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FAQs in response to NOT-HL-12-156 and Notice-HL-12-157:

Notice of Change of Award Information and Receipt Date for RFA-HL-13-008 “The NIH Centers for Accelerated Innovations (U54) (NOT-HL-12-156)
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Notice of Change in Scope and Additional Information and Clarifications for RFA-HL-13-008 The NIH Centers for Accelerated Innovations (U54) (NOT-HL-12-157)

A. RATIONALE FOR CHANGE

A1: What drove NHLBI’s decision to modify the RFA two days before the application deadline?

It is widely recognized that the NIH budget is currently faced with major fiscal challenges that will require a streamlining of many of our new initiatives in accordance with our responsibility as stewards of public funds. These fiscal realities have compelled us to modify the budget plan for the NCAI accordingly. As originally conceived by a working group of distinguished outside experts, the NCAI program is most likely to succeed if it consists of at least two and perhaps three centers. It had been anticipated that other components of the NIH would join the NHLBI in this effort so that multiple centers could be established. Unfortunately, because of the continued uncertainty of the budget situation and the substantial financial commitment associated with participation in the NCAI program, the NHLBI is currently the sole supporter of this initiative. As soon as it became clear to us that the program launch would be limited to NHLBI resources, we were forced to reconsider the implementation of the program. Our decision was to retain the overall level of the NHLBI’s financial commitment to the program, but to expect the financial commitment to be distributed among 1-3 centers that can effectively leverage resources. Out of respect for applicants who submitted a letter of intent, it was decided to convey this change to applicants prior to peer review and provide them an opportunity to revise their applications accordingly. It was our judgment that this rapid communication of the change in fiscal circumstances was the most appropriate action on behalf of our investigator community, rather than imposing any budgetary changes post-review. We disseminated that decision as soon as it was made. Please visit the Centers NOT-HL-12-156 page for a more detailed explanation.

B. APPLICATION SUBMISSION/WITHDRAW INFORMATION

B1: What is the new application due date?

October 19, 2012

B2: What should I do if I already submitted my application? Do I have to withdraw my application?

No, you do not need to withdraw your application. You have two choices:

  1. If, after reading the content of the Notice, you feel comfortable with your application as originally proposed, you may do nothing and your application will be reviewed with other applications we receive.
  2. If you would like to submit a modified application, then you will first need to withdraw your original application. You can then submit a modified application on or before the new receipt date.

B3: How do I withdraw my application?

To withdraw an application, please send a letter stating you would like to withdraw your application to:

Valerie Lambert Prenger, PhD, MHS
Director, Office of Scientific Review
National Heart, Lung, and Blood Institute
Rockledge Centre II, Room 7214
6701 Rockledge Drive
Bethesda, Maryland 20892-7924 (express mail zip: 20817)
301-435-0270
301-480-0730 (Fax)

The NHLBI needs an original, signed letter containing the following information:

1. RFA number
2. Contact PI Name
3. Grant Title
4. Original grant submission date
5. Statement saying that you would like to withdraw the application
6. Signature of Institutional Signing Official
7. Signature of contact PI

To start the process, you may fax the letter to Dr. Prenger at the Office of Scientific Review and follow that by mailing the original.

B4: What if we already sent in the application and it’s within the newly posted budgetary guidance?

If you have sent your application in and it will not be revised, there is no need for it to be withdrawn and re-submitted.

C. FUNDING AND NUMBERS OF AWARDS

C1: Has the NHLBI commitment of funds changed?

No. The NHLBI intends to commit up to $2M in years 1 and 7, and up to $4M in years 2-6.

C2: Is the program changing from a 7-year to a one-year?

No. An applicant for a Center may request a project period of up to 7 years. The NHLBI’s maximum total budget for the program remains $24M for a 7-year funding period.

C3: Has the number of awards changed?

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 one to three awards for fiscal year 2013.

C4: If the NHLBI makes >1 award, will the $2M be divided equally per awardee?

The number of awards and the amount of each award will be determined by the NHLBI after considering the requested budgets and the recommendations made as part of the peer review process.

D. BUDGET INFORMATION

D1: How does increasing the number of awards affect our budget and why does it delay submission?

