Opportunity Information: Apply for RFA AI 19 045
This funding opportunity, titled "HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required)" (RFA AI 19 045), is a National Institutes of Health (NIH) cooperative agreement designed to support the operations of Clinical Trials Units (CTUs) that can run HIV/AIDS clinical studies developed by NIH-supported HIV/AIDS Clinical Trials Networks. The central idea is to fund organizations that already have, or can build and maintain, the real-world infrastructure needed to carry out complex clinical research in people, not just plan it on paper. Because the award mechanism is a cooperative agreement, recipients should expect substantial NIH program involvement in oversight and coordination, reflecting a partnership model rather than a fully independent grant.
The CTUs funded under this announcement are expected to provide both scientific and administrative expertise and the on-the-ground capacity to execute network-developed protocols. In practical terms, this means a CTU must be able to participate in the development and implementation of clinical trials and supply the core operational components required to run studies reliably and safely. Key expectations include providing clinical sites capable of enrolling and following participants, maintaining local laboratory capacity to support study testing and specimen handling, and ensuring pharmacy support appropriate for investigational products and protocol-driven medication management. The announcement also emphasizes that CTUs should support two or more HIV/AIDS Clinical Trials Networks, signaling that NIH is looking for units that can operate at a scale and level of flexibility sufficient to contribute across multiple network portfolios rather than serving only a single program.
The opportunity falls under the health activity category and is associated with CFDA number 93.855. It is listed as a discretionary funding opportunity and uses the UM1 activity code, which typically supports multi-component, milestone-driven or programmatically coordinated efforts and often aligns with large clinical research operations. While the listing does not provide an award ceiling or the expected number of awards in the provided excerpt, the operational scope described suggests substantial responsibilities related to staffing, regulatory compliance, data and safety processes, laboratory and pharmacy operations, and consistent coordination with NIH network leadership and other sites.
Eligibility is broad and includes a wide range of domestic and certain non-domestic entities. Eligible applicants include state, county, city or township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations that are not federally recognized governments; public housing authorities and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations other than small businesses; small businesses; and other eligible entities. The announcement also specifically highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and foreign (non-U.S.) organizations. This wide eligibility reflects the reality that HIV/AIDS clinical research often requires diverse clinical settings and partnerships, including community-based sites and international locations where the epidemic burden and research needs may be substantial.
Important dates in the provided record include a creation date of 2019-05-01 and an original closing date of 2019-11-18. In summary, the FOA aims to strengthen and sustain the clinical trial infrastructure that NIH HIV/AIDS networks rely on by funding CTUs that can deliver high-quality, compliant, and coordinated trial operations, including clinics, laboratories, and pharmacies, while contributing to protocol development and supporting multiple networks at once.Apply for RFA AI 19 045
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.855.
- This funding opportunity was created on 2019-05-01.
- Applicants must submit their applications by 2019-11-18. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled 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), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required) - RFA AI 19 045
What is this funding opportunity?
This funding opportunity is titled "HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required)" (RFA AI 19 045). It is a National Institutes of Health (NIH) cooperative agreement intended to support the operations of Clinical Trials Units (CTUs) that can run HIV/AIDS clinical studies developed by NIH-supported HIV/AIDS Clinical Trials Networks.
What is the main purpose of the award?
The main purpose is to fund organizations that already have, or can build and maintain, real-world infrastructure to carry out complex HIV/AIDS clinical research involving human participants. The focus is on executing network-developed clinical study protocols reliably and safely, not merely planning or proposing research concepts.
What does "UM1 Clinical Trial Required" mean in this context?
The opportunity uses the UM1 activity code and explicitly requires clinical trials. In practice, this indicates support for coordinated, operations-heavy clinical research efforts where the funded unit is expected to carry out clinical trials as part of NIH-supported HIV/AIDS clinical trial networks.
What is a cooperative agreement, and how is it different from a traditional NIH grant?
This opportunity uses a cooperative agreement mechanism, meaning recipients should expect substantial NIH program involvement in oversight and coordination. It is described as a partnership model where NIH plays an active role, rather than a fully independent award where the recipient operates with minimal federal program direction.
What is a Clinical Trials Unit (CTU) under this FOA?
