the World Bank as low-, lower-middle-, or upper-middle-income economies). Specific health areas of focus should be justified and highly relevant to priorities in LMICs. Additionally, the FIC is dedicated to building partnerships between U.S. and LMIC investigators and prioritizes collaborations with and training of LMIC researchers.

Potential applicants interested in proposing projects related to HIV/AIDS should ensure that the research aligns with NIH HIV/AIDS high priority research topics by reviewing the NIH HIV/AIDS Research Priorities and the NIH Office of AIDS Research Strategic Plan.

Pre-application Consultation

As an U54 cooperative agreement, NIH program staff will be involved in negotiating benchmarks and execution of the project. Applicants are strongly encouraged to consult with NIH program staff early in the process of planning an application; this provides a critical opportunity for applicants to confirm that planned activities are responsive to this FOA. Applicants should contact program staff listed in Section VII. Agency Contacts Scientific/ Research Contacts specific to the applicants proposed scope of work. All inquiries should also include the email recipient [email protected] and should be sent in advance of the application due date.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Local Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• 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 full SAM and 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 his/her organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019.

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

2. Cost Sharing

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

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 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 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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:

Tiffani Bailey Lash, Ph.D.
Telephone: 301-496-9321
Fax: 301-480-1614
Email: [email protected]

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application must include the following components:

• Overall: Required
• Administrative Core: Required
• Technology Core: Required
• Clinical Core: Required
• Dissemination Core: Required

Overall Component

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Specific Aims: Describe the specific aims for the proposed POCTRN TRDC. Each POCTRN TRDC is charged with creating a dynamic structure that identifies promising emerging technologies and facilitates their translation into clinical application. The high-quality clinical and translational research is expected to make an impact broadly.

Research Strategy:

• Address overall objectives, long-term goals, and milestones of the TRDC.
• Address the track record for the respective field of expertise of the TRDC and provide examples of successfully integrating and translating healthcare and technology developments.
• Describe the clinical drivers for introducing (or expanding the use of) innovative point-of-care, home-based, and other testing technologies in the chosen setting or clinical application.
• Describe how the TRDC’s expertise, capabilities and partnerships will enable it to have a significant impact in the chosen setting or clinical application.

It is expected that the POCTRN TRDCs will identify current and future resources and affiliations with partnering institutions, examples given but not limited to academic, industrial, federal and nonprofit organizations.

Letters of Support: An Institutional Letter of Support should be provided stating the institutional support for the proposed TRDC.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide; any instructions provided here are in addition to the SF424 (R&R) Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form (Overall)

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

Administrative Core

When preparing your application, use Component Type Administrative Core

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package. Funds should be requested in the Consultant Costs category of the budget for support of EAC member travel expenses for the annual meeting.

The Program Director/Principal Investigator (PD/PI) is required to devote at least 3 person-months to the entire TRDC, within which 1.2 months must be devoted to the Administrative Core . For Multiple PD/PI applications, all PD/PIs must devote a minimum of 3.0 person months each to the entire TRDC. From within this time commitment, all PD/PIs in a multiple PD/PI application must devote a combined 1.2 months to the Administrative Core.

In addition to the EAC travel, funds should be requested in the budget for the PD/PI (and other key staff, as appropriate) to attend a yearly one or two day in-person meeting of the Network Steering Committee. The Network Steering Committee meeting will be rotated annually among the participating TRDCs.

The budget and percent effort for each member of the TRDC staff should be broken down by component.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Describe the specific aims to address organization, governance, collaboration, communication, as well as evaluation and continuous improvement and quality and efficiency.