The plan to allow for support of an increased number of awards means that the available funds may now be distributed among up to three applications rather than concentrated on one application. The date for submission was delayed to permit applicants to revise their respective budgets should they wish to do so.

D2: Is a budgetary adjustment required?

No. However, applicants may want to consider the available funds and the planned number of awards in deciding whether an adjustment is desirable.

D3: How does the NHLBI recommend that applicants revise budgets to accommodate the change in possible award number, without knowing the number of available awards?

In deciding whether to revise an application, investigators may want to consider the Institute’s plan to allow for support of an increased number of awards and its implication that the available funds may now be distributed among up to three applications rather than concentrated on one application. In considering how to revise your budget to fit within potential reduced award amounts, please note that the modified FOA will afford you the flexibility to restructure your budget in ways that you believe will maximize the generation of commercially viable technologies. Specifically, the FOA will no longer include any prescriptions regarding numbers and mix of technologies (i.e., therapeutics/preventatives, devices, diagnostics) in the Center portfolio at any given time. It is anticipated that the most responsive applications will seek to maximize the investment in technology development studies relative to expanding infrastructure costs.

D4: How does the NHLBI recommend streamlining the budget if proposed infrastructure is already lean?

The NHLBI is not able to make such recommendations. Peer review will consider the relative allocation of costs between technology development studies and infrastructure in each application.

D5: Will the NHLBI request/allow budget modifications after peer-review for meritorious applications?
Awards will be made so that the result is a program that is most likely to be effective in achieving the goals of the NCAI program.

E. SCOPE

E1: What guidance does the NHLBI have regarding changing the scope of the application?

In considering how to revise your budgets to fit within potential reduced award amounts, please note that the modified FOA will afford you the flexibility to restructure your budget in ways that you believe will maximize the generation of commercially viable technologies. Specifically, the FOA will no longer include any prescriptions regarding numbers and mix of technologies (i.e., therapeutics/preventatives, devices, diagnostics) in the center portfolio at any given time. Further, guidance on suggested dollar limits to support individual projects has been removed. It is anticipated that the most responsive applications will seek to maximize the investment in technology development studies relative to expanding infrastructure costs.

E2: What does “Please make appropriate adjustments to your budget while continuing to maximize the number of technologies moving through the Center” mean?

Appropriate budget adjustments are those that in your view would be most likely to influence a funding decision. Since the objective of the program is to move innovative technologies along toward commercialization, applications that seek to maximize the investment in technology development studies relative to expanding infrastructure costs would be more likely to be viewed favorably in making funding decisions.

E3: Can the applicant adjust the type of technologies selected in any given year in order to meet the reduced budget requirements?
Yes. The FOA will no longer include any prescriptions regarding the type or mix of technologies (i.e., therapeutics/preventatives, devices, diagnostics) in the center portfolio at any given time.

E4: Can the applicant reduce the number of technologies going through the Center in any given year to meet the reduced budget requirements?

Yes. The FOA will no longer include any prescriptions regarding numbers of technologies in the center portfolio at any given time.

E5: Is there suggested dollar limit not to exceed for individual technology development?

No. Guidance on dollar limits to support individual projects has been removed.

F. Review of Applications

F1: How will the reviewers judge applications that have modified budgets (possibly with smaller numbers of technologies with less breadth) compared to those applicants that did not change budgets in response to the Notices?

The applications will be scored on their strength using what technologies have been proposed. Reviewers do not compare one application to another. The budget will be recommended or changes to the budget recommended based on what is proposed in that specific application.

Reviewers will be informed of the Notices regarding the RFA and the changes prior to review. The NHLBI will inform reviewers that the numbers and breadth of technologies proposed will vary between applications and should not be a consideration in their scoring.

Frequently Asked Questions (FAQs) NIH Centers for Accelerated Innovations

FOA Clarifications:

1. How many budget components are to be submitted?

A separate budget component should be submitted for the following components found in the Research Strategy Section:

  • Center Administration and Governance
  • Investigator engagement, technology solicitation, and technology selection
  • Technology development by the Center
  • Project Management
  • Skills Development Component

2. Is a Resource Sharing Plan Required?

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.

