and Human Services (HHS)
EXPIRED
Participating Organization(s) |
National Institutes of Health (NIH) |
National Heart, Lung, and Blood Institute (NHLBI) |
|
Funding Opportunity Title |
The NIH Centers for Accelerated Innovations (U54) |
Activity Code |
U54 Specialized Center- Cooperative Agreements |
Announcement Type |
New |
Related Notices |
|
Funding Opportunity Announcement (FOA) Number |
RFA-HL-13-008 |
Companion Funding Opportunity |
None |
In response to this FOA, an institution can only submit, or be part of, a single application. Applications should include detailed evidence of significant institutional commitment. |
|
Catalog of Federal Domestic Assistance (CFDA) Number(s) |
93.233, 93.837, 93.838, 93.839 |
Funding Opportunity Purpose |
The NIH Centers for Accelerated Innovations (NCAI) will develop Centers that (1) solicit and select promising emerging technologies, such as therapeutics (e.g., drugs, biologics), preventatives, diagnostics, devices, tools, etc. and (2) facilitate their translation to commercialized products that improve patient care and enhance health. The NCAI will nurture the development of high priority early-stage technologies within the NHLBI s mission in a manner consistent with business case development and regulatory requirements by providing (1) funding for product definition studies (e.g. feasibility studies, prototype development, or proof-of-concept studies), (2) unified and coordinated access to expertise in areas required for early technology development, including scientific, regulatory, reimbursement, business, legal, and project management, and (3) training and hands-on experience in entrepreneurism. Establishing public-private partnerships and providing non-federal funds will be critical for success. |
Posted Date |
May 17, 2012 |
Letter of Intent Due Date |
August 19, 2012 |
Application Due Date(s) |
(Extended to October 19, 2012 per NOT-HL-12-156), Originally September 19, 2012 |
AIDS Application Due Date(s) |
Not Applicable |
Scientific Merit Review |
March 2013 |
Advisory Council Review |
May 2013 |
Earliest Start Date(s) |
August 2013 |
Expiration Date |
(Extended to October 20, 2012 per NOT-HL-12-156), Originally September 20, 2012 |
Due Dates for E.O. 12372 |
Not Applicable |
Required Application Instructions
It is critical that applicants follow the instructions in the PHS398 Application Guide except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. While some links are provided, applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.
Part 1. Overview Information
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission
Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information
This program will establish Centers that will create infrastructure and processes to provide the support required to translate novel early stage scientific advances and discoveries into commercially viable products [such as therapeutics (e.g., drugs, biologics), preventatives, diagnostics, devices, tools, etc.] that improve patient care and advance public health. The NIH Centers for Accelerated Innovations (NCAI) will foster the development of high priority early-stage technologies that address diseases within the NHLBI’s mission in a manner consistent with business case development and regulatory requirements by (1) providing funding for scientific product definition studies (feasibility, validation, prototype development, or proof of concept studies); (2) providing unified and coordinated access to expertise in areas required for early technology development, including scientific, regulatory, reimbursement, business, legal, and project management; (3) leveraging existing NIH resources, such as Science Moving Towards Research Translation and Therapy (SMARTT) and the Clinical and Translational Science Awards (CTSAs); (4) establishing novel partnerships and strengthening existing alliances between stakeholders, including public, private, non-profit, and academic sectors; (5) providing Innovators with training and hands-on experience in entrepreneurism; and (6) creating cultural and systemic changes by providing the necessary resources to proactively and more rapidly move from breakthrough innovations to products that will have health, economic, and societal impact.
Cardiovascular and lung diseases account for 3 of the 4 leading causes of death, 4 of the 10 leading causes of infant death, $382 billion in health care dollars per year, and 22% of the total economic costs of illness, injuries, and death. Over twenty-three million blood transfusions are performed per year at the cost of approximately $10 billion dollars. Although NIH invests billions of dollars a year in biomedical research, which has led to great advances in scientific tools and biological insights, there are barriers to effectively translating basic science discoveries from academia to patient benefit. These barriers include (1) a gap in funding on a national level between basic research discoveries and scientific proof of feasibility or validation studies required for early stage technology development; (2) a lack of knowledge and understanding by academic researchers about how new technologies are brought to market; and (3) a lack of access to sufficient technology development and commercialization resources that are required for early stage technology development. A new approach is required to enable early stage collaboration between academia, government, non-profit organizations, and industry to de-risk academic discoveries for hand-off to the private sector for commercial development.
For this Funding Opportunity Announcement (FOA), the following definitions apply:
Each Center will have the expertise required to identify (solicit and select) and develop promising early stage technologies in order to accelerate their translation into commercial technologies to enhance human health. Each Center will provide (1) funding to conduct product definition studies, whose support is predicated upon the review of proposals for medical need, scientific merit, and commercial potential, (2) resources and expertise [business plan development, market research, intellectual property (IP) protection, regulatory submission, evaluation and review processes, reimbursement, project management, etc.], and, (3) educational and networking activities with linkages to local or virtual resources. To achieve these objectives, each Center will focus on research projects that have progressed to a point where a potential commercial product can be envisioned, but additional research and development efforts are required to define the product (demonstrate feasibility and proof-of-concept).
