Opportunity Information: Apply for RFA AI 14 058

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Host Directed TB Therapy New Approaches (UH2/UH3)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
  • This funding opportunity was created on Nov 12, 2014 and posted on Nov 12, 2014.
  • Applicants must submit their applications by Mar 25, 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 $2,900,000.00 to eligible and selected applicants.
  • Eligible applicants include: Small businesses Independent school districts City or township governments For profit organizations other than small businesses County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) State governments Special district governments Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Private 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

Host Directed TB Therapy New Approaches (UH2/UH3) is a National Institutes of Health (NIH) funding opportunity (RFA-AI-14-058) focused on accelerating new treatment strategies for Mycobacterium tuberculosis (TB) that remain relevant for people who also have HIV. The central idea is to advance host-directed therapies (HDTs), meaning approaches that work by modifying or supporting the patient’s own immune or biological responses rather than directly targeting the bacteria alone. NIH is particularly interested in HDT candidates that might also help against HIV, either through direct anti-HIV effects or by strengthening immune responses in a way that benefits HIV/TB co-infected individuals. A key constraint and advantage of this program is that it emphasizes repurposing: the host-directed agents should already be approved for clinical use for another condition, or at least be in late-stage clinical trials, which can shorten the path to human proof-of-concept testing.

The award uses a staged cooperative agreement mechanism (UH2/UH3), which is designed to move projects from preparatory work into a clinical proof-of-concept (POC) trial if early milestones are met. The first stage, the UH2 phase, can last up to two years and supports the work needed to make a POC trial feasible and scientifically justified. This includes generating or completing critical preclinical data, building the necessary collaborations and clinical partnerships, and developing a full POC clinical trial protocol along with the supporting operational plans and documentation. The second stage, the UH3 phase, can last up to three years and supports execution of the planned POC clinical study, but only after the project successfully meets the specified preclinical and clinical milestones established during the UH2 period. Because it is a cooperative agreement, NIH is expected to have substantial involvement during the project, typically including coordination around milestones, progress evaluation, and alignment with program goals.

In practical terms, the FOA is meant to fund a pipeline that starts with readiness activities and then transitions into early clinical testing, rather than stopping at preclinical work. The POC clinical trial supported under UH3 is intended to provide early evidence on whether a host-directed approach can improve TB treatment outcomes in a way that makes sense for real-world use where HIV co-infection is common. Projects that can credibly address both TB treatment needs and the immunologic complexity of HIV/TB co-infection align most closely with the stated priorities.

The opportunity falls under NIH health research activities and is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). Cost sharing is not required. NIH estimated total funding for the announcement was about $2.9 million. The FOA was posted on November 12, 2014, with an original and current closing date of March 25, 2015, and an archive date of April 25, 2015 (indicating this specific solicitation is no longer open, though it remains useful as a reference for similar future NIH opportunities).

Eligibility was broad and included many types of domestic and international applicants. Eligible entities included small businesses, for-profit organizations, nonprofits (including both 501(c)(3) and certain non-501(c)(3) organizations), public and private institutions of higher education, and a wide range of government entities (state, county, city/township, special district). Tribal governments and tribal organizations were eligible, as were public housing authorities/Indian housing authorities. The FOA also explicitly included institutions serving specific populations (such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities), as well as faith-based and community-based organizations. Foreign organizations and foreign institutions were eligible to apply, and foreign components of U.S. organizations were allowed under NIH policy, making this a globally accessible call consistent with the international burden of TB and HIV.

For full details, NIH pointed applicants to the official FOA page (http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-14-058.html). The contact listed for technical access issues was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

Frequently Asked Questions (FAQs)

What is the "Host Directed TB Therapy New Approaches (UH2/UH3)" opportunity?

It is a National Institutes of Health (NIH) funding opportunity announcement (FOA) focused on accelerating new treatment strategies for Mycobacterium tuberculosis (TB), especially approaches that remain relevant in people who also have HIV. The specific FOA identifier provided is RFA-AI-14-058.

What is the main scientific focus of this FOA?

The FOA prioritizes host-directed therapies (HDTs) for TB. HDTs aim to modify or support a patient's own immune or biological responses to improve TB treatment outcomes, rather than only directly targeting the TB bacteria.

What does "host-directed therapy (HDT)" mean in this context?

In this FOA, host-directed therapy refers to treatment strategies that work by altering or supporting the host (patient) immune or biological pathways to help control TB infection and improve treatment outcomes, as opposed to relying solely on antimicrobials that directly kill or inhibit the bacteria.

Why is HIV specifically highlighted in this TB funding opportunity?

