Bioengineering Partnerships with Industry (U01 Clinical Trial Optional) PAR-24-325 is sponsored by National Institute of Biomedical Imaging and Bioengineering (NIBIB). This funding opportunity solicits applications from research partnerships between academic and industrial investigators.

PAR-24-325: Bioengineering Partnerships with Industry (U01 Clinical Trial Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 Eye Institute ( NEI ) National Cancer Institute ( NCI ) Funding Opportunity Title Bioengineering Partnerships with Industry (U01 Clinical Trial Optional) U01 Research Project – Cooperative Agreements Notices of Special Interest associated with this funding opportunity March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility . Assistance Listing Number(s) 93. 286, 93.

866, 93. 394, 93. 395, 93.

867 Funding Opportunity Purpose This Funding Opportunity Announcement (FOA) solicits applications from research partnerships formed by academic and industrial investigators to accelerate the development and adoption of promising bioengineering tools and technologies that can address important biomedical 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 technologies.

The goal of the program is to support technological innovations that deliver new capabilities which can realize meaningful solutions within 5 – 10 years. Funding Opportunity Goal(s) To support hypothesis-, design-, technology-, or device-driven research related to the discovery, design, development, validation, and application of technologies for biomedical imaging and bioengineering.

The program includes biomaterials (biomimetics, bioprocessing, organogenesis, rehabilitation, tissue engineering, implant science, material science, interface science, physics and stress engineering, technology assessment of materials/devices), biosensors/biotransducers (technology development, technology assessment, development of algorithms, telemetry), nanotechnology (nanoscience, biomimetics, drug delivery systems, drug bioavailability, microarray/combinatorial technology, genetic engineering, computer science, technology assessment), bioinformatics (computer science, information science, mathematics, biomechanics, computational modeling and simulation, remote diagnosis and therapy), imaging device development, biomedical imaging technology development, image exploitation, contrast agents, informatics and computer sciences related to imaging, molecular and cellular imaging, bioelectrics/biomagnetics, organ and whole body imaging, screening for diseases and disorders, and imaging technology assessment and surgery (technique development and technology development).

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed All applications are due by 5:00 PM local time of applicant organization.

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

Required Application Instructions It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide , except where instructed to do otherwise (in this NOFO or in a Notice from NIH Guide for Grants and Contracts ). Conformance to all requirements (both in the Application Guide and the NOFO) is required and strictly enforced.

Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

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

Use the NIH ASSIST system to prepare, submit and track your application online. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants. gov and eRA Commons to track your application.

Check with your institutional officials regarding availability. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description Section II.

Award Information Section III. Eligibility Information Section IV. Application and Submission Information Section V.

Application Review Information Section VI. Award Administration Information Section VII. Agency Contacts Section VIII.

Other Information Part 2. Full Text of Announcement Section I. Notice of Funding Opportunity Description This Funding Opportunity Announcement (FOA) solicits applications from research partnerships formed by academic and industrial investigators to drive the development and speed the adoption of promising bioengineering tools and technologies that can address important biomedical problems for which insufficient or no solutions exist.

The partners on each application will establish an inter-disciplinary, multi-institutional research team to develop these tools and technologies as robust, well-characterized solutions that fulfill an unmet need. Collaboration with an industrial partner is required.

The use of engineering principles is encouraged to establish integrative, quantitative, and innovative bioengineering approaches to developing technologies that are capable of enhancing our understanding of life science processes or the practice of medicine. The intended outcome is technological innovations that deliver new capabilities which can realize meaningful solutions within 5 – 10 years.

Developing a technology is expected to require innovation, but novelty in and of itself is not a primary requirement.

For many years, the NIH has recognized that the application of principles and techniques from physics, mathematics, chemistry, computer sciences, and engineering can be used to solve significant biomedical problems, leading in turn to new understanding of biological processes, novel products, and innovative tools to improve health.

Such solutions typically require inter-disciplinary, multi-institutional partnerships to combine strengths unique to each group to accelerate the development and adoption of promising bioengineering technologies.

Moreover, it is essential to engage industry for the eventual broader application and adoption of the technologies and tools by end-users in the medical community to realize the full potential and bring the benefits of these technological innovations to patients.

Partnerships expand access to a range of resources and facilitate problem-solving from initiation through validation, a Federally required approval process, to market delivery and clinical use. For example, technology testing and validation often require specialized animal research facilities and/or clinical settings with patients and clinical expertise.

These resources are common in many academic settings, but unusual for most industrial environments. Academic investigators may also experience barriers. They often focus on the discovery phase of an invention with the typical priorities set on the demonstration of feasibility (a proof of principle studies) and publication of their findings.

