Opportunity Information: Apply for RFA HL 09 006
Apply for RFA HL 09 006
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Microbiome of the Lung and Respiratory Tract in HIV Infected Individuals and HIV Uninfected Controls (U01)" 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 Dec 4, 2008 and posted on Dec 4, 2008.
- Applicants must submit their applications by Mar 25, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $525,000.00 in funding.
- Eligible applicants include: For profit organizations other than small businesses Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) Small businesses State governments County governments Public housing authorities/Indian housing authorities City or township governments Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education 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 Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Special district governments.
- 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 NHLBI funding opportunity RFA HL 09 006 is a cooperative agreement (U01) focused on building a high-quality, deeply sequenced, molecularly defined picture of the lung and lower respiratory tract microbiome in people living with HIV compared with matched HIV-uninfected controls, including healthy controls. The central idea is to move beyond culture-based microbiology and use modern molecular and high-throughput sequencing approaches to identify bacteria and, where feasible, other classes of organisms that may influence respiratory health in HIV, such as viruses, fungi, protozoa, and cell wall deficient organisms. The anatomic emphasis is on the lung itself, defined here as the airways and airspaces below the glottis and the lung parenchyma, with optional inclusion of the nasal and/or oropharyngeal cavities to help interpret potential sources and overlap across the respiratory tract.
The program is designed to produce a dataset with enough depth, rigor, and standardization to support meaningful analyses linking microbiome patterns to clinical outcomes. NHLBI specifically points applicants toward examining how shifts in respiratory microbiota may relate to the pathogenesis and progression of HIV-associated lung disease, the development of HIV-related respiratory complications, and the effects of anti-HIV therapies on microbial communities. In practical terms, the expectation is not only descriptive cataloging of organisms, but also data generation and study design that enable downstream questions about disease progression, complications, and treatment effects, using consistent, high-quality methods that can be compared across sites.
Structurally, NHLBI intends to fund a coordinated, multi-site effort consisting of four Clinical/Sequencing Research Sites plus a single Data Coordinating Center (DCC). The clinical/sequencing sites are responsible for enrolling and characterizing participants and carrying out microbiome profiling approaches for lung (and optionally upper airway) samples. Each clinical/sequencing site application should lay out a clear strategy to characterize the lung microbiome and is encouraged to include at least one hypothesis-driven, mechanistic aim, meaning an aim that goes beyond association and attempts to test a biologically grounded explanation for observed microbiome differences or links to clinical phenotypes. The DCC role is to support the network by coordinating data standards, facilitating integration across sites, and enabling the combined analyses that a multi-center microbiome program requires.
A defining feature of this FOA is its emphasis on collaboration and shared infrastructure. Awardees must agree to work closely with the other funded clinical/sequencing sites and the DCC, and also to coordinate with projects funded under the NIH Roadmap Human Microbiome Project (HMP) in overlapping areas. The intent is to promote cooperation, harmonize methods where possible, facilitate scientific exchange, and leverage shared resources so the overall program produces an integrated, broadly useful body of work rather than disconnected single-site datasets.
From an administrative standpoint, the opportunity is classified as discretionary funding through NIH, administered by NHLBI, with the activity area listed under Lung Diseases Research (CFDA 93.838). It does not require cost sharing or matching. The total estimated funding listed is $4,000,000, with an award ceiling of $525,000. The FOA was posted on December 4, 2008, with an original and current closing date of March 25, 2009, and an archive date of April 25, 2009, indicating it is an older, time-limited solicitation rather than an open-ended program announcement.
Eligibility is broad and includes many common NIH-eligible applicant types across academia, government, nonprofit, and industry. Eligible applicants explicitly include public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), small businesses and other for-profit organizations (other than small businesses are also listed), and multiple levels of government (state, county, city/township, special district), along with public housing authorities/Indian housing authorities. The FOA also highlights eligibility for a range of mission-relevant and underserved-serving organizations and institutions, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, U.S. territories or possessions, and faith-based or community-based organizations, among others. The cooperative agreement mechanism also implies that NHLBI expects substantial programmatic involvement and coordination compared with a standard investigator-initiated grant, consistent with the networked, multi-site design.
Overall, this FOA is aimed at creating a coordinated Lung HIV Microbiome Program that can generate standardized, high-throughput microbiome data from well-characterized HIV-infected and uninfected participants, enabling analyses that connect respiratory microbial community changes to HIV-related lung disease mechanisms, clinical complications, and the influence of antiretroviral therapy, with strong expectations for cross-site collaboration and centralized data coordination.
Frequently Asked Questions (FAQs)
What is RFA HL 09-006 trying to accomplish?
RFA HL 09-006 (NHLBI) is focused on building a high-quality, deeply sequenced, molecularly defined picture of the lung and lower respiratory tract microbiome in people living with HIV, compared with matched HIV-uninfected controls (including healthy controls). The goal is to generate standardized, rigorous data that can support meaningful analyses linking microbiome patterns to clinical outcomes and respiratory health in HIV.
Which parts of the respiratory tract are the main focus?
The primary anatomic emphasis is the lung itself, defined as the airways and airspaces below the glottis plus the lung parenchyma. The FOA also allows optional inclusion of the nasal and/or oropharyngeal cavities to help interpret potential sources of organisms and overlap across the respiratory tract.
What kinds of microbes are expected to be studied?
The program is designed to move beyond culture-based microbiology using modern molecular and high-throughput sequencing approaches to identify bacteria and, where feasible, other classes of organisms that may influence respiratory health in HIV. Examples mentioned include viruses, fungi, protozoa, and cell wall deficient organisms.