3. Are the terms PI and Center Director used interchangeably in the Administrative Management Plan Section of the FOA (see Section IV.6, Research Strategy, B. Administration and Governance, Administrative Management Plan)?

Yes.

4.Please note the correction under Special Instructions, Resource and Funding Plan, 3. Statement of need, bullet three.

Current language:

What will be the impact of an award under this FOA on the Center’s ability to conduct the required Product Definition Studies to advance technologies toward commercialization? In answering the question, please provide the current success rate of technology commercialization at the Center and the anticipated impact of an award on the success rate.

Modified Language:

What will be the impact of an award under this FOA on your current institution's ability to conduct the required Product Definition Studies to advance technologies toward commercialization? In answering the question, please provide the current success rate of technology commercialization at your current institution and the anticipated impact of an award on the success rate.

A. GENERAL INFORMATION

A1: When will the awards be made?

RESPONSE: The estimated award date is Summer 2013.

A2: When are letters of intent due?

RESPONSE: The letters of intent are due August 19th, 2012.

A3: When are applications due?

RESPONSE: The application must be received by September 19th, 2012.At the time of submission, please remember to send two additional paper copies of the application (and all copies of the Appendix files) 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: nhlbichiefreviewbranch@nhlbi.nih.gov

A4: How many Centers will the NHLBI fund?

RESPONSE: The number of awards is contingent on the NIH appropriations, as well as the submission of a sufficient number of meritorious applications.

A5: May the Center be virtual?

RESPONSE: Yes.

A6: Does the applicant have to be a non-profit?

RESPONSE: No.

A7: May an institution send in more than one application?

RESPONSE: No. An institution can only submit, or be part of, a single application.

A8: If there is a leadership change at the NHLBI, will the program continue to be supported?

RESPONSE: The NHLBI does not anticipate that a change in leadership will affect support for this program.

A9: Does the applicant institution need to be a degree granting institution?

RESPONSE: No

A10: Is there a page limit on the Resources and Funding Plan?

RESPONSE: The Resources and Funding Plan is included as a portion of Part D. Technology Development by the center, in the Research Strategy section. Part D has a total page limit of 12 pages. A detailed description of the Resources and Funding Plan is found under Special Instructions of Section IV. 6.

A11: Does the applicant institution need to be the recipient of an NIH Clinical and Translational Science Award?

RESPONSE: No.

A12: Given the breadth and scale of expertise that the NHLBI is requesting for program leadership, is the NHLBI exceeding the NIH salary cap?

RESPONSE: No. The NHLBI is obligated to follow the current NIH policy regarding salary limitations.

A13: Is this a trans-NIH program?

RESPONSE: The NHLBI is currently the only Institute/Center (IC) funding the program. If other ICs join the program, this will broaden the scope of technologies available to enter the Centers.

B. PROGRAM DIRECTOR(S)/PRINCIPAL INVESTIGATOR(S) and LEADERSHIP

B1: What are the qualities of an ideal PD/PI?

RESPONSE: The Center PD(s)/PI(s) should demonstrate the necessary operational, business, and scientific expertise, as well as a documented track record of success in transitioning technologies from the discovery phase to commercialization.

B2: Are multiple PD(s)/PI(s) allowed?

RESPONSE: Yes. Please see Section IV.6 of the FOA.

B3: Is there a preference regarding single versus multiple PD/PI leadership?

RESPONSE: No.

B4: Given the requirements for the Center Director, are qualified personnel expected to come from an academic department (research faculty) or from an administrative unit (such as the technology transfer office, office of industrial relations, etc.)?

RESPONSE: The origin of the PD(s)/PI(s) is not pre-conceived. The Center leadership has to have the expertise necessary to fulfill the qualifications listed in the FOA.

B5: Does the PD(s)/PI(s) expertise in commercialization of technologies have to be in the NHLBI space?

RESPONSE: No

B6: If the multiple PD/PI mechanism is used, may the PD(s)/PI(s) be from different institutions?

