Opportunity Information: Apply for RFA AI 12 008
Apply for RFA AI 12 008
- The National Institutes of Health in the health income security and social services sector is offering a public funding opportunity titled "Leadership Group for a Clinical Research Network on Microbicides to Prevent HIV Infection (UM1)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research 93.865 Child Health and Human Development Extramural Research.
- This funding opportunity was created on Jan 27, 2012 and posted on Jan 27, 2012.
- Applicants must submit their applications by Sep 28, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments For profit organizations other than small businesses City or township governments County governments Small businesses Special district governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education.
- 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 not 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:
This funding opportunity (RFA-AI-12-008) is a National Institutes of Health (NIH) cooperative agreement solicitation for the Leadership Group that will run a clinical research network focused on microbicides to prevent HIV infection. The central aim is not to fund a single stand-alone research project, but to support an organized, network-level leadership structure with the authority and capacity to set priorities, design and execute clinical studies, and adjust the overall research agenda as the science evolves. The Leadership Group is expected to align the network's work with the National Institute of Allergy and Infectious Diseases (NIAID) HIV/AIDS scientific priorities referenced in the announcement, meaning the award is designed to directly support NIAID's strategic prevention goals in the microbicide space.
The award mechanism is a UM1 cooperative agreement, which signals substantial federal scientific and programmatic involvement compared with a typical grant. In practice, this means the NIH/NIAID will be an active partner in planning, oversight, and major decisions, while the awardee leadership team is responsible for day-to-day execution and for delivering network performance. The opportunity sits within the broad federal activity category of Health, Income Security, and Social Services, and it is associated with CFDA numbers 93.242, 93.855, 93.856, and 93.865, reflecting its relevance to mental health research, allergy and infectious diseases, microbiology and infectious diseases, and child health and human development research portfolios.
A defining requirement of this FOA is that an application for the Leadership Group must be submitted as three separate but linked UM1 applications. Together, these three components make up the full Leadership Group structure. The first component is the Leadership and Operations Center (LOC), which would function as the network's operational headquarters. The LOC would typically be responsible for overall leadership, protocol development coordination, clinical operations management, regulatory and compliance coordination, training and quality management systems, communications across participating sites, and the general administrative infrastructure needed to run multi-site clinical research efficiently and consistently.
The second required component is the Laboratory Center (LC). This center is meant to provide the network's core laboratory capacity and scientific standardization, which is critical in microbicide trials where biological endpoints, specimen handling, and assay consistency can make or break interpretability. The LC would generally be expected to establish and maintain standardized laboratory procedures, perform or coordinate specialized testing, ensure quality assurance and quality control across labs and sites, manage specimen tracking and biorepository-related workflows where applicable, and support the scientific validity of lab-based endpoints that inform safety, pharmacology, adherence, and efficacy-related analyses.
The third component is the Statistical and Data Management Center (SDMC), which anchors the network's data integrity and analytic rigor. The SDMC is typically responsible for building and maintaining the data capture and management systems, ensuring data quality and timeliness, supporting protocol design from a statistical perspective (including sample size, randomization, interim monitoring, and endpoint definitions), conducting analyses, and producing reports for investigators, oversight bodies, and the NIH partner team. In a clinical network environment, the SDMC is also central to maintaining standard operating procedures for data, ensuring traceability and audit readiness, and supporting any required safety and performance monitoring processes.
Key administrative details include that this opportunity was posted on January 27, 2012, with an original and final closing date of September 28, 2012, and it was archived on October 29, 2012. The FOA states there is no cost sharing or matching requirement, which means applicants are not required to contribute non-federal funds as a condition of the award, although applicants would still need to propose a realistic budget and infrastructure capable of meeting network obligations.
Eligibility is broad and includes many U.S.-based organizational types: state, county, city or township governments; special district governments; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations other than small businesses; and small businesses. The eligibility section also explicitly includes a range of mission- and community-focused institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions. Foreign institutions (non-U.S. entities) are not eligible to apply as applicants; however, non-domestic components of U.S. organizations may participate, and "foreign components" as defined by NIH policy are allowed, which typically means discrete project elements may be carried out internationally under the umbrella of an eligible U.S. applicant organization when justified and compliant with NIH rules.
Overall, the FOA is structured to fund the leadership backbone of a coordinated clinical research network for HIV prevention microbicides, emphasizing integrated operations, centralized laboratory capacity, and robust statistical and data management. The three linked-center model is meant to ensure the network can consistently design and run complex clinical studies, generate reliable laboratory and clinical endpoints, and maintain high-quality data and analysis, all in close coordination with NIAID priorities and oversight. For reference and official details, the opportunity points to the NIH Grants Guide RFA posting at http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-008.html, and it lists the NIH OER webmaster contacts for access or linking issues.
Frequently Asked Questions (FAQs)
What is the funding opportunity RFA-AI-12-008?
RFA-AI-12-008 is a National Institutes of Health (NIH) cooperative agreement solicitation to support a Leadership Group that will run a clinical research network focused on microbicides to prevent HIV infection.
What is the main goal of this FOA?
The central goal is to fund an organized, network-level leadership structure (not a single stand-alone research project) with the authority and capacity to set priorities, design and execute clinical studies, and adjust the network research agenda as the science evolves.
Is this intended to fund a single research project?
No. The announcement emphasizes that the purpose is not to fund one independent project, but to support the leadership backbone and coordinated infrastructure of a multi-site clinical research network.