Each Center should establish under these cooperative agreements an infrastructure that will both promote the technology and nurture the Innovator along the pathway towards commercialization. The intent is also to facilitate and stimulate the academic community to commercialize technology by reducing the barriers associated with navigating an unfamiliar technology and business development pathway.
The Centers will select early stage technologies that address unmet medical needs or offer great scientific opportunities and offer either immediate commercial potential or otherwise present compelling reasons for continued development (e.g. targets a rare disease). NHLBI program priority areas for technology development research include technologies to detect, prevent, or treat cardiovascular, lung, blood and sleep disorders as follows:
Centers should support the further development of technologies requiring product definition studies. Applications proposing Centers that will support hypothesis driven research will not be considered, and will be returned to the applicant institution without review.
Through a combination of in-house efforts and collaboration, each NIH Center funded under this FOA will perform functions as described in section IV.6 to specifically address the critical knowledge and funding gaps that hinder the early steps needed to turn novel discoveries into technologies for biomedical advancement and patient care.
Center leadership must possess the necessary operational, business, and scientific expertise with a documented track record of success in transitioning technologies from the discovery phase to product commercialization. In addition, each Center is required to demonstrate the core competencies necessary to fulfill the objectives of this FOA, including access to expertise in business plan development, market research, IP protection, regulatory and reimbursement processes, project management, clinical studies, and appropriate domain experts. Centers will have the ability to support projects that cover various facets of technology development ranging from early stage laboratory-based technology feasibility or validation studies through clinical testing. Centers will support the development of relevant technologies using a milestone driven approach to transition technologies from the Center to the next appropriate source of independent financing or strategic partner with the ultimate goal of commercialization.
An important characteristic of the Centers is the ability to collaborate effectively with entities that possess the resources and expertise required to commercialize technologies developed through the Center. A Center should have a structure that takes into account the full range of technology development expertise (including business, legal, regulatory, clinical, scientific, etc.) and partnerships necessary to facilitate identifying and developing discoveries into technologies that address defined medical and scientific needs. Each Center should establish under these cooperative agreements an infrastructure that will promote this type of leveraged interaction to successfully develop the technologies accepted into the Center. The cooperative approach outlined in this FOA allows for interactions among successful applicants, with the assistance of the NHLBI, the US Food and Drug Administration (FDA), and the US Patent and Trademark Office (USPTO), the Office of Entrepreneurship and Innovation (OIE), and the Centers for Medicare and Medicaid Services (CMS) to promote the development of integrated plans and processes required to conduct product-definition studies that facilitate translation and commercialization.
Each Center must demonstrate access to adequate numbers of technologies within the NHLBI priorities described above such that approximately three new technologies are accepted into the Center for development per year. It is expected that at least 6 technologies (3 new) will be under some form of development each year from years 2 through 6 of the award and that appropriate negotiated agreements will be in place between the Center Partners for both the technology development and for access to the research investigators. Use or development of standardized simplified institutional agreements to streamline interactions and decrease barriers to technology transfer and commercialization are strongly encouraged.
This FOA will provide funding for a Skills Development Component to provide Innovators with hands-on learning experience about the design and conduct of product definition studies and the commercialization processes required for transitioning a technology out of academic labs. Activities could include, but are not limited to, conducting the required scientific and business product definition studies, training in market assessment and business plan development, and interacting with potential strategic partners and investors. The skills development programs could range from didactic education to mentoring. Examples include, but are not limited to:
Cross-disciplinary (science, business, regulatory, etc.) career development is highly encouraged to achieve the goal of exposing Innovators to the myriad processes required to translate discoveries into marketable products. Providing the broader investigator community with access to forums, seminars, workshops and related activities is encouraged.
Federal funding provided under this FOA for these Centers is not expected to be adequate to fully fund the completion of the high quality work necessary for a technology to exit the Center. Hence, it is expected that the Center will have additional funding identified at the time of application and committed at the time of award that can augment the federal investment for product definition studies. Further, it is expected that the Centers will develop a financially self-sustaining architecture through agreements with the source institutions allowing for revenue from licensing, milestone payments, royalties, or other mechanisms.
Funding Instrument |
Cooperative Agreement |
Application Types Allowed |
New The OER Glossary and the PHS398 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. The NHLBI intends to commit up to $2 million total costs to fund at least one award for fiscal year 2013. For a Center, the NHLBI intends to commit up to $4 million total costs per year for years 2 6 and up to $2 million total costs for year 7. |
Award Budget |
An applicant for a Center may request a project period of up to 7 years. The NHLBI’s maximum total budget for a Center is $24M for a 7-year funding period. |
Award Project Period |
Up to seven 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.
Higher Education Institutions
The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:
Nonprofits Other Than Institutions of Higher Education
For-Profit Organizations
Governments
Other
Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible
to apply.
Foreign components, as defined in the NIH
Grants Policy Statement, are not allowed.
