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)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Neurological Disorders and Stroke (NINDS)

Funding Opportunity Title

Bioengineering Research Partnerships (BRP) R01

Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-10-234

Related Notices

  • June 4, 2014 - Notice NOT-14-074 supersedes instructions in Section III.3 regarding applications that are essentially the same.
  • March 3, 2014 - See Notice NOT-NS-14-014. Notice of NINDS Participation.

Funding Opportunity Announcement (FOA) Number

PAR-14-092

Companion Funding Opportunity

PA-12-284, R21  Exploratory/Developmental Research Grant
PAR-13-137, R01  Research Project Grant

Number of Applications

See Section III. 3. Additional Information on Eligibility.

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

93.286, 93.172, 93.865, 93.399, 93.396, 93.395, 93.394, 93.393, 93.273, 93.867, 93.279, 93.113, 93.866, 93.853  

Funding Opportunity Purpose

This Funding Opportunity Announcement (FOA) encourages bioengineering applications that will accelerate the development and adoption of promising tools and technologies that can address important biomedical research problems. The objectives are to establish these tools and technologies as robust, well-characterized solutions that fulfill an unmet need and are capable of enhancing our understanding of life science processes or the practice of medicine. Awards will focus on supporting multidisciplinary teams that apply an integrative, quantitative bioengineering approach to developing these technologies and engage biomedical researchers or clinicians throughout the project. The goal of the program is to support projects that can realize meaningful solutions within 5-10 years. 

Key Dates
Posted Date

February 6, 2014

Open Date (Earliest Submission Date)

April 20, 2014

Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

May 20, 2014, September 18, 2014, May 20, 2015, September 18, 2015), by 5:00 PM local time of applicant organization.

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

AIDS Application Due Date(s)

September 7, 2014, January 7, 2015, September 7, 2015, January 7, 2016, by 5:00 PM local time of applicant organization.

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

Scientific Merit Review

October-November 2014, February-March 2015, October-November 2015, February-March 2016

Advisory Council Review

January 2015, May 2015, January 2016, May 2016

Earliest Start Date

April 2015, July 2015, April 2016, July 2016

Expiration Date

January 8, 2016

Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

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


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Table of Contents

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

Part 2. Full Text of Announcement


Section I. Funding Opportunity Description


Purpose

The goal for a Bioengineering Research Partnership (BRP) is to drive the development and speed the adoption of promising tools and technologies that can address important biomedical research problems for which there is a scarcity of solutions. The use of engineering principles is encouraged to establish these tools and technologies as robust, well-characterized solutions that fulfill an unmet need. A synergistic partnership between the engineering, life, physical, and computational sciences is also encouraged, where the unique skills of each discipline combine to enhance our understanding of life science processes or the practice of medicine.

The purpose of this FOA is to encourage BRP applications that: 1) will establish a robust bioengineering solution to a problem in biomedical research or the practice of medicine; 2) will develop a strategic alliance of multidisciplinary partners based on a well-defined leadership plan; and 3) can realize a specific end-point within 5-10 years based on a detailed plan of quantitative milestones.

Background

For more than a decade, the NIH has recognized that the application of principles and techniques from physics, mathematics, chemistry, computer sciences, and engineering can solve significant biomedical problems leading to new understanding of biological processes, novel products, and innovative tools that improve basic knowledge, human health, and quality of life. Three distinct program announcements, the Bioengineering Research Partnership (BRP), Bioengineering Research Grant (BRG), and Exploratory/Developmental Bioengineering Research Grant (EBRG) encourage and support the use of bioengineering and other physical scientific methods to solve problems in biological and biomedical research, and clinical practice. To facilitate a multidisciplinary approach, these announcements include review criteria that emphasize a project may incorporate bioengineering principles to drive new understanding or changes in practice.

