Department of Health and Human Services

Part 1. Overview Information
Participating Organization(s)

National Institutes of Health (NIH)
 

Components of Participating Organizations

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Funding Opportunity Title

Point-of-Care Technologies Research Network (U54)

Activity Code

U54 Specialized Center- Cooperative Agreements

Announcement Type

Reissue of RFA-EB-06-002

Related Notices

  • August 16, 2011 - See Notice NOT-EB-11-008. This Notice is to clarify the page limit requirements for describing Prototype Development and Testing Projects.

Funding Opportunity Announcement (FOA) Number

RFA-EB-11-002

Companion FOA

None

Number of Applications

See Section III. 3. Additional Information on Eligibility.

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.286

FOA Purpose

The purpose of this FOA is to solicit applications for Cooperative Agreement (U54) awards for continued support of the NIBIB's Point-of-Care Technologies Research Network (POCTRN), which comprises individual Centers that work to facilitate the collaborative merging of scientific and engineering advances with user-defined health needs in point-of-care testing.  This opportunity is open to existing POCTRN grantees as well as new applicants.

The overall goal of POCTRN is to accelerate the development of clinically relevant point-of-care technologies, through the following Center functions: assessment of clinical and user needs to inform device design and further define publicly available clinical needs information; evaluation of promising point-of-care prototype devices from the perspective of device performance and potential for clinical impact; completion of clinical testing appropriate for the stage of development of the chosen prototype and the target clinical application, to facilitate translation and commercialization; training and education of relevant stakeholders in the development and utilization of POC technologies, which may include technology developers, industry partners, practitioners and the lay community (as potential users); development of partnerships with industry and other stakeholders to facilitate commercialization; and utilization of Network collaboration as needed to achieve goals and increase the visibility of point-of-care testing.

Key Dates
Posted Date

June 22, 2011

Letter of Intent Due Date

August 28, 2011

Application Due Date(s)

September 28, 2011

AIDS Application Due Date(s)

Not Applicable

Scientific Merit Review

Standard dates apply

Advisory Council Review

May, 2012

Earliest Start Date(s)

July, 2012

Expiration Date

September 29, 2011

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, 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.

Table of Contents

Part 1. Overview Information
Part 2. Full Text of 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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

1. Background and Goals

Despite having the highest annual per-capita health expenditures of developed countries, the U.S. suffers from comparably poor health of its population and contestable quality of its health care delivery system.  Many changes to the system are being proposed to address current inadequacies, driven by the challenges of responding to the needs of an increasingly unhealthy population comprised of individuals with multiple chronic conditions.  A goal of these changes is higher quality care at reduced cost, with a shift in focus from utilization of specialized care for the treatment of late-stage disease to an emphasis on patient-centered approaches and coordinated care teams that promote wellness and effective disease management.  The evolving healthcare system includes new delivery models in which more significant roles for primary care physicians and nurses are envisioned, with substantial involvement of the patient in decision-making and self-care. These expanded scopes of practice require the development of inexpensive and easy-to-use 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, and other health care practitioners, as well as provide an opportunity to deliver health care in low-resource settings, such as in developing 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.  The purpose of this initiative is to support the ongoing efforts of this national research network in its efforts to build expertise in the development of integrated systems that address unmet clinical needs in point-of-care testing through the creation of multidisciplinary partnerships.  

Research Scope:

Each POCTRN Center funded under this FOA will perform functions as described below to create a dynamic structure that identifies promising emerging technologies and facilitates their translation into clinical application.  The Centers will work jointly to create a network with broad expertise in the development of point-of-care technologies.

Through a combination of in-house effort and collaboration, the U54 POCTRN Centers will cover facets of the development of point-of-care technologies ranging from exploratory technology development through early stage clinical testing of prototype devices.  Clinical trials will not be covered within the context of this FOA, although it is expected that the Centers will establish collaborations within the clinical research community to facilitate late-stage clinical studies and to assist with overcoming technology commercialization and adoption challenges. 

The scope of work covered within each Center will include clinical testing of prototype point-of-care devices; collaborations with physical scientists, computational scientists, and engineers (as well as researchers from other relevant disciplines, as appropriate) on exploratory technology development projects; assessment and communication of unmet clinical needs in point-of-care testing; creation of training opportunities for technology developers and other stakeholders on clinical issues related to the development of point-of-care devices; and development of external partnerships (e.g., technology, clinical, industry, and regulatory) necessary to move enabling technologies toward clinical applications. 