Applicant organizations must complete the following registrations as described in the PHS398 Application Guide to be eligible to apply for or receive an award. Applicants must have a valid Dun and Bradstreet Universal Numbering System (DUNS) number in order to begin each of the following registrations.
All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) must also work with their institutional officials to register with the eRA Commons or ensure their existing eRA Commons account is affiliated with the eRA Commons account of the applicant organization.
All registrations must be completed by the application due date. Applicant organizations are strongly encouraged to start the registration process at least4-6 weeks prior to the application due date.
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 PD(s)/PI(s), visit the Multiple Program Director(s)/Principal Investigator(s) Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the PHS398 Application Guide.
Center leadership (including the PD(s)/PI(s)) must possess the necessary operational, business, and scientific expertise with a documented track record of success in transitioning technologies from the discovery phase to commercialization.
This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.
NIH will not accept any application in response to this FOA that is essentially the same as one currently pending initial peer review unless the applicant withdraws the pending application.
In response to this FOA, an institution can only submit, or be part of, a single application. Applications should include detailed evidence of significant institutional commitment.
Applicants are required to prepare applications according to the current PHS 398 application forms in accordance with the PHS 398 Application Guide.
It is critical that applicants follow the instructions in the PHS398 Application Guide, except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.
Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.
By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:
The letter of intent should be sent to:
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: [email protected]
Applications must be prepared using the PHS 398 research
grant application forms and instructions for preparing a research grant
application. Submit a signed, typewritten original of the application,
including the checklist, and three signed photocopies in one package to:
Center for Scientific Review
National Institutes of Health
6701 Rockledge Drive, Room 1040, MSC 7710
Bethesda, MD 20892-7710 (U.S. Postal Service Express or regular mail)
Bethesda, MD 20817 (for express/courier service; non-USPS service)
At the time of submission, two additional paper copies of
the application and all copies of the Appendix files must be sent to:
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
Fax: 301-480-0730
Email: [email protected]
All page limitations described in the PHS398 Application Guide and the Table of Page Limits must be followed, with the following exceptions or additional requirements: as described in Section IV.6
All instructions in the PHS398 Application Guide must be followed, with the following additional instructions:
Resource Sharing Plan
Individuals are required to comply with the instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model Organisms, and Genome Wide Association Studies (GWAS)) as provided in the PHS398 Application Guide, with the following modification:
Letters of Support
Include documentation of support for the Center for non-federally funded activities as described in Section IV.6 under Special Instructions.
Appendix
Do not use the Appendix to circumvent page limits. Follow all instructions for the Appendix (please note all format requirements) as described in the PHS398 Application Guide.
Part I. Overview Information contains information about Key Dates.
Information on the process of receipt and determining if
your application is considered on-time is described in detail in the PHS398
Application Guide.
Applicants may track the status of the application in the eRA Commons, NIH’s electronic system for grants
administration.
This initiative is not subject to intergovernmental review.
All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH Grants
Policy Statement.
Pre-award costs are allowable only as described in the NIH Grants
Policy Statement.
The federal funds provided by an NIH Center for Accelerated Innovations award should only be used for advancing the allowable research-related elements of the Center (see Section IV.6 under Special Instructions, Resources and Funding Plan).
Applications must be received on or before the due dates in Part I. Overview Information.
All instructions in the PHS398 Application Guide must be
followed except as noted below.
The Research Strategy section should take the following structure:
A. Overview of the proposed Center (up to 12 pages)
Provide the overall objectives of the Center, including the short and long-term goals. Describe how the Center's expertise, capabilities, partnerships, and resources will enable it to have a significant influence on accelerating the pace and increasing the probability of success for discoveries and innovations being developed into commercial products. Provide a detailed description of the Center’s leadership team. Describe the criteria used to select the partners, explain why they elected to join, and describe the qualities and strengths that each Partner brings to the Center. Describe how the Center will facilitate and promote interaction with existing institutional, local, virtual, and NIH or other federal, state, or local government programs.
The application should include a plan for transition of the Center to a self-sustainable architecture. Sustainability plans could include agreements for equity or percentage of royalties from successful technologies that could be used for future product definition studies. Applicants should include such agreements with the source institution in the Consortium/Contractual Agreements section of the Research Plan that clearly delineate a reasonable sustainability plan.
B. Center Administration and Governance (up to 12 pages)
Administrative Management Plan
Applicants should provide an administrative plan appropriate for effective management of a complex Center structure. Center leadership, including PD(s)/PI(s), should demonstrate the necessary operational, business, and scientific expertise with a documented track record of success in transitioning technologies from the discovery phase to commercialization. For applications designating multiple PD(s)/PI(s), describe the rationale for choosing a multiple PD(s)/PI(s) approach and provide a leadership plan. (Note: For multi-PD(s)/PI(s) applications, include the leadership plan under the "Center Administration" section of the application and do NOT use the multi-PD(s)/PI(s) leadership section of the PHS398 form). One or more Associate Directors should be named who will be involved in all aspects of Center operations and who will serve as Acting Center Director in the absence of the Director. Applicants must include a description of the process that would be used to recommend a successor to the Director, should unanticipated circumstances require such action. For all applications (single and multiple PD(s)/PI(s)), describe the governance and organizational structure of the leadership team, research projects, and Partners. Include communication plans, processes for making decisions on scientific direction, and procedures for resolving conflicts. Delineate the roles and administrative, technical, and scientific responsibilities for the project staff as they relate to the various functions of the Center. Include a plan to integrate and coordinate Center activities to accomplish overall goals. Define appropriate short and long term metrics to evaluate the overall success of the Center achieving short and long term goals, including tracking the progress of technologies after exit from the Center.
