Opportunity Information: Apply for RFA AI 12 018
Apply for RFA AI 12 018
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Clinical Trials Units for NIAID Networks (UM1)" 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 Apr 10, 2012 and posted on Apr 10, 2012.
- Applicants must submit their applications by Jan 29, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $70,000,000.00 to eligible and selected applicants.
- Eligible applicants include: State governments City or township governments County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Special district governments Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities.
- 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 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:
The funding opportunity RFA-AI-12-018, titled "Clinical Trials Units for NIAID Networks (UM1)," is a National Institutes of Health (NIH) discretionary grant announcement from the National Institute of Allergy and Infectious Diseases (NIAID). It uses the UM1 cooperative agreement mechanism, which generally means the award supports a large, multi-component clinical research effort where NIH staff are expected to have substantial scientific and programmatic involvement during performance. The program is positioned under NIH health-related research activities and aligns with CFDA program areas 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The opportunity was posted on April 10, 2012, with an application due date of January 29, 2013, and it was later archived on March 1, 2013.
At its core, this FOA sought applications to establish or support Clinical Trials Units (CTUs) that would serve as operational sites within NIAID clinical research networks. CTUs are the on-the-ground infrastructure that make large, network-driven clinical studies possible. In practical terms, CTUs typically provide the staffing, facilities, regulatory and compliance capacity, participant recruitment and retention capability, clinical and laboratory procedures, data and specimen handling, pharmacy and investigational product management, and quality assurance needed to run complex clinical trials under standardized network protocols. By funding CTUs, NIAID aimed to ensure that its networks had reliable, high-performing sites capable of conducting multiple trials over time, often across diverse populations and geographic settings, while maintaining consistent protocol execution and participant safety standards.
The FOA specifically targeted CTUs aligned with six major NIAID network research areas. First, it emphasized adult HIV therapeutic strategies, including efforts related to HIV cure research as well as the management of noninfectious comorbidities and key infectious comorbidities such as hepatitis and tuberculosis. Second, it focused on strategies addressing HIV and HIV-associated infections in pediatric and maternal populations, reflecting the unique clinical, pharmacologic, and ethical considerations in children and during pregnancy. Third, it called for integrated HIV prevention strategies, which typically implies combination approaches that may include behavioral, biomedical, and structural interventions working together rather than in isolation. Fourth, it highlighted microbicide strategies to prevent HIV infection, an area centered on topical or localized products intended to reduce transmission risk, often studied in populations at increased risk. Fifth, it included vaccines to prevent HIV infections, supporting the infrastructure required for vaccine efficacy and immunogenicity trials that can involve specialized laboratory assays and long-term follow-up. Sixth, it covered strategies to address antibacterial resistance, indicating that these CTUs were also expected to support clinical research addressing the growing threat of resistant bacterial infections, which can include evaluating novel therapeutics, optimized treatment strategies, or other interventions.
The announcement listed a sizeable estimated total funding level of $70,000,000, signaling an intention to support a substantial network footprint rather than isolated, single-site studies. Because CTUs function as network nodes, the overall budget level typically reflects the need to sustain multiple sites, maintain readiness for rapid study start-up, and support several concurrent or sequential protocols.
Eligibility was intentionally broad and included many types of U.S. organizations and governmental entities, such as state, county, city/township, and special district governments; independent school districts; and public housing authorities/Indian housing authorities. It also included public and private institutions of higher education, nonprofits both with and without 501(c)(3) status, and for-profit organizations (including small businesses and other for-profit entities). The FOA also explicitly included a wide range of mission-focused and community-anchored entities, such as faith-based or community-based organizations, Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and various tribal and regional organizations. Importantly, non-U.S. entities (foreign institutions) were eligible to apply, and foreign components were allowed consistent with NIH policy, reflecting the global nature of infectious disease research and the need for trial capacity in diverse international settings.
The FOA stated there was no cost sharing or matching requirement, which generally lowers barriers to entry for applicants that may have strong clinical and community capacity but limited ability to provide significant institutional cost contributions. The funding instrument being a cooperative agreement rather than a standard grant also implies that applicants needed to be prepared for close coordination with NIAID and network leadership, including adherence to network governance, common protocol procedures, data standards, and performance expectations.
For those seeking the full official details, NIAID directed applicants to the NIH Grants Guide posting (linked in the announcement) and provided NIH Office of Extramural Research (OER) webmaster contacts for technical access issues.
Frequently Asked Questions (FAQs): RFA-AI-12-018 - Clinical Trials Units for NIAID Networks (UM1)
What is the funding opportunity RFA-AI-12-018?
RFA-AI-12-018 is a National Institutes of Health (NIH) discretionary grant announcement from the National Institute of Allergy and Infectious Diseases (NIAID) titled "Clinical Trials Units for NIAID Networks (UM1)." It solicited applications to establish or support Clinical Trials Units (CTUs) that function as operational sites within NIAID clinical research networks.
Which NIH institute issued this opportunity?
The opportunity was issued by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of NIH.
What type of award mechanism does this opportunity use?
This funding opportunity uses the UM1 cooperative agreement mechanism. A cooperative agreement generally indicates substantial scientific and programmatic involvement by NIH staff during the project period, in contrast to a standard grant where the awardee typically has more autonomous control.
