Opportunity Information: Apply for RFA HL 14 001
Apply for RFA HL 14 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Centers for Advanced Diagnostics and Experimental Therapeutics in Lung Diseases Stage II (CADET II)(UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.838 Lung Diseases Research 93.839 Blood Diseases and Resources Research.
- This funding opportunity was created on Oct 21, 2013 and posted on Jul 17, 2013.
- Applicants must submit their applications by Nov 1, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $75,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Private institutions of higher education For profit organizations other than small businesses Public and State controlled institutions of higher education City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Independent school districts State governments Public housing authorities/Indian housing authorities County governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized).
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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 Centers for Advanced Diagnostics and Experimental Therapeutics in Lung Diseases Stage II (CADET II) funding opportunity (RFA-HL-14-001) is a National Institutes of Health (NIH) cooperative agreement designed to push lung and sleep-disordered breathing therapies closer to real-world clinical impact. The program is built around accelerating the development of new therapeutic products by focusing on disease-relevant biology, meaning applicants are expected to ground their product development plans in well-supported pathobiologic processes tied to lung disease and sleep-disordered breathing. In practical terms, CADET II is meant to move beyond basic discovery and into structured preclinical development activities that can de-risk a candidate therapy and make it more ready for later-stage testing.
A key point in this FOA is how it differs from the earlier CADET I effort. CADET I supported exploration and validation of therapeutic targets, which is often the phase where investigators are still asking whether a biological pathway or molecule is truly causal or actionable in disease. CADET II assumes that step has already been achieved: the target is considered validated, and the work now centers on preclinical research for therapeutic products directed at that target. That framing signals that competitive applications should not be primarily target-discovery projects. Instead, they should propose a coherent preclinical plan aimed at advancing an intervention, such as demonstrating proof-of-concept efficacy in appropriate models, optimizing a lead, evaluating pharmacology or delivery approaches, establishing feasibility for manufacturing or formulation when relevant, and generating the kinds of data that would support a later transition toward clinical development.
The mechanism is a cooperative agreement (UH2/UH3), which usually indicates a milestone-driven program with substantial NIH involvement. While the FOA text provided here does not list the specific milestones, the general expectation for UH2/UH3 programs is a phased structure where early activities (often the UH2 phase) focus on defined development objectives and go/no-go criteria, and later activities (often the UH3 phase) support more advanced work contingent on successful completion of the initial milestones. Because NIH has a more hands-on role in cooperative agreements than in standard grants, applicants should expect active programmatic oversight, coordination, and an emphasis on clear deliverables, timelines, and decision points.
CADET II is explicitly described as center-based and flexible in scope, with NIH noting that projects may vary substantially in objectives and research breadth. That language leaves room for a wide range of lung disease and sleep-disordered breathing areas, different therapeutic modalities, and different development strategies, as long as the work is preclinical and product-focused with a validated target. The overall intent is translational: to bridge the common gap between academic discovery and therapy development by supporting the steps that often require specialized expertise, coordinated project management, and rigorous preclinical validation.
From a funding and administrative standpoint, this was a discretionary NIH opportunity in the health research category, tied to CFDA numbers 93.838 (Lung Diseases Research) and 93.839 (Blood Diseases and Resources Research). The FOA listed an estimated total program funding level of $75,000,000 and an award ceiling of $1,000,000, with no cost-sharing or matching requirement. The opportunity was posted July 17, 2013, with an original closing date of October 17, 2013, later reflected as November 1, 2013, and an archive date of December 1, 2013.
Eligibility was broad across U.S.-based organizations, including public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (other than small businesses), small businesses, and a range of government entities (state, county, city/township, special districts, independent school districts, and public housing authorities). The FOA also explicitly included a variety of mission-focused institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, AANAPISIs, Alaska Native and Native Hawaiian-serving institutions, as well as faith-based or community-based organizations and eligible federal agencies. At the same time, it clearly limited foreign involvement: non-U.S. entities were not eligible to apply, non-U.S. components of U.S. organizations were not eligible, and foreign components (as defined by NIH policy) were not allowed.
Overall, CADET II is best understood as an NIH-supported, milestone-oriented preclinical development program for lung disease and sleep-disordered breathing therapeutics, intentionally positioned after target validation and before clinical trials. The emphasis is on advancing product candidates through rigorous, relevant preclinical studies and doing so in a way that is structured, deliverable-driven, and aligned with translational development needs under the cooperative agreement model. For full details, NIH referenced the official announcement at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-14-001.html and provided NIH Office of Extramural Research (OER) webmaster contacts for access and linking issues.
Frequently Asked Questions (FAQs)
What is the CADET II funding opportunity (RFA-HL-14-001)?
CADET II (Centers for Advanced Diagnostics and Experimental Therapeutics in Lung Diseases Stage II) is a National Institutes of Health (NIH) cooperative agreement funding opportunity intended to accelerate the preclinical development of therapies for lung diseases and sleep-disordered breathing. It is designed to move therapeutic candidates closer to real-world clinical impact by supporting structured, product-focused preclinical work.
What is the main goal of CADET II?
The main goal is to advance new therapeutic products by focusing on disease-relevant biology and well-supported pathobiologic processes tied to lung disease and sleep-disordered breathing. The program emphasizes translational progress by funding preclinical development activities that can de-risk a candidate therapy and prepare it for later-stage testing.
How is CADET II different from CADET I?