Potential Centers could be structured around themes that address the coupling of promising technologies with clinical needs and opportunities in specific health care settings such as:

Alternatively, Centers could be focused on disease groupings for which point-of-care technologies have significant potential to address future health care challenges, such as cardiovascular and neurological disease.

The above lists are intended to be exemplary rather than exhaustive or prescriptive. 

Within the selected clinical theme, each Center will perform the following functions:

To accomplish these functions, each POCTRN Center should adopt the following structure: (1) Clinical Needs Assessment and Impact Analysis; (2) Prototype Development and Testing; (3) Training; and (4) Center Administration.   Additional details regarding each structural element and the information required for submission can be found in Section IV.6, "Research Plan".

Centers will have the ability to support projects within this framework that cover all stages of development, from exploratory efforts through clinical testing of prototype devices.  The distribution of these projects should take into consideration Center milestones, availability of promising technologies, and the overall goal of transitioning functional prototypes out of the Center toward later stage clinical testing and commercialization.

While the ultimate desired outcome of the work supported under this initiative is the commercialization and adoption of point-of-care technologies, it is recognized that the expertise and resources of the Centers will best facilitate development of "functional prototypes" as the immediate output of Center activities.  An important characteristic of funded Centers is therefore the ability to collaborate effectively with entities that possess the resources and expertise to commercialize the prototype devices developed through Center activities.  The structure of a POCTRN Center should, in general, take into account the full range of technology and clinical partnerships necessary to facilitate the identification and integration of enabling technologies into devices that address defined clinical needs and health care delivery challenges that are specific to the intended use in a given care setting.

Section II. Award Information
Funding Instrument

Cooperative Agreement.

Application Types Allowed

New
Renewal

The OER Glossary and the PHS398 Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

NIBIB intends to fund up to three (3) awards, with a total budget of up to $5M, for fiscal year 2012, with the number of awards contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Direct costs are limited to $1.2M per year.  Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation.  See NOT-OD-05-004.

Award Project Period

A project period of up to five years may be requested. 

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.

Section III. Eligibility Information

1. Eligible Applicants
 
Eligible Organizations

Higher Education Institutions:

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

Nonprofits Other Than Institutions of Higher Education

For profit Organizations

Governments

Other

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

Required Registrations

Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.

All Program Directors/Principal Investigators (PD/PIs) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least four (4) weeks prior to the application due date.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director/Principal Investigator (PD/PI) 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 PHS398 Application Guide.  Please note that all applications (both single and multiple PD/PI) must include a leadership plan under the "Center Administration" component.   

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application. NIH will not accept any application that is essentially the same as one already reviewed.     

Section IV. Application and Submission Information

1. Address to Request Application Package

Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

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

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

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

The letter of intent should be sent to:

Brenda Korte, Ph.D.
Program Director
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Blvd, Suite 200
Bethesda, MD 20892-5477 (20817 for FedEx, UPS, and other courier services)
Phone: 301-402-1231
FAX: 301-480-4973
Email: kortebr@mail.nih.gov

Application Submission

Applications must be prepared using the PHS 398 research grant application forms and instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)

At the time of submission, two additional paper copies of the application and all copies of the appendix files must be sent to:

David T. George, Ph.D.
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Boulevard, Suite 920, Room 956, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Telephone: 301-496-8633
Email: georged@nih.gov

Page Limitations

All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements:

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 

Information on the process of receipt and determining if your application is considered “on-time” is described in detail in the PHS398 Application Guide.

Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants administration.

4. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

5. Funding Restrictions

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

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

6. Other Submission Requirements and Information

Applications must be received on or before the due dates in Part I. Overview Information. If an application is received after that date, it will not be reviewed.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review and responsiveness by the NIBIB. Applications that are incomplete and/or nonresponsive will not be reviewed.  

Research Plan

All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:

Instead of the Research Plan outlined in Section 5.5 of the PHS 398 form, the U54 Research Plan should take the following structure:

(A) Overview of the Proposed POCTRN Center

(B) Center Administration

(C) Clinical Needs Assessment and Impact Analysis

(D) Prototype Development and Testing

(E) Training

(A) Overview of the Proposed POCTRN Center – limited to 6 pages

Provide the long-term goals and overall objectives of the Center.  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.