Objectives

The primary objective of this FOA is to encourage basic, applied, or clinical bioengineering solutions to unmet needs in biological or biomedical research that can enhance the capabilities of end-users to improve our understanding of life science processes or the practice of medicine within 5-10 years. A BRP may bring together new or existing technologies to form creative solutions that have the potential to be widely adopted and improve human health. To deliver practical solutions within this timeframe, applicants are encouraged to use a design-directed research strategy with well-defined end goal(s) and intermediate, quantitative milestones. Goals may include but are not limited to establishing proof of concept, pre-commercial prototype production, licensure, release of software packages, designs or models, demonstrating the biological effectiveness of engineered constructs, elucidating the structural and functional relevance of biomolecules or tissues, first-in-human testing, or starting the investigational device exemption or investigational new drug process.

A second key objective is to encourage collaborations and partnerships among allied quantitative and biomedical disciplines. The value of strategic partnerships is well supported by the literature of both economics and science and technology policy, which documents greater success at research and development by groups that work in strategic alliances, often involving multiple institutions, compared to those working separately. In addition to the benefits to be derived from the research, the collaborations and partnerships can create opportunities for trans-disciplinary communication and training of a new generation of scientists capable of interacting across traditional technical boundaries. A BRP is typically composed of between three and six partners from multiple institutions or multiple departments from the same institution, with each partner bringing critical strengths to the project. The team may require experience in technology development, appropriate model systems for validation, human factors research, regulatory approval, project management, or commercialization to realize and disseminate a robust solution. Potential beneficiaries should be active participants in the partnership from the beginning to provide assurance that proposed solutions will meet community needs. Partnerships with companies that have relevant expertise or may eventually engage in future commercialization or with organizations that can test and disseminate technologies are encouraged under the BRP program. Each critical partner is expected to provide substantive contributions to intellectual or technical aspects of the project and should be clearly differentiated from partners who supply necessary but not unique components or services.

Scope of the Program

Funding may be requested to develop, adapt, enhance, optimize, validate, or otherwise accelerate the adoption of promising bioengineering solutions, but not for support of commercial production or pivotal clinical trials. The approach used does not necessarily need to be extremely novel and may be based on integrating or scaling-up existing technologies in untested ways. Overall impact of these new capabilities may include but is not limited to reducing disparities in care, providing new insight into basic biological processes, promoting wellness and independent living, engineering integrated biological and physical systems, increasing access to and usability of technologies to improve quality of life, reducing cost and complexity of high-demand tools, or increasing throughput, sensitivity and specificity of laboratory and clinical studies.  Innovation for this FOA is based on a coherent plan to deliver emerging or new capabilities to end-users, including through combination of proven approaches and recognizing their resources, workflow, and skills. Developing a technology is expected to require innovation, but novelty in and of itself is not a requirement. For this FOA, it is innovative to deliver a new capability to solve an unmet need. Innovation in this case is heightened by a technology that can be easily adopted into routine practice and will give users, for example biomedical researchers, healthcare professionals, or citizens, new understanding or will change practice.

Projects must clearly serve the mission of one or more of the NIH Institutes or Centers (ICs) participating in this FOA. Investigators are strongly encouraged to contact the scientific contacts for individual IC policies, such as maximum costs and project duration that will be supported, as well as feedback on the scope and relevance of the proposed project and guidance on the development of appropriate goals and milestones. Applications seeking to establish proof-of-concept are encouraged to respond to the Exploratory Bioengineering Research Grant (EBRG) FOA (http://grants.nih.gov/grants/guide/pa-files/PA-12-284.html).  Smaller team projects tackling problems that cannot be addressed within 5-10 years or that have open-ended aims are encouraged to respond to the Bioengineering Research Grant (BRG) FOA (http://grants.nih.gov/grants/guide/pa-files/PAR-13-137.html).

The National Eye Institute (NEI) supports research on blinding eye diseases, visual disorders, mechanisms of visual function, preservation of sight, and the special health problems and requirements of the blind. It is particularly interested in supporting bioengineering research in visual system prosthetics, therapies for visual system regeneration, ophthalmic imaging, and assistive devices for the visually impaired. Potential applicants are encouraged to review the scientific program areas supported by NEI: http://www.nei.nih.gov/funding/nprp.asp and to contact program staff prior to submitting an application.