Research Strategy: Applicants are expected to:

• Provide an administrative plan appropriate for effective management of a complex TRDC structure.
• Describe the governance and organizational structure of the leadership team and the research project, and include communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts. Multiple PD/PI applications will use the Multiple PD/PI Leadership Plan to describe the governance and organizational structure of the leadership team and the research project, and include communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts.
• Delineate the roles and administrative, technical, and scientific responsibilities for the project staff as they relate to the various functions of the TRDC.
• Include a plan for the integration of TRDC activities to accomplish overall goals.
• Describe operating procedures for ensuring responsiveness to members of the research community who wish to access the TRDC and utilize TRDC resources.
• Each TRDC will be required to form an External Advisory Committee (EAC) that will consist of external scientific experts and the NIH Program Officer. For new applications, potential EAC members should not be named, contacted or appointed prior to submission of the application; however, the scientific disciplines of anticipated committee members should be described. Renewal applications must provide the names of current EAC members and a brief description of their qualifications.

A critical aspect of the TRDC’s administrative function is establishing and effectively managing a range of collaborations and partnerships. In the Administrative Plan:

• Provide one or more examples of effective collaborations the PD/PI has established, including descriptions of the motivation for initiating the collaboration, the goals defined for the collaboration, and the outcomes achieved.
• Briefly describe processes for problem-solving, communication, and prioritization of work.
• Describe the most critical aspect of the interaction(s) that made the collaboration successful.
• Describe any challenges encountered and how these were overcome.
• Provide examples of partnerships with industry (or other potential commercialization partners) that will enable the TRDC to effectively transition functional prototypes to later stages of (externally funded) development and commercialization.
• For Renewal applications, describe how the TRDC successfully developed an expanding partnership and collaborator base to achieve TRDC goals, including the leveraging of the TRDC structure to establish externally funded collaborations.

Letters of Support: Only letters of support specific to Administrative Core should be attached to this section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

Appendix:

Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

Renewal application must attach the most recent EAC report, include copies of the TRDC’s most recent EAC report and include the TRDC’s response in the Appendix.

Technology Core

When preparing your application in ASSIST, use Component Type Technology Core .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted

SF424 (R&R) Cover (Technology Core )

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project- Title this component Technology Core
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Technology Core )

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Technology Core )

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals:Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Technology Core )

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Technology Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Technology Core )

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allow for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

The budget and percent effort for each member of the Center staff should be broken down by component.

PHS 398 Research Plan (Technology Core )

Specific Aims: Describe the specific aims to address selection, development/ refinement and management of TRDC projects.

Research Strategy:

TRDCs are expected to evaluate and select promising point-of-care and home-based prototype devices from the perspective of device performance and potential for clinical impact. TRDCs will facilitate the development or refinement of technologies (depending on NIH Institute or Center requirements) that have significant potential to address clinical needs in point-of-care or home-based testing and for ultimate commercialization. A detailed plan for the process by which new projects will be solicited, reviewed, funded and managed must be provided.

The Technology Core Research Plan should provide the following information:

1. Description of technology development/refinement and testing projects to be initiated at the onset of the grant award.

• Describe individual technology development and/or optimization testing projects.
• Provide information regarding the potential clinical impact of the proposed technology development or evaluation projects.
• Describe the appropriateness of the technologies for the proposed health care applications.
• Provide measurable milestones (both quantitative and qualitative) for each project along with a clearly defined and justified timeframe and process for evaluation of progress toward the milestones (go/no-go decisions).
• Provide options for appropriate transitions of the project (such as, but not limited to, moving into the Clinical Core, continued refinement or discontinuation.)

2. Plan for identifying and selecting new meritorious prototype development/refinement and testing projects.

• TRDCs are expected to collaborate with the CTSC on the process for soliciting and reviewing applications from external organizations. TRDCs will assign a program manager to oversee engagement with CTSC and to lead TRDC and Network efforts.
• Describe the strategy for identifying and selecting POC or home-based technologies to be tested/refined in the TRDC, such as plans to solicit and review applications, evaluate project progression and outcome, process to prioritize projects based on the center’s resources and expertise. TRDC leadership will establish review criterion and send the projects to reviewers with the expertise to review project applications.
• The selection of future sub-project awards for funding beyond those presented in the initial grant application will be made in consultation with the TRDC’s Scientific Subcommittee of the Network Steering Committee, which will be formed from NIH programmatic and scientific staff, the TRDC Program Director (PD) / Principal Investigator (PD/PI) and external scientific experts. It is expected that the majority of technologies selected for development and testing will come from outside the U54 awardee institution.

