NIH’s new Application Submission System & Interface for Submission Tracking (ASSIST) is available for the electronic preparation and submission of multi-project applications through Grants.gov to NIH. Applications to this FOA must be submitted electronically using ASSIST or an institutional system-to-system solution; paper applications will not be accepted. ASSIST replaces the Grants.gov downloadable forms currently used with most NIH opportunities and provides many features to enable electronic multi-project application submission and improve data quality, including: pre-population of organization and PD/PI data, pre-submission validation of many agency business rules and the generation of data summaries in the application image used for review.

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) and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. 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 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

1. Background

The evolving healthcare system within the United States, and globally, includes new delivery models in which more significant roles for physicians, nurses and health care practitioners are envisioned, with substantial involvement of the patient in decision-making and self-care. These expanded scopes of practice require the development of affordable and easy-to-use accurate medical devices, as well as appropriate means for information sharing, to provide timely health status information at the point of care. Examples of point-of-care devices that can provide these needed capabilities 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 at-home 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, other health care practitioners and patients, as well as provide an opportunity to deliver health care in low-resource settings, such as in low- and middle-income countries or disaster environments, where often there is a complete lack of diagnostic and monitoring tools.

In 2007, the NIBIB created the Point-of-Care Technologies Research Network (POCTRN) 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. Additional Centers were added to the POCTRN in 2011. Information about the existing program can be found at www.poctrn.org.

2. Research and Objectives

The network of POCTRN Research Centers 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 (See individual NIH Institute/Center Areas of Interest). The scope of work covered within each Center will include 1) assessment and communication of unmet clinical needs in point-of-care testing; 2) collaborations with physical scientists, computational scientists, and engineers (as well as researchers from other relevant disciplines, as appropriate) on technology development projects; 3) development of external partnerships (e.g., technology, clinical, industry, and regulatory) necessary to move enabling technologies toward clinical applications; 4) clinical testing of prototype point-of-care devices and 5) creation of training opportunities for technology developers and other stakeholders on clinical issues related to the development of point-of-care devices. The POCTRN Research Centers provide support to point-of-care stakeholders through sub-awards and other resources (e.g. consultations, database tools, training modules, connections with clinical collaborators and providing de-identified clinical specimens for testing POC devices).

A key component of the POCTRN Research Centers includes the ability to provide sub-award support for point-of-care projects that have significant potential to address clinical needs in point-of-care testing and for ultimate commercialization. It is expected that the POCTRN Research Center leadership will establish a review process, manage a solicitation and selection process for projects and the distribution of sub-award funds for point-of-care projects according to Center focus and milestones, budget period, availability of meritorious projects and the overall goal of transitioning functional prototypes out of the Center toward later- stage clinical testing and commercialization. Proposed technology development projects submitted in this application will be initiated at the onset of the grant award. The selection of future sub-award projects for funding beyond those presented in the initial grant application, will be made in consultation with the Scientific Officers and approved by the NIH Program Officer. The details of the full governance structure are provided in Section VI.2, Cooperative Agreement Terms and Conditions of Award . Although Center institutions may receive funding for collaborative sub-award projects, it is expected that the majority of funds will be used to fund sub-award projects outside of the U54 awardee institution.

3. Organizational Structure

The structure of a POCTRN Research Center 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 Research Center will be comprised of four Core Components: (1) Administrative (Admin Core); (2) Technology Development/Refinement (Technology Dev Core); (3) Clinical Translation and Validation (Clinical Trans Valid) and (4) Technology Training and Dissemination (Technology Train Dis).

1) Admin Core

The appropriate leadership and structure to manage the many facets of these large and complex Centers will be a key component in establishing a successful Center. The Admin Core serves as the managing component of the Center that is charged with effectively leading the organization, governance, collaboration within the Network, communication with stakeholders, as well as evaluation and continuous improvement in quality and efficiency of the Research Center by establishing an External Advisory Board (EAB). The EAB is appointed by the Center Program Director/Principal Investigator (PD/PI) and advises the PD/PI on future directions of the Center. The Center's Scientific Subcommittee of the Network Steering Committee will also provide scientific and administrative oversight of Center functions, including the review and selection of projects to receive sub-award funding.