What does it mean that this is a cooperative agreement?
Based on the description provided, it means CTUs funded under this opportunity were expected to coordinate closely with NIAID and network leadership. This often includes following network governance, common protocol procedures, data standards, and performance expectations so that multiple sites can run standardized network protocols consistently.
What is a Clinical Trials Unit (CTU) in the context of this FOA?
In this FOA, a CTU is the on-the-ground infrastructure that enables large, network-driven clinical studies to operate. CTUs are described as operational sites within NIAID clinical research networks that make complex clinical trials feasible and consistent across locations and populations.
What kinds of capabilities do CTUs typically provide?
The opportunity describes CTUs as typically providing staffing, facilities, regulatory and compliance capacity, participant recruitment and retention capability, clinical and laboratory procedures, data and specimen handling, pharmacy and investigational product management, and quality assurance needed to run complex clinical trials under standardized network protocols.
What is the main purpose of funding CTUs under this opportunity?
The purpose was to ensure NIAID clinical research networks had reliable, high-performing sites capable of conducting multiple trials over time (including concurrent or sequential protocols), maintaining consistent protocol execution, and meeting participant safety and quality standards across diverse populations and geographic settings.
Which research areas or network topics were specifically targeted?
The FOA targeted CTUs aligned with six major NIAID network research areas:
- Adult HIV therapeutic strategies (including HIV cure research and management of comorbidities such as hepatitis and tuberculosis)
- HIV and HIV-associated infections in pediatric and maternal populations
- Integrated HIV prevention strategies
- Microbicide strategies to prevent HIV infection
- Vaccines to prevent HIV infections
- Strategies to address antibacterial resistance
What does "adult HIV therapeutic strategies" include in this announcement?
It includes adult HIV therapeutic strategies with emphasis on HIV cure research and management of noninfectious comorbidities, as well as key infectious comorbidities such as hepatitis and tuberculosis.
Why does the FOA call out pediatric and maternal HIV research specifically?
The FOA indicates this focus reflects unique clinical, pharmacologic, and ethical considerations in children and during pregnancy, and it sought CTU capacity aligned to those needs.
What is meant by "integrated HIV prevention strategies" in the FOA?
The description indicates integrated prevention typically implies combination approaches that may include behavioral, biomedical, and structural interventions working together rather than in isolation.
What are "microbicide strategies" as described here?
Microbicide strategies are described as topical or localized products intended to reduce HIV transmission risk, often studied in populations at increased risk of infection.
What types of activities might CTUs support for HIV vaccine research?
The FOA describes HIV vaccine prevention efforts as requiring infrastructure for vaccine efficacy and immunogenicity trials, which can involve specialized laboratory assays and long-term follow-up.
How does antibacterial resistance fit into a CTU-focused FOA?
The FOA includes strategies to address antibacterial resistance and notes CTUs were expected to support clinical research responding to resistant bacterial infections. Examples described include evaluating novel therapeutics, optimized treatment strategies, or other interventions.
How much total funding was estimated for this opportunity?
The announcement listed an estimated total funding level of $70,000,000, indicating an intention to support a substantial network footprint rather than isolated single-site studies.
What does the $70,000,000 estimate suggest about the program scale?
Because CTUs operate as network nodes and are intended to support multiple protocols over time, the large estimated total funding level suggests support for multiple sites, sustained readiness for rapid study start-up, and the ability to run several protocols over time.
Which CFDA program areas are associated with this opportunity?
The FOA aligns with CFDA program areas 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
When was this opportunity posted?
It was posted on April 10, 2012.
What was the application due date?
The application due date was January 29, 2013.
Is this funding opportunity still active?
No. The announcement was later archived on March 1, 2013.
Is cost sharing or matching required?
No. The FOA stated there was no cost sharing or matching requirement.
Who was eligible to apply?
Eligibility was broad. The FOA included many types of U.S. organizations and governmental entities (state, county, city/township, special district governments; independent school districts; and public housing authorities/Indian housing authorities), as well as public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), and for-profit organizations (including small businesses and other for-profit entities).
Are community-based and mission-focused organizations included in eligibility?
Yes. The FOA explicitly included faith-based or community-based organizations and a range of mission-focused and community-anchored entities.
Are minority-serving institutions and tribal institutions eligible?
Yes. The FOA explicitly included Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and various tribal and regional organizations.
Are foreign (non-U.S.) entities eligible to apply?
Yes. The FOA states that non-U.S. entities (foreign institutions) were eligible to apply, and foreign components were allowed consistent with NIH policy.
Why does the FOA allow foreign eligibility and foreign components?
The description ties this to the global nature of infectious disease research and the need for clinical trial capacity in diverse international settings.
What kind of coordination should applicants expect under a network CTU model?
The FOA indicates CTUs function as network nodes and should be prepared for close coordination with NIAID and network leadership, including adherence to network governance, common protocol procedures, data standards, and performance expectations.
Where can applicants find the official full details?
NIAID directed applicants to the NIH Grants Guide posting linked in the announcement for full official details.
Who is listed for technical access help related to the announcement?
The announcement provided NIH Office of Extramural Research (OER) webmaster contacts for technical access issues.
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