Opportunity Information: Apply for RFA AI 13 023
Apply for RFA AI 13 023
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Integrated Preclinical/Clinical Program for HIV 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): 93.855 Allergy and Infectious Diseases Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jun 24, 2013 and posted on Jun 24, 2013.
- Applicants must submit their applications by Nov 13, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $9,100,000.00 to eligible and selected applicants.
- Eligible applicants include: City or township governments State governments Small businesses Native American tribal governments (Federally recognized) Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) 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 Independent school districts Special district governments Native American tribal organizations (other than Federally recognized tribal governments) County governments Public housing authorities/Indian housing authorities For profit organizations other than small businesses Public and State controlled institutions of higher education.
- 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 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 Microbicides and Biomedical Prevention (IPCP MBP) (U19) is a National Institutes of Health (NIH) cooperative agreement funding opportunity designed to push forward a pipeline of non-vaccine biomedical prevention approaches for HIV. The central idea is to fund teams that can move promising prevention concepts through an integrated, iterative process that links preclinical development with early, exploratory human studies. In practice, this means supporting multi-project, multidisciplinary programs that can discover, optimize, and translate candidate products and strategies, rather than funding isolated, single-lab efforts. The FOA emphasizes maintaining a strong and diverse portfolio of prevention options, reflecting the reality that different populations, exposure routes, and real-world constraints often require different tools.
Scientifically, the opportunity targets non-vaccine biomedical prevention (nBP) strategies, specifically including microbicides, pre-exposure prophylaxis (PrEP) approaches, and multipurpose prevention technologies (MPTs). MPTs are especially notable because they are intended to address multiple sexual and reproductive health needs at once, for example combining HIV prevention with contraception or potentially other STI prevention, depending on the candidate. The program is particularly focused on interventions intended for the male and female genital tracts and the gastrointestinal (GI) tract, recognizing that HIV transmission and acquisition can occur across multiple mucosal surfaces. The FOA encourages both single-agent candidates and combination approaches, which can be important for increasing potency, broadening coverage, reducing the risk of resistance, or improving practicality and adherence.
A defining feature of the IPCP MBP initiative is its strong emphasis on delivery strategies, including both pericoital use (products used around the time of sex) and sustained delivery systems (products designed for longer-acting protection). The FOA explicitly calls out a wide range of drug delivery systems (DDS) that applicants may develop and test, including gels, films, quick-dissolving tablets, intravaginal rings (IVRs), implants, oral formulations, injectable approaches, and MPT-based delivery systems. This reflects an understanding that prevention efficacy is not only about the active drug or biologic, but also about whether the product format fits people’s lives and supports consistent use. Long-acting and sustained-release formats, in particular, are often pursued to reduce adherence burdens compared to daily or event-driven regimens.
From a development standpoint, the program’s goal is to support translation from preclinical research into pre-Phase I clinical studies. That generally implies a focus on generating the kinds of data needed to justify and design first-in-human work, such as formulation development, stability, manufacturing feasibility, pharmacokinetics and pharmacodynamics concepts, safety signals in relevant models, and other evidence that a candidate is ready to be evaluated in people. The language of “integrated and iterative” also signals that the NIH expects feedback loops between lab-based work and early clinical insights, so that lessons learned in exploratory clinical settings can inform subsequent optimization of candidates, formulations, dosing, or delivery systems.
Administratively, this is a discretionary funding opportunity using a cooperative agreement mechanism (U19). A cooperative agreement typically means the NIH anticipates substantial programmatic involvement during the project period, such as coordination, milestone-based management, or collaborative interactions between awardees and NIH staff. The activity category is health research, aligned with CFDA numbers 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The FOA notes that it includes significant modifications compared with prior versions of the Integrated Preclinical Clinical Program, which is a strong hint that applicants would need to pay close attention to updated expectations around structure, required components, coordination, milestones, governance, or clinical and regulatory planning.
The estimated total funding listed for the opportunity is $9.1 million, and the program does not require cost sharing or matching. Key dates show it was posted June 24, 2013, with an original and current closing date of November 13, 2013, and an archive date of December 14, 2013. While those dates indicate the specific announcement is historical, the summary still captures how NIH was framing priorities for advancing HIV prevention products at that time: integrated product development, emphasis on real-world usable delivery formats, and a deliberate bridge between preclinical work and early clinical evaluation.
Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, local, county, city, township, and special district governments; federally recognized and other tribal governments and tribal organizations; public and state-controlled and private institutions of higher education; nonprofit organizations (with or without 501(c)(3) status); independent school districts; public housing authorities/Indian housing authorities; small businesses; and for-profit organizations other than small businesses. The FOA also explicitly includes a range of designated institution 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, regional organizations, U.S. territories or possessions, and eligible federal agencies. Importantly, foreign organizations and foreign institutions are eligible to apply, and non-U.S. components of U.S. organizations are also eligible, with foreign components allowed under NIH policy. That breadth fits a field like HIV prevention, where global collaboration and research in diverse epidemic settings can be essential.
The full announcement was hosted by NIH with the funding opportunity number RFA-AI-13-023, titled “Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP MBP) (U19).” For technical access issues, the notice points applicants to the NIH Office of Extramural Research (OER) webmaster contacts.
FAQs: Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP MBP) (U19)
What is this funding opportunity?
The Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP MBP) (U19) is an NIH cooperative agreement funding opportunity intended to advance a pipeline of non-vaccine biomedical prevention approaches for HIV by supporting integrated programs that connect preclinical development with early, exploratory human studies.
What is the official funding opportunity number and title?
The NIH funding opportunity number is RFA-AI-13-023. The title is "Integrated Preclinical/Clinical Program for HIV Microbicides and Biomedical Prevention (IPCP MBP) (U19)."