(B) Center Administration – limted to 6 pages

Applicants should provide an administrative plan appropriate for effective management of a complex Center structure.  For applications designating multiple PDs/PIs, describe the rationale for choosing a multiple PD/PI approach and provide a leadership plan.  (Note: For multi-PD/PI applications, include the leadership plan under the "Center Administration" section of the application and do NOT use the multi-PD/PI leadership section of the PHS398 form).  For all applications (single and multiple PD/PI), 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 is required to form an External Advisory Board (EAB) that will consist of external scientific experts and the NIBIB Science Officer.  The EAB is appointed by the PD/PI and advises the PD/PI on future directions of the Center.  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.  Membership should be rotated periodically.  The EAB should 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 Center Annual Progress Report.

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.

For Renewal applications, please provide the names of current EAB members and a brief description of their qualifications. 

Funds should be requested in the Consultant Costs category of the budget for support of EAB member travel expenses for the annual meeting. 

For Renewal applications, include copies of the Center's most recent EAB report in the application. Locate the report immediately after the Inclusion Enrollment Report section (Renewal or Revision applications only) and before the Literature Cited.

In addition, a Network Steering Committee will be created from NIBIB staff and Center PD/PIs to provide scientific and administrative oversight. Funds should be requested in the budget for the PD/PI (and other staff, as appropriate) to attend a yearly in-person meeting of the Network Steering Committee.

A critical aspect of the Center's administrative function is establishing and effectively managing a range of collaborations and partnerships.  Provide in the application 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.

Also, 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.

Additional considerations:

The Program Director/Principal Investigator (PD/PI) is required to devote at least 3 person-months (25%) effort to management of the Center. For applicants proposing multiple PD/PIs, the total effort of all PD/PIs should be at least 3 person-months (25% effort), with a distribution that is commensurate with each PD/PI's role, and with an amount of effort that demonstrates significant involvement of each PD/PI.  A management structure that facilitates effective communication across the clinical/technology boundary is strongly encouraged. 

The budget and percent effort for each member of the Center staff should be broken down by component (center administration, clinical needs assessment and impact analysis, prototype development and testing projects, and training). The budget should include a detailed justification for key personnel. 

(C) Clinical Needs Assessment and Impact Analysis – limited to 6 pages

Applicants should 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.  This plan should demonstrate 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.  Applicants should discuss the integration of clinical needs information into all aspects of Center function.  The Center staff should include a researcher 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.

Also, applicants can 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.

Within this section, address plans to broadly and effectively dissemination of the results of clinical needs assessment and impact analysis activities in a way that will inform device design and accelerate development toward commercialization.

(D) Prototype Development and Testing Projects – limited to 6 pages per project

Centers are expected to facilitate the development of technologies that have significant potential to address clinical needs in point-of-care testing with significant potential for ultimate commercialization.  In collaboration with external partners, the Centers will support various projects that cover all stages of technology development, from exploratory research through clinical testing of prototype devices.  It is expected that the Centers will transition projects described in the original application to later stages of development and testing during the five-year grant period, including the transition of functional prototypes outside of the Center for further testing and commercialization, with new projects identified and initiated following NIBIB approval. 

While there is no specified time period for projects, applicants should consider project transitions when defining project periods and transition plans, with adequate funds budgeted in later years of the grant period to allow for transitioning or retiring current projects and recruiting and selecting new projects.

Applicants should provide the following information:

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

Describe individual prototype development and/or testing projects using the Research Plan format outlined in Section 5.5 of the PHS 398 form.

Within this format, 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 applictions.  Provide measureable 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 transition of the project given the possible range of outcomes of milestone evaluation. 

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

Describe the process by which new prototype development and testing projects will be identified and collaborations established.  Include criteria to be used in identifying and prioritizing potential new technologies. 

The selection of projects for funding beyond those presented in the initial grant application will require NIBIB approval prior to initiation.  (Please see Section VI.2, “Cooperative Agreement Terms and Conditions of Award” for the full governance structure.) 

Given the goal of creation of a resource for technology developers, it is expected that the majority of technologies selected for development and testing will come from outside the U54 awardee institution.

3. Strategy for selecting and managing prototype development and testing projects

It is critical that each Center maintain an appropriate balance of prototype development 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.

(E) Training – limted to 6 pages

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 should propose specific and detailed plans to provide training opportunities to 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.   If appropriate, applicants should describe additional plans to educate relevant stakeholders on the development and potential impact of POC technologies.