The tasks of robust system engineering and validation studies that would eventually lead to a broader application and acceptance of the technologies by end-users in the medical community are usually considered to be part of product development process.

Moreover, by establishing the academic-industrial team, combined diverse expertise and points of view of the participants become a unique resource that may considerably facilitate and accelerate solving diverse problems associated with the inception and development of new ideas.

The partnership model is expected to more readily overcome various barriers to accelerating the development and adoption of promising tools and technologies faced by either academia or industry working alone.

The primary objective of this NOFO is to support Bioengineering Partnerships with Industry (BPI) to: 1) establish a robust engineering solution to a problem in biomedical research or the practice of medicine; 2) develop a strategic alliance of multi-disciplinary partners, one of which must be an industrial partner, based on a well-defined leadership plan; and 3) realize a specific endpoint and deliverables within 5-10 years based on a detailed plan with a timeline and quantitative milestones.

A distinguishing feature of this NOFO will be the requirement of an appropriate academic-industrial partnership: a strategic alliance of academic and industrial investigators who work together as partners to identify and translate a technological solution to advance human health.

These partnerships are expected to solidify pre-existing collaborations or spur the creation of new collaborations to drive the fields of bioengineering and biomedical imaging further than if they had not been formed. Achieving the goal of the BPI program will likely require leveraging the expertise of engineering and the life, physical, or computational sciences.

Engaging clinical researchers or clinician scientists in the relevant biomedical fields, when appropriate, is strongly encouraged, although not required. Projects proposed in response to this NOFO must propose to accelerate the development and adoption of promising, integrative, and quantitative bioengineering tools and technologies as robust, well-characterized solutions that can address an important and unmet biomedical need.

Projects may span the development in the research settings, validation, translation into clinical settings as needed, and incorporation of these solutions as endpoints into research protocols to enhance our understanding of life science processes or the practice of medicine to benefit patients.

Funding may be requested to develop, adapt, enhance, optimize, validate, or otherwise accelerate the adoption of promising biomedical engineering solutions, but not for support of commercial production or later stage (Phase II or Phase III) clinical trials. A project may bring together new or existing technologies to form creative and practical solutions that have the potential to be widely adopted and improve human health.

To deliver practical solutions within the time-frame of 5-10 years, applicants are encouraged to use a design-directed research strategy with well-defined end goals 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.

Key to this NOFO is the required partnership with industry, which typically consists of partners from multiple institutions or multiple departments from the same institution and industrial partners, with each partner bringing critical strengths to the project. Both the academic and industrial partners are expected to provide substantive contributions to the intellectual or technical aspects of the project.

The roles of the industrial partner(s) should be clearly differentiated from team members who supply necessary but not unique components for 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 and industrial partners that have relevant expertise or may eventually engage in future commercialization or with organizations that can test and disseminate technologies are encouraged.

To be responsive to this FOA, application must include an academic-industrial partnership. Applications that do not include an academic-industrial partnership will not go forward to peer review. Additionally, projects must be consistent with the mission of one or more of the NIH Institutes or Centers (ICs) participating in this NOFO.

Investigators are strongly encouraged to contact the Scientific/Research contacts identified in this NOFO to discuss the scope and relevance of their proposed project and guidance on the development of appropriate goals and milestones.

Institute statements of interest : National Institute of Biomedical Imaging and Bioengineering (NIBIB) NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care.

An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases.

However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest ( https://www. nibib.

nih. gov/research-funding ) to determine if their research fits within the NIBIB mission . NIBIB Guidance for Support of Clinical Trial Applications NOTE: For this Notice of Funding Opportunity, if an application proposes a clinical trial NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications".

Briefly, NIBIB will only support mission-focused (see NIBIB's program areas ) early stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern.

Also, mechanistic trials are not supported unless the primary focus of the project is on technology development. Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this NOFO for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies ( https://grants. nih.

gov/policy/clinical-trials. htm ) and consistent with the types of clinical trial applications that NIBIB supports. Prior to funding an application, NIBIB program staff will contact the applicant to discuss the proposed timeline and go-no go milestones and any changes suggested by the review panel or program staff.

A final timeline and approved milestones will be specified in the Notice of Award. Progress toward achieving the milestones will be evaluated by NIBIB program staff. Program staff may involve independent consultants or subject matter experts with relevant expertise.