The National Institute of Environmental Health Sciences (NIEHS) supports research focused on understanding the impact of the environment on human health and the use of that knowledge to improve public health to prevent disease and disability.  At the core of that mission is the development of technologies to identify and characterize the factors in our environment that we are exposed to and to assess the biological response at both the molecular and physiological level.  Of particular emphasis in our Bioengineering Research Partnerships portfolio are projects that reflect the recommendations of the National Research Council reports on Toxicology in the 21st Century and Exposure Science in the 21st Century.  Of particular emphasis are approaches that integrate exposure to multiple environmental factors across scales of space, time, and biological organization; technologies for assessing biological response on a global scale such as multi-omic and computational modeling approaches; and technologies such as microphysiological systems that enable screening potential toxicants in systems that more comprehensively reflect the response of human populations.  A key product would be to enable the untargeted discovery of associations between environmental exposures and biological responses, a concept that has been termed the exposome.

The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical technologies.  The Institute is committed to integrating engineering with the physical and life sciences to advance basic research and medical care.  One way that this is achieved is through the support of research and development of new biomedical imaging and bioengineering tools and technologies to improve the prevention, detection, treatment, and monitoring of disease.  NIBIB scientific program areas that are appropriate for the BRP mechanism can be found at http://www.nibib.nih.gov/Research/ProgramAreas.  The NIBIB supports research from early stage technology development through first in human demonstrations and early feasibility clinical studies.

The mission of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation.  The NICHD is interested in supporting bioengineering research that advances the development of technology and medicine to accomplish this mission.  For additional information about specific scientific programs of research interest to a Branch in the NICHD, please visit our home page at http://www.nichd.nih.gov.

The National Institute on Aging (http://www.nia.nih.gov) supports multidisciplinary research on understanding the nature of aging and the aging process, and diseases and conditions associated with growing older, in order to extend the healthy, active years of life. Of interest are technology systems to integrate, process, analyze, communicate, and present data so that the older individuals are engaged and empowered in their own healthcare with reduced burden to their care providers. The development of these systems has the potential to significantly improve the quality of life for people with disabilities, people aging with mild impairments, as well as individuals with multiple chronic conditions. Examples of topics of interest include: (1) the development and validation of technologies to monitor health or deliver care in a real-time, accessible, effective, and minimally obtrusive way; (2) the development of new or improved sensor technologies to monitor ambulatory patients inside and outside of their homes and help them maintain independence longer, and (3) the development of applications that lead to new assistive devices for disabled older persons to foster independent living and aid their caregivers.

Section II. Award Information
Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed

New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Award Project Period

The maximum project period is 5 years. 

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

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.

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

Required Registrations

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.

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

All PD(s)/PI(s) must have an eRA Commons account and should work with their organizational officials to either create a new account or to affiliate an existing account with the applicant organization’s eRA Commons account. 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.

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(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.

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 that is essentially the same as one already reviewed within the past thirty-seven months (as described in the NIH Grants Policy Statement), except for submission:

Renewals

Applicants may submit one competitive renewal application. BRP Awards will be restricted to a maximum of ten years.    

Section IV. Application and Submission Information


1. Requesting an Application Package

Applicants must download the SF424 (R&R) application package associated with this funding opportunity using the “Apply for Grant Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the SF424 (R&R) 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.

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

Page Limitations

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

Required and Optional Components

The forms package associated with this FOA includes all applicable components, required and optional. Please note that some components marked optional in the application package are required for submission of applications for this FOA. Follow all instructions in the SF424 (R&R) Application Guide to ensure you complete all appropriate “optional” components.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments: Applicants are required to include the following four items: Leadership Plan, Needs Assessment, Quality Management and Sustainability Plan, and Facilities and Other Resources. For applications that do not utilize Multiple PD/PI, these four items must be uploaded as separate attachments in pdf format with filenames that correspond to the individual items (Leadership Plan, Needs Assessment, Quality Management and Sustainability Plan, Facilities and Other Resources).  For Multiple PD/PI applications, the Leadership Plan should be uploaded using the Multiple PD/PI Leadership Plan on the PHS 398 Research Plan form, whereas the Needs Assessment, Quality Management and Facilities and Other Resources plans should be uploaded as separate attachments in pdf format with filenames that correspond to the individual items (Needs Assessment, Quality Management and Sustainability Plan, Facilities and Other Resources).  Applications lacking these required items will be deemed incomplete and will not be reviewed. Each item is limited to 6 pages.

