Opportunity Information: Apply for RFA HL 13 008

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "The NIH Centers for Accelerated Innovations (U54)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233 National Center on Sleep Disorders Research 93.837 Cardiovascular Diseases Research 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research.
  • This funding opportunity was created on Sep 17, 2012 and posted on May 17, 2012.
  • Applicants must submit their applications by Oct 19, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $2,000,000.00 to eligible and selected applicants.
  • Eligible applicants include: Small businesses For profit organizations other than small businesses Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Special district governments County governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) State governments City or township governments Private institutions of higher education Independent school districts Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession 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.
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Opportunity Summary:

The NIH Centers for Accelerated Innovations (NCAI) U54 opportunity (Funding Opportunity Number RFA-HL-13-008) is a National Institutes of Health cooperative agreement aimed at building specialized Centers that speed up the path from early-stage biomedical technologies to real-world, commercialized health products. The core idea is to create organized, well-supported innovation hubs that actively find promising inventions and then help move them through the practical steps needed to reach patients, particularly in areas aligned with the National Heart, Lung, and Blood Institute (NHLBI) mission. Rather than funding basic discovery science alone, this program focuses on the "translation" phase where many good ideas stall due to lack of product development funding, regulatory planning, business strategy, or industry connections.

A key feature of the program is that each Center is expected to run a structured process to solicit, review, and select a pipeline of emerging technologies. The technologies of interest are broad and can include therapeutics (such as drugs and biologics), preventatives, diagnostics, medical devices, and enabling tools or platform technologies. Once selected, the Center supports these projects with targeted, milestone-driven resources intended to de-risk them for follow-on investment and eventual commercialization. The end goal is tangible: products that improve patient care and enhance health, not just publications or early prototypes that cannot be adopted.

The support offered through NCAI is framed around three main contributions. First, Centers provide funding for product definition studies, which can include feasibility testing, proof-of-concept work, prototype development, and other early development activities that clarify whether a technology can realistically become a viable product. Second, Centers offer unified and coordinated access to the kinds of expertise innovators commonly lack, including scientific and technical guidance, regulatory strategy, reimbursement and payer considerations, business development, legal and intellectual property support, and hands-on project management. Third, the program emphasizes training and practical experience in entrepreneurship, meaning investigators and teams are expected to learn how to think like product developers and founders, including how to build a business case and prepare for partnerships, licensing, or startup formation.

Because this is a cooperative agreement (U54), NIH typically expects substantial involvement from the agency compared with a standard research grant. In practice, that usually means the Centers operate with defined objectives, reporting expectations, and coordination with NIH program staff to ensure the program is meeting translational and commercialization goals. The program also highlights that public-private partnerships are critical to success, and it explicitly calls out the importance of securing non-federal funds. This emphasis signals that Centers should actively cultivate relationships with industry, investors, foundations, health systems, or other partners who can provide capital, expertise, validation environments, or downstream commercialization pathways. The expectation is that federal funding helps bridge early development gaps, while private or other non-federal support helps carry technologies further toward market readiness.

In terms of administrative details, this opportunity falls under the "Discretionary" opportunity category and uses the cooperative agreement funding instrument. The activity category is Health, and it is associated with CFDA program areas including sleep disorders research (93.233) as well as cardiovascular (93.837), lung (93.838), and blood diseases/resources research (93.839). The estimated total funding listed is $2,000,000, and there is no cost sharing or matching requirement stated in the announcement, even though the program strongly encourages non-federal financial participation as a practical success factor.

Eligibility is broad across the U.S. research and innovation ecosystem. Eligible applicants include small businesses, other for-profit organizations, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), public and private institutions of higher education, and a wide range of government entities (state, county, city/township, special district governments, and certain housing authorities). The announcement also indicates eligibility for various mission-driven institution types and community-based organizations, including faith-based or community-based organizations, Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, regional organizations, and U.S. territories or possessions, along with eligible federal agencies. Foreign institutions and other non-U.S. entities are not eligible, and foreign components are not allowed under NIH policy as referenced in the notice.

Key dates provided in the listing show it was posted May 17, 2012, with an original closing date of September 19, 2012, later extended to a current closing date of October 19, 2012, and an archive date of November 20, 2012. The official announcement and full requirements were available through the NIH Grants Guide at the link provided in the source. For technical issues accessing the announcement, the contact listed is the NIH Office of Extramural Research (OER) webmaster (FBOWebmaster@OD.NIH.GOV).

Frequently Asked Questions (FAQs)

What is the NIH Centers for Accelerated Innovations (NCAI) U54 opportunity?

