Opportunity Information: Apply for RFA HL 10 003
Apply for RFA HL 10 003
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Phase II Clinical Trials of Novel Therapies for Lung Diseases (U01)" 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 93.838 Lung Diseases Research.
- This funding opportunity was created on Feb 23, 2009 and posted on Feb 23, 2009.
- Applicants must submit their applications by Sep 15, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $40,600,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $800,000.00 in funding.
- The number of recipients for this funding is limited to 6 candidate(s).
- Eligible applicants include: State governments For profit organizations other than small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education City or township governments Public housing authorities/Indian housing authorities County governments Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Independent school districts.
- 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.
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Opportunity Summary:
The Phase II Clinical Trials of Novel Therapies for Lung Diseases (U01) opportunity (Funding Opportunity Number RFA-HL-10-003) is a National Institutes of Health program run through the National Heart, Lung, and Blood Institute (NHLBI). Its central goal is to fund proof-of-concept Phase II clinical trials that evaluate a new, innovative intervention aimed at a lung disease or a sleep-related cardiopulmonary disorder. The emphasis is on interventions that, if successful, could meaningfully shift or improve clinical management rather than producing only incremental gains. In practical terms, applicants are expected to propose a real Phase II trial designed to test an intervention with enough novelty and clinical promise that the results could influence how patients are treated.
A defining feature of this announcement is that every application must also include at least one ancillary study that is tightly connected to the main clinical question. That requirement signals that NHLBI is not only interested in whether an intervention works, but also in generating additional scientifically valuable information alongside the trial itself. Ancillary work in this context is meant to be strongly integrated with the main trial objectives, such as complementary analyses, mechanistic questions, biomarkers, sub-studies, or other closely aligned components that deepen the interpretability and impact of the clinical trial findings.
The award mechanism is a cooperative agreement (U01), which typically means the project is carried out with substantial NIH involvement compared with a standard research project grant. While the applicant organization leads the study, the cooperative structure usually reflects a more collaborative relationship with NHLBI in areas such as trial oversight, milestones, coordination, and adherence to NHLBI expectations for clinical trial conduct.
In terms of funding scale, NHLBI planned to commit up to $40.6 million in total costs across four years for this initiative. The anticipated award pattern was up to two awards per receipt date across three receipt dates, for a total of roughly four to six awards overall (the source listing also notes an expected awards figure of six). The posted award ceiling is listed as $800,000, which provides a sense of the upper limit for individual award amounts as presented in the opportunity summary.
Eligibility is broad and includes many types of U.S.-based applicant organizations. Eligible applicants include public and private institutions of higher education, nonprofit organizations (both 501(c)(3) and non-501(c)(3)), for-profit organizations other than small businesses as well as small businesses, and multiple levels of government (state, county, city/township, special district, and certain public housing authorities/Indian housing authorities). The eligibility list also explicitly includes tribal governments and tribal organizations (including those not federally recognized), regional organizations, and a range of mission-focused institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, faith-based or community-based organizations, and U.S. territories or possessions. The announcement states there is no cost sharing or matching requirement, which can reduce barriers for applicants planning resource-intensive clinical trial work.
Administratively, the opportunity was posted on February 23, 2009, with an original and current closing date of September 15, 2010, and an archive date of October 16, 2010. The activity category is health, and the relevant CFDA numbers listed are 93.233 (National Center on Sleep Disorders Research) and 93.838 (Lung Diseases Research), reflecting the programmatic alignment with both sleep-related cardiopulmonary disorders and lung disease research. For full details, NHLBI directed applicants to the official FOA text hosted on the NIH grants site, and provided NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "Phase II Clinical Trials of Novel Therapies for Lung Diseases (U01)" and it is associated with Funding Opportunity Number (FON) RFA-HL-10-003.
Which federal agency and institute run this program?
This is a National Institutes of Health (NIH) program administered through the National Heart, Lung, and Blood Institute (NHLBI).
What is the main purpose of this opportunity?
