Opportunity Information: Apply for RFA AI 12 019
Apply for RFA AI 12 019
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Leadership Group for a Clinical Research Network on Antibacterial Resistance (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 Jan 13, 2012 and posted on Jan 13, 2012.
- Applicants must submit their applications by Jun 1, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $10,000,000.00 to eligible and selected applicants.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Small businesses State governments Private institutions of higher education For profit organizations other than small businesses County governments City or township governments 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 not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Leadership Group for a Clinical Research Network on Antibacterial Resistance (UM1) funding opportunity (RFA-AI-12-019) is an NIH cooperative agreement designed to stand up and run the central leadership structure for a national clinical research network focused on antibacterial resistance (AR). The main idea is that NIH is not simply funding a single research project; it is funding an organizing and management entity that will set the scientific direction and oversee the execution of a coordinated clinical research agenda aimed at addressing high-priority questions in AR. Because this is a cooperative agreement (UM1), the award is meant to be carried out in close collaboration with NIH, with substantial federal involvement in planning, oversight, and coordination.
The funded Leadership Group (LG) is expected to have overall responsibility for designing, prioritizing, implementing, and managing the network’s clinical research program. In practical terms, that means the LG would be the hub that decides what studies should be done first, how protocols will be developed and reviewed, how sites and investigators will be coordinated, and how the network will maintain consistent standards across multiple studies and participating institutions. The LG is positioned as the operational and scientific backbone for turning AR priorities into real-world, multicenter clinical studies, including the organizational capacity to launch trials, manage study performance, and keep the network aligned with evolving AR threats and scientific opportunities.
Applications must be structured to include one overall (overview) component plus three required functional components. The first required component is the Leadership and Operations Center (LOC), which would typically cover governance, program management, regulatory coordination, communications, meeting support, protocol development workflows, and general network operations. The second required component is the Laboratory Center (LC), which would provide the laboratory infrastructure needed to support AR clinical research, such as standardized microbiology methods, resistance characterization, quality assurance, and harmonized lab procedures so results are comparable across sites. The third required component is the Statistics and Data Management Center (SDMC), responsible for study design support, statistical leadership, data systems, database management, data quality control, analysis plans, reporting, and ensuring that clinical data are collected and handled consistently and securely across the network.
This opportunity was posted January 13, 2012, with an application due date of June 1, 2012, and it was later archived July 2, 2012. NIH anticipated making a single award, with an estimated total funding level of about $10,000,000. The activity area is health, and it is associated with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). No cost sharing or matching was required, which generally means applicants were not expected to contribute a defined portion of funds from non-federal sources as a condition of the award.
Eligibility was broad across U.S.-based organizations and governments, including state, county, and city governments; special district governments; public and state-controlled and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); independent school districts; public housing authorities/Indian housing authorities; and Native American tribal governments or organizations. The FOA also explicitly included a range of institution types that NIH often highlights for eligibility, such as 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, U.S. territories or possessions, and eligible federal agencies. Non-U.S. (foreign) institutions were not eligible to apply, and non-U.S. components of U.S. organizations were also not eligible to apply; however, foreign components (as NIH defines them in the NIH Grants Policy Statement) were allowed, which typically means limited, well-justified international elements could be included under a U.S. applicant organization when scientifically necessary.
Overall, the FOA is best understood as support for a centralized, multi-component leadership and infrastructure entity that can run a coordinated clinical research network targeting antibacterial resistance, rather than a traditional investigator-initiated research grant. It emphasizes integrated operations (LOC), rigorous and standardized laboratory capability (LC), and strong statistical and data systems leadership (SDMC), all under a single Leadership Group charged with driving and managing a national AR clinical research agenda in partnership with NIH.
Frequently Asked Questions (FAQs)
What is the Leadership Group for a Clinical Research Network on Antibacterial Resistance (UM1) opportunity?
This funding opportunity (RFA-AI-12-019) is an NIH cooperative agreement (UM1) to establish and operate the central leadership structure for a national clinical research network focused on antibacterial resistance (AR). It is aimed at creating the organizing and management hub that sets direction and oversees a coordinated, multi-site clinical research agenda in AR.
Is this grant funding a single research project?
No. The opportunity is designed to fund an organizing and management entity (the Leadership Group) that will design, prioritize, implement, and manage a network-wide clinical research program. The emphasis is on network leadership and infrastructure to run coordinated clinical studies, not a single standalone research study.
What does it mean that this is a cooperative agreement (UM1)?
