HIV Vaccines Clinical Trials Network Leadership and Operations Center (UM1 Clinical Trial Required) | RFA AI 19 006

Opportunity Information: Apply for RFA AI 19 006

The National Institutes of Health (NIH) released this discretionary funding opportunity, RFA-AI-19-006, to support a single Leadership and Operations Center (LOC) for the HIV Vaccines Clinical Trials Network under a UM1 cooperative agreement mechanism that requires a clinical trial component. In practical terms, NIH is looking for an organization that can serve as the central hub for the network, providing both the day-to-day operational backbone and the high-level scientific direction needed to plan, coordinate, and run HIV vaccine clinical research across multiple sites and partners. Because this is a cooperative agreement, the work is expected to be carried out in close collaboration with NIH program staff, with substantial federal involvement in steering, oversight, and coordination compared with a standard grant.

The LOC is intended to be responsible for the overall administrative and scientific leadership of the HIV Vaccines Clinical Trials Network. That central leadership role typically includes network-wide coordination of protocol development and trial implementation, harmonizing procedures across sites, supporting regulatory and compliance activities, facilitating communication among investigators and stakeholders, and keeping complex clinical trial operations on schedule and aligned with network priorities. The emphasis on “leadership and operations” signals that NIH is not just funding a research project, but rather the core infrastructure and management entity that enables a broad portfolio of HIV vaccine clinical trials to function efficiently and consistently.

Eligibility is broad and includes many U.S.-based public and private entities. Eligible applicants include state, county, and city or township governments; 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; Native American tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education); for-profit organizations other than small businesses; small businesses; and other unspecified eligible entities. The announcement also explicitly highlights additional eligible applicant 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, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

At the same time, there are important limits related to foreign participation. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed. This means a U.S.-based applicant can include certain foreign collaborations or activities that meet NIH’s definition and requirements for foreign components, even though a foreign institution cannot serve as the primary applicant.

The opportunity is categorized under the Health, Income Security and Social Services activity category and is associated with CFDA numbers 93.121, 93.242, 93.855, and 93.865. The sponsoring agency is NIH. The original closing date listed for applications was August 1, 2019, and the FOA record creation date is January 24, 2019. The source information provided does not list an award ceiling or expected number of awards, but the structure and purpose indicate NIH intended to fund an LOC that functions as the network’s central coordinating and leadership entity rather than a standalone, single-site study.

• The National Institutes of Health in the health, income security and social services sector is offering a public funding opportunity titled "HIV Vaccines Clinical Trials Network Leadership and Operations Center (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): 93.121, 93.242, 93.855, 93.865.
• This funding opportunity was created on 2019-01-24.
• Applicants must submit their applications by 2019-08-01. (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.

Apply for RFA AI 19 006

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