2) Technology Dev Core

The Technology Dev Core identifies, evaluates and supports point-of-care technology development/refinement in-house and external to the Center. Support can be in the form of sub-awards, tools and/or other resources. It is expected that the project period for sub-awarded projects will be 6 months up to two years to allow for several technologies to be tested and moved into the next stage of clinical testing during the five-year grant period. Exceptions to this are possible if justification is provided for an extended project period. Therefore, adequate funds should be budgeted in later years of the grant period to allow for transitioning or retiring current projects and recruiting and selecting new technology development/refinement projects. The first round of sub-awards are to be made in Year one of the grant period. Although there is flexibility in the support amount and time periods of the sub-awards, 6 month awards at $50,000 or 1 year at $100,000 is suggested. The number of awards would depend on meritorious applications and the Center's goals and budget.

3) Clinical Trans Valid Core

Clinical validation, adoption, and feasibility testing are necessary to ensure that the prototypes supported under this program will have a reasonable rate of success for public uptake.

POCTRN Research Centers are expected to validate the prototypes, and undertake rigorous feasibility and adoption testing for the point-of-care 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), within low-resource settings and among the intended users and/or caregivers. An important characteristic of funded Research Centers is therefore the ability to collaborate effectively with entities that possess the resources and expertise to commercialize the prototype devices developed through Research Center activities. Support for clinical translation can also be in the form of sub-awards, tools and/or other resources.

4) Technology Train Dis Core

The Technology Train Dis Core provides training activities for point-of-care technology stakeholders such as scientists, engineers, clinicians and other medical professionals, patients, policy makers and investors. Within the Technology Train Dis Core, the Research Centers will also conduct assessments of clinical and user needs to inform device design and further define and disseminate publicly available clinical needs information.

Additional details regarding each structural component and the information required for submission can be found in Section, Research Plan .

National Institute of Biomedical Imaging and Bioengineering Statement of Interest

The mission of the NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies. The NIBIB is committed to integrating engineering with the life and physical science to advance basic research and medical care. 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 personal health informatics technologies. The NIBIB will support point-of-care technologies to detect, measure, and, where appropriate analyze biological information including molecular, genomic, cellular, clinical, behavioral, physiological, and environmental parameters at the site of patient care to assist prevention, diagnosis, treatment, and management of diseases. NIBIB is interested in supporting Research Center(s) that could be structured around one or more themes addressing emerging technologies, clinical needs, and/or opportunities in specific health settings, such as, but not limited to:

Promising Technologies (examples)

• Cell phone-based imaging, sensing, and diagnostics
• Wearable devices for the diagnosis, management and treatment of diseases
• Tattoo-based sensors

Clinical Needs for a Major Disease or National Public Health Problem (examples)

• Influenza Testing
• Sexually Transmitted Infections Testing
• Maternal, Newborn and Child Health Development Disorders

Healthcare Settings (examples)

• Primary Care
• Low Resource Settings
• Ambulatory Care

The above suggestions are intended to be exemplary rather than exhaustive or prescriptive. Previously funded POCTRN Research Centers 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 Statement of Interest

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 in clinical and other settings where the point-of-care testing will be deployed. 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. Functional prototypes that have been validated in animal models, when applicable, will be candidates for clinical validation studies within the Center. Technologies that have preliminary safety data in humans and appropriate FDA clearance for human testing (such as Investigational Device Exemption), when applicable, will be matched to ongoing or future clinical studies to test clinical utility and impact, which could include, but are not limited to, the following examples:

