Opportunity Information: Apply for RFA HL 16 001
Apply for RFA HL 16 001
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Molecular Imaging of the Lung Phase 2 (R01)" 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, 2015 and posted on Mar 17, 2015.
- Applicants must submit their applications by Jun 15, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $450,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Independent school districts Private institutions of higher education Small businesses Public housing authorities/Indian housing authorities For profit organizations other than small businesses City or township governments Native American tribal organizations (other than Federally recognized tribal governments) State governments Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) County governments Special district governments 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 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 allowed.
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Opportunity Summary:
Molecular Imaging of the Lung - Phase 2 (R01) is a National Institutes of Health (NIH) funding opportunity (RFA-HL-16-001) that supports the next step in developing molecular imaging tools for pulmonary disease. The program is focused on in vivo imaging technologies that use molecular probes designed to bind to, highlight, or otherwise report on specific biological pathways or cell populations involved in the development and progression of lung diseases. The broader aim is to move beyond conventional anatomical imaging and enable more precise, biology-driven readouts that can detect disease earlier, improve diagnosis, track progression noninvasively, help predict prognosis, and speed the development of targeted drug delivery and lung-directed therapies.
This announcement is explicitly positioned as a Phase 2 effort that builds on earlier Phase 1 work funded under RFA-HL-12-036. Phase 1 primarily emphasized the front end of probe and approach development, including selecting biologic targets, designing and producing probes, and completing initial characterization. Phase 2 shifts the emphasis to translation: taking promising probes and associated imaging methods that have already been identified and moving them from animal-model proof-of-concept toward realistic applicability for human lung diseases. Importantly, applicants do not need to have participated in or been funded by Phase 1 to apply; the key expectation is that the proposed work is ready for translational advancement rather than early exploratory target discovery.
Phase 2 projects are required to include in vivo studies in appropriate animal models of lung disease and also include studies using human tissues and/or cells. That dual requirement signals that NIH wants applicants to connect mechanistic and performance data in living systems with evidence of relevance in human biology, for example by confirming target expression in human specimens, validating binding or activation in human-derived cells, or demonstrating disease-associated signal patterns in human tissues. The FOA also encourages proposals that include Investigational New Drug (IND)-enabling activities for novel probes and imaging approaches, meaning studies that help prepare an imaging agent for regulatory submission and eventual clinical evaluation. While not every project must be IND-enabling, the encouragement indicates a strong preference for work that meaningfully shortens the path to human use.
The mechanism is an R01 (Research Project Grant), placing it in the category of full research projects rather than small pilots. NIH anticipated making about five awards, with an estimated total funding level of approximately $3.5 million. The listed award ceiling is $450,000 (as provided in the source information). There is no cost sharing or matching requirement, which is typical for many NIH research grants and reduces administrative burden for applicants.
Eligibility is broad across U.S.-based organizations and includes many public and private entity types: nonprofits (with or without 501(c)(3) status), public and private institutions of higher education, small businesses, for-profit organizations (other than small businesses are explicitly included), and a wide range of government bodies such as state, county, city/township, special district governments, and certain tribal entities. The eligibility language also explicitly includes many institution categories often highlighted in federal opportunities, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions. Foreign institutions are not eligible to apply directly, and non-U.S. components of U.S. organizations are not eligible; however, foreign components are allowed as defined by the NIH Grants Policy Statement, which generally means discrete foreign collaborations may be included when justified.
Key timing details in the source record show the FOA was posted March 17, 2015, with an original and current closing date of June 15, 2015, and an archive date of July 16, 2015. The activity category is health, and the related CFDA program number listed is 93.838 (Lung Diseases Research). For full details, NIH provided an additional information link to the NIH Grants Guide page for the FOA, and contact support is routed through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.
FAQs: Molecular Imaging of the Lung - Phase 2 (R01) (RFA-HL-16-001)
What is the Molecular Imaging of the Lung - Phase 2 (R01) opportunity?
Molecular Imaging of the Lung - Phase 2 (R01) is a National Institutes of Health (NIH) funding opportunity (RFA-HL-16-001) that supports the next step in developing molecular imaging tools for pulmonary disease. It is focused on in vivo imaging technologies that use molecular probes to bind to, highlight, or otherwise report on specific biological pathways or cell populations involved in lung disease development and progression.
What is the overall goal of this program?
The broader goal is to move beyond conventional anatomical imaging and enable biology-driven readouts that can detect disease earlier, improve diagnosis, track progression noninvasively, help predict prognosis, and accelerate targeted drug delivery and lung-directed therapy development.