The Centers should promote and facilitate the open exchange of information regarding the scope, methods, analysis, results and lessons learned from each project. Data from failed projects should be collected and analyzed to capture lessons learned from those experiences. The applicant should describe the plan to promote information exchange and the dissemination of research outcomes to the research community at large. Establishing an open access repository for collecting such knowledge is encouraged.
External Advisory Board
Each Center is required to form an External Advisory Board (EAB) that includes people familiar with the Center’s environment and possessing expertise with competencies required to assess the technology development processes and progress (e.g., technology transfer and intellectual property, business practices, science, legal, new venture funding and activities, technology commercialization, emerging market opportunities, industry, relevant domain expertise). EAB members should be from outside the host institution(s). The EAB advises on Center operations, provides guidance on future directions of the Center, and facilitates access to non-federal resources. The EAB will also provide connections and access to resources (e.g. legal, business plan development, regulatory, funding, mentors etc.) for Innovators during the technology development process. NHLBI Program Officer(s) will also participate on the EAB.
The Center applicant should provide the names and affiliations of up to three members of the EAB and describe how their experience and expertise relates to the goals of this FOA and will contribute to the success of the Center. Letters of Support from these members should be included in the application. The NHLBI recognizes that the EAB will most likely include more than 3 members; however, the applicant should not name more than 3 members in the application. The qualities and expertise of additional EAB members should be described; however, they should not be named in the application or contacted or appointed prior to review. The EAB should meet at least quarterly during the first year and then as needed to provide oversight and meet the FOA requirements. The EAB must meet in person at least once annually. The EAB should prepare a written report of its recommendations to the Center PD(s)/PI(s). This report, along with the PD(s)/PI(s) response to EAB recommendations, must be supplied as part of the Center Annual Progress Report. Funds should be requested in the Consultant Costs category of the budget to support EAB member travel expenses for the annual meeting.
External Selection Committee
Each Center is required to assemble a cadre of experts to serve as reviewers on the External Selection Committee (ESC). The ESC should be assembled only after an NCAI is awarded; therefore the members of the committee shoud not be named in the application. This committee will review and prioritize candidate technologies for acceptance into the Center. It is expected that the Center will have processes in place that ensure fair, equitable, unbiased, and timely evaluation of candidate technologies. ESC members should be from outside the host institution(s) and represent a balance of expertise covering both scientific and business aspects of technology development and commercialization. It is anticipated that some of the ESC reviewers will vary depending on the particular technology under review. Funds should be requested in the budget for the conduct of the ESC sessions. ESC recommendations will undergo secondary review by the NHLBI Technology Review Committee as described in Section VI. 2 under Cooperative Agreement Terms and Conditions of Award.
Program Steering Committee
A Program Steering Committee (PSC) will be created that includes NHLBI, FDA, USPTO, OIE, and CMS staff, Center PD(s)/PI(s), and other Center staff as appropriate to provide scientific and administrative oversight as described in Section VI.2 under Cooperative Agreement Terms and Conditions of Award. Funds should be requested in the budget for the PD(s)/PI(s) in the Center Administration and Governance section of the budget (and other Center staff as appropriate) to attend the yearly in-person Program Steering Committee meeting in Bethesda, Maryland.
Collaborations and Partnerships
A critical aspect of the Center's administrative function is to establish and effectively manage a range of collaborations and partnerships with other institutions and the community to help advance a technology closer to commercialization. Provide in the application one or more examples of effective cross disciplinary collaborations relevant to technology development that the PD(s)/PI(s) has established, the goals defined for the collaboration, and the outcomes achieved. Describe the most critical aspect of the interaction(s) that made the collaboration successful. Describe processes for problem-solving, communication and prioritizing work. Describe any potential challenges that will be encountered and how these will be overcome.
Commitment and Kick-off Meeting
Application to participate in the NCAI Program should not be undertaken lightly, as it entails a significant commitment in terms of time, organizational skills, and administrative ability. Successful Center applicants will be expected to attend an in-person Kickoff Meeting within two months of award; the meeting will take place in the Washington DC area for one and one-half days. Funds should be requested in the budget for support of Center leadership travel expenses for the Kick-off Meeting.