3. Develop a strategy for managing technology development/refinement and testing projects.

It is critical that each TRDC maintains an appropriate balance of prototype development/refinement and testing projects across the development pipeline. In addition to providing individual project descriptions.

• Briefly describe the TRDC’s strategy in choosing the combination of projects as it relates to the focus of each project and the stage of development. Renewal applicants should describe progress in the first grant period, emphasizing the TRDC’s process of selecting promising emerging technologies and prototypes in the context of Center-identified clinical and user needs.
• Provide examples of the successful transition of technologies along the development pipeline . As appropriate, describe evaluation processes that facilitate the TRDC’s appropriate investment in new projects and the timely transition of existing projects.

Letters of Support: Only letters of support specific to Technology Core ' should be attached to this section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

PHS Inclusion Enrollment Report (Technology Core )

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Clinical Core

When preparing your application in ASSIST, use Component Type Clinical Core

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Clinical Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project: Title this component Clinical Core .
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Clinical Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Core)

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Clinical Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Clinical Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Clinical Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

The budget and percent effort for each member of the Center staff should be broken down by component.

PHS 398 Research Plan (Clinical Core)

Specific Aims: Describe the specific aims to facilitate clinical validation of POC technology projects.

Research Strategy:

The Clinical Core will primarily serve as a clinical laboratory for innovators to facilitate clinical validation of POC and home-based technologies. New projects to the TRDC can be identified and selected to participate Clinical Core or Technology Core projects can transition into the Clinical Core.

The Clinical Core plan must include the following:

• Description of clinical capacities within the center to validate POC and home-based technologies, such as the ability to test integration of POC technologies into clinical workflow and biospecimen banks available for validating POC or home-based technologies.
• Description of the strategy for identifying and selecting POC and home-based technologies to be clinically validated in the TRDC, such as plans to solicit and review applications, evaluate project progression and outcome, process to prioritize projects based on the TRDC’s resources and expertise.
• Description of POC and home-based technologies that can be validated in the TRDC at the onset of the award and successful examples if there are any.
• Description of existing connection and collaboration with the clinical research community with supporting letters or other evidence demonstrating successful collaboration.
• Description of the strategy for matching promising POC and home-based technologies with ongoing or future clinical studies.
• Description of the strategy outlining how the POC or home-based technology will be used in the specific setting and how feasibility testing will occur to support and facilitate the implementation of the POC or home-based technology in the identified setting.

Letters of Support: Only letters of support specific to Clinical Core should be attached to this section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

PHS Inclusion Enrollment Report (Clinical Core)

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Dissemination Core

When preparing your application in ASSIST, use Component Type Dissemination Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

SF424 (R&R) Cover (Dissemination Core )

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project: Title this component Dissemination Core .
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Dissemination Core )

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Dissemination Core )

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Dissemination Core )

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Dissemination Core )

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Dissemination Core )

Budget forms appropriate for the specific component will be included in the application package.

The budget and percent effort for each member of the Center staff should be broken down by component.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Dissemination Core )

Specific Aims: Describe the specific aims to address user training and clinical needs and user assessments.

Research Strategy:

User and Developer Training

The training of physical scientists, computational scientists, and engineers (as well as researchers from other relevant disciplines, and other stakeholders as appropriate) on clinical and process issues related to the development of point-of-care devices is critical to accelerating the translation of enabling technologies into clinical use.

Applicants are expected to:

• Propose specific and detailed plans to provide training opportunities to user and technology developers across various career levels, either through individual training opportunities such as fellowships or sabbatical opportunities, or through workshops or other activities that target broader audiences.
• Describe plans to educate relevant stakeholders (e.g. clinicians and other medical professionals, patients, policy makers, investors) on the development and potential impact of POC and home-based technologies.

Clinical Needs and User Assessments

Important aspects of training activities include guidance on the integration of clinical/user needs information into the device design process and the practical challenges associated with developing POC and home-based technologies for use in low-resource and decentralized settings, including lessons learned from go/no-go decisions made in the prototype development and testing efforts.

