Opportunity Information: Apply for RFA HL 12 022
Apply for RFA HL 12 022
- 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 (UM1)" 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.
- This funding opportunity was created on Mar 17, 2011 and posted on Mar 17, 2011.
- Applicants must submit their applications by Sep 13, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Public housing authorities/Indian housing authorities County governments Special district governments Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Private institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Small businesses Native American tribal governments (Federally recognized).
- 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 Organizations) are not eligible to apply. Foreign (non U.S.) components of U.S. Organizations are not allowed.
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Opportunity Summary:
The National Heart, Lung, and Blood Institute (NHLBI) at the National Institutes of Health (NIH) released this funding opportunity (RFA-HL-12-022) to support proof-of-concept Phase II clinical trials that evaluate novel therapies for lung diseases or sleep-related cardiopulmonary disorders. The core idea is to fund mid-stage clinical studies that go beyond early safety work and directly test whether an intervention shows enough signal of benefit to justify larger, definitive trials, with an emphasis on approaches that could meaningfully change how patients are managed in real clinical settings. The awards use a cooperative agreement mechanism (UM1), meaning NHLBI program staff are expected to have substantial involvement during the project, which typically translates into closer coordination on trial conduct, milestones, and oversight than in a standard research grant.
A defining requirement of this announcement is that each application must include at least one basic research ancillary study that is tightly linked to the main clinical question. In practical terms, applicants are expected not only to run a Phase II trial but also to integrate a mechanistic or biologically informative component that helps explain why the intervention works (or does not), identifies biomarkers, clarifies patient subgroups most likely to respond, or otherwise deepens the scientific value of the trial. The ancillary study is not meant to be a loosely related add-on; it should be integrated with the clinical trial design and directly support interpretation and future translation of the findings.
This FOA falls under the health funding activity category and is associated with CFDA 93.838 (Lung Diseases Research). It does not require cost sharing or matching funds. The opportunity was posted on March 17, 2011, with an application closing date of September 13, 2012, and it was later archived on October 14, 2012. While archived opportunities are no longer open for submission, the summary remains useful as a reference point for how NHLBI structures cooperative-agreement Phase II trial programs and the types of expectations it sets for integrated clinical and basic science work.
Eligibility was broad across U.S.-based institutions and organizations. Eligible applicants included 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 wide range of governmental entities (state, county, city/township, special district, independent school districts, and public housing authorities). The FOA also explicitly recognized several categories often highlighted in federal eligibility language, including Historically Black Colleges and Universities (HBCUs), Hispanic-Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), tribal governments (including federally recognized tribes), regional organizations, U.S. territories or possessions, and faith-based or community-based organizations, as well as eligible federal agencies. At the same time, it clearly excluded non-domestic entities: foreign organizations could not apply, and foreign components of U.S. organizations were not allowed.
For applicants, the practical implication of the UM1 cooperative agreement structure is that proposals would need to present a well-developed clinical trial plan appropriate for Phase II, including clear endpoints, feasibility and recruitment considerations, operational and data management planning, and a rationale for why the intervention is truly novel and positioned to affect clinical practice if successful. They would also need to show that the ancillary basic research is feasible, scientifically rigorous, and logistically integrated with the clinical protocol (for example, by specifying biospecimen collection aligned with trial visits, standardized processing, and analyses tied to the trial hypotheses).
The sponsoring agency is NIH (specifically NHLBI). The full announcement was made available through the NIH grants guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-12-022.html. For access or technical issues related to the posting, the notice directed users to contact the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the funding opportunity RFA-HL-12-022?
RFA-HL-12-022 is a National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH) funding opportunity designed to support proof-of-concept Phase II clinical trials focused on lung diseases or sleep-related cardiopulmonary disorders.
What is the main goal of this FOA?
The goal is to fund mid-stage Phase II clinical studies that move beyond early safety evaluations and test whether a novel intervention shows enough signal of benefit to justify larger, definitive trials, especially interventions that could change real-world patient management if successful.
What types of studies are supported under this announcement?
This FOA supports proof-of-concept Phase II clinical trials evaluating novel therapies for lung diseases or sleep-related cardiopulmonary disorders, along with at least one required basic research ancillary study that is tightly linked to the main clinical question.
What does "proof-of-concept Phase II clinical trial" mean in this context?
In this context, it means a Phase II trial intended to directly test whether an intervention shows signs of benefit (a meaningful signal) rather than focusing only on initial safety, with the aim of determining whether the therapy is promising enough for larger, definitive trials.
What diseases or conditions are in scope for this FOA?
The FOA targets lung diseases and sleep-related cardiopulmonary disorders.
Who is the sponsoring agency?
The sponsoring agency is the NIH, specifically the National Heart, Lung, and Blood Institute (NHLBI).
What funding mechanism is used (UM1), and why does it matter?
