Opportunity Information: Apply for RFA AI 14 036
Apply for RFA AI 14 036
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Mucosal Environment and HIV Prevention (MEHP II) (R01)" 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 Jul 22, 2014 and posted on Jul 22, 2014.
- Applicants must submit their applications by Nov 21, 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 $1,200,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,200,000.00 in funding.
- Eligible applicants include: Public housing authorities/Indian housing authorities State governments For profit organizations other than small businesses Special district governments Private institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts County governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education City or township governments Native American tribal governments (Federally recognized) Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal 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 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 Mucosal Environment and HIV Prevention II (MEHP II) (R01) funding opportunity (RFA-AI-14-036) is a National Institutes of Health (NIH) discretionary grant program focused on strengthening the science behind non-vaccine biomedical HIV prevention approaches. Its central goal is to fund innovative, proof-of-concept and feasibility research that can help move the field toward safer and more effective microbicides and pre-exposure prophylaxis (PrEP) strategies. The emphasis is on generating new, hypothesis-driven knowledge about the mucosal environments where HIV exposure and transmission can occur, and on understanding how prevention products and drug delivery approaches behave and interact within those environments.
A key feature of this FOA is its focus on the biology and conditions of the male and female genital tract and the gastrointestinal (GI) mucosa, viewed through both “micro†and “macro†environmental lenses. In practice, this means the program is interested in research that examines how local mucosal factors (for example, mucus properties, epithelial integrity, immune cell presence and activation, microbiome composition, local inflammation, and other tissue-level or luminal conditions) and broader contextual factors (for example, physiological states or co-existing conditions that shape mucosal function) influence the performance, distribution, safety, and protective potential of biomedical prevention products. The intent is to address gaps that can explain why a product or delivery strategy may work well in one context but not another, or why safety and tolerability can vary across tissues, sexes, or exposure routes.
MEHP II explicitly supports high-risk, innovative research, meaning proposals can be exploratory as long as they are rigorous and hypothesis-driven, and they advance understanding in ways that are likely to inform future prevention design and optimization. Projects may involve active pharmaceutical ingredients (APIs), formulations and excipients, or devices that are already under development, but the FOA does not require that an application include an API or a specific product. The program is open to biomedical research that clarifies fundamental interactions at mucosal surfaces, including how delivery systems behave in real mucosal conditions, how mucosal immune biology affects drug or product activity, and what biological or environmental variables may predict efficacy or adverse effects.
At the same time, the FOA draws a clear boundary around what it will not fund: it is not intended to support the preclinical or clinical development of new non-vaccine biomedical prevention candidates or their delivery systems. In other words, the focus is not on advancing a new product through a development pipeline, but on producing enabling science that helps the field design, refine, and deploy prevention strategies more intelligently and safely. The work supported is meant to de-risk and inform later-stage development rather than substitute for it.
From an administrative standpoint, MEHP II uses the NIH R01 grant mechanism and falls under the NIH health research activity area, with CFDA listings 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research). The opportunity was posted July 22, 2014, with an application closing date of November 21, 2014, and it was archived December 22, 2014. The estimated total funding listed is $1,200,000, and the award ceiling is also $1,200,000. Cost sharing or matching is not required.
Eligibility is broad and includes many types of domestic and international applicants. Eligible U.S. entities include state, county, city/township, and special district governments; public and state-controlled institutions of higher education; private institutions of higher education; independent school districts; public housing authorities/Indian housing authorities; and a wide range of nonprofit and for-profit organizations (including small businesses). The FOA also allows applications from federally recognized tribal governments and other tribal organizations, as well as a variety of mission-specific institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions (AANAPISIs). Foreign organizations and foreign institutions are eligible, non-U.S. components of U.S. organizations are eligible, and NIH-defined foreign components are allowed, reflecting an openness to globally relevant mucosal HIV prevention science.
Overall, MEHP II is best understood as a targeted research call aimed at improving the scientific foundation for microbicides and PrEP by studying the real biological environments where these interventions must operate. It prioritizes mechanistic insight and practical understanding of mucosal interactions, encourages bold and innovative approaches, and is designed to produce knowledge that can guide the creation and optimization of future HIV prevention products rather than fund their direct development.
Frequently Asked Questions (FAQs)
What is the Mucosal Environment and HIV Prevention II (MEHP II) (R01) funding opportunity?
MEHP II (RFA-AI-14-036) is a National Institutes of Health (NIH) discretionary grant funding opportunity that supports research to strengthen the science behind non-vaccine biomedical HIV prevention approaches. It specifically emphasizes innovative, hypothesis-driven proof-of-concept and feasibility research that can inform safer and more effective microbicides and pre-exposure prophylaxis (PrEP) strategies.
What is the central goal of MEHP II?
The central goal is to generate enabling scientific knowledge about mucosal environments where HIV exposure and transmission can occur, and to understand how prevention products and drug delivery approaches behave and interact within those environments. The intent is to produce information that can guide future prevention design and optimization.
What types of HIV prevention approaches are in scope?
The opportunity focuses on non-vaccine biomedical HIV prevention approaches, with an emphasis on research that can advance the field toward improved microbicides and PrEP. It supports studies that clarify how products and delivery approaches function in real mucosal conditions relevant to HIV exposure and transmission.
Which mucosal sites and biological environments are emphasized?