The NCAI U54 opportunity (Funding Opportunity Number RFA-HL-13-008) is an NIH cooperative agreement designed to establish specialized Centers that speed up the transition of early-stage biomedical technologies into real-world, commercialized health products. It focuses on building organized innovation hubs that can identify promising inventions and help move them through the practical steps needed to reach patients, especially in areas aligned with the National Heart, Lung, and Blood Institute (NHLBI) mission.

What is the main purpose of this program?

The program targets the "translation" phase, where many strong biomedical ideas stall due to gaps such as insufficient product development funding, missing regulatory planning, limited business strategy, or lack of industry connections. The goal is to de-risk selected technologies and position them for follow-on investment and commercialization, leading to products that improve patient care and health outcomes.

What does "U54 cooperative agreement" mean in this context?

This opportunity uses a cooperative agreement (U54) funding instrument, which typically involves substantial NIH involvement compared with a standard research grant. Centers are generally expected to operate with defined objectives, meet reporting expectations, and coordinate with NIH program staff to help ensure the program achieves translational and commercialization goals.

Is this grant intended to fund basic research?

No. The emphasis is not on basic discovery science alone. Instead, the focus is on applied translation activities that help technologies move toward real-world use and commercialization, rather than stopping at publications or early prototypes that cannot be adopted.

What types of technologies can be supported through an NCAI Center?

The technologies of interest are broad and may include therapeutics (including drugs and biologics), preventatives, diagnostics, medical devices, and enabling tools or platform technologies.

How are technologies chosen for support within a Center?

Each Center is expected to run a structured process to solicit, review, and select a pipeline of emerging technologies. Once selected, projects receive targeted, milestone-driven resources intended to de-risk them for follow-on investment and commercialization.

What kind of support does the NCAI program provide to selected projects?

The opportunity describes three main contributions:

  • Funding for product definition studies (such as feasibility testing, proof-of-concept work, prototype development, and other early development activities).
  • Coordinated access to expertise that innovators often lack, including scientific/technical guidance, regulatory strategy, reimbursement and payer considerations, business development, legal and intellectual property support, and hands-on project management.
  • Training and practical experience in entrepreneurship, helping investigators and teams learn product-development and founder-style thinking, including building a business case and preparing for partnerships, licensing, or startup formation.

What are "product definition studies" in this program?

Product definition studies are early development efforts that clarify whether a technology can realistically become a viable product. Examples listed include feasibility testing, proof-of-concept work, and prototype development, along with other early development activities.

What does "milestone-driven" support mean here?

The Center support is described as targeted and milestone-driven, meaning resources are expected to be tied to defined goals and measurable progress steps that reduce risk and move a technology closer to commercialization readiness.

Does the program include entrepreneurship training?

Yes. The program emphasizes training and practical entrepreneurship experience so investigators and teams learn how to build a business case and prepare for commercialization pathways such as partnerships, licensing, or forming a startup.

How important are public-private partnerships to this program?

Public-private partnerships are highlighted as critical to success. Centers are expected to cultivate relationships with industry, investors, foundations, health systems, or other partners that can provide capital, expertise, validation environments, or downstream commercialization pathways.

Is cost sharing or matching required?

No cost sharing or matching requirement is stated in the announcement. However, the program explicitly emphasizes the importance of securing non-federal funds as a practical factor in achieving successful translation and commercialization outcomes.

What is the estimated total funding for this opportunity?

The estimated total funding listed is $2,000,000.

What is the opportunity category and activity area?

The opportunity is listed as a "Discretionary" opportunity category. The activity category is Health.

Which CFDA program areas are associated with this opportunity?

The listing associates this opportunity with CFDA program areas including sleep disorders research (93.233) and cardiovascular (93.837), lung (93.838), and blood diseases/resources research (93.839).

Who is eligible to apply?

Eligibility is broad and includes small businesses, other for-profit organizations, nonprofit organizations (including 501(c)(3) and non-501(c)(3) entities), public and private institutions of higher education, and many types of government entities (state, county, city/township, special district governments, and certain housing authorities). The listing also indicates eligibility for various mission-driven and community-based organizations, including faith-based or community-based organizations, Hispanic Serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, regional organizations, U.S. territories or possessions, and eligible federal agencies.

Are foreign institutions or non-U.S. entities eligible?

No. Foreign institutions and other non-U.S. entities are not eligible, and foreign components are not allowed under the referenced NIH policy.

What are the key dates for this funding opportunity?

The listing indicates the opportunity was posted on May 17, 2012. The original closing date was September 19, 2012, and it was extended to a current closing date of October 19, 2012. The archive date is November 20, 2012.

Where could applicants find the official announcement and full requirements?

The official announcement and full requirements were available through the NIH Grants Guide at the link provided in the source listing.

Who should be contacted for technical issues accessing the announcement?

For technical issues accessing the announcement, the contact listed is the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.

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