If justified, future milestones may be revised based on data and information obtained during the previous project period. If a funded project does not meet the milestones, funding for the project may be discontinued. National Institute on Aging (NIA) NIA is interested in applying bioengineering approaches to studies of brain aging and Alzheimer's Disease and AD-Related Dementias (AD/ADRD).

As described in the AD/ADRD Research Implementation Milestones based on recommendations from the NIH AD/ADRD Research Summits, NIA is interested in supporting research aimed at enabling technologies and AD/ADRD monitoring.

This includes studies of wearable technologies, high frequency data capture platforms to enable continuous monitoring of research participants, technologies to capture environmental exposures, and methods for monitoring individuals at all stages of AD/ADRD progression to better understand the collective influence of biological, environmental, and behavioral and social factors on aging and AD/ADRD.

NIA is also interested in supporting research on standardized diagnostic screening of MCI and dementia, technologies to prevent/slow cognitive decline, practical applications of innovative technologies to support people living with AD/ADRD and their caregivers (telemedicine GPS, robotics, and social networking), biosensors and prosthetic devices to improve physical function, new technologies for sleep disorders in older persons, improved imaging technology to visualize neural activity during cognitive behavior in older adults, and development of high-throughput measuring and monitoring of neural function in 3D or organoid cultures of human brain cells.

NIA is also interested in potential applications of novel imaging and bioengineering technologies and associated computational and display tools to the biology of aging, aging systems design, and age-related changes and diseases.

Additionally, NIA seeks to promote imaging of any of the pillars or hallmarks of aging which include protein homeostasis, nuclear and DNA integrity, metabolism and mitochondrial quality control, cellular senescence, autophagy and cell death, and other proposed hallmarks as described in the literature.

More specifically, NIA is interested in applications that compare unperturbed to altered aging, where the comparison is between whether there is an intervention that may include any of the numerous pharmacological, genetic, dietary and/or exercise interventions or other experimental paradigms that alter the apparent rate of aging.

This may also be considered in the context of human populations, where possible, with a special interest in health disparities, comparisons among groups within the human population covering a range of multi-morbidities, the known progeroid syndromes or existing well-controlled study cohorts where there are rigorous data on health and behaviors.

NIA is also interested in the application of imaging of aging to test whether short-term manipulations can be effective surrogates for longer-term studies of aging (e.g., acute versus chronic low-level stressors). NIA also encourages small businesses developing technologies for the development and testing of innovative technologies that address aging and/or AD/ADRD.

Clinical trial applications involving behavioral interventions are expected to be guided by the NIH Stage Model for Behavioral Intervention Development . National Eye Institute (NEI) The National Eye Institute (NEI) supports a broad range of basic, translational and clinical research related to the health and disease of the eye and visual system.

Research proposed should focus on the development of tools, novel therapies, or diagnostics for the treatment of visual system diseases and disorders. NEI will only support clinical trial applications for this FOA that fulfill the NIH requirements for either a mechanistic or minimal risk trials.

A mechanistic trial is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.

A minimal risk trial is one in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

National Cancer Institute (NCI) NCI is interested in the translation of scientific discoveries and engineering developments into methods or tools that address problems in basic cancer research for the purpose of advance the understanding of cancer biology; or in applied cancer research for assessment of cancer risk, cancer prevention, diagnosis, treatment and/or disease management.

Examples of focused research areas include, but are not limited to: In vitro and in vivo imaging technologies Liquid biopsy technologies that are focused on known and emerging molecular and cellular entities in liquid biopsy for improving cancer detection, diagnosis and treatment, monitoring treatment response, assessing cancer risk, risk of recurrence, prognosis, and minimal residual disease Technologies for the detection and evaluation of cancers of unknown primary Technologies for neoantigen identification, including circulating dendritic cell-displayed antigens and neoantigens.

Advanced technologies for circulating neoantigen-specific immune repertoire profiling Technologies to evaluate metastatic potential of circulating hybrid cells Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Cooperative Agreement: A financial assistance mechanism used when there will be substantial Federal scientific or programmatic involvement. Substantial involvement means that, after award, NIH scientific or program staff will assist, guide, coordinate, or participate in project activities.

See Section VI. 2 for additional information about the substantial involvement for this NOFO. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. Optional: Accepting applications that either propose or do not propose clinical trial(s). Need help determining whether you are doing a clinical trial?

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. Application budgets are not limited but need to reflect the actual needs of the proposed project. The scope of the proposed project should determine the 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 from this NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education Nonprofits Other Than Institutions of Higher Education Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education) Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education) For-Profit Organizations (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession Independent School Districts Public Housing Authorities/Indian Housing Authorities Native American Tribal Organizations (other than Federally recognized tribal governments) Faith-based or Community-based Organizations Non-domestic (non-U.S.) Entities (Foreign Organizations) Non-domestic (non-U.S.) Entities (Foreign Organizations) 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. Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award.