Applicants are expected to:

• Demonstrate the ability to plan and execute assessments of clinical and user needs to inform device design and further define and disseminate publicly available clinical needs information.
• Provide a summary of clinical and user needs from recent assessments as well as a detailed plan for future assessments that extend beyond widely available information to capture specific details that can inform device design.
• Provide a plan that demonstrates an understanding of rigorous methodologies for needs assessment as well as knowledge of and access to appropriate users and other stakeholders. Issues that should be evaluated in the needs assessment in the context of the intended diagnostic application, setting and user include (but are not limited to) requirements for device performance (such as sensitivity and specificity), device robustness, and device usability.
• Discuss the integration of clinical needs information into all aspects of TRDC function. The TRDC is expected to have the appropriate staff with demonstrated expertise in performing needs assessments. For Renewal applicants, include in this discussion examples of how the TRDC successfully collected and analyzed user needs information and utilized this information to drive device design and testing.
• Suggest studies to evaluate issues of significance in the development, commercialization, and/or adoption of POC and home-based technologies. These studies should contribute to increased understanding of the value and potential impact of POC and home-based technologies with respect to changing health care delivery and improving patient outcomes. Issues related to the creation of "commercial ready" prototypes, such as cost and manufacturing considerations, can be addressed in the context of this component of TRDC activities, from a perspective appropriate to the stage of development and role of the TRDC in the development process. Impact considerations can extend beyond market potential and include topics such as addressing minority health and NIH-designated populations that experience health disparities and rare diseases.

Dissemination

POCTRN TRDCs will broadly and effectively disseminate the results of clinical needs and user assessment and impact analysis activities in a way that will inform device design and accelerate development toward commercialization.

Applicants are expected to:

• Develop an outreach plan to educate and train POC and home-based technology end users about when and how to use POC and home-based technologies, quality control procedures, trouble shooting, and how to integrate the POC or home-based technology into existing technologies to maximize the benefit of the technology for the end users, etc.
• Describe a plan to identify user training short term needs upon the deployment of a POC or home-based technology and the needs in the long term related to sustained use of such technologies.
• Disseminate findings on user needs and lessons learned from their outreach to the entire POC and home-based technology research community through conference presentation, webinar, publication, or other means.

Letters of Support: Only letters of support specific to Dissemination Core ' should be attached to this section.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide

Appendix: Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

PHS Inclusion Enrollment Report (Dissemination Core )

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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

See more tips for avoiding common errors.

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

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

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

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

Section V. Application Review Information

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

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

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

Does the TRDC’s strategy for selecting prototype development or refinement and testing projects suggest potential for meaningful outcome in the chosen healthcare setting or clinical application area?

Do the proposed projects in TRDC show promise for commercialization in the future?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

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

Does the investigator team of Administrative Core have expertise and past clinical research experience in the scientific areas corresponding for the proposed projects? Do they also possess knowledge of and experience with relationships with appropriate internal and external stakeholders and user groups?

Does the investigative team of Clinical Core have demonstrated expertise in Clinical Needs and User Assessments

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

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

For TRDC,

• Does the TRDC provide an adequate plan to solicit technologies selected for development and testing outside the U54 awardee institution that will lead to selection of promising technologies for further development and testing?
• Are clear milestones and timelines defined for each prototype development or refinement and testing project?
• Does the TRDC’s strategy demonstrate the ability to effectively partner and manage multidisciplinary projects and deal with sensitive but critical go/no-go decisions in a team-based environment?
• Does the organizational structure of the TRDC indicate an ability to integrate the full range of TRDC functions to achieve the specified goals and work effectively at the clinical/technology interface?
• Does the application propose a strong plan to function on a national (or international) level with access to its resources?

For Clinical Core,

• Does the Clinical Core demonstrate the ability to evaluate patient-centered needs and outcomes, such as patient and caregiver perceptions of device usefulness, acceptability within the local sociocultural context, user friendliness, and comfort?
• Does the Clinical Needs and User Assessment plan clearly demonstrate an understanding of current clinical needs and rigorous methodologies and data analysis approaches for future assessments?

