Opportunity Information: Apply for RFA AI 12 003
Apply for RFA AI 12 003
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19)" 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.
- This funding opportunity was created on Oct 13, 2011 and posted on Oct 13, 2011.
- Applicants must submit their applications by Feb 29, 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 $7,700,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Independent school districts For profit organizations other than small businesses County governments Public and State controlled institutions of higher education Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) State governments Native American tribal organizations (other than Federally recognized tribal governments).
- 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 Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19) is a National Institutes of Health cooperative agreement opportunity led by the National Institute of Allergy and Infectious Diseases (NIAID) with participation from the National Institute of Mental Health (NIMH). The central aim is to move promising topical microbicide candidates forward through a tightly connected set of preclinical and early clinical activities, with an emphasis on an iterative, feedback driven development pathway. In practical terms, the program is designed to support teams that can generate preclinical data, translate those findings into exploratory clinical studies, and then cycle results back into formulation, delivery, safety, and acceptability refinements to increase the likelihood of developing a product that is not only biologically effective, but also safe and realistic for real world use in preventing sexual transmission of HIV. The FOA allows work on either single agents or combination topical microbicides, reflecting the broader prevention landscape where combinations may offer improved potency, resistance barriers, or user fit depending on the context of use.
This is a multi project, multidisciplinary program award (U19), meaning applicants are expected to propose an integrated package of related projects rather than a single standalone study. The solicitation specifically requires at least two research projects plus an Administrative Core, underscoring that the funded effort should be organized like a coordinated program with shared leadership, harmonized milestones, and active management of cross project dependencies. Beyond these minimum components, applicants can typically include additional scientific cores if needed to support shared resources, standardized methods, specialized assays, clinical operations, behavioral science, biostatistics, regulatory support, formulation development, or other functions that enable the projects to operate as one coherent development pipeline.
A notable structural requirement is that at least one component of the application, either a research project or a scientific core, must be led by a private sector entity, which can be a for profit or not for profit company. This requirement signals a strong interest in connecting academic and public sector innovation with product development capabilities found in industry, such as manufacturing know how, formulation and device engineering, quality systems, scalability planning, and preparation for later stage development steps. It also reflects an intent to ensure that funded programs maintain a clear path toward a deployable microbicide product rather than stopping at proof of concept science.
Because the funding instrument is a cooperative agreement, NIH involvement is expected to be more hands on than in a typical research project grant. While the applicant organization conducts the work, cooperative agreements generally include substantial federal scientific or programmatic involvement, such as participation in steering or oversight activities, coordination across awardees, and alignment on milestones and go/no go decision points. This structure fits the FOA's translational emphasis, where coordinated planning, timely decision making, and standardized evaluation approaches can be critical to moving candidates through preclinical and early clinical stages efficiently.
Eligibility is broad and includes many U.S. organization types (public and private higher education institutions, nonprofits with or without 501(c)(3) status, small businesses, other for profit organizations, and numerous government entities). The announcement also allows non U.S. (foreign) institutions to apply, permits foreign components within U.S. organizations, and allows foreign components as defined by the NIH Grants Policy Statement. The eligible applicant list explicitly includes categories such as HBCUs, Hispanic serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith based and community based organizations, U.S. territories or possessions, and regional organizations, reflecting NIH's wide eligibility posture when the scientific need benefits from diverse settings and capabilities.
Financially, the FOA lists an estimated total funding amount of $7.7 million, and it does not require cost sharing or matching. The opportunity was posted on October 13, 2011, with an application deadline of February 29, 2012, and an archive date of March 31, 2012. It is tied to multiple CFDA program areas, including mental health research (93.242) and allergy and infectious diseases research and microbiology/infectious diseases research (93.855 and 93.856), which aligns with the dual institute involvement and the combined biomedical and behavioral or acceptability dimensions implied by topical prevention products.
In short, this FOA was built to fund coordinated, multi component programs that can take a topical microbicide concept and push it forward through integrated preclinical and exploratory clinical work, while also addressing user acceptability and practical deployment considerations. The required administrative structure, the expectation of iterative translation between lab and clinic, and the mandated participation of a private sector partner all point to a product oriented approach aimed at advancing a candidate toward real world HIV prevention impact.
Frequently Asked Questions (FAQs)
What is the name of this funding opportunity?
The opportunity is titled "Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19)."
Which federal agency and institutes are leading this program?
This is a National Institutes of Health (NIH) cooperative agreement opportunity led by the National Institute of Allergy and Infectious Diseases (NIAID), with participation from the National Institute of Mental Health (NIMH).
What is the main goal of the IPCP HTM (U19) program?
The central aim is to move promising HIV topical microbicide candidates forward through an integrated set of preclinical and early clinical activities using an iterative, feedback-driven development pathway. The program emphasizes cycling findings between lab and early clinical work to refine formulation, delivery, safety, and acceptability in order to increase the likelihood of developing a product that is effective, safe, and realistic for real-world use to prevent sexual transmission of HIV.