• ECG, cholesterol, Hemostasis, and HbA1C monitoring at home or primary care facility to supplement standard monitoring in central laboratory
• Detection of arrhythmia risk and monitoring of heart failure progression at home or primary care facility
• Sensors to continuously monitor drug levels such as antibiotics, TB drugs, anti-retroviral drugs, coumadin, corticosteroids, and chemotherapeutics
• Integrated sensor that can monitor multiple parameters, such as heart rate, respiratory rate, temperature and blood pressure
• Mobile applications in conjunction with POC monitoring devices to alert and monitor asthma condition or sleep quality
• Mobile applications in conjunction with POC monitoring devices to improve patient enrollment, drug adherence and patient follow-up in clinical trials
• Diagnosis of sickle cell disease in low-resource settings
• Diagnostic tools for use in an Emergency Department, such as to rule-out myocardial infarction

The NHLBI encourages the rapid clinical validation of POC technologies for diagnosis, monitoring and intervention delivery. While additional work to customize or integrate the technology into the existing or planned clinical studies can be supported by the Center, the NHLBI Center is not expected to support new technology development, but instead to clinically validate recently developed but not yet validated POC technologies.

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. Technologies eligible for in-house validation in the NHLBI Center should have functional prototypes ready to be tested in clinical settings, and technologies to be matched with ongoing or future clinical studies should have preliminary safety data in humans and appropriate FDA clearance for human testing (such as Investigational Device Exemption) when applicable. Applicants are required to include metrics for evaluating technology matureness and readiness for clinical validation studies to be conducted within POCTRN Centers or be matched with ongoing/planned clinical studies.

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 for symptom 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 as a project or specific aims within a to test efficacy or effectiveness of a given intervention. 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.

National Institute on Aging Statement of Interest

Alzheimer’s disease (AD) is the leading cause of dementia in those over the age of 65 and as many as 5 million Americans age 65 and older have AD. As the population ages, the number of people age 65 and older with AD is projected to increase between two and three-fold by 2050 without a cure or prevention of the disease. AD is one of the most persistent and devastating dementing disorders of old age, because it eventually leads to a complete loss of memory and of the ability to function independently. The NIA is interested in research Centers which will facilitate the development of a pipeline of point-of-care technologies for patients with Alzheimer’s Disease and Related Dementia (ADRD) 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.

The NIA 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.

The NIA is interested in supporting a Center focused on the development and validation of technologies to diagnose, monitor, treat, and/or manage, persons with AD and dementia and to extend their healthy, active years of life. Area of interest include but are not limited to:

• Development and integration of point-of-care technologies to enable personalized decision-making and coordinated care for older adults with cognitive impairment who have multiple chronic conditions, to reduce length-of-stay and/or readmission.
• Development of innovative monitoring technologies, including applications of machine learning and integration of cognitive instruments into electronic health records for early detection of cognitive decline and monitoring universal outcomes for diverse aging populations at point-of-care.
• Development of socially assistive robots to provide cognitive therapy, provide in place monitoring, assistance and care coordination for individuals with dementia.
• Development and modification of technology platforms to enable delivery of appropriate care for individuals with cognitive impairment and dementia.

Office of Behavioral and Social Sciences Research Statement of Interest

The OBSSR is interested in supporting research in a Center to support the development and validation of technologies to diagnosis, monitor, treat, and/or manage modifiable behavioral risk factors underlying chronic conditions. The OBSSR is particularly interested in the monitoring of clinical outcomes relevant to behavioral medicine and the integration of the data collected by point of care technologies into electronic health records. The OBSSR will also consider devices that could be useful for the management of modifiable behavioral risk factors and outcomes that influence disease occurrence or progression.

Examples include but are not limited to:

• Sleep
• Physical Activity
• Sedentary Behavior
• Diet
• Treatment Adherence
• Stress Response
• Depressive Symptoms

Where applicable, emphasis is encouraged on devices that are sensitive to co-morbid conditions and multiple associated behavioral risk factors.

Fogarty International Center Statement of Interest

The FIC is interested in facilitating research in a Center on the development, validation, and adoption of technologies related to HIV/AIDS infection. 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. 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). Additionally, the FIC is dedicated to building partnerships between U.S. and LMIC investigators and prioritizes collaborations with and training of LMIC researchers.

Note* Applicants are strongly encouraged to contact POCTRN Scientific/Research Contacts to discuss whether their applications are relevant to the respective Institute(s)'s mission and appropriate for this Funding Opportunity Announcement.