For Dissemination Core

• Is the training program structured in a way that facilitates the transfer of knowledge about clinical needs in point-of-care and distributed settings and the practical challenges associated with developing point-of-care and home-based technologies?

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

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

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

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

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

Study Timeline

Specific to applications involving clinical trials

Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

Not Applicable.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

Not Applicable.

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

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

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

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

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

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.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in theNIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website. This includes any recent legislation and policy applicable to awards that is highlighted on this website.

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

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: Grantee 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).

Prior Approval of Pilot Projects

Recipient-selected projects that involve {clinical trials or studies involving greater than minimal risk to human subjects} require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: Generaland Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

• Federalwide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, in accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identity, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution's specific legal obligations for serving qualified individuals with disabilities, including reasonable accommodations and making services accessible to them, see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

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

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees 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 award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.

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

The Program Director/Principal Investigator (PD/PI) will have the primary responsibility to define objectives and approaches of the TRDC and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the studies. PD/PIs will work closely with the Coordination and Technology Support Center (CTSC), as well as with other Network PD/PIs, to align standard processes for all TRDC activities. PD/PIs may also engage the CTSC for specialized support, as needed.

The primary responsibilities of the awardees are to:

-Develop and execute Clinical Needs and User Assessments

-Draft funding solicitations and participate in planning and executing review meetings.

-Coordinate and manage the issuance of sub-project awards to external organizations. NIBIB GMS approval is needed prior to the issuance of sub-project awards

-Determine experimental approaches, design protocols, conduct experiments, and disseminate results

-Define and monitor project milestones for prototype development and testing projects, with go/no-go decisions made in appropriate timeframes

-Obtain relevant overall TRDC IRB and IACUC approvals, regardless of whether subcontractors have separate approvals

-Ensure utilization of rigorous methodologies for clinical needs and user assessments with appropriate representation of users and/or stakeholders

-Establish an External Advisory Committee and coordinate annual meetings. PD/PI may change the membership of EAC members as needed. EAC members should be from outside the host institution and represent a balance of expertise covering both the technology and clinical aspects of the TRDC. The EAC must meet at least once annually and prepare a written report of its recommendations, addressed to the PD/PI. This report, along with the PD/PI's response to EAC recommendations, must be supplied as part of the annual TRDC Research Performance Progress Report (RPPR) .

-Participate in collaborative activities with other TRDCs as part of the Network

-Develop and/or maintain external partnerships to support TRDC goals

-Ensure diverse representation in technology evaluation efforts and subproject selection

-Provide information to the NIH Science Officer, the NIH Program Director, and/or the NIH Grants Management Specialist concerning progress, go/no-go decisions, technology evaluation processes, and the initiation of new sub-project awards

-Seek formal approval from NIH staff, with final decision from the Grants Management Specialist, prior to initiation of new prototype development and sub-project awards

-Prepare and submit an annual Research Performance Progress Report (RPPR) to the NIH in the format requested

-Prepare for annual administrative site visits by NIH staff if requested

-PD/PIs and TRDC staff (as appropriate) are expected to participate in an annual grantees meeting.

Awardees will retain custody of and have primary rights to the technologies, 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 Scientist will:

-Review and comment on critical stages in the research program before subsequent stages are implemented

-Participate in TRDC go/no-go decision-making on prototype development and testing projects

-Interact with the PD/PI(s) on a regular basis to monitor progress

-Serve as a resource for the TRDC in identifying opportunities and partnerships that benefit TRDC activities

-Advise the NIH Program Official on the overall direction and progress of the TRDC

-May consult with other NIH staff, as well as non-NIH experts in the field, in order to carry out these responsibilities.

The NIH Program Official will:

-Be responsible for the normal scientific and programmatic stewardship of the award and be named in the award notice.