Why does the FOA emphasize molecular and high-throughput sequencing rather than culture-based methods?
The central idea is to go beyond what traditional culture can detect and instead use modern molecular profiling and sequencing methods to identify organisms in the lung and lower respiratory tract microbiome with greater depth and detail.
Is the program only descriptive, or does it aim to connect microbiome findings to health outcomes?
The expectation is not only descriptive cataloging of organisms. The FOA emphasizes producing a dataset with enough depth, rigor, and standardization to enable analyses that link microbiome patterns to clinical outcomes, including HIV-associated lung disease pathogenesis and progression, respiratory complications, and the effects of anti-HIV therapies on microbial communities.
What types of scientific questions does NHLBI specifically encourage applicants to address?
NHLBI points applicants toward examining how shifts in respiratory microbiota may relate to: (1) the pathogenesis and progression of HIV-associated lung disease, (2) development of HIV-related respiratory complications, and (3) effects of anti-HIV therapies on microbial communities.
What is the overall structure of the funded program?
NHLBI intends to support a coordinated, multi-site effort consisting of four Clinical/Sequencing Research Sites plus a single Data Coordinating Center (DCC). This structure is meant to support standardized methods and combined analyses across multiple sites.
What does a Clinical/Sequencing Research Site do under this FOA?
The clinical/sequencing sites are responsible for enrolling and characterizing participants and carrying out microbiome profiling approaches for lung samples (and optionally upper airway samples). Each site application is expected to present a clear strategy for characterizing the lung microbiome.
Is a hypothesis-driven, mechanistic aim required for Clinical/Sequencing Research Sites?
Clinical/sequencing sites are encouraged to include at least one hypothesis-driven, mechanistic aim. In this FOA, a mechanistic aim is described as going beyond association and attempting to test a biologically grounded explanation for observed microbiome differences or links to clinical phenotypes.
What is the role of the Data Coordinating Center (DCC)?
The DCC is intended to support the network by coordinating data standards, facilitating integration across sites, and enabling the combined analyses that a multi-center microbiome program requires.
How important is cross-site collaboration in this opportunity?
Collaboration is a defining feature. Awardees must agree to work closely with the other funded clinical/sequencing sites and the DCC. The FOA emphasizes shared infrastructure, harmonized methods where possible, scientific exchange, and leveraging shared resources so the overall program produces an integrated dataset rather than disconnected single-site efforts.
Does this FOA require coordination with any other NIH initiatives?
Yes. Awardees are expected to coordinate with projects funded under the NIH Roadmap Human Microbiome Project (HMP) in overlapping areas to promote cooperation, harmonize methods where possible, and leverage shared resources.
What funding mechanism is used for this opportunity?
This FOA uses a cooperative agreement mechanism (U01). The cooperative agreement structure implies substantial programmatic involvement and coordination compared with a standard investigator-initiated grant, aligning with the networked, multi-site design described.
Which NIH institute is administering the funding?
The opportunity is administered by the National Heart, Lung, and Blood Institute (NHLBI) as discretionary funding through NIH.
What is the CFDA number and activity area listed for this FOA?
The activity area is listed under Lung Diseases Research, CFDA 93.838.
Is cost sharing or matching required?
No. The FOA states that it does not require cost sharing or matching.
How much total funding is estimated, and what is the award ceiling?
The total estimated funding listed is $4,000,000, and the award ceiling is $525,000.
When was the FOA posted, and what are the key dates?
The FOA was posted on December 4, 2008. The original and current closing date is March 25, 2009. The archive date is April 25, 2009.
Is this an open, ongoing opportunity?
No. Based on the provided dates (closing date in 2009 and archive date in 2009), it is described as an older, time-limited solicitation rather than an open-ended program announcement.
Who can apply (in general terms)?
Eligibility is broad and includes many common NIH-eligible applicant types across academia, government, nonprofit, and industry.
Are institutions of higher education eligible?
Yes. Public and private institutions of higher education are explicitly listed as eligible applicants.
Are nonprofit organizations eligible, including those without 501(c)(3) status?
Yes. Nonprofit organizations are eligible, and the FOA explicitly includes nonprofits with or without 501(c)(3) status.
Are for-profit organizations eligible?
Yes. The eligibility list includes small businesses and other for-profit organizations.
Are government entities eligible applicants?
Yes. Multiple levels of government are listed as eligible, including state, county, city/township, and special district governments. Public housing authorities/Indian housing authorities are also listed.
Does the FOA encourage applications from underserved-serving or mission-relevant institutions?
Yes. The FOA highlights eligibility for a range of institutions and organizations, including HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, U.S. territories or possessions, and faith-based or community-based organizations, among others.
What comparisons are central to the study design described?
The FOA centers on comparing people living with HIV to matched HIV-uninfected controls, including healthy controls, to understand differences in the lung and lower respiratory tract microbiome.
What is meant by creating a "standardized" dataset in this program?
The FOA emphasizes depth, rigor, and standardization so that microbiome data and associated clinical characterization can be meaningfully analyzed and compared across sites, supporting combined analyses and broader usefulness.
Is inclusion of upper airway sites required?
No. Sampling of the nasal and/or oropharyngeal cavities is described as optional, intended to help interpret potential sources and overlap across the respiratory tract.
What is the overall program described as?
It is described as a coordinated Lung HIV Microbiome Program intended to generate standardized, high-throughput microbiome data from well-characterized HIV-infected and uninfected participants, enabling analyses that connect microbial community changes to HIV-related lung disease mechanisms, clinical complications, and the influence of antiretroviral therapy.
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