What does "Phase 2" mean for this FOA?
This announcement is explicitly positioned as a Phase 2 effort that builds on earlier Phase 1 work funded under RFA-HL-12-036. Phase 1 emphasized early steps like selecting targets, designing and producing probes, and initial characterization. Phase 2 shifts emphasis to translation, moving promising probes and imaging methods from animal-model proof-of-concept toward realistic applicability for human lung diseases.
Do applicants need to have been funded under Phase 1 (RFA-HL-12-036) to apply?
No. Applicants do not need to have participated in or been funded by Phase 1. The key expectation is that the proposed work is ready for translational advancement rather than early exploratory target discovery.
What types of imaging approaches are supported?
The FOA is focused on in vivo imaging technologies that use molecular probes designed to bind to, highlight, or report on specific biological pathways or cell populations relevant to lung disease.
Is the FOA focused on anatomical imaging or molecular/biological readouts?
The focus is on moving beyond conventional anatomical imaging toward more precise, biology-driven readouts that reflect disease mechanisms and molecular processes.
Are in vivo animal studies required?
Yes. Phase 2 projects are required to include in vivo studies in appropriate animal models of lung disease.
Are studies using human tissues and/or cells required?
Yes. Projects are also required to include studies using human tissues and/or cells, reflecting a clear expectation that the proposed imaging approach demonstrates relevance to human biology.
Why does NIH require both animal studies and human tissue/cell studies?
The dual requirement signals that NIH wants applicants to connect performance and mechanistic data in living systems with evidence of relevance in human biology. Examples described include confirming target expression in human specimens, validating binding or activation in human-derived cells, or demonstrating disease-associated signal patterns in human tissues.
Are IND-enabling activities required?
They are encouraged but not stated as required for every project. The FOA encourages proposals that include Investigational New Drug (IND)-enabling activities for novel probes and imaging approaches, reflecting a strong preference for work that shortens the path to human use and eventual clinical evaluation.
What does "IND-enabling" mean in the context of this FOA?
IND-enabling activities are studies that help prepare an imaging agent for regulatory submission and eventual clinical evaluation. The FOA frames these activities as a way to meaningfully reduce the time and steps needed to reach human application.
What grant mechanism is used for this opportunity?
The funding mechanism is an R01 (Research Project Grant), indicating full research projects rather than small pilot awards.
How many awards did NIH anticipate making?
NIH anticipated making about five awards under this FOA.
What was the estimated total funding level for the FOA?
The estimated total funding level was approximately $3.5 million.
What is the award ceiling for this opportunity?
The listed award ceiling is $450,000 (as provided in the source information).
Is cost sharing or matching required?
No. There is no cost sharing or matching requirement.
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and includes nonprofits (with or without 501(c)(3) status), public and private institutions of higher education, small businesses, and for-profit organizations (other than small businesses are explicitly included). A wide range of government entities are also eligible, including state, county, city/township, and special district governments, as well as certain tribal entities.
Are specific institution types explicitly included in the eligibility language?
Yes. The eligibility language explicitly includes institution categories often highlighted in federal opportunities, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions.
Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply directly.
Can a U.S. organization include a non-U.S. component?
No. Non-U.S. components of U.S. organizations are not eligible.
Are any foreign collaborations allowed at all?
Yes. Foreign components are allowed as defined by the NIH Grants Policy Statement, which generally means discrete foreign collaborations may be included when justified.
What is the CFDA program number associated with this funding opportunity?
The related CFDA program number listed is 93.838 (Lung Diseases Research).
What is the activity category for this opportunity?
The activity category is health.
When was the FOA posted?
The source record indicates the FOA was posted on March 17, 2015.
What were the closing and archive dates?
The original and current closing date listed is June 15, 2015, and the archive date is July 16, 2015.
Where can applicants find the official NIH posting and details?
NIH provided an additional information link to the NIH Grants Guide page for the FOA.
Who is listed as the support contact for access or linking issues?
Contact support is routed through the NIH Office of Extramural Research (OER) webmaster for access or linking issues.
What kind of projects are most aligned with the Phase 2 emphasis described?
Projects that already have promising probes and associated imaging methods identified and are ready to move beyond early target discovery into translational advancement. The FOA emphasizes moving from animal-model proof-of-concept toward realistic applicability for human lung diseases and encourages IND-enabling steps when relevant.
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