The central goal is to support proof-of-concept Phase II clinical trials that evaluate a new, innovative intervention aimed at a lung disease or a sleep-related cardiopulmonary disorder.
What types of studies are expected to be proposed?
Applicants are expected to propose a real Phase II clinical trial designed to test a novel intervention with enough clinical promise that the results could influence clinical management and patient treatment, rather than producing only incremental improvements.
What kinds of health conditions are in scope?
The scope includes lung diseases and sleep-related cardiopulmonary disorders, consistent with the program focus described and the associated CFDA listings.
What is meant by an "innovative intervention" in this announcement?
Based on the description provided, the intervention should be new and clinically promising, with the potential to meaningfully shift or improve clinical management if the Phase II results are successful (as opposed to generating only small, incremental gains).
Is an ancillary study required?
Yes. A defining feature of this announcement is that every application must include at least one ancillary study that is tightly connected to the main clinical question.
What is the purpose of the required ancillary study?
The ancillary study requirement signals that NHLBI is interested not only in whether the intervention works, but also in generating additional scientifically valuable information alongside the trial to deepen the interpretability and impact of the clinical trial findings.
What types of ancillary studies fit this requirement?
The opportunity description indicates ancillary work should be strongly integrated with the main trial objectives. Examples mentioned include complementary analyses, mechanistic questions, biomarkers, sub-studies, or other closely aligned components tied to the main clinical question.
What is the award mechanism for this opportunity?
The mechanism is a cooperative agreement (U01).
What does a cooperative agreement (U01) imply about NIH involvement?
A U01 typically means substantial NIH involvement compared with a standard research project grant. While the applicant organization leads the study, the cooperative structure usually reflects a more collaborative relationship with NHLBI in areas such as trial oversight, milestones, coordination, and adherence to NHLBI expectations for clinical trial conduct.
How much funding was NHLBI planning to commit overall?
NHLBI planned to commit up to $40.6 million in total costs across four years for this initiative.
How many awards were expected to be made?
The anticipated award pattern was up to two awards per receipt date across three receipt dates, for a total of roughly four to six awards overall. The source listing also notes an expected awards figure of six.
Is there a stated maximum award amount?
The posted award ceiling is listed as $800,000, which indicates the upper limit for individual award amounts as presented in the opportunity summary.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S.-based applicant organizations, including public and private institutions of higher education; nonprofit organizations (both 501(c)(3) and non-501(c)(3)); for-profit organizations (including small businesses and for-profits other than small businesses); and multiple levels of government.
Are small businesses eligible to apply?
Yes. The eligibility list explicitly includes small businesses.
Are for-profit organizations eligible to apply?
Yes. Eligible applicants include for-profit organizations other than small businesses as well as small businesses.
Are government entities eligible to apply?
Yes. Eligible applicants include state governments, county governments, city or township governments, special district governments, and certain public housing authorities or Indian housing authorities.
Are tribal governments and tribal organizations eligible?
Yes. The eligibility list explicitly includes tribal governments and tribal organizations, including those not federally recognized.
Are U.S. territories or possessions eligible?
Yes. The eligibility list includes U.S. territories or possessions.
Are mission-focused institution types (such as HBCUs and HSIs) included in eligibility?
Yes. The eligibility list explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and also references faith-based or community-based organizations.
Is cost sharing or matching required?
No. The announcement states there is no cost sharing or matching requirement.
When was this opportunity posted?
The opportunity was posted on February 23, 2009.
What was the closing date for applications?
The original and current closing date listed is September 15, 2010.
When was the opportunity archived?
The archive date is October 16, 2010.
What is the activity category for this opportunity?
The activity category is health.
Which CFDA numbers are associated with this program?
The CFDA numbers listed are 93.233 (National Center on Sleep Disorders Research) and 93.838 (Lung Diseases Research).
Where were applicants directed to find the official full details?
NHLBI directed applicants to the official Funding Opportunity Announcement (FOA) text hosted on the NIH grants site for full details.
Who was listed as a contact for access or linking issues?
The opportunity information notes NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues related to the FOA text.
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