CADET I supported exploration and validation of therapeutic targets (figuring out whether a pathway or molecule is causal/actionable). CADET II assumes the target has already been validated and focuses instead on preclinical research and development of therapeutic products directed at that validated target. Applications that are primarily target-discovery or target-validation efforts would not align with CADET II's stated focus.
What stage of research is CADET II intended to support?
CADET II is positioned after target validation and before clinical trials. It supports structured preclinical development designed to move beyond basic discovery into activities that strengthen confidence in a product candidate and support later transition toward clinical development.
What kinds of activities does CADET II expect applicants to propose?
Based on the description provided, competitive projects would typically propose a coherent preclinical plan to advance an intervention. Examples mentioned include proof-of-concept efficacy in appropriate models, lead optimization, evaluating pharmacology or delivery approaches, assessing feasibility for manufacturing or formulation when relevant, and generating data that could support later clinical development steps.
Does CADET II require a validated target?
Yes. CADET II is framed around the assumption that the therapeutic target is already validated. The emphasis is on preclinical development of therapeutic products aimed at that target, grounded in well-supported disease-relevant biology.
What funding mechanism is used for CADET II?
CADET II uses an NIH cooperative agreement mechanism (UH2/UH3). Cooperative agreements generally involve substantial NIH programmatic involvement and are commonly milestone-driven with defined deliverables and decision points.
What does a UH2/UH3 cooperative agreement generally imply?
While the specific milestones are not listed in the information provided, UH2/UH3 programs are generally phased. Early activities (often the UH2 phase) focus on defined objectives and go/no-go criteria, and later activities (often the UH3 phase) support more advanced work contingent on successfully meeting the initial milestones. Applicants should expect an emphasis on timelines, deliverables, and NIH oversight typical of cooperative agreements.
How involved is NIH expected to be under this mechanism?
The program is described as a cooperative agreement, which typically means NIH has a more hands-on role than under standard grants. The description indicates active programmatic oversight, coordination, and an emphasis on clear deliverables, timelines, and decision points.
Is CADET II described as a center-based program?
Yes. CADET II is explicitly described as center-based and flexible in scope, with NIH noting that projects may vary substantially in objectives and research breadth.
How flexible is the scope of projects under CADET II?
The opportunity is described as flexible, with projects potentially varying substantially in objectives and research breadth. This suggests multiple lung disease and sleep-disordered breathing areas, therapeutic modalities, and development strategies could fit, as long as the work remains preclinical, product-focused, and targeted to a validated biological process relevant to disease.
What disease areas are included?
The opportunity is focused on lung diseases and sleep-disordered breathing. Projects are expected to be grounded in well-supported pathobiologic processes tied to these areas.
Is this opportunity focused on diagnostics, therapeutics, or both?
The description emphasizes accelerating the development of new therapeutic products and advancing candidate therapies through preclinical development. The overall framing is centered on therapies for lung disease and sleep-disordered breathing.
What is the estimated total program funding level?
The FOA listed an estimated total program funding level of $75,000,000.
What is the award ceiling for this opportunity?
The FOA listed an award ceiling of $1,000,000.
Is cost-sharing or matching required?
No. The opportunity states there is no cost-sharing or matching requirement.
What is the funding category and type of opportunity?
This was described as a discretionary NIH opportunity in the health research category.
What CFDA numbers are associated with this opportunity?
The opportunity is tied to CFDA 93.838 (Lung Diseases Research) and CFDA 93.839 (Blood Diseases and Resources Research).
When was the opportunity posted?
The opportunity was posted on July 17, 2013.
What were the closing dates for CADET II?
The original closing date was October 17, 2013, later reflected as November 1, 2013.
When was the opportunity archived?
The archive date was December 1, 2013.
Who is eligible to apply?
Eligibility was broad across U.S.-based organizations, including public and private institutions of higher education; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations (other than small businesses); small businesses; and a range of government entities (state, county, city/township, special districts, independent school districts, and public housing authorities).
Are small businesses eligible?
Yes. The eligibility list explicitly includes small businesses.
Are for-profit organizations eligible?
Yes. The eligibility list includes for-profit organizations (other than small businesses) and also includes small businesses separately.
Are nonprofits required to have 501(c)(3) status?
No. The eligibility list includes nonprofit organizations with and without 501(c)(3) status.
What types of government entities are eligible?
Eligible government entities included state, county, city/township, special districts, independent school districts, and public housing authorities.
Are minority-serving and mission-focused institutions included in eligibility?
Yes. The FOA explicitly included institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, AANAPISIs, and Alaska Native and Native Hawaiian-serving institutions.
Are faith-based or community-based organizations eligible?
Yes. The eligibility description explicitly included faith-based or community-based organizations.
Are federal agencies eligible to apply?
Yes. The eligibility description included eligible federal agencies.
Are foreign (non-U.S.) organizations eligible to apply?
No. Non-U.S. entities were not eligible to apply.
Can a U.S. organization apply if the project includes a non-U.S. component?
No. The FOA states that non-U.S. components of U.S. organizations were not eligible.
Are foreign components allowed under NIH policy for this FOA?
No. The FOA clearly states that foreign components (as defined by NIH policy) were not allowed.
Where can applicants find the official FOA announcement?
NIH referenced the official announcement at: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-14-001.html
Who is the listed contact for access or linking issues related to the announcement?
The provided information notes NIH Office of Extramural Research (OER) webmaster contacts for access and linking issues.
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