C. Investigator engagement, technology solicitation, and technology selection (up to 12 pages)
Applicants should provide details on their ability to maintain a robust pipeline of NHLBI mission-relevant candidate technologies at the appropriate stage of development for entry into the Center throughout the period of the award. Applicants should:
D. Technology development by the Center (up to 12 pages)
Recognizing that technology development requirements will differ depending on the technology type, the developmental stage, the Innovator s experience, and the ecosystem resources, describe technology development plans that include:
E. Project Management (up to 6 pages)
Describe project management structure and processes for assessing progress and making go/no-go decisions:
F. Skills Development Component (up to 6 pages)
Active involvement by the PD/PI and other senior Center personnel is required to facilitate mentoring and multidisciplinary developmental activities for the technology Innovators. A lead individual(s) to oversee the organization and activities of the Skills Development Component should be named in Key Personnel. Applicants should provide:
The USPTO and FDA have the following educational materials available:
FDA: http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/ucm232821.htm
http://www.fda.gov/Training/CDRHLearn/default.htm
http://www.fda.gov/Training/ForHealthProfessionals/default.htm
USPTO: http://www.uspto.gov/products/index.jsp
http://www.uspto.gov/ip/training/index.jsp
http://www.uspto.gov/inventors/iac/index.jsp
The USPTO will make available customized IP education and mentorship to entrepreneurs and Innovators associated with winning applications.
The United States Economic Development Administration’s Regional Offices will offer assistance to winning applicants to advance local economic growth by creating a regional ecosystem necessary to promote innovation and entrepreneurship.
Upon receipt, applications will be evaluated for completeness by the Office of Scientific Review and responsiveness by the NHLBI, NIH. Applications that are incomplete or nonresponsive will not be reviewed. Include separate budgets for each component (Center Administration and Governance; Investigator Engagement, Technology Solicitation, Technology Selection; Technology Development, Project Management, Skills Development).
The Center Director/Principal Investigator (PD/PI) is required to devote at least 3 person-months (25%) effort to manage the Center. For applicants proposing multiple PD(s)/PI(s), the total combined effort of all PD(s)/PI(s) should be at least 3 person-months (25% effort), with a distribution that is commensurate with each PD(s)/PI(s) role, and with an amount of effort that demonstrates significant involvement of each PD(s)/PI(s). A management structure that facilitates effective interdisciplinary communication is strongly encouraged. The percent effort for each member of the Center staff should be broken down by component (Center Administration and Governance; Investigator engagement, Technology Solicitation, and Technology Selection; Engagement, Technology Solicitation, Technology Selection, Technology Development, Project Management; Management Skills Development). The budget should include a detailed justification for key personnel.
Show the entire budget period and the total dollars on the PHS398 Face Page. Categorical budget details can be provided for the additional years (>5) by using more than one Form Page 5.
Evaluation of Responsiveness
Prior to peer review, the NHLBI Office of Scientific Review and Program staff will determine whether applications are responsive to this FOA. All applications will be administratively evaluated to determine whether applicants:
Institutional Commitment: Applicants must provide letters from the appropriate high ranking authorized institutional official including those from the Partners that:
Resources and Funding Plan: Applicants must submit a Resources and Funding Plan, which includes details on resources that have already been secured or are anticipated during the project period to support product definition studies and any evidence of non-federal fundraising plans. It is expected that the level of non-federal funding will be equal to or greater than the NHLBI funds being requested throughout the project period. The Resources and Funding Plan should include the following subsections:
1. Additional Resources and Strategic Partnerships
Indications of institutional support will be considered a strength in the review of these applications and the selection for funding. Sources of additional non-federal funds that equal or exceed the federal investment are strongly encouraged. Appropriate levels of additional non-federal funds must be accessible to achieve the goals of this FOA.
Provide a detailed description of available resources, strategic partnerships, and evidence of non-federal investments that will allow the applicant to meet the requirements of this FOA. Verifiable details on sources of non-federal funding that have already been secured or are anticipated during the project period should be provided. It is expected that the value of the existing resources and non-federal funding will be sufficient to meet the application requirements of this FOA. Include letters of support in Item 14, Letters of Support in the PHS 398 Research Plan Component. Place documentation of support from non-federal resources and funders that corroborates the Resources and Funding Plan, such as term sheets or redacted bank statements, in the Appendix materials.
Examples of additional resources include, but are not limited to, partnerships with law schools or business schools, state economic development agencies, local incubators/accelerators, clinical research organizations, clinical trials networks or other existing resources in place at the Center. Sources of non-federal funding could include, but are not necessarily limited to, foundations, participating institutions, a State or local governmental body, angel investors, venture capital firms, individual benefactors, or any combination of the above. Applicants may also value in-kind support if it represents a substantial resource available to the Center in meeting the requirements of this FOA. Within the Resources and Funding Plan, applicants should clearly itemize the resources and funding that will be secured and indicate the total value (see Use of Non-Federal Resources and Funds below). If the fundraising efforts of the Center are in progress at the time of submission, and/or if the third-party funding is contingent upon NIH selecting the application for funding, then such plans should be clearly described in the Resources and Funding Plan.