The awards use a cooperative agreement mechanism (UM1). This matters because NHLBI program staff are expected to have substantial involvement during the project, which generally means closer coordination and oversight of trial conduct, milestones, and related planning than is typical in a standard research grant.
How does a cooperative agreement (UM1) differ from a standard research grant in practice?
Under a UM1 cooperative agreement, NHLBI program staff typically play a more active role in the project. The FOA notes substantial involvement by staff, which usually translates into coordination on trial conduct, milestone expectations, and oversight activities.
Is an ancillary basic research study required?
Yes. A defining requirement is that each application must include at least one basic research ancillary study that is tightly linked to the main clinical question.
What is the purpose of the required ancillary basic research study?
The ancillary study is intended to add mechanistic and biological insight that strengthens interpretation and future translation of the clinical trial results. Examples described in the FOA include helping explain why the intervention works (or does not), identifying biomarkers, clarifying patient subgroups most likely to respond, or otherwise increasing the scientific value of the trial.
Can the ancillary study be a loosely related add-on?
No. The FOA indicates the ancillary study is not meant to be a loosely related add-on. It should be integrated with the clinical trial design and directly support interpretation and future translation of the findings.
How should the ancillary study be integrated with the clinical trial?
The FOA emphasizes logistical and scientific integration. For example, it mentions aligning biospecimen collection with trial visits, using standardized processing, and tying analyses to the trial hypotheses so the basic research component directly supports the clinical trial question.
What kinds of clinical trial planning does this FOA expect?
Applicants are expected to present a well-developed Phase II clinical trial plan, including clear endpoints, feasibility and recruitment considerations, operational planning, data management planning, and a rationale for why the intervention is novel and could affect clinical practice if successful.
What kinds of basic research planning does this FOA expect?
The basic research ancillary study should be feasible and scientifically rigorous, and it should be logistically integrated with the clinical protocol. The FOA highlights elements such as planned biospecimen collection aligned to trial visits, standardized processing, and analyses linked to trial hypotheses.
Does this FOA require cost sharing or matching funds?
No. The FOA states that cost sharing or matching funds are not required.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.838 (Lung Diseases Research).
What is the activity category for this FOA?
It falls under the health funding activity category.
When was this opportunity posted and when did it close?
It was posted on March 17, 2011, and the application closing date was September 13, 2012.
Is this funding opportunity still open?
No. The FOA was archived on October 14, 2012, and archived opportunities are no longer open for submission.
If it is archived, why is the FOA still useful?
The summary can still serve as a reference for how NHLBI structures cooperative-agreement Phase II trial programs and the expectations it sets for integrated clinical and basic science components.
Who was eligible to apply?
Eligibility was broad across U.S.-based institutions and organizations. Eligible applicants included 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 various governmental entities (state, county, city/township, special district, independent school districts, and public housing authorities).
Were small businesses eligible to apply?
Yes. Small businesses were listed among eligible applicants.
Were for-profit organizations eligible to apply?
Yes. For-profit organizations were eligible, except that the eligibility list specified for-profit organizations (other than small businesses) as one category and also separately listed small businesses as eligible.
Were nonprofit organizations without 501(c)(3) status eligible?
Yes. The FOA explicitly included nonprofit organizations with and without 501(c)(3) status.
Which government entities were eligible?
A wide range of governmental entities were eligible, including state, county, city/township governments, special district governments, independent school districts, and public housing authorities.
Were Historically Black Colleges and Universities (HBCUs) and other minority-serving institutions eligible?
Yes. The FOA explicitly recognized eligibility categories that commonly appear in federal opportunities, including HBCUs, Hispanic-Serving Institutions, Alaska Native and Native Hawaiian Serving Institutions, and Tribally Controlled Colleges and Universities (TCCUs).
Were tribal governments eligible?
Yes. The FOA included tribal governments (including federally recognized tribes) among the explicitly recognized eligible categories.
Were U.S. territories or possessions eligible?
Yes. The FOA explicitly recognized U.S. territories or possessions as eligible.
Were faith-based or community-based organizations eligible?
Yes. The FOA explicitly recognized faith-based or community-based organizations as eligible.
Were federal agencies eligible to apply?
Yes. The FOA indicated that eligible federal agencies were included among eligible applicants.
Are foreign organizations eligible to apply?
No. The FOA excluded non-domestic entities, stating that foreign organizations could not apply.
Are foreign components of U.S. organizations allowed?
No. The FOA stated that foreign components of U.S. organizations were not allowed.
Where can the full announcement be found?
The full announcement was made available through the NIH grants guide at http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-12-022.html.
Who should be contacted for access or technical issues related to the posting?
For access or technical issues related to the posting, the notice directed users to contact the NIH Office of Extramural Research (OER) webmaster at FBOWebmaster@OD.NIH.GOV.
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