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

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

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:

o Hispanic-serving Institutions

o Historically Black Colleges and Universities (HBCUs)

o Tribally Controlled Colleges and Universities (TCCUs)

o Alaska Native and Native Hawaiian Serving Institutions

o 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)

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

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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 DUNS number and 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 underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

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

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. 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 NOT-OD-11-101).

A button to access the online ASSIST system 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.

Most applicants will use NIH’s ASSIST system to prepare and submit applications through Grants.gov to NIH. Applications prepared and submitted using applicant systems capable of submitting electronic multi-project applications to Grants.gov will also be accepted.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, including Supplemental Grant Application Instructions 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

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.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Fax: 301-480-1614
Email: [email protected]

Component Types Available in ASSIST	Research Strategy/Program Plan Page Limits
Overall	6
Admin Core	6
Technology Dev Core	12
Clinical Trans Valid	12
Technology Train Dis	6

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

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

The application should consist of, one of each, of the following components:

Overall: required

Admin Core: required

Technology Dev Core: required

Clinical Trans Valid: required

Technology Train Dis: required

When preparing your application in ASSIST, use Component Type Overall .

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

Complete entire form.

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

Follow standard instructions.

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.

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.

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.

Specific Aims: Describe the specific aims for the proposed POCTRN Research Center. Each POCTRN Research Center 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:

Applicants are expected to:

• Address overall objectives, long-term goals, and milestones of the Research Center.
• Address their track record for the respective field of expertise of the Research Center and provide examples of successfully integrating and translating healthcare and technology developments.
• Describe the clinical drivers for introducing (or expanding the use of) point-of-care technologies in the chosen setting or clinical application.
• Describe how the Center'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 Centers will include Center sustainability plans addressing post award efforts. Sustainability may include support from partnering institutions or other financial arrangements.

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

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.

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

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

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

Complete only the following fields:

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

Enter Human Embryonic Stem Cells in each relevant component.

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.

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.

• 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 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 EAB 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 Center, within which 1.2 months must be devoted to the Admin Core". For Multiple PD/PI applications, all PD/PIs must devote a minimum of 3.0 person months each to the entire Center. From within this time commitment, all PD/PIs in a multiple PD/PI application must devote a combined 1.2 months to the Admin Core.

In addition to the EAB 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 Centers.

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 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.

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 Center structure. Multiple PD/PI applications will use the Multiple PD/PI Leadership Plan to address effective management of a complex Center 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 Center.
• Include a plan for the integration of Center activities to accomplish overall goals.
• Describe operating procedures for ensuring responsiveness to members of the research community who wish to access the Center and utilize Center resources.
• Each Center will be required to form an External Advisory Board (EAB) that will consist of external scientific experts and the NIH Program Officer. For new applications, potential EAB members should not be contacted or appointed prior to submission of the application; however, the scientific disciplines of anticipated committee members should be described. The application should not list the names of potential members of the EAB. Renewal applications must provide the names of current EAB members and a brief description of their qualifications.

A critical aspect of the Center'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 Center to effectively transition functional prototypes to later stages of (externally funded) development and commercialization.
• For Renewal applications, describe how the Center successfully developed an expanding partnership and collaborator base to achieve Center goals, including the leveraging of the Center structure to establish externally funded collaborations.
• Letters of Support: Only letters of support specific to Admin 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 EAB report, include copies of the Center's most recent EAB report and include the Center's response in the Appendix.

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

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Technology Dev Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Technology Dev 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 Dev 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 Dev 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 Dev 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 Dev Core)

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

Research Strategy:

Centers are expected to select and evaluate promising point-of-care prototype devices from the perspective of device performance and potential for clinical impact. Centers will facilitate the development or refinement of technologies (depending on Institute or Center requirements) that have significant potential to address clinical needs in point-of-care 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 Dev 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 Validation Core or continued refinement.)