Which NIH Institute is this aligned with?
The Leadership Group is expected to align the network's work with National Institute of Allergy and Infectious Diseases (NIAID) HIV/AIDS scientific priorities referenced in the announcement, supporting NIAID's strategic prevention goals in the microbicide space.
What award mechanism is used for this opportunity?
The award mechanism is a UM1 cooperative agreement.
What does a UM1 cooperative agreement mean in practice?
A UM1 cooperative agreement signals substantial federal scientific and programmatic involvement compared with a typical grant. Under this structure, NIH/NIAID is an active partner in planning, oversight, and major decisions, while the awardee leadership team is responsible for day-to-day execution and delivering network performance.
What is being funded: a single application or multiple linked applications?
The FOA requires that the Leadership Group application be submitted as three separate but linked UM1 applications. Together, these three components make up the complete Leadership Group structure.
What are the three required components of the Leadership Group?
The three required components are: (1) a Leadership and Operations Center (LOC), (2) a Laboratory Center (LC), and (3) a Statistical and Data Management Center (SDMC).
What is the role of the Leadership and Operations Center (LOC)?
The LOC functions as the network's operational headquarters. It would typically be responsible for overall leadership, coordinating protocol development, managing clinical operations, coordinating regulatory and compliance activities, supporting training and quality management systems, managing communications across participating sites, and providing the administrative infrastructure needed to run multi-site clinical research efficiently and consistently.
What is the role of the Laboratory Center (LC)?
The LC provides the network's core laboratory capacity and scientific standardization. It would generally be expected to establish and maintain standardized laboratory procedures, perform or coordinate specialized testing, ensure quality assurance and quality control across labs and sites, manage specimen tracking and biorepository-related workflows where applicable, and support the scientific validity of lab-based endpoints related to safety, pharmacology, adherence, and efficacy analyses.
What is the role of the Statistical and Data Management Center (SDMC)?
The SDMC anchors the network's data integrity and analytic rigor. It is typically responsible for building and maintaining data capture and management systems, ensuring data quality and timeliness, supporting protocol design from a statistical perspective (including sample size, randomization, interim monitoring, and endpoint definitions), conducting analyses, and producing reports for investigators, oversight bodies, and the NIH partner team. It also supports data SOPs, traceability, audit readiness, and required safety and performance monitoring processes.
Who is expected to make day-to-day decisions for the network?
Day-to-day execution is the responsibility of the awardee leadership team, while NIH/NIAID remains an active partner involved in planning, oversight, and major decisions.
What is the overall research area and purpose of the network?
The network is focused on clinical research on microbicides intended to prevent HIV infection, with an emphasis on coordinated study design and execution, reliable laboratory and clinical endpoints, and high-quality data and analysis under a unified network leadership structure.
What federal activity category is associated with this opportunity?
The opportunity is within the broad federal activity category of Health, Income Security, and Social Services.
Which CFDA numbers are associated with this FOA?
The opportunity is associated with CFDA numbers 93.242, 93.855, 93.856, and 93.865.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award.
Even without cost sharing, do applicants still need to propose a budget?
Yes. While cost sharing is not required, applicants still need to propose a realistic budget and an infrastructure capable of meeting the network obligations described in the FOA.
When was this opportunity posted and when did it close?
The opportunity was posted on January 27, 2012. The original and final closing date was September 28, 2012. It was archived on October 29, 2012.
Is this FOA still open for applications?
No. Based on the provided dates, the final closing date was September 28, 2012, and the opportunity was archived on October 29, 2012.
What types of organizations are eligible to apply?
Eligibility is broad and includes many U.S.-based organizational types, including state, county, city or township governments; special district governments; public housing authorities/Indian housing authorities; public and state-controlled institutions of higher education; private institutions of higher education; nonprofit organizations (with and without 501(c)(3) status); for-profit organizations other than small businesses; and small businesses.
Are mission-focused institution types included in the eligible applicant categories?
Yes. The eligibility section explicitly includes Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities (TCCUs), Alaska Native and Native Hawaiian serving institutions, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.
Are foreign institutions eligible to apply as the applicant organization?
No. Foreign institutions (non-U.S. entities) are not eligible to apply as applicants.
Can international activities be included in an application?
Yes, in limited ways. Non-domestic components of U.S. organizations may participate, and foreign components (as defined by NIH policy) are allowed. This typically means discrete project elements may be carried out internationally under an eligible U.S. applicant organization when justified and compliant with NIH rules.
Why does the FOA require three linked centers instead of one centralized application?
The three linked-center model is designed to ensure the network has integrated operations (LOC), centralized laboratory capacity and standardization (LC), and robust statistical and data management capabilities (SDMC) so it can consistently design and run complex clinical studies, generate reliable endpoints, and maintain high-quality data and analysis.
Where can applicants find the official RFA posting?
The FOA points to the NIH Grants Guide RFA posting at: http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-12-008.html
Who is listed for technical help with access or linking issues?
The opportunity lists NIH Office of Extramural Research (OER) webmaster contacts for access or linking issues.
Browse more opportunities from the same category: Health Income Security and Social Services
Next opportunity: Leadership Group for a Clinical Research Network on Integrated Strategies to Prevent HIV Infection (UM1)
Previous opportunity: Leadership Group for a Clinical Research Network on Therapeutics for HIV/AIDS and HIV associated Infections in Adults (UM1)
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