What does "non-vaccine biomedical prevention (nBP)" mean in this FOA?
In this FOA, non-vaccine biomedical prevention refers to HIV prevention strategies that are not vaccines, including microbicides, pre-exposure prophylaxis (PrEP) approaches, and multipurpose prevention technologies (MPTs).
Which scientific areas and intervention types are specifically targeted?
The opportunity targets non-vaccine biomedical prevention strategies, specifically including microbicides, PrEP approaches, and MPTs, with an emphasis on interventions for the male and female genital tracts and the gastrointestinal (GI) tract.
What are multipurpose prevention technologies (MPTs) in this program?
MPTs are products intended to address multiple sexual and reproductive health needs at once. The FOA gives an example of combining HIV prevention with contraception, and notes the possibility of addressing other STI prevention depending on the candidate.
Does the FOA support single-agent candidates, combination approaches, or both?
Both. The FOA encourages development of single-agent candidates and combination approaches, recognizing combinations may help increase potency, broaden coverage, reduce resistance risk, or improve practicality and adherence.
Why does the FOA emphasize delivery strategies?
The FOA highlights that real-world prevention effectiveness depends not only on the active drug or biologic, but also on whether the product format is usable and supports consistent use. It therefore emphasizes delivery strategies including pericoital use and sustained delivery systems.
What does "pericoital use" mean in the context of this FOA?
Pericoital use refers to products used around the time of sex.
What does "sustained delivery" mean in this FOA?
Sustained delivery refers to products designed for longer-acting protection, often pursued to reduce adherence burdens compared to daily or event-driven regimens.
What types of drug delivery systems (DDS) are mentioned as examples?
The FOA explicitly mentions gels, films, quick-dissolving tablets, intravaginal rings (IVRs), implants, oral formulations, injectable approaches, and MPT-based delivery systems.
What is the overall development goal (preclinical vs. clinical stage)?
The program aims to support translation from preclinical research into pre-Phase I clinical studies, focusing on generating the kinds of data needed to justify and design first-in-human work.
What kinds of preclinical/translation data does the FOA imply will be important?
The FOA points to data that help justify and design early human studies, such as formulation development, stability, manufacturing feasibility, pharmacokinetics and pharmacodynamics concepts, safety signals in relevant models, and other evidence indicating a candidate is ready for evaluation in people.
What does the FOA mean by an "integrated and iterative" program?
It signals that NIH expects a linked workflow between lab-based development and early clinical insights, including feedback loops where findings from exploratory clinical studies inform ongoing optimization of candidates, formulations, dosing, delivery systems, or other development decisions.
Is this funding meant for isolated projects or larger team-based programs?
The FOA emphasizes supporting multi-project, multidisciplinary programs that can discover, optimize, and translate candidate products and strategies, rather than isolated, single-lab efforts.
What is the funding mechanism and what does it imply?
The mechanism is a cooperative agreement (U19). A cooperative agreement typically implies substantial NIH programmatic involvement during the project period, such as coordination, milestone-based management, and collaborative interactions between awardees and NIH staff.
What is the activity category and which CFDA numbers are associated with it?
The activity category is health research. The CFDA numbers listed are 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
How much total funding is estimated for this opportunity?
The estimated total funding listed is $9.1 million.
Is cost sharing or matching required?
No. The FOA states there is no cost sharing or matching requirement.
What are the key dates for this FOA?
The FOA was posted on June 24, 2013. The original closing date and current closing date are both November 13, 2013. The archive date is December 14, 2013.
Is this announcement still open?
Based on the listed closing and archive dates (closing date November 13, 2013; archive date December 14, 2013), this specific announcement is historical.
Why does the FOA mention maintaining a "strong and diverse portfolio" of prevention options?
The FOA notes that different populations, exposure routes, and real-world constraints can require different HIV prevention tools, so it emphasizes supporting a range of prevention options rather than relying on a single approach.
Which anatomical sites or exposure routes does the program emphasize?
The FOA particularly focuses on interventions intended for the male and female genital tracts and the gastrointestinal (GI) tract, reflecting that HIV transmission and acquisition can occur across multiple mucosal surfaces.
Who is eligible to apply?
Eligibility is broad and includes many U.S. and non-U.S. organization types, including various levels of government, tribal governments and tribal organizations, higher education institutions (public/state-controlled and private), nonprofits (with or without 501(c)(3) status), independent school districts, public housing authorities/Indian housing authorities, small businesses, and for-profit organizations other than small businesses.
Are foreign organizations eligible?
Yes. The FOA explicitly states that foreign organizations and foreign institutions are eligible to apply, and that non-U.S. components of U.S. organizations are eligible as well, with foreign components allowed under NIH policy.
Are U.S. territories or possessions included in eligible applicant types?
Yes. The FOA explicitly includes U.S. territories or possessions among eligible applicant categories.
Does the FOA explicitly encourage applications from specific institution types?
The FOA explicitly includes institution 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, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), and also includes faith-based or community-based organizations.
Are federal agencies eligible to apply?
Yes. The FOA includes eligible federal agencies among the eligible applicant types.
What does the FOA say about changes compared to prior versions of the program?
The FOA states it includes significant modifications compared with prior versions of the Integrated Preclinical Clinical Program, suggesting applicants should pay close attention to updated expectations around areas such as structure, required components, coordination, milestones, governance, or clinical and regulatory planning.
Where was the full announcement hosted and who is the sponsoring agency?
The full announcement was hosted by the National Institutes of Health (NIH).
Who should be contacted for technical access issues?
For technical access issues, the FOA points applicants to the NIH Office of Extramural Research (OER) webmaster contacts.
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