NIH indicates that the program is intended to support TB treatment approaches that remain relevant for people with HIV, including those who are co-infected with TB and HIV. The FOA notes interest in HDT candidates that might also help against HIV, either through direct anti-HIV effects or by strengthening immune responses that benefit HIV/TB co-infected individuals.

Does the FOA require that the HDT also treat HIV?

The information provided states that NIH is particularly interested in HDT candidates that might also help against HIV, either through direct anti-HIV effects or via immune strengthening that benefits co-infected individuals. It does not state that an anti-HIV effect is mandatory, but it is described as a priority interest area.

What is the repurposing emphasis and why does it matter?

A key constraint and advantage described is repurposing: the host-directed agents should already be approved for clinical use for another condition, or at least be in late-stage clinical trials. This is intended to shorten the path to human proof-of-concept testing.

Are early-stage experimental compounds eligible for this program?

Based on the description provided, the FOA emphasizes repurposing and indicates the host-directed agents should already be clinically approved for another indication or be in late-stage clinical trials. Earlier-stage compounds are not aligned with that stated emphasis.

What funding mechanism does this FOA use?

The FOA uses a staged cooperative agreement mechanism, UH2/UH3, designed to move projects from preparatory work into a clinical proof-of-concept trial if early milestones are met.

How does the UH2/UH3 staged structure work?

The first stage (UH2) supports preparatory activities for up to two years. If the project meets specified milestones established during UH2, it can transition to the second stage (UH3), which supports execution of the planned proof-of-concept clinical study for up to three years.

What activities are supported during the UH2 phase?

UH2 (up to two years) supports work needed to make a proof-of-concept clinical trial feasible and scientifically justified. The described activities include generating or completing critical preclinical data, building collaborations and clinical partnerships, and developing a full proof-of-concept clinical trial protocol with operational plans and documentation.

What activities are supported during the UH3 phase?

UH3 (up to three years) supports conducting the planned proof-of-concept clinical study, but only after successful achievement of the preclinical and clinical milestones established during the UH2 period.

Is transition from UH2 to UH3 automatic?

No. The description indicates that the UH3 phase is supported only after the project successfully meets specified milestones established during the UH2 period.

What is meant by a "cooperative agreement" in this FOA?

As described, the award is a cooperative agreement in which NIH is expected to have substantial involvement during the project. This typically includes coordination around milestones, progress evaluation, and alignment with program goals.

What is the intended end result of the funded work?

The FOA is meant to fund a pipeline that begins with readiness activities and then transitions into early clinical testing. The UH3 proof-of-concept trial is intended to provide early evidence about whether a host-directed approach can improve TB treatment outcomes in a way that makes sense for real-world use where HIV co-infection is common.

Is this FOA focused on preclinical research only?

No. The practical intent described is to move from preparatory and enabling work into a proof-of-concept clinical trial (UH3), rather than stopping at preclinical work.

What disease areas or research categories are associated with this opportunity?

The opportunity falls under NIH health research activities and is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).

Was cost sharing required?

No. The information provided explicitly states that cost sharing is not required.

How much total funding did NIH estimate for this announcement?

NIH estimated total funding for the announcement at about $2.9 million.

When was the FOA posted and what were the key dates?

The FOA was posted on November 12, 2014. The original and current closing date listed was March 25, 2015. The archive date was April 25, 2015.

Is this specific solicitation still open?

No. The archive date (April 25, 2015) indicates that this specific solicitation is no longer open, though it may still be useful as a reference for similar future NIH opportunities.

Who was eligible to apply?

Eligibility was described as broad and included many types of domestic and international applicants. Eligible entities included small businesses, for-profit organizations, nonprofits (including 501(c)(3) and certain non-501(c)(3) organizations), public and private institutions of higher education, and government entities (state, county, city/township, special district).

Were tribal entities eligible?

Yes. Tribal governments, tribal organizations, and tribally controlled colleges and universities were explicitly included as eligible.

Were public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities were listed as eligible entities.

Were institutions serving specific populations explicitly included?

Yes. The FOA explicitly included institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, Alaska Native and Native Hawaiian-serving institutions, and tribally controlled colleges and universities.

Were faith-based and community-based organizations eligible?

Yes. Faith-based and community-based organizations were included in the eligible applicant types listed.

Could foreign organizations apply?

Yes. Foreign organizations and foreign institutions were eligible to apply, and foreign components of U.S. organizations were allowed under NIH policy.

Where can applicants find the official FOA details?

NIH directed applicants to the official FOA page at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-14-058.html

Who was the contact for technical access issues?

The contact listed for technical access issues was the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.

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