Leadership Plan:  Applicants are encouraged to build collaborations and partnerships among allied quantitative and biomedical disciplines. An organizational structure that clearly defines the partnership and relationships among the various components must be described in the Leadership Plan and illustrated in an organizational chart.  This plan should also describe the governance and organizational structure of the leadership team and the research project, including communication plans, processes for making decisions on scientific direction, intellectual property, and procedures for resolving conflicts. The roles and administrative, technical, and scientific responsibilities for the project or program should be delineated for the PDs/PIs and other collaborators.  For publications, policies to address the ordering and recognition of authors, and decisions about what material to publish, consistent with the interests of commercial partners (where applicable), should be presented.  Under terms and procedures to be defined in the Leadership Plan, the partnership has the responsibility and authority to use BRP funds in the most productive way to achieve the goals defined at the time of the award. To accomplish these tasks, the PDs/PIs can adjust funding among BRP participants to support new partners or to reduce support to existing partners as needed. The BRP should establish a Scientific Steering Group that consists of representatives from each of the partnering organizations and meets regularly to discuss project status, problems, and directions. Those individuals identified in the Leadership Plan, who together would have the intellectual and leadership responsibilities, would likely be members of the Scientific Steering Group. Technology transfer officials from the participating organizations are also encouraged to be members of the Scientific Steering Group. Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included.

Needs Assessment: This attachment should be entitled "Needs_Assessment.pdf". Applicants are required to carry out a needs assessment to establish performance requirements and identify significant issues faced by stakeholders. A needs assessment should provide strong, systematic evidence for the most efficient and effective route to addressing an unmet need.  Critically evaluate primary or secondary data that has been used to identify deficiencies in current capabilities and the origins of the problem or critical barrier. Describe the audience who will benefit from the proposed work and how their needs have been identified. Distinguish "wants" from "needs" and outline the involvement of those who will benefit in the development of a solution. Describe how finite resources can best be deployed to develop and disseminate a feasible and applicable solution. Identify any human factors incorporated into the proposed research that optimize human interaction, productivity, and understanding while using the technology.

Quality Management and Sustainability Plan: This attachment should be entitled "Quality_Plan.pdf". Describe systematic activities that will be implemented to monitor and evaluate the chosen technology, including studies of reliability and reproducibility of performance. The rationale for selected models and endpoints in the studies, the adequacy of controls, approaches for minimizing bias, the justification of sample size including power calculations, and the statistical methods used to analyze and interpret results should be detailed.  If appropriate, statistical analysis and modeling techniques should be critically evaluated. Explain plans to develop calibrations or standards. Plans for increasing transparency of findings through depositing dataset in repositories and preserving samples and collections are encouraged. For projects focused on clinical translation, quality systems should be described, including design controls and good manufacturing practices. Discuss plans for sustaining work beyond the BRP funding period. Issues related to sustainability, such as costs, manufacturing considerations, scale-up, standardization, and interoperability should also be described.

Facilities and Other Resources: Describe the unique resources available to each partner in the project, institutional support, and how the project will benefit.  Discuss the strategies the partnership will use to foster a trans-disciplinary environment, including tools for improving communicating and training.  

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions: investigators should list research products directly related to the proposed project. Research products include but are not limited to publications, patents, datasets, copyrights, models, curated collections, and software, but exclude unpublished documents and invited lectures.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed. Given the complexity of these partnerships, key investigators are expected to commit significant effort to the project; the PD/PI of a single PD/PI application must contribute at least 3 (25%) calendar months of effort and for Multiple PD/PI applications each PD/PI must contribute at least 1.8 (15%) calendar months of effort.

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: The problem to be addressed and the timeliness and appropriateness of the solution must be stated concisely. Key milestones, uniqueness of the team, and the expected outcomes of the project, if successful, should be described succinctly.