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

• Centers are expected to develop a process for soliciting and reviewing applications from outside of the center to be funded by the center.
• Describe the strategy for identifying and selecting POC technologies to be tested/refined in the Center, 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. Center leadership will establish review criterion and send the projects to reviewers with the expertise to review project applications.
• The selection of future sub-award projects for funding beyond those presented in the initial grant application, will be made in consultation with the Center’s Scientific Subcommittee of the Network Steering Committee, which will be formed from NIH programmatic and scientific staff, the Center 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 Center maintain an appropriate balance of prototype development/refinement and testing projects across the development pipeline. In addition to providing individual project descriptions.

• Briefly describe the Center'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 Center'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 facilitated the Center's appropriate investment in new projects and the timely transition of existing projects.

Letters of Support: Only letters of support specific to Technology Dev 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 Dev Core)

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

When preparing your application in ASSIST, use Component Type Clinical Trans Valid

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

SF424 (R&R) Cover (Clinical Trans Valid)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Clinical Trans Valid)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Clinical Trans Valid)

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 Trans Valid)

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 Trans Valid)

• 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 Trans Valid)

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 Trans Valid)

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

Research Strategy:

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

The Clinical Trans Valid plan must include the following:

• Description of clinical capacities within the center to validate POC technologies, such as the ability to test integration of POC technologies into clinical workflow, bio specimen banks available for validating POC technologies.
• Description of the strategy for identifying and selecting POC technologies to be clinically validated in the center, 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.
• Description of POC technologies that can be validated in the center 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 technologies with ongoing or future clinical studies.
• Description of the plan to establish a searchable database with emerging POC technologies to be validated in clinic as well as clinical researchers (and their clinical studies) and other stakeholders (such as health department) interested in validating POC technologies in clinic or other real-world settings.
• Description of the strategy outlining how the POC technology will be used in the specific setting and how feasibility testing will occur to support and facilitate the implementation of the POC technology in the identified setting.

Letters of Support: Only letters of support specific to Clinical Trans Valid 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 Trans Valid)

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

When preparing your application in ASSIST, use Component Type Technology Train Dis' Dissemination.

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

SF424 (R&R) Cover (Technology Train Dis)

Complete only the following fields:

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

PHS 398 Cover Page Supplement (Technology Train Dis)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Technology Train Dis)

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 Train Dis)

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 Train Dis)

• 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 Train Dis)

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 (Technology Train Dis)

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, 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 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 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 Center function. The Center 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 Center 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 technologies. These studies should contribute to increased understanding of the value and potential impact of POC 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 Center activities, from a perspective appropriate to the stage of development and role of the Center in the development process. Impact considerations can extend beyond market potential and include topics such as addressing health disparities and rare diseases.

Dissemination

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

Letters of Support: Only letters of support specific to Technology Train Dis' 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 Train Dis)

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

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

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) 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.

This initiative is not subject to intergovernmental review.

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

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

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

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

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

See more tips for avoiding common errors.

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.

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

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the Center 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 Center 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 Center that by its nature is not innovative may be essential to advance a field.

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

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? 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 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?

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

If the Center 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 children, justified in terms of the scientific goals and research strategy proposed?

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?

As applicable for the Center 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.

Review for the Overall Center

-Does the Center provide adequate long-term goals, milestones and overall research objectives?

- Is there an appropriate sustainability plan?

-Does the Center'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 Center indicate an ability to integrate the full range of Center 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?

Review Criteria for the Admin Core

Does the investigator team have expertise and past clinical research experience in the scientific areas corresponding for the proposed projects?

-Does the investigator team possess knowledge of and relationships with appropriate stakeholders and user groups?

Review Criteria for the Technology Dev Core

-Does the Center provide an adequate plan to solicit technologies selected for development and testing outside the U54 awardee institution?

-Does the Center's strategy for selecting prototype development or refinement and testing projects suggest potential for meaningful outcome in the chosen health-care setting or clinical application area?

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

-Will the Center's technology evaluation processes enable selection of promising technologies for further development and testing?

-Are clear milestones and timelines defined for each prototype development or refinement and testing project?

Review Criteria for the Clinical Trans Valid

- Does the Center 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?