Examples of adequate documentation of planned (i.e., future/expected) non-federal resources and funding may include a term sheet and/or letter of commitment from the source of funds or resources stipulating the terms of the proposed commitment/investment, although other forms of documentation may be considered. At the time of application, evidence of a firm non-federal funding commitment is ideal, but not required. Appropriate documentation of non-federal resources and funding support may include a conditional letter of commitment stating that the third-party commitment/funding is contingent upon NIH selecting the application for an award.
Successful applicants may be provided access to USPTO programs to assist with their specific intellectual property needs. Visit/contact the USPTO Inventor Assistance Center to explore available intellectual property resources that may be incorporated into the applicant’s Resources and Funding Plan.
2. Use of Non-Federal Resources
The federal funds provided by this award can only be used for advancing the research-related elements of the Center, such as the laboratory based or design aspects of product definition studies, salary support, and activities associated with investigator engagement, solicitation, project management and skills development activities. The use of any non-federal funds and resources will be at the discretion of the Center. Applicants should provide sufficient information regarding the use of non-federal support to demonstrate a substantial, value-added contribution toward the goals of this FOA. In particular, applicants are expected to address the following questions regarding the use of non-federal resources and funds.
A separate table delineating the non-federal funds for anticipated technology development costs (research and development, business plan development, market research, legal counsel and other non-scientific consultant costs) may be included in the appendix to demonstrate institutional commitment and/or access to additional required capital.
3. Statement of Need
Applicants must provide a concise Statement of Need . This statement is expected to provide answers to the questions listed below:
4. Technology Licensing
The relationship between the Center and the technology transfer office(s) must be described and should enable the most appropriate path to develop a technology towards commercialization. Any agreements between the Center and the technology source institution designed to reduce the burden of licensing and hurdles to downstream commercialization of technologies should be described. Examples may include institutional template agreements that are designed to facilitate technology transfer to the private sector with license terms that defer up-front cash payments and avoid onerous fees. Include descriptions of all agreements for equity positions or royalty payments that the Center will receive from successfully commercialized technologies. It is expected that Centers will use these returns to support future product definition studies. Appropriate documentation (Letters of Support, Agreements, and Memoranda of Understanding) should be included in the application in the Letters of Support or Consortium/Contractual Agreements sections as appropriate.
Pre-submission Meeting
The NIH recognizes that individual institutions will be able to respond in different ways to the opportunities presented in this FOA. Applicants are strongly encouraged to contact NIH program staff early in the application process and they should have a thorough understanding of the intent and expectations of this FOA before developing an application. A pre-submission meeting will be conducted at the NHLBI offices (6701 Rockledge Drive., Room 9112/9116, Bethesda, MD) on June 15th, 2012 from 1pm to 4pm EST. The NHLBI, NCAI partners, and other NIH staff will explain the goals and objectives of the NCAI program and answer questions. For applicants that cannot participate in person the event will be webcast at https://webmeeting.nih.gov/nhlbicentersrfa/. NHLBI requests that participants register by June 8 via e-mail at [email protected], and indicate whether they will attend in person or via the webcast. Please visit the Centers website at http://www.nhlbi.nih.gov/about/dera/otac/caip/caip_index.html for answers to commonly asked questions about the program. Submit additional questions to be addressed at the presubmission meeting in advance of the event at [email protected]. Questions and answers will be posted on the Centers website after the call. Additional information about the event is available at the Centers website.
Applicants are required to follow the instructions for post-submission materials, as described in NOT-OD-10-115.
Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.
Reviewers will provide an overall impact/priority score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).
Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.
Significance
Does the project address an important problem or a critical barrier to progress in the field? 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?
Specific for this FOA: How will an award enhance the Center’s ability to conduct the scientific feasibility studies in a way that will further the goals of the Center? What activities will be enabled that are not possible or practical without the award?
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(s)/PI(s), do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?
Specific for this FOA: Does the Center leadership (including the PD(s)/PI(s)) demonstrate the necessary operational, business and scientific expertise to run a Center with a documented track record of success in transitioning technologies from the discovery phase to commercialization? Does the Center have the ability to address regulatory issues, including but not limited to knowledge of guidelines and experience taking products through the regulatory process? Does the Center have a functional succession plan in place in the event of a change in 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?
Specific for this FOA: Does the applicant create the unique public private partnerships with an integrated environment of resources required to inform the scientific feasibility studies in a way that will bridge the gap between the laboratory and market?
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?
If the project involves clinical research, are the plans for 1) protection of
human subjects from research risks, and 2) inclusion of minorities and members
of both sexes/genders, as well as the inclusion of children, justified in terms
of the scientific goals and research strategy proposed?
Specific for this FOA: Will the solicitation, selection and technology development processes result in the identification and advancement of NHLBI mission-relevant technologies? Does the applicant have appropriate decision-making processes in place to make timely milestone-driven go/no-go decisions about technologies being developedHow adequate are the proposed evaluation plans and metrics?
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?