A UM1 cooperative agreement involves substantial federal involvement. The award is intended to be carried out in close collaboration with NIH, including NIH participation in planning, oversight, and coordination of the network and its clinical research agenda.
What is the main purpose of the funded Leadership Group (LG)?
The Leadership Group serves as the operational and scientific backbone of the network. It is expected to set scientific priorities, oversee the execution of the coordinated research agenda, manage protocol development and review processes, coordinate sites and investigators, and ensure consistent standards across studies and participating institutions.
What responsibilities is the Leadership Group expected to handle?
Based on the opportunity description, the Leadership Group is expected to have overall responsibility for designing, prioritizing, implementing, and managing the network's clinical research program. This includes deciding which studies to launch, managing protocol workflows, coordinating multicenter operations, monitoring study performance, and keeping the network aligned with evolving antibacterial resistance threats and scientific opportunities.
How must the application be structured?
Applications must include one overall (overview) component plus three required functional components: (1) a Leadership and Operations Center (LOC), (2) a Laboratory Center (LC), and (3) a Statistics and Data Management Center (SDMC).
What is the Leadership and Operations Center (LOC) component?
The LOC typically covers governance and program management functions for the network. As described, it includes areas such as regulatory coordination, communications, meeting support, protocol development workflows, and general network operations.
What is the Laboratory Center (LC) component?
The LC provides laboratory infrastructure needed to support AR clinical research. The description highlights responsibilities such as standardized microbiology methods, resistance characterization, quality assurance, and harmonized laboratory procedures to ensure results are comparable across participating sites.
What is the Statistics and Data Management Center (SDMC) component?
The SDMC is responsible for statistical leadership and data systems supporting the network. Responsibilities described include study design support, database and data systems management, data quality control, analysis planning, reporting, and ensuring clinical data are collected, handled, and managed consistently and securely across the network.
How many awards did NIH anticipate making under this opportunity?
NIH anticipated making a single award.
What was the estimated total funding level?
The estimated total funding level was about $10,000,000.
When was this opportunity posted and when were applications due?
The opportunity was posted on January 13, 2012. The application due date was June 1, 2012.
Is the funding opportunity still active?
No. The opportunity was archived on July 2, 2012.
What is the activity area for this opportunity?
The activity area is health, with a focus on antibacterial resistance clinical research network leadership and infrastructure.
What CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
Was cost sharing or matching required?
No. The opportunity specified that no cost sharing or matching was required, meaning applicants were not expected to contribute a defined non-federal funding portion as a condition of the award.
Who was eligible to apply?
Eligibility was broad across U.S.-based organizations and governments. Examples explicitly included state, county, and city governments; special district governments; public and state-controlled and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit organizations (including small businesses); independent school districts; public housing authorities/Indian housing authorities; and Native American tribal governments or organizations.
Did the opportunity highlight specific institution types as eligible?
Yes. The description explicitly included institution types often highlighted by NIH, such as 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, U.S. territories or possessions, and eligible federal agencies.
Were non-U.S. (foreign) institutions eligible to apply?
No. Non-U.S. (foreign) institutions were not eligible to apply.
Could a U.S. organization include non-U.S. components?
No. Non-U.S. components of U.S. organizations were not eligible to apply under this opportunity as described.
Are any international elements allowed at all?
Yes, foreign components (as defined by NIH in the NIH Grants Policy Statement) were allowed. This generally indicates that limited, well-justified international elements could be included under a U.S. applicant organization when scientifically necessary, as long as they fit NIH's definition and policy framework.
What is the overall focus of the funded work?
The overall focus is to support a centralized, multi-component leadership and infrastructure entity capable of running a coordinated clinical research network targeting antibacterial resistance. The FOA emphasizes integrated operations (LOC), rigorous and standardized laboratory capability (LC), and strong statistical and data systems leadership (SDMC), all under a single Leadership Group working in partnership with NIH.
What kinds of clinical research activities is the network meant to support?
The network is described as having the organizational capacity to launch multicenter clinical studies, manage study performance, coordinate protocols and sites, and maintain consistent standards across multiple studies and institutions in order to address high-priority questions in antibacterial resistance.
What makes the Leadership Group central to the network?
The Leadership Group is positioned as the hub for decision-making and coordination. It is expected to translate antibacterial resistance priorities into real-world, multicenter clinical studies by setting the research agenda, organizing protocol development, aligning participating sites, and ensuring consistent operational, laboratory, and data standards.
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