Opportunity Information: Apply for RFA AI 14 025
Apply for RFA AI 14 025
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Integrated Preclinical/Clinical Program for HIV Topical Microbicides and Biomedical Prevention (IPCP MBP) (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 Jun 4, 2014 and posted on Jun 4, 2014.
- Applicants must submit their applications by Nov 18, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $4,700,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $2,600,000.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts State governments Public housing authorities/Indian housing authorities County governments Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses City or township governments.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) 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) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession.
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Opportunity Summary:
The Integrated Preclinical/Clinical Program for HIV Topical Microbicides and Biomedical Prevention (IPCP MBP) (U19) is a National Institutes of Health (NIH) cooperative agreement funding opportunity designed to push forward non-vaccine biomedical approaches that can prevent HIV transmission and acquisition. The program is aimed at supporting teams that can run an integrated, end-to-end development effort, meaning applicants are expected to link preclinical work and clinical planning or execution in a way that is iterative and mutually informative. Rather than treating laboratory development and human testing as separate, linear steps, the IPCP MBP model emphasizes a coordinated pipeline where findings from formulation, safety, pharmacology, and early human studies can rapidly feed back into product redesign and optimization.
The core objective is the development of a topical microbicide, a pre-exposure prophylaxis (PrEP) approach, or a multipurpose prevention technology (MPT). In this context, MPT generally refers to a product concept that could address HIV prevention while also potentially providing protection against other sexually transmitted infections and/or offering contraceptive benefits, depending on the specific product design and active agents. The opportunity is focused specifically on non-vaccine biomedical prevention products or strategies intended for use in the male and/or female genital tract, and also the gastrointestinal (GI) tract. Including the GI tract reflects the reality of HIV transmission risks and the need for products that can protect mucosal tissues beyond only vaginal or penile exposure.
A defining feature of this program is the breadth of acceptable delivery formats. Applicants can propose drug delivery systems such as gels, films, quick-dissolving tablets, intravaginal rings (IVRs), implants, and systemic approaches such as oral or injectable modalities. This flexibility is meant to encourage innovation around real-world use and adherence, since product acceptability, dosing frequency, and user experience often determine whether a prevention tool succeeds outside the lab. For example, long-acting methods like rings, implants, or injections may be attractive where daily adherence is challenging, while on-demand products like gels or films may fit other populations and preferences.
The mechanism is a U19 cooperative agreement, which signals substantial NIH scientific and programmatic involvement compared with a standard grant. In practical terms, this typically means awardees should expect active coordination with NIH staff, milestone-driven progress expectations, and a higher level of structured collaboration and reporting. The announcement also notes that this iteration includes significant modifications compared with prior versions of the Integrated Preclinical Clinical Program FOA, indicating NIH updated requirements, emphasis areas, or structure based on lessons learned from earlier rounds.
From an administrative standpoint, this opportunity was posted June 4, 2014 under Funding Opportunity Number RFA-AI-14-025, with an original and current closing date of November 18, 2014, and an archive date of December 19, 2014. It falls under the broad health category and is associated with CFDA numbers 93.242, 93.855, and 93.856, reflecting links to mental health research grants as well as allergy, infectious diseases, and microbiology/infectious disease research. NIH expected to make one award, with an estimated total funding level of $4.7 million and an award ceiling of $2.6 million. There is no cost sharing or matching requirement stated for applicants.
Eligibility is intentionally broad and includes a wide range of organization types, reflecting the multidisciplinary nature of product development and the need for partnerships across academia, nonprofits, industry, and government. Eligible applicants include for-profit organizations (other than small businesses), small businesses, nonprofit organizations with or without 501(c)(3) status, public and private institutions of higher education, tribal governments and tribal organizations (including federally recognized entities), state and local governments, independent school districts, special district governments, public housing authorities/Indian housing authorities, U.S. territories or possessions, and certain non-U.S. entities such as foreign organizations and regional organizations. The eligibility list also explicitly includes a number of institution types and community-focused entities such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, tribally controlled colleges and universities, and faith-based or community-based organizations, underscoring NIH interest in inclusive participation and diverse research networks.
Overall, the IPCP MBP (U19) opportunity is best understood as a targeted, milestone-oriented program meant to fund a highly coordinated development effort for practical HIV prevention tools. It is not simply a basic science grant, nor only a clinical trial award. Instead, it is structured to support a product-focused development pathway that blends formulation and delivery innovation, preclinical evaluation, and clinical translation for prevention products intended to work at mucosal sites where HIV exposure occurs.
FAQs: Integrated Preclinical/Clinical Program for HIV Topical Microbicides and Biomedical Prevention (IPCP MBP) (U19)
What is the IPCP MBP (U19) funding opportunity?