Research Strategy: As part of the Research Strategy, applicants are asked to address the following points:

Significance: Briefly describe the area of bioengineering research that is the focus of the BRP. Explain the importance of the problem or critical barrier to progress in the field and why a multidisciplinary approach is needed to realize a solution.  Explain how the proposed project will improve scientific knowledge, technical capability, and/or clinical practice by providing new capabilities to users. State concisely the importance and health relevance of the research proposed to achieve the Specific Aims. Describe how the concepts, methods, technologies, treatments, services, or preventative interventions that drive the field will be changed if the Specific Aims are achieved.  Critically evaluate existing knowledge and approaches that have been or are being applied in the area and specifically describe how the proposed BRP approach will advance the field.

Innovation: Innovation for this FOA is based on a coherent plan to deliver emerging or new capabilities to end-users, including through combinations of proven approaches and recognizing their resources, workflow, and skills. Developing a technology is expected to require innovation, but novelty in and of itself is not a primary requirement. For the purpose of this FOA it is innovative to deliver a new capability to solve an unmet need. Innovation in this case is heightened by a technology that can be easily adopted into routine practice and will give users, for example biomedical researchers, healthcare professionals or citizens, new understanding or will change practice. Identify the nature of innovations involved and explain their importance to the success and potential impact of the application. To the extent relevant, explain how the application challenges and seeks to shift current research or clinical practice paradigms.  Describe any novel theoretical concepts, approaches or methodologies, instrumentation or intervention(s) to be developed or used, advanced system integration, and any advantage over existing methodologies, instrumentation, or intervention(s).  Explain any refinements, improvements, or new applications of theoretical concepts, approaches or methodologies, system integration, combinations, scale-up, instrumentation, or interventions.

Approach: Technical feasibility for the approach should be clearly established by preliminary results so that any risks present can be mitigated using engineering and project management principles.  Comparison of performance specifications with current practices is expected, such as sensitivity, specificity, reproducibility, reliability, portability, throughput, operability by biological researchers or healthcare workers, potential research or clinical utility and cost of acquisition and operation as applicable. Describe the overall strategy, methodology, and analyses to be used to accomplish the specific aims of the project.  Discuss potential problems, alternative strategies, and benchmarks for success anticipated to achieve the aims.  If the project is in the early stages of development, describe any strategy to establish feasibility, and address the management of any high risk aspects of the proposed work.  An integrative systems approach or a design-driven approach and their appropriateness for the proposed project should be described, including plans for collecting, analyzing, interpreting, and archiving data. Details for making the performance of technologies sufficiently selective, sensitive, or otherwise appropriate for the identified problem should be supported with quantitative benchmarks. Potential technical challenges and possible alternative approaches to achieve the aims of the project should be discussed. If the proposed BRP research is closely related to ongoing research, explain how the research activities of the BRP will complement but not overlap the existing research. The robustness and reproducibility of preliminary results should be described along with independent validation or replication of results if available. Alternative interpretations of preliminary data, including relevant literature in support or disagreement with the results, should be described. For projects that pursue feasibility in humans, the approach should describe contact with appropriate regulatory bodies and milestones for achieving regulatory approval.

Project Timeline: Include quantitative milestones, a schedule of tasks and events including responsible personnel, and/or other evaluative criteria. Projects must identify annual milestones, and provide timelines highlighting dependencies between tasks.

Additionally, applicants for competitive renewal should be aware that BRP funding will not be extended past the end of the second funding award and should describe plans for sustaining their project.

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 SF424 (R&R) Application Guide, with the following modifications:

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.

Planned Enrollment Report

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

PHS 398 Cumulative Inclusion Enrollment Report

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

Foreign Institutions

Foreign (non-U.S.) institutions must follow policies described in the NIH Grants Policy Statement, and procedures for foreign institutions described throughout the SF424 (R&R) Application Guide.

3. Submission Dates and Times

Part I. Overview Information contains information about Key Dates. 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.

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

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.

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

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit Applying Electronically.

Important reminders:
All PD(s)/PI(s) 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. See Section III of this FOA for information on registration requirements.

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. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness by the Center for Scientific Review, NIH. Applications that are incomplete will not be reviewed.

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

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

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-13-030.

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.