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.

Resource Sharing Plan

Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS) as provided in the PHS398 Application Guide.

Appendix

Do not use the appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.

Section V. Application Review Information

1. Criteria

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.

Overall Impact

Reviewers will provide an overall impact/priority 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).

Scored Review Criteria  

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.

Significance

Does the Center address an important problem or a critical barrier to progress in the field? 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?

Investigator(s)

Are the PD/PIs, collaborators, and other researchers well suited to the Center? If Early Stage Investigators or New Investigators, or 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?  

Innovation

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

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the Center? 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? 

If the Center involves clinical research, are the plans for 1) protection of human subjects from research risks, and 2) inclusion of minorities and members of both sexes/genders, as well as the inclusion of children, justified in terms of the scientific goals and research strategy proposed?

Environment

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

Additional Review Criteria

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/priority score, but will not give separate scores for these items.

Review Criteria for Center Administration

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 information provided in the application suggest an 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 Center possess knowledge of and relationships with appropriate stakeholders and user groups?

Does the Center demonstrate the desire and ability to function on a national (or international) level with access to its resources?   

Review Criteria for Clinical Needs Assessment and Impact Analysis

Does the Clinical Needs Assessment plan clearly demonstrate an understanding of current clinical needs and rigorous methodologies and data analysis approaches for future assessments?  

Is the expertise necessary to perform rigorous needs assessments represented on the team?

Review Criteria for Prototype Development and Testing

Does the Center's strategy for selecting prototype development 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 and testing project?

Review Criteria for Training

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?   

Protections for Human Subjects

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 Human Subjects Protection and Inclusion Guidelines.

Inclusion of Women, Minorities, and Children 

When the proposed Center involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

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

Resubmissions

Not Applicable

Renewals

For Renewals, did the Center successfully establish and manage collaborations to achieve its goals? Were the Center's resources clearly made available on a national (or international) level?

Has the Center worked with appropriate user and stakeholder groups to identify clinical and users needs, beyond widely available information? Was this clinical and user needs information used to drive device design and integrated into other aspects of Center function?

Has the Center successfully selected promising protototype development and testing projects, and transitioned these technologies along the development pipeline in a timely manner, with appropriate go/no-go decisions and with potential for commercialization?

Revisions

Not Applicable

Additional Review Considerations

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/priority score.

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIBIB , in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

Applications will be assigned to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Council of the NIBIB. The following will be considered in making funding decisions:

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons

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

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in 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 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 the DUNS, CCR Registration, and Transparency Act requirements as noted on the Award Conditions and Information for NIH Grants website.

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: 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.

Cooperative Agreement Terms and Conditions of Award

The following special terms of award are in addition to, and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is applicable when State and local Governments are eligible to apply), and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement (NIH U54), 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 Point-of-Care Technologies Research Network consists of the Center awardees under this FOA.

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:

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 Responsibilities

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

The NIBIB Project Scientist will:

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

The NIBIB Program Official will:

Areas of Joint Responsibility include:

The NIBIB Project Scientist and the PD/PIs of each Center funded under this FOA will be responsible for forming a 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:

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. 

Center Subcommittees may also be created by each Center to perform Center functions, including the review and selection of projects to be presented for funding consideration under "Prototype Development and Testing".  These Center subcommittees will consist of the Center PD/PI, the NIBIB Project Scientist, and other Center staff, as appropriate. 

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.

3. Reporting

When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.

 A final progress report, 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. 

Section VII. Agency Contacts

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

Application Submission Contacts

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Telephone 301-435-0714
TTY 301-451-5936
Email: GrantsInfo@nih.gov

eRA Commons Help Desk(Questions regarding eRA Commons registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: commons@od.nih.gov

Scientific/Research Contact(s)

Brenda Korte, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-401-1231
Email: kortebr@mail.nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

David T. George, Ph.D.
National Institute of Biomedical Imaging and Bioengineering, NIH
6707 Democracy Boulevard, Suite 920, Room 956, MSC 5469
Bethesda, MD 20892-5469 (20817 for FedEx, UPS, and other courier services)
Telephone: 301-496-8633
Email: georged@nih.gov

Financial/Grants Management Contact(s)

Ms. Angela Eldridge
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4793
Email: aeldridg@mail.nih.gov

Section VIII. Other Information

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

Authority and Regulations

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 Parts 74 and 92.


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