RESPONSE: Yes. However, the NIH will require that a single institution be responsible for managing the funds of the award. If a multiple PD/PI mechanism is used, one institution will be a subaward from the main award. An agreement between the PD(s)/PI(s) institutions will need to be attached to the application.

B7: If the Center has an individual from a major corporation on the leadership board, how should the awarding institution pay that individual (consultant, salary, etc.)?

RESPONSE: Payment arrangements for this individual are at the discretion of the awardee institution.

C. FEDERAL AND NON-FEDERAL RESOURCES

C1: What is the NHLBI’s investment in the Centers?

RESPONSE: For each Center, the NHLBI intends to commit up to $24 million total costs over a 7 year period. (The NHLBI intends to commit up to $2 million total costs to each Center funded in fiscal year 2013. 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).

C2: Will resources in addition to the NHLBI investment be required? If so, how much ''additional funding'' does the NHLBI anticipate will be required for a technology to successfully advance through the program?

RESPONSE: Appropriate levels of additional non-federal funds must be accessible to achieve the goals of this FOA. Sources of additional non-federal funds that equal or exceed the federal investment are strongly encouraged. The NHLBI expects applicants to successfully develop technologies so that they are able to attract independent financing.

C3: Does the Center need to demonstrate diversity in non federal funding?

RESPONSE: Diversity in sources of non-federal funding is not required The NHLBI needs to know that you have funding and can access it when needed.

C4: Are in-kind services included as a non-federal resource?

RESPONSE: Yes.

C5: Do additional resources need to be committed at the time of application? At the time of award?

RESPONSE: At the time of application, evidence of a firm non-federal funding commitment is ideal, but not required. 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 award, it is expected that the Center will have additional funding committed that can augment the federal investment for product definition studies. 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.

C6: Are there restrictions on the sources for additional resources?

RESPONSE: Sources of non-federal funding could include, but are not 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 cost-saving resource available to the Center in meeting the requirements of this FOA.

C7: Are there restrictions on the use of federal resources?

RESPONSE: The NIH grant awards provide for reimbursement of actual, allowable costs incurred and are subject to Federal cost principles. General guidance on cost considerations with links to the applicable cost principals for various types of organizations may be found in the NIH Grants Policy Statement at: http://grants.nih.gov/grants/policy/nihgps_2011/nihgps_ch7.htm#cost_considerations

C8: Does the NHLBI funding include indirect costs?

RESPONSE: Yes. The NHLBI intends to commit up to $24 million in total costs over a 7 year period.

C9: Is the amount of additional non-federal funds encouraged based on the total or direct costs?

RESPONSE: The amount of additional non-federal funds encouraged is based on direct costs.

C10: Are there any “strings attached” to the NHLBI funding for Centers?

RESPONSE: No. The NHLBI expects no return on investment outside of accelerating technology development and improving health.

C11: May the award be used to support cores (i.e., imaging)?

RESPONSE: No, not in the traditional way a scientific Core is supported by a Center grant award. Funds from the CAI award may be used to access existing Core services if required to develop a particular technology.

C12: May the Center set up an early-stage investment fund?

RESPONSE: Yes.

C13: What do you envision as the source of funds for a sustainable Center?

RESPONSE: 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, equity, or percentage of royalties from successful technologies that could be used for future product definition studies.

C14: Are conditional commitments from partners acceptable to develop certain types of technologies?

RESPONSE: Yes, but the applicant needs to inform the NHLBI regarding the conditions of the agreement.

C15: The SBIR mechanism funds proof of concept in Phase I. May the applicant use state SBIR funds as part of the match, as there is overlap between SBIR and Center objectives as related to proof of concept?

RESPONSE: There are some overlaps in objectives in the SBIR and Center programs, but the types of institutions that may apply for the funds differs. Non-SBIR State funds for economic development may be leveraged.

C16: Does the NHLBI envision the Centers having incubation space (i.e., experimental work space)?

RESPONSE: The NHLBI anticipates that most work will be conducted in the innovator’s laboratory, but if an applicant has access to incubator space with the required resources, that is acceptable.

C17: What is the level of business planning (market research, commercialization planning, business plan development) that the award may fund?