Review Criteria for the Technology Train Dis Core

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

-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?

-Is the Center structured in a way that facilitates the transfer of knowledge about clinical needs in point-of-care and the practical challenges associated with developing point-of-care technologies?

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

For research that involves human subjects but does not involve one of the six 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 six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed Center 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 children to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

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

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

Not Applicable.

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

Not Applicable.

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

Not Applicable.

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

Reviewers will comment on whether the 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 .

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

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

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:

• 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 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.
• Relevance of the proposed project to participating Institute or Center priorities?

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.

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

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

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and http://www.hhs.gov/ocr/civilrights/understanding/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

Cooperative Agreement Terms and Conditions of Award

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 Center and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the studies.

The primary responsibilities of the awardees are to:

-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 Center IRB and IACUC approvals, regardless of whether subcontractors have separate approvals

-Develop and execute Clinical Needs and User Assessments

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

-Serve as a voting member on the Network Steering Committee

-Establish an External Advisory Board and coordinate annual meetings. PD/PI may change the membership of EAB members as needed. EAB members should be from outside the host institution and represent a balance of expertise covering both the technology and clinical aspects of the Center. The EAB 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 EAB recommendations, must be supplied as part of the annual Center Progress Reports."

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

-Develop and/or maintain external partnerships to assist in meeting goals

-Ensure national 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 projects

-Seek prior approval from NIH staff (NIH Program Director and Grants Management Specialist) prior to initiation of new prototype development and testing projects

-Prepare and submit an annual progress report to the NIH in the format requested

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

-PD/PIs and Center 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 Center 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 voting member on Center subcommittees and the External Advisory Board for the Center

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

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

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

-Additionally, an NIH Program Official will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

The NIH Program Official will:

-Be responsible for the normal scientific and programmatic stewardship of the award

-In consultation with NIH staff and non-NIH experts in the field, review and approve new prototype development and testing project plans prior to initiation

-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

-Be a voting member of the Network Steering Committee

Areas of Joint Responsibility include:

The NIH Project Scientist(s) and the PD/PIs of each Center funded under this FOA will form the Network Steering Committee. The Network Steering Committee will act as the main governing board that will review the progress of the research activities, develop collaborative protocols, identify technological impediments to the progress, select strategies to surmount them, and identify opportunities for sharing techniques and tools developed within each individual project.

The Network Steering Committee will:

-Advise NIH Project Scientist of scientific developments and opportunities that may enhance the goals of the program.

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

-Serve as a venue for coordination across Centers 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 Independent Experts Committee (IEC):

The IEC will independently monitor the effectiveness of the approach being taken by the Network and evaluate the progress of the POCTRN. The IEC will be composed of senior scientists, engineers, clinicians, industry and/ or federal agency representatives with relevant expertise who are not PI(s)/PD(s) or supported by a POCTRN Research Center. NIH Program Officers will appoint the members of the IEC. This group will participate in the annual grantees meetings, review of progress reports, and other activities as needed to provide an independent review of the Network progress.

The IEC will:

-Be responsible for reviewing and evaluating the progress of the POCTRN.

-Report to the NIH Program Officers.

-Select one IEC member as chair.

-Allow NIH Program Officers to attend IEC meetings as non-voting participants.

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. It will have three members: 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, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

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

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: [email protected]

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: [email protected] (preferred method of contact)

Telephone: 301-945-7573

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

Jue Chen, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0550
Email: [email protected]

Wen G. Chen, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-451-3989
Email: [email protected]

Partha Bhattacharyya, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-3138
Email: [email protected]

Dana Wolff-Hughes, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-0979
Email: [email protected]

Laura Povlich, Ph.D.
Fogarty International Center (FIC)
Telephone: 301-827-2227
Email: [email protected]

David T. George, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8633
Fax: 301-480-0675
Email: [email protected]

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

Ann Marie Brasile Mejac
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-827-8016
Email: [email protected]

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-594-3788
Email: [email protected]

Kasima Garst
Fogarty International Center (FIC)
Telephone: 301-496-5710
Email: [email protected]

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.