--Review and approve new prototype development and testing project plans prior to initiation

- Oversee the Coordination and Technology Support Center (CTSC) to ensure adequate operational guidance is provided to the Network

-Carry out continuous review of all activities to ensure objectives are being met

-Have the option to recommend, with the advice of the NIH Science Officer, the withholding of support to a participating organization if technical performance requirements are not met

-Help coordinate collaborative efforts that involve multiple awardees

-Appoint members of the Independent Experts Committee (IEC), which provides an annual review of POCTRN progress and reports to the Program Official. The IEC is composed of senior scientists, engineers, clinicians, industry, and federal agency representatives with relevant expertise and serves a consulting role to the NIH

-May consult with other NIH staff, as well as non-NIH experts in the field, in order to carry out these responsibilities

Areas of Joint Responsibility include:

The PD/PIs of each TRDC funded under this FOA, and leadership of the Coordination and Technology Support Center (CTSC) will form the Network Steering Committee. The NIH Project Scientists will participate on the Network Steering Committee as non-voting members. The Network Steering Committee will act as the main governing body to coordinate Network efforts. The committee will be organized and led by the CTSC and will review the progress of Network activities, develop collaborative protocols, identify impediments to progress and select strategies to surmount them, and create opportunities for sharing techniques and tools developed within each TRDC.

The Network Steering Committee will:

-Advise NIH Project Scientists of scientific developments and opportunities that may enhance the goals of the network.

-Help to develop uniform procedures and policies for the governance of the awards under this FOA

-Serve as a venue for coordination across TRDCs as it relates to advancing the field, for example by reporting progress, disseminating best practices and collectively evaluating new procedures, resources, and technologies.

-Each Network Steering Committee member will have one vote and will be required to accept and implement policies approved by the Committee. The Network Steering Committee may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed.

-The Network Steering Committee will meet once a year at a minimum, with additional meetings scheduled as necessary to accomplish the goals of POCTRN

The NIH Program Official will be responsible for programmatic oversight of the CTSC. The TRDC PD/PIs and NIH Project Scientists will routinely engage with the CTSC in various capacities to support the objectives of the TRDCs and the Network. Dissemination of standard processes and best practices will be a primary goal of the CTSC, jointly responsible with the TRDC’s for clinical needs assessments, proposal solicitations, proposal reviews, project milestone development and evaluations, data coordination, and project and portfolio management. The TRDCs will use a web-based platform, developed and maintained by the CTSC, for proposal management and project tracking. The CTSC will provide training and support for these systems and will collaborate jointly with each TRDC to customize components. The CTSC will be able to provide additional operational support and expertise to TRDC PD/PIs, as needed. It will be the responsibility of the NIH Program Official to determine the appropriateness of requests for utilization of CTSC resources.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel composed of three members will be convened including: a designee of the Network Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two. In the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM)about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

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

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

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

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

Tiffani Bailey Lash, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email:[email protected]

Yordan Valtchov Kostov
National Institute on Drug Abuse (NIDA)
Phone: 301-496-4227
E-mail: [email protected]

Laura Povlich
Fogarty International Center (FIC)
Phone: 301-496-1653
E-mail: [email protected]

Miguel R. Ossandon Ph.D (He/Him/His)
National Cancer Institute (NCI)
Phone: 240-276-5714
[email protected]

Jue Chen
National Heart, Lung, and Blood Institute (NHLBI)
Phone: 301-435-0532
E-mail: [email protected]

Erin Iturriaga, DNP
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email: [email protected]

Jonathan A. Glock, MPH
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3258
Email: [email protected]

Emrin Horgusluoglu, Ph.D.
National Center for Complementary & Integrative Health (NCCIH)
Phone: 240-383-5302
Email: [email protected]

Manana Sukhareva, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-3397
Email: [email protected]

Angelos Bacas
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4785
Email: [email protected]

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: [email protected]

Bruce R Butrum
Fogarty International Center (FIC)
Phone: 301-451-6830
E-mail: [email protected]

Shane Woodward, MBA
National Cancer Institute (NCI)
Phone: 301-768-1971
Email: [email protected]

Annmarie Brasilemejac
National Heart, Lung, and Blood Institute (NHLBI)
Phone: (301) 827-8016
E-mail: [email protected]

Dhana Khurana
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-669-2966
Email: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
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 45 CFR Part 75 and 2 CFR Part 200.