Specific for this FOA: Does the applicant have the business alliances or partnerships to transition technologies from discovery to the next stage of independent financing? Does the applicant demonstrate and utilize its core competencies to maximize the chance of success? Does the applicant demonstrate the necessary agreements and relationship with the TTO to ensure the most appropriate path for product definition and exit? How do the Partners, that comprise the Center, together add value and economy of scale to the product definition process that enhance the likelihood of successful technology development towards commercialization? How are disputes resolved between the Center and the technology source institution and the Innovator?
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/priority score, but will not give separate scores for these items.
Review Criteria for Center Administration
To what extent will the award increase the potential to commercialize new technologies compared to what would likely be commercialized without an award?
What is the quality of the organizational structure of the Center and does this structure indicate an ability to integrate the full range of Center functions to achieve the specified goals and work effectively at the clinical/technology/business interface?
How does the quality of the information provided in the application demonstrate ability to effectively manage multidisciplinary projects and deal with sensitive but critical go/no-go decisions in a team-based environment?
How well do the applicants demonstrate that the Center possesses knowledge of and relationships with appropriate stakeholders and user groups?
What is the quality of the plans for enlisting ESC and EAB members and how well developed are plans to minimize and manage potential conflicts?
Review Criteria for technology solicitation and selection
Does the applicant clearly demonstrate access to a diverse portfolio of technologies to sustain the development pipeline for the duration of the award?
How well does the Center's strategy for selecting Product Definition projects suggest potential for meaningful outcome in the chosen health care setting or clinical application area?
Will the Center's technology evaluation processes enable selection of promising technologies for further development and testing?
Review Criteria for technology development
Does the proposed Center bridge the gap between the lab and the market, create unique public-private partnerships with an integrated environment of resources that maximize capital investments and leverage private with public investment? Does the proposed Center remove barriers to translate knowledge into useful medically relevant products, and encourage the culture needed for sustained technology development where evaluation of innovations for commercialization becomes the norm? Has the applicant developed or adopted streamlined IP strategies for licensing agreements and equity/royalty partitioning to enhance the success and sustainability of the Center?
How reasonable are the plans for obtaining non-federal funds to perform the scientific feasibility studies, acquiring community resources or promoting community involvement in the Center’s activity?
How well does the IP strategy ensure successful due diligence, IP protection and cost coverage and reduce the licensing burden for advancing technologies toward commercialization?
How well do the applicants demonstrate ability to access appropriate domain experts and mentors?
How well does the application support the ability of the Center to access required business expertise as expected in this FOA?
What time or cost savings might be realized as a result of the award?
Review Criteria for project management
Does the application describe a project management structure that will efficiently and effectively promote the transition of early stage technologies through development processes required for successful transition to the private sector?
Review Criteria for skills development
Is the Skills Development Component structured in a way that facilitates the transfer of knowledge about technology development and commercialization to the Innovator and the broader investigator community?
Protections for Human Subjects
For research that involves human subjects but does
not involve one of the six categories of research that are exempt under 45 CFR
Part 46, the committee will evaluate the justification for involvement of human
subjects and the proposed protections from research risk relating to their
participation according to the following five review criteria: 1) risk to
subjects, 2) adequacy of protection against risks, 3) potential benefits to the
subjects and others, 4) importance of the knowledge to be gained, and 5) data
and safety monitoring for clinical trials.
For research that involves human subjects and meets the criteria for one or
more of the six categories of research that are exempt under 45 CFR Part 46,
the committee will evaluate: 1) the justification for the exemption, 2) human
subjects involvement and characteristics, and 3) sources of materials. For
additional information on review of the Human Subjects section, please refer to
the Human
Subjects Protection and Inclusion Guidelines.
Inclusion of Women, Minorities, and Children
When the proposed project involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines.
Vertebrate Animals
The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.
Biohazards
Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.
Resubmissions
Not Applicable.
Renewals
Not Applicable.
Revisions
Not Applicable.
As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score.
Applications from Foreign Organizations
Not Applicable.
Select Agent Research
Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).
Resource Sharing Plans
Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genome Wide Association Studies (GWAS).
Budget and Period of Support
Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.
Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the NHLBI, in accordance with NIH peer review policy and procedures, using the stated review criteria. Review assignments will be shown in the eRA Commons.
As part of the scientific peer review, all applications:
Appeals of initial peer review will not be accepted for applications submitted response to this FOA.
Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center and will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
After the peer review of the application is completed, the PD(s)/PI(s)( 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.
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,
CCR Registration, and Transparency Act requirements as noted on the Award
Conditions and Information for NIH Grants website.
All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.
The following special terms of the award are in addition to and not in lieu of, otherwise applicable OMB administrative guidelines, HHS grant administration regulations at 45 CFR Parts 74 and Part 92, and other HHS, PHS, and NIH grant administration policies.
The administrative and funding instrument used for this program will be the cooperative agreement (U54), an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the awardees is anticipated during the performance of the activities. Under the cooperative agreement, the NIH purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the awardees for the project as a whole, although specific tasks and activities may be shared among the awardees and the NIH as defined below.
The NIH Centers for Accelerated Innovations consist of the Center Awardees under this FOA.