RESPONSE: This will be dependent on what your institution allows. Federal funds need to be used for expenses covered under the NHLBI mission. Commercialization is generally not funded by the NIH, but leveraging business school students to work with scientists in designing studies to meet business requirements is acceptable.

C18: Given the fact that larger institutions may be able to generate a higher match, how does this affect Review criteria and ranking?

RESPONSE: The NHLBI is considering the ability of the applicant to meet the goals of the FOA, and the review is not institution size or match dependent.

D. PARTNERS AND INSTITUTIONAL SUPPORT

D1. What type of institutional support will be expected for successful applicants?

RESPONSE: Clear evidence of strong institutional commitment from an appropriate senior authorized official(s) will be required.

D2: Do applicant institutions need partners?

RESPONSE: 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 important defined medical and scientific needs.

D3: Is my institution allowed to partner with multiple applicant institutions?

RESPONSE: No. Any given institution can only submit, or be part of, a single application. At the time of submission, applicants and partners should be defined. For example, if institution B is a partner to the applicant institution A, institution B may not also submit separately as the lead applicant.

D4: Should Center partners be regional or national?

RESPONSE: There are no geographical restrictions on partners. However, strong evidence of successful communication and collaboration between partner institutions will be essential.

D5: May an applicant have international/foreign partners?

RESPONSE: Yes. Foreign partners are permitted but may not receive federal funds.

D6: What is the ideal Center/TTO relationship?

RESPONSE: The ideal relationship between the Center and the technology transfer office(s) is one that enables the most appropriate and least time-consuming path to develop a technology towards commercialization. Agreements between the Center and the technology source institution should be designed to reduce the burden of licensing and hurdles to downstream commercialization of technologies. 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 and royalties. An agreement should detail 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 for the relationship includes Letters of Support, Agreements, and Memoranda of Understanding.

D7: What is the purpose of the MOU requested between the awardee institution and the partner institution?

RESPONSE: The MOU between the awardee and its partner(s) will allow the Center to have access to the innovator and the technology should it be chosen for development by the Center.

D8: If an organization has a narrow focus in a specific technology area, is that organization permitted to apply for the award?

RESPONSE: The organization is permitted to apply, however, the FOA requires development of a mixture of technologies.

D9: May the awardee institution partner after the award has been made?

RESPONSE: Yes.

D10: Do the collaborating institutions need to demonstrate past and/or existing collaborations?

RESPONSE: Evidence of an applicant’s past relationship with a proposed Center partner or evidence of a developing relationship with a new partner is considered to be a strength.

D11: Is there a number of partners for which the NHLBI is looking?

RESPONSE: No.

D12: May an applicant partner with a for-profit entity?

RESPONSE: Yes

D13: Are there restrictions on international partnerships for continued development after the technology exits the Center?

RESPONSE: No

D14: May partners receive funding through the successful applicant?

RESPONSE: Yes. The awardee institution will be responsible for managing the subcontract funds of the award.

D15: Do the innovators that apply to have a technology accepted into the Center need to be affiliated with a research institution at the time of application?

RESPONSE: No.

E. PROGRAM SUCCESS/EVALUATION

E1: What are the NHLBI’s metrics of success after 4 years (administrative review)?

RESPONSE: The NHLBI will conduct an administrative review after four years that will include outside experts to evaluate each Center’s effectiveness 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.

E2: What are the NHLBI’s metrics of success after 7 years?

RESPONSE: Long term metrics relevant to the success of the program may include numbers of (a) technology licenses, (b) products to market and their impact on health, (c) companies created, (d) jobs created, (e) returns back to the Center (for sustainability) (f) development partnerships, (g) investigators mentored and trained in the business development process, as well as creation of best practices on developing effective public/private/philanthropic relationships and commercializing federally funded innovations.

E3: What is the scope of successful exits from the Center?

RESPONSE: Successful exits from the Center include new company formation or licensing to an existing for profit or not for profit organization.

E4: Does the NIH have an idea of what ''success'' will look like? When a Center has its interim review, what criteria will be used to assess whether funding continues?

RESPONSE: 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.