For this particular announcement, note the following:

Innovation for this FOA is based on a coherent plan to deliver emerging or new capabilities to end-users, including through combination of proven approaches and recognizing their resources, workflow, and skills. Developing a technology to solve an unmet need is expected to require this type of innovation, but novelty in and of itself is not a requirement.

Overall Impact

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

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 project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Will the project address a problem or critical barrier for which there is a scarcity of other solutions? If the goals of the BRP are achieved, will they provide new capabilities that will enhance biomedical research or clinical practice? Will the technological advances improve human health? 

Investigator(s)    

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? 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? Does the partnership have appropriate experience with enhancing, adapting, optimizing, validating or otherwise accelerating the development and adoption of biomedical technologies? Does the team have experience assessing and meeting stakeholder needs?  Will the PD(s)/PI(s) provide an appropriate level of effort to effectively lead the project, manage resources, and coordinate the partners, 3 person-months minimum for a single PD/PI or 1.8 person-months minimum for each Multiple PD(s)/PI(s)?

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? Will the project deliver new capabilities taking into account end-user resources, workflow, and skills?  Will the proposed approaches or concepts solve current scientific or technical problems in creative ways?  

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 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? Are the BRP engineering, scientific, and clinical approaches and methods adequately developed, well-integrated, and appropriate to the aims of the project? Is a timetable with adequate research milestones proposed? Are appropriate specifications and evaluation procedures provided for assessing technological progress? Is the Leadership plan clear, sound, appropriate, and practical? If partnership with industry or organization is proposed, does this positively affect the research goals and technology dissemination?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of 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? Does the partnership foster trans-disciplinary communication and training opportunities across traditional scientific and technical boundaries?  

Additional Review Criteria

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

Review Criteria for Leadership Plan

Do the organizational structure and leadership plan of the project indicate an ability to meet the proposed goal(s) within 5-10 years? Does the information provided 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 Scientific Steering Group possess knowledge of and relationships with appropriate stakeholders and user groups?

Review Criteria for Needs Assessment

Does the Needs Assessment clearly demonstrate an understanding of deficiencies in current capabilities and the critical barrier(s) faced? Are rigorous methodologies and data analysis approaches used for continuing to assess needs?

Review Criteria for Quality Management and Sustainability Plan

Are there clear milestones and timelines for developing and testing technologies? Is the evaluation plan transparent, repeatable, realistic, and relevant? Are appropriate standards, benchmarks, and model systems used to assess performance? Are analytical frameworks including models, statistical methods, and data reduction techniques deployed to inform experimental design and provide objective evaluation? Does the information provided suggest that the results of the BRP partnership can be sustained beyond the BRP funding period?

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 Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Children 

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of 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.

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

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the reviewers will consider the progress made in the last funding period, whether annual milestones have been met, if communication among the partnership has been effective, and if there is still an unmet need. The committee will also evaluate the plans for sustaining the project beyond the renewal period and the success of dissemination efforts, and whether the application achieved the prior aims and expected outcomes.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

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

Applications from Foreign Organizations

Reviewers will assess whether the project presents special opportunities for furthering research programs through the use of unusual talent, resources, populations, or environmental conditions that exist in other countries and either are not readily available in the United States or augment existing U.S. resources.

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)

Are there plans for disseminating the proposed technology so that it will become a robust solution widely adopted by end-users?.

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), 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:

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:

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’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 the DUNS, SAM 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

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the annual Non-Competing Progress Report (PHS 2590 or RPPR) 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

eRA Commons Help Desk (Questions regarding eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, post submission issues)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

Web ticketing system: https://public.era.nih.gov/commonshelp
TTY: 301-451-5939
Email: commons@od.nih.gov

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact CenterTelephone: 800-518-4726

Web ticketing system: https://grants-portal.psc.gov/ContactUs.aspx
Email: support@grants.gov

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

Scientific/Research Contact(s)

NIH scientific contacts listed at the following website should be contacted for answers to questions about scientific issues: http://www.nibib.nih.gov/Funding/Bioengineering/Contacts

Peer Review Contact(s)

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

Financial/Grants Management Contact(s)

NIH financial contacts listed at the following Web site should be contacted for answers to questions about financial issues: http://www.nibib.nih.gov/Funding/Bioengineering/Contacts

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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