The PD(s)/PI(s) will have the primary responsibility for:
The PD(s)/PI(s) will have the primary responsibility to define objectives and approaches of the Center and to plan, conduct, analyze, and publish results, interpretations, and conclusions of the studies. The primary responsibilities of the awardees are to:
Awardees will retain custody of and have primary rights to the technologies, data, and software developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
If change of a PD/PI is necessary, support of the award is not automatic, but may be continued with NIH funding component prior approval, provided that: The Center leadership has submitted a written request for a change of Program Director, countersigned by the Cooperative Agreement Principal Investigator and the appropriate institutional business official, to the NIH Program Staff describing the reasons for the change. The Biographical Sketch of the proposed new PD/PI must be provided. The information in the request establishes that the purpose of the Center Program to be conducted under the direction of the new Program Director will remain unchanged, and that the new Program Director has the appropriate technology development and administrative expertise to lead the Center. The request must be submitted far enough in advance of the requested effective date to allow the necessary time for review. Requests for change of institution will not be accepted.
NIH Responsibilities:
NIH Staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below
The NHLBI Project Scientist(s) (Officer) will:
Additionally, an NHLBI Program Officer will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.
The NHLBI Program Officer will:
NHLBI Technology Review Committee will make final product definition project selections based on Center and ESC recommendations and NHLBI priorities. The committee comprises NHLBI, USPTO, OIE, CMS and FDA representatives. FDA, OIE, CMS and USPTO staff serves in an advisory capacity, while NHLBI staff makes the final decisions. The NHLBI Technology Review Committee will meet as needed, and provide technology selection recommendations to the Center PI(s) and the EAB.
The NHLBI will conduct an administrative review after four years that will include outside expertise to evaluate the effectiveness of each Center at meeting the requirements of this FOA and meeting the metrics and milestones defined by the applicant. The results of the review will guide the NHLBI in determining the level and duration of each Center’s funding for the remaining years of the awards, and whether or not to renew the program.
Areas of Joint Responsibility Include:
The NHLBI Project Scientist and the PD(s)/PI(s) of each Center funded under this FOA will be responsible for forming a Program Steering Committee (PSC). The PSC will act as the main governing board across the multiple awards and will review the progress of the research activities, develop collaborative protocols, identify technological impediments to the progress, select strategies to surmount them, and identify opportunities for sharing techniques and tools developed within each Center.
The Program Steering Committee will:
Each PSC member will have one vote and will be required to accept and implement policies approved by the Committee. The NHLBI will have only one vote. The PSC may, as it deems necessary, invite additional, non-voting scientific advisors to meetings at which research priorities and opportunities are discussed.
The Program Steering Committee will meet in person once a year at a minimum, with additional meetings scheduled as necessary to accomplish the goals of the program.
The NHLBI is responsible for organizing and providing overall support for the Centers. In addition to regular grant stewardship, the NHLBI Project Scientists will be involved substantially with the awardees as partners, consistent with the Cooperative Agreement mechanism. The FDA, OIE, CMS, and USPTO will work collaboratively with the NHLBI to provide regulatory and IP related support and resources.
Dispute Resolution:
Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to arbitration. An Arbitration Panel will be convened. It will have three members: a designee of the Program Steering Committee chosen without NIH staff voting, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special arbitration procedure in no way affects the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulations 42 CFR Part 50, Subpart D and HHS regulations 45 CFR Part 16.
When multiple years are involved, awardees will be required to submit the Non-Competing Continuation Grant Progress Report (PHS 2590) annually and financial statements as required in the NIH Grants Policy Statement.
A final progress report, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.
The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.
We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.
GrantsInfo (Questions regarding application instructions and
process, finding NIH grant resources) Telephone 301-710-0267
TTY 301-451-5936
Email: [email protected]
eRA Commons Help Desk (Questions regarding eRA Commons
registration, tracking application status, post submission issues)
Phone: 301-402-7469 or 866-504-9552 (Toll Free)
TTY: 301-451-5939
Email: [email protected]
Kathleen Rousche, PhD
Scientific Program Manager
Office of Translational Alliances and Coordination
Division of Extramural Research Activities
National Heart, Lung and Blood Institute
6701 Rockledge Drive, MSC 7924, Room 7215
Bethesda, MD 20892
Phone: 301-496-2149
Direct: 301-594-5507
Email: [email protected]
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Room 7214
Bethesda, MD 20892-7924
Bethesda, MD 20817 (express/courier service)
Telephone: 301-435-0270
Fax: 301-480-0730
[email protected]
Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).
Theresa Jarosik
Division of Extramural Research Activities
National Heart, Lung, and Blood Institute
6701 Rockledge Drive, Room 7128 (MSC 7926)
Bethesda, MD 20892 (Express Zip Code: 20817)
Telephone: 301-435-0166
Email: [email protected]
Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.
Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.
Weekly TOC for this Announcement
NIH Funding Opportunities and Notices
|
| ||||||
|
|
|
Department of Health and Human Services (HHS) |
|
|||
|
NIH... Turning Discovery Into Health® |
||||||