E5: Is it possible for a technology that successfully exits the Center to apply directly for a Phase II SBIR grant?

RESPONSE: There is currently no mechanism in place to skip Phase I of the SBIR grant. The reauthorization language suggests that this might be a future possibility. The NHLBI encourages you to review the Small Business Administration public draft document and comment.

E6: Does exit from the Center indicate that the technology has to leave the Center?

RESPONSE: No. An exit from the Center for the NHLBI means that the technology is no longer supported by the Center funds. A technology may stay in the Center and be supported by other resources.

F. CENTER TECHNOLOGIES/TECHNOLOGY DEVELOPMENT

F1: Will the scientific and commercial potential of individual technologies be peer reviewed?

RESPONSE: No. The Center must demonstrate access to adequate numbers of technologies within the NHLBI priorities as instructed in Section IV.6 of the FOA. In the Technology Table requested in Section IV.6 of the FOA, applicants are asked to list no more than one dozen technologies in total to which they have access, including examples of devices, therapeutics, diagnostics, and tools. The scientific and commercial potential of specific technologies described in the application will not be peer reviewed and therefore will not impact the score of the grant.

F2: What type of technologies and how many technologies will a Center be required to develop during a specific time period?

RESPONSE: The terms of the cooperative agreement require that each Center has at least one therapeutic/preventative, one device and one diagnostic concurrently under development. It is anticipated that at least 6 technologies (3 new) will be in some form of development each year from years 2 through year 6 of the award.

F3: How long should a given technology be expected to be in development at a Center?

RESPONSE: The funding from the award will support the technologies in the Center for approximately 1, but not more than 2 years, depending on technology type. After two years, the technology may stay in the Center for further development if supported by alternate resources.

F4: Must technologies being developed by a Center have some type of intellectual property protection?

RESPONSE: The technology must have clear commercial value, which is usually defined as a competitive advantage that is supported by a patent or some other type of intellectual property protection. However, studies conducted within the Center can be designed to achieve IP protection. If a manuscript was published focusing on a technology, it is not commercially viable.

F5: If intellectual property for a technology is owned by a private company, may the technology be offered to an academic institutional consortium for development?

RESPONSE: This does not meet the spirit of educating innovators in technology development/commercialization as one of the goals of the funding opportunity.

F6: Will the costs for patent filing be covered by the Centers award?

RESPONSE: The degree to which costs for patent filing will be covered is institution-dependent. In many instances, patent costs are included under the Indirect Costs of the award.

F7: Must patents for technologies be filed internationally?

RESPONSE: The NHLBI does not make this decision, but for many devices and therapeutics, many of the large companies that may be interested in the products require an international patent.

F8: In the secondary review of technologies, will the NHLBI have veto power over the technologies put forth by the External Advisory Board?

RESPONSE: Technically, yes. The NHLBI needs to confirm that the proposed technology is commercially viable, within our mission, and exhibits significant medical need or scientific opportunity. If we have several technologies, the NHLBI may try to help balance across programs.

F9: As there may be little commercial interest in technologies with small markets (for example, orphan diseases and others), will these types of technologies be considered for development by a Center?

RESPONSE: Yes. The development of commercially recognizable technologies in areas of significant medical need, such as orphan diseases, is critically important to the NIH/NHLBI, regardless of market size.

F10: Are we expecting each Center to support all focal areas of the NHLBI, including heart, lung, blood, and sleep disorders?

RESPONSE: The NHLBI would like to see the trans-NHLBI mission being addressed

F11: As with other NIH funding mechanisms, are there any ''Open Access'' requirements for publications and works resulting from technology development by this Center?

RESPONSE: The NIH open access rules apply. The NHLBI would like to provide information to the research community at large to reveal how and why decisions were made related to successful and unsuccessful technology development (for example, what failed and what worked, and why). The NHLBI will encourage awardees to enter this data into a publically available database.

F12: How much money will be designated to develop a technology?

RESPONSE: The NHLBI anticipates that up to $200,000 will be used to develop a single technology. The NHLBI understands that the required funds for technology development will vary significantly depending on technology type, and there is flexibility in the amounts used per technology.

