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Rationale for Revision of RFA-HL-13-008, the NIH Centers for Accelerated Innovations

Additional Information Regarding Changes in Award Information and Receipt Date (NOT-HL-12-156)

The following text provides additional information and clarifications concerning the recent (September 17, 2012) NIH Guide Notice ( about the NIH Centers for Accelerated Innovations (NCAI). Unfortunately, limitations inherent in the process of placing notices in the NIH Guide precluded its use as a way to disseminate rapidly a detailed explanation of the changes. We regret that the Notice may have disrupted your planning and would therefore like to provide you with a more detailed rationale for the revisions in the FOA. It is important to emphasize that the NHLBI remains highly committed to the NCAI program and that the intent of the revisions is to establish a critical mass of innovative centers that can effectively translate discovery science into new commercial technologies. The Notice revisions are designed to ensure that the program succeeds in achieving this goal.

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 truly regret the inconvenience related to the short notice of our decision, but we can assure you that we acted without delay to disseminate it by email and through the NIH Guide Notice.

We are encouraged by the enthusiastic response of the investigator community to the NCAI program as evidenced by the number of letters of intent. The applicants and their partners should be assured that the NHLBI Director has personally re-affirmed a steadfast commitment to ensuring the success of the NCAI program. Because we realize that you may find it necessary to restructure your planned budgets, we have extended the receipt date. In considering how to revise your budgets to fit within potential reduced award amounts, the modified FOA affords PIs the flexibility necessary to restructure their budgets in ways that 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. In addition, decisions regarding funding will be determined by which awards will be most likely to comprise a balanced and effective program.

We have received a number of specific questions that we are in the process of addressing and will post them to the NCAI FAQ web site as quickly as possible.

Last Updated September 2012

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