The Integrated Preclinical/Clinical Program for HIV Topical Microbicides and Biomedical Prevention (IPCP MBP) (U19) is an NIH cooperative agreement designed to advance non-vaccine biomedical approaches that can prevent HIV transmission and acquisition. It supports teams that can run an integrated development effort connecting preclinical work with clinical planning or execution in an iterative way.
What is the main goal of this program?
The core objective is the development of a topical microbicide, a pre-exposure prophylaxis (PrEP) approach, or a multipurpose prevention technology (MPT) intended to prevent HIV. The program emphasizes a coordinated pipeline where formulation, safety, pharmacology, and early human study findings can rapidly inform product redesign and optimization.
What types of prevention products are in scope?
In-scope products and strategies include non-vaccine biomedical prevention approaches intended for use in the male and/or female genital tract and the gastrointestinal (GI) tract. Product concepts include topical microbicides, PrEP approaches, and MPTs.
What does MPT mean in this opportunity?
MPT stands for multipurpose prevention technology. In this context, it generally refers to a product concept that could address HIV prevention while also potentially providing protection against other sexually transmitted infections and/or offering contraceptive benefits, depending on the product design and active agents.
Which anatomical sites are specifically highlighted for intended use?
The opportunity focuses on products intended for mucosal sites where HIV exposure occurs, specifically the male and/or female genital tract and the gastrointestinal (GI) tract.
Does this opportunity include vaccine research?
No. The program is focused specifically on non-vaccine biomedical prevention products or strategies.
What does "integrated preclinical/clinical" mean for applicants?
Applicants are expected to link preclinical work and clinical planning or execution so the program operates as an end-to-end, coordinated development pipeline. Rather than treating lab development and human testing as separate, linear steps, the model emphasizes iterative feedback where results can guide product refinement.
What kinds of delivery formats are allowed?
The program allows a broad range of delivery formats, including gels, films, quick-dissolving tablets, intravaginal rings (IVRs), implants, and systemic approaches such as oral or injectable modalities.
Why does the FOA allow so many different delivery formats?
The flexibility is intended to encourage innovation that improves real-world use and adherence. Product acceptability, dosing frequency, and user experience can determine whether a prevention tool succeeds outside controlled settings. Long-acting methods (rings, implants, injections) and on-demand methods (gels, films) may fit different populations and preferences.
What is the funding mechanism for this opportunity?
This opportunity uses a U19 cooperative agreement mechanism.
What does a U19 cooperative agreement imply compared with a standard grant?
A U19 cooperative agreement signals substantial NIH scientific and programmatic involvement. Awardees should generally expect active coordination with NIH staff, milestone-driven progress expectations, and a higher level of structured collaboration and reporting than a typical grant.
Has this FOA changed compared with earlier versions?
Yes. The announcement notes that this iteration includes significant modifications compared with prior versions of the Integrated Preclinical Clinical Program FOA, indicating NIH updated requirements, emphasis areas, or structure based on lessons learned.
What is the Funding Opportunity Number (FOA number)?
The Funding Opportunity Number is RFA-AI-14-025.
When was this opportunity posted?
It was posted on June 4, 2014.
What are the closing date and archive date listed for this opportunity?
The original and current closing date is November 18, 2014, and the archive date is December 19, 2014.
How many awards did NIH expect to make?
NIH expected to make one award.
What is the estimated total funding and the award ceiling?
The estimated total funding level is $4.7 million, and the award ceiling is $2.6 million.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated for applicants.
What broad category does this opportunity fall under?
It falls under the broad health category.
Which CFDA numbers are associated with this opportunity?
The opportunity is associated with CFDA numbers 93.242, 93.855, and 93.856.
What types of organizations are eligible to apply?
Eligibility is broad and includes for-profit organizations (other than small businesses), small businesses, nonprofit organizations with or without 501(c)(3) status, public and private institutions of higher education, tribal governments and tribal organizations (including federally recognized entities), state and local governments, independent school districts, special district governments, public housing authorities/Indian housing authorities, U.S. territories or possessions, and certain non-U.S. entities such as foreign organizations and regional organizations.
Are community-focused and minority-serving institutions explicitly included?
Yes. The eligibility list explicitly includes HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, AANAPISIs, tribally controlled colleges and universities, and faith-based or community-based organizations.
Are foreign or non-U.S. organizations eligible?
Yes. The eligibility list includes certain non-U.S. entities, including foreign organizations and regional organizations.
Is this program more oriented toward basic science, clinical trials, or product development?
It is positioned as a product-focused development pathway rather than only a basic science grant or only a clinical trial award. It blends formulation and delivery innovation, preclinical evaluation, and clinical translation for prevention products intended to work at mucosal sites where HIV exposure occurs.
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