F13: Is an IT based technology, as it relates to treatment, considered eligible for entry into a Center?

RESPONSE: Yes, as long as the Center is developing a diverse mixture of technologies, and is not focused solely on IT based technologies.

F14: How much preliminary data should an applicant have surrounding a technology (i.e., R21 equivalent) prior to entering the Center?

RESPONSE: The technology should be sufficiently developed prior to Center entry. The Center studies should be for non-hypothesis driven, product definition studies to develop a technology that already has a defined commercial potential.

F15: Will a Center support international first-in-man studies for a medical device?

RESPONSE: No. Foreign partners may not receive federal funds. The technology must exit the Center prior to a first-in-man study outside the United States.

F16: Do technologies need to come from academic institutions?

RESPONSE: Not necessarily, but the NHLBI anticipates that the majority of technologies will originate from academic institutions.

F17: Do projects need to have had previous NHLBI funding, and is leveraging existing or prior NHLBI funded technologies a scoring factor?

RESPONSE: No. Technologies entering the Center do not need to have had prior NHLBI support.

F18: May the technologies to be included in the proposal be privately funded by independent groups, including VCs?

RESPONSE: Yes, as long as your institution manages and perceived conflicts appropriately.

F19: What was the thought process behind having six technologies in the Center per year?

RESPONSE: Six technologies per year was a recommendation made by the Centers Working Group. The NHLBI anticipates that as technologies being developed do not meet milestones, new technologies will enter the Center to replace those that failed.

F20: Is there a definition of various subcategories of technologies (for example, a device may be a therapeutic or a diagnostic)?

RESPONSE: The NHLBI expects the awardee to balance the multiple technology types across their portfolio.

F21: How long will the Technology Review process take?

RESPONSE: The NHLBI anticipates that the Technology Review process will take less than three months, but the specific length of time has not yet been determined.

G. EDUCATION AND SKILLS COMPONENT

G1: Regarding the Education and Skills Component of the award, is training and education limited to the innovator, or are students included?

RESPONSE: The NHLBI envisions that the training and educational opportunities will be open to the community at large, which would include students. The innovators, in addition to the opportunities open to the community, will require education through mentoring.

G2: What is the amount set aside for the Education and Skills Component?

RESPONSE: The NHLBI has not set aside a specific amount of funds for use in the Education and Skill Component of the award. However, this is a substantial component of the award and that is why the NHLBI is requiring an Education and Skills Component leader.

G3: To what extent may a Center fund formal educational structures versus experiential learning that occurs directly with the funded projects?

RESPONSE: The funding of formal educational structures is permitted. For example, an applicant institution may start a new class in commercialization/entrepreneurship.

H. APPLICATION REVIEW

H1: Will applicants receive questions for clarification post-review?

RESPONSE: If there are questions, the NHLBI will ask for clarification.

H2: Will there be a site visit following the Review process?

RESPONSE: The NHLBI currently has no plans for a site visit.

H3: Will reviewers take into account the breadth or lack of technology development experience of the applicants?

RESPONSE: The NHLBI is cognizant of the fact that levels of institutional experience will vary, and that is part of the program balance. Applicants need to show the NHLBI that they have the expertise and resources required to run a successful Center.

H4: What will be the constitution of the Review Panel?

RESPONSE: The Review Panel will include individuals with scientific, business, regulatory, and commercialization expertise. The NHLBI recognizes that an appropriate Review is critical to the success of this program.

H5: Will the ability to leverage the NIH resources be a scoring factor?

RESPONSE: No.

I. ADDITIONAL QUESTIONS/CONTACT INFORMATION

I1: To whom does one address questions about the program?

RESPONSE: You may email questions to NHLBICentersRFA@mail.nih.gov, or call the NHLBI Office of Translational Alliances and Coordination at 301-496-2149.
I2: Is the Pre-Submission Meeting held on June 15th, 2012 archived?

RESPONSE: Yes. The pre-submission meeting may be viewed at https://webmeeting.nih.gov/p92855756/. Center FAQs are found at http://www.nhlbi.nih.gov/about/org/dera/otac/caip/Centers_FAQs.html.

Page last updated September, 2012

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