All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.

3. 9. 2 Electronically Submitted Applications for additional information.

System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually . The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.

NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM. Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM. gov registration process.

The same UEI must be used for all registrations, as well as on the grant application. eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants. gov registrations; all registrations must be in place by time of submission.

eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application. Grants. gov – Applicants must have an active SAM registration in order to complete the Grants.

gov registration. Program Directors/Principal Investigators (PD(s)/PI(s)) All PD(s)/PI(s) must have an eRA Commons account. PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.

If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

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 their organization to develop an application for 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 How to Apply-Application Guide. This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1. 2 Definition of Terms .

3. Additional Information on Eligibility Applicant organizations may submit more than one application, provided that each application is scientifically distinct. The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.

3. 7. 4 Submission of Resubmission Application .

This means that the NIH will not accept: A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application. A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2. 3. 9.

4 Similar, Essentially Identical, or Identical Applications ). Section IV. Application and Submission Information 1.

Requesting an Application Package The application forms package specific to this opportunity must be accessed through ASSIST, Grants. gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.

gov Workspace are available in Part 1 of this NOFO. See your administrative office for instructions if you plan to use an institutional system-to-system solution. 2.

Content and Form of Application Submission It is critical that applicants follow the instructions in the Research (R) Instructions in the How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced.

Applications that are out of compliance with these instructions may be delayed or not accepted for review. All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed. Instructions for Application Submission The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

All instructions in the How to Apply - Application Guide must be followed. SF424(R&R) Project/Performance Site Locations All instructions in the How to Apply- Application Guide must be followed. SF424(R&R) Other Project Information All instructions in the How to Apply- Application Guide must be followed.

Other Attachments: Applicants are required to include a Leadership Plan. For applications that do not utilize Multiple PDs/PIs, this item must be uploaded as a separate attachment in pdf format with a filename that corresponds to the item (Leadership Plan). For Multiple PD/PI applications, the Leadership Plan should be uploaded using the Multiple PD/PI Leadership Plan attachment on the PHS 398 Research Plan form.

Applications lacking this required item will be deemed incomplete and will not be reviewed. The Leadership Plan is limited to 6 pages. Leadership Plan: All applications are required to develop a strategic alliance of multi-disciplinary partners, one of which must be an industrial partner, based on a well-defined Leadership Plan.

As part of the 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, including clear descriptions regarding the roles of the industrial partner(s).

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 BPI funds in the most productive way to achieve the goals defined at the time that the award is made. To accomplish these tasks, the PDs/PIs can adjust funding among BPI participants to support new partners or to reduce support to existing partners as needed.

Plans for enhancing the abilities and opportunities for investigators to work across disciplinary boundaries should also be included. SF424(R&R) Senior/Key Person Profile All instructions in the How to Apply- Application Guide must be followed. Biographical Sketch.

Indicate experience in project management as well as assessing and meeting stakeholder needs. All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement All instructions in the How to Apply- Application Guide must be followed. All instructions in the How to Apply- Application Guide must be followed, with the following additional instructions: Specific Aims: The problems 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: Note for Applications Proposing the involvement of Human Subjects and/or Clinical Trials: Use the Research Strategy section to discuss the overall strategy, methodology, and analyses of your proposed research, but do not duplicate information collected in the PHS Human Subjects and Clinical Trial Information form.

The PHS Human Subjects and Clinical Trial Information form will capture detailed study information, including eligibility criteria; inclusion of women, minorities, and children; protection and monitoring plans; and statistical design and power. You are encouraged to refer to information in the PHS Human Subjects and Clinical Trial Information form as appropriate in your discussion of the Research Strategy (e.g., see Section 2.

4 Inclusion of Women, Minorities, and Children). Significance: Briefly describe the area of bioengineering research that is the focus of the BPI. Explain why a multidisciplinary multi-institutional approach with both academic and industrial participations 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. Critically evaluate existing knowledge and approaches that have been or are being applied in the area and specifically describe how the proposed BPI approach will advance the field.

Innovation: Describe the innovative features of the proposed project, based on a coherent plan that applies integrative, quantitative bioengineering approaches to accelerating the development and delivery of new capabilities to fulfill an unmet biomedical need, including through the integration of proven approaches.

Describe how the project develops new or brings together existing technologies to form creative and practical solutions that have the