What kinds of research activities does the program expect to support?
The program is designed to support teams that can generate preclinical data, translate those findings into exploratory clinical studies, and then feed clinical results back into additional refinements (for example, formulation, delivery approach, safety, and acceptability considerations) as part of a connected development pipeline.
Does the FOA allow single-agent microbicides, combination products, or both?
Both are allowed. The FOA permits work on either single-agent topical microbicides or combination topical microbicides, reflecting the prevention landscape where combinations may offer advantages such as improved potency, higher barriers to resistance, or improved fit for users depending on context.
What does it mean that this is a U19 award?
U19 is a multi-project, multidisciplinary program award. Applicants are expected to propose an integrated package of related projects rather than a single standalone study, with coordinated leadership and active management of cross-project dependencies.
Is this a standard research grant or a cooperative agreement?
This opportunity uses a cooperative agreement mechanism (U19), which generally involves more hands-on NIH involvement compared with typical research project grants. While the awardee conducts the work, the structure anticipates substantial federal scientific and/or programmatic involvement.
What kinds of NIH involvement are implied by the cooperative agreement structure?
Based on the FOA description, cooperative agreement involvement can include participation in steering or oversight activities, coordination across awardees, and alignment around milestones and go/no-go decision points. This is intended to support efficient progress through translational stages with standardized evaluation and timely decision-making.
What is the minimum required structure of an application under this FOA?
The solicitation requires at least two research projects plus an Administrative Core. This minimum structure signals that the funded effort should operate as a coordinated program with shared leadership, harmonized milestones, and active integration across components.
Are additional cores beyond the Administrative Core permitted?
Yes. In addition to the required Administrative Core (and the minimum two research projects), applicants can typically include additional scientific cores if needed to provide shared resources and functions that help the overall program operate as a coherent pipeline.
What types of additional scientific cores might be included?
The FOA description notes that additional cores may support shared resources or standardized functions such as specialized assays, clinical operations, behavioral science, biostatistics, regulatory support, formulation development, and other capabilities that enable the projects to function as one integrated development effort.
Is private sector participation required?
Yes. At least one component of the application, either a research project or a scientific core, must be led by a private sector entity. The private sector entity may be a for-profit or a not-for-profit company.
Why does the FOA require a private sector-led component?
The FOA frames this requirement as a way to connect academic and public sector innovation with industry product development capabilities. Examples mentioned include manufacturing know-how, formulation and device engineering, quality systems, scalability planning, and preparation for later-stage development steps. The intent is to keep a clear path toward a deployable microbicide product rather than stopping at proof-of-concept science.
Who is eligible to apply?
Eligibility is broad and includes many U.S. organization types, including public and private higher education institutions, nonprofits (with or without 501(c)(3) status), small businesses, other for-profit organizations, and numerous government entities.
Are non-U.S. (foreign) institutions eligible to apply?
Yes. The announcement allows non-U.S. (foreign) institutions to apply.
Are foreign components allowed within a U.S.-based application?
Yes. The FOA permits foreign components within U.S. organizations and also allows foreign components as defined by the NIH Grants Policy Statement.
Does the eligible applicant list include minority-serving institutions and other specialized organization types?
Yes. The eligible applicant list explicitly includes categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based and community-based organizations, U.S. territories or possessions, and regional organizations.
What is the estimated total funding amount?
The FOA lists an estimated total funding amount of $7.7 million.
Is cost sharing or matching required?
No. The FOA does not require cost sharing or matching.
When was this opportunity posted, and what were the key dates?
The opportunity was posted on October 13, 2011. The application deadline was February 29, 2012. The archive date was March 31, 2012.
Which CFDA program areas are associated with this FOA?
The FOA is tied to multiple CFDA program areas, including mental health research (93.242) and allergy and infectious diseases research and microbiology/infectious diseases research (93.855 and 93.856).
How does NIMH participation relate to a topical microbicide program?
Based on the information provided, the program is not only focused on biological effectiveness but also on safety and real-world feasibility, including user acceptability. The inclusion of mental health research CFDA alignment is consistent with behavioral and acceptability dimensions often relevant to prevention products.
What is meant by an "iterative, feedback-driven" development pathway in this FOA?
It refers to a cycle where preclinical findings inform exploratory clinical studies, and the results from those clinical studies then feed back into additional refinements (such as formulation, delivery, safety assessments, and acceptability considerations). The goal is a tightly connected lab-to-clinic-to-lab loop to improve the candidate product over time.
What kind of overall program approach is NIH seeking through this FOA?
The FOA emphasizes a product-oriented, coordinated program that integrates preclinical and early clinical work, includes a required administrative structure, uses harmonized milestones and active management, and includes a private sector-led component to strengthen the path toward a deployable HIV prevention microbicide.
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