A CTU, as described here, is an organization (or an operational unit within an organization) that provides the scientific, administrative, and practical on-the-ground capacity to implement HIV/AIDS clinical studies developed by NIH-supported networks. The emphasis is on having the operational components needed to run trials in real clinical environments.
What kinds of activities are CTUs expected to perform?
CTUs are expected to support both the development and implementation of clinical trials and to supply the core operational components required to run studies reliably and safely. The FOA highlights that CTUs should provide scientific and administrative expertise and be able to execute network-developed protocols.
What core infrastructure components are specifically emphasized?
The FOA emphasizes the need for: (1) clinical sites capable of enrolling and following participants, (2) local laboratory capacity for study testing and specimen handling, and (3) pharmacy support appropriate for investigational products and protocol-driven medication management.
Does a CTU need to have clinical sites for participant enrollment and follow-up?
Yes. The FOA explicitly expects CTUs to provide clinical sites that can enroll participants and follow them over time, reflecting the practical demands of conducting clinical trials in people.
Is laboratory capacity required?
Yes. The FOA highlights maintaining local laboratory capacity to support study testing and specimen handling as a key operational expectation for CTUs.
Is pharmacy support required?
Yes. The FOA emphasizes pharmacy support appropriate for investigational products and protocol-driven medication management, which is typically essential in clinical trials involving study medications.
Do applicants need to support more than one HIV/AIDS Clinical Trials Network?
Yes. The announcement emphasizes that CTUs should support two or more HIV/AIDS Clinical Trials Networks. This signals NIH is seeking units with enough scale and flexibility to contribute across multiple network portfolios rather than serving only a single program.
Is this opportunity focused on planning studies or running them?
It is focused on running them. The description stresses operational capacity and infrastructure for executing complex clinical research in people, with CTUs participating in protocol development and implementation for network-developed studies.
What is the health area or activity category for this opportunity?
The opportunity falls under the health activity category and is focused on HIV/AIDS clinical trials operations within NIH-supported clinical trials networks.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.855.
Is this a discretionary funding opportunity?
Yes. The listing describes it as a discretionary funding opportunity.
Does the excerpt list an award ceiling or the expected number of awards?
No. In the provided excerpt, an award ceiling and the expected number of awards are not specified.
What does the described operational scope suggest about responsibilities?
The operational scope suggests substantial responsibilities related to staffing, regulatory compliance, data and safety processes, laboratory and pharmacy operations, and ongoing coordination with NIH network leadership and other sites.
Who is eligible to apply?
Eligibility is broad and includes many domestic and certain non-domestic entities. Eligible applicants include various levels of government (state, county, city or township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, federally recognized Native American tribal governments, tribal organizations not recognized as governments, public housing authorities and Indian housing authorities, nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education), for-profit organizations other than small businesses, small businesses, and other eligible entities.
Are federally recognized tribal governments eligible?
Yes. Federally recognized Native American tribal governments are listed as eligible applicants.
Are tribal organizations that are not federally recognized governments eligible?
Yes. Tribal organizations that are not federally recognized governments are included in the eligible applicant types.
Are colleges and universities eligible?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are both listed as eligible.
Are nonprofit organizations eligible?
Yes. Nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education) are listed as eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations other than small businesses are listed as eligible, and small businesses are also listed separately as eligible.
Are faith-based or community-based organizations eligible?
Yes. The announcement specifically highlights faith-based or community-based organizations among additional eligible applicants.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are specifically highlighted as eligible in the announcement.
Are foreign (non-U.S.) organizations eligible?
Yes. The announcement specifically highlights foreign (non-U.S.) organizations as eligible applicants.
Are Minority Serving Institutions (MSIs) specifically mentioned as eligible?
Yes. The announcement highlights Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).
Are federal agencies eligible?
Yes. The announcement highlights eligible federal agencies as additional eligible applicants.
What are the important dates listed in the provided record?
The provided record lists a creation date of 2019-05-01 and an original closing date of 2019-11-18.
What is the overall goal of NIH in funding CTUs through this FOA?
The overall goal is to strengthen and sustain the clinical trial infrastructure that NIH HIV/AIDS networks rely on by funding CTUs that can deliver high-quality, compliant, and coordinated trial operations (including clinics, laboratories, and pharmacies), contribute to protocol development, and support multiple networks at once.
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