MEHP II emphasizes the male and female genital tract and the gastrointestinal (GI) mucosa. It prioritizes research that considers these mucosal environments as the key biological contexts in which biomedical prevention products must operate.
What does the FOA mean by studying mucosal environments through "micro" and "macro" lenses?
The "micro" lens refers to local mucosal and tissue-level factors such as mucus properties, epithelial integrity, immune cell presence and activation, microbiome composition, local inflammation, and other luminal or tissue conditions. The "macro" lens refers to broader contextual or physiological states and co-existing conditions that shape mucosal function and may influence product performance, safety, distribution, or protective potential.
What kinds of research questions does MEHP II want to address?
The FOA is designed to address gaps that can explain why a product or delivery strategy may work well in one context but not another, and why safety or tolerability can vary by tissue type, sex, or exposure route. It supports work that improves mechanistic understanding of mucosal interactions that matter for prevention effectiveness and safety.
Is this opportunity intended to fund development of new HIV prevention products?
No. MEHP II explicitly states it is not intended to support the preclinical or clinical development of new non-vaccine biomedical prevention candidates or their delivery systems. The focus is on enabling science that de-risks and informs later-stage development rather than substituting for product development activities.
Can applications include an active pharmaceutical ingredient (API), formulation, excipients, or a device?
Yes. Projects may involve APIs, formulations and excipients, or devices that are already under development. However, the FOA does not require an application to include an API or a specific product.
Do applicants need to propose a specific microbicide or PrEP product to be eligible?
No. The opportunity does not require that an application include a specific product or API. It is open to biomedical research that clarifies fundamental interactions at mucosal surfaces, including how delivery systems behave under real mucosal conditions and how mucosal biology affects product activity.
Does MEHP II support high-risk or exploratory ideas?
Yes. MEHP II explicitly supports high-risk, innovative research. Proposals can be exploratory as long as they are rigorous, hypothesis-driven, and advance understanding in ways likely to inform future HIV prevention design and optimization.
What is meant by "proof-of-concept" and "feasibility" research in this FOA?
Based on the FOA description, proof-of-concept and feasibility research refers to studies that test innovative, hypothesis-driven ideas to generate credible mechanistic insights about mucosal environments and prevention product interactions, producing knowledge that can guide future strategy refinement and design.
What kinds of mucosal factors are explicitly mentioned as relevant to product performance and safety?
The FOA highlights factors including mucus properties, epithelial integrity, immune cell presence and activation, microbiome composition, local inflammation, and other tissue-level or luminal conditions, as well as broader physiological states or co-existing conditions that shape mucosal function.
How does MEHP II define the intended impact of funded projects?
Funded projects are intended to improve the scientific foundation for microbicides and PrEP by producing mechanistic insight and practical understanding of mucosal interactions. The overall objective is to inform smarter, safer, and more effective future prevention products and deployment strategies.
What grant mechanism is used for MEHP II?
MEHP II uses the NIH R01 grant mechanism.
What is the program area and CFDA listing information associated with this FOA?
The FOA falls under NIH health research activities and lists CFDA 93.855 (Allergy and Infectious Diseases Research) and 93.856 (Microbiology and Infectious Diseases Research).
What are the key dates for this funding opportunity?
The opportunity was posted on July 22, 2014. The application closing date was November 21, 2014. It was archived on December 22, 2014.
Is this opportunity currently open?
No. The FOA was archived on December 22, 2014, and the application closing date was November 21, 2014.
How much funding is available under MEHP II?
The estimated total funding listed is $1,200,000, and the award ceiling is also $1,200,000.
Is cost sharing or matching required?
No. Cost sharing or matching is not required.
Who is eligible to apply (in general terms)?
Eligibility is broad and includes many domestic and international applicants. Eligible applicants include various U.S. government entities, higher education institutions (public and private), nonprofit and for-profit organizations (including small businesses), tribal governments and tribal organizations, and a range of mission-specific institution types. Foreign organizations and institutions are eligible, and non-U.S. components of U.S. organizations and NIH-defined foreign components are allowed.
Which U.S. government entities are listed as eligible?
Eligible U.S. government entities include state governments, county governments, city/township governments, special district governments, independent school districts, and public housing authorities/Indian housing authorities.
Are colleges and universities eligible to apply?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.
Are nonprofits and for-profit organizations eligible?
Yes. A wide range of nonprofit and for-profit organizations are eligible, including small businesses.
Are tribal governments and tribal organizations eligible?
Yes. Federally recognized tribal governments and other tribal organizations are listed as eligible.
Are HBCUs, Hispanic-serving institutions, and other mission-specific institution types eligible?
Yes. The FOA explicitly allows applications from Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribal Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian-serving institutions, and Asian American Native American Pacific Islander-serving institutions (AANAPISIs).
Are foreign organizations or foreign institutions eligible to apply?
Yes. Foreign organizations and foreign institutions are eligible. The FOA also allows non-U.S. components of U.S. organizations and NIH-defined foreign components.
What is the main boundary on the type of work MEHP II will not fund?
The FOA draws a clear boundary that it is not intended to support the preclinical or clinical development of new non-vaccine biomedical prevention candidates or their delivery systems. The work should focus on enabling science rather than advancing a new product through a development pipeline.
How should applicants think about the difference between "enabling science" and "product development" for this FOA?
Based on the description provided, enabling science focuses on understanding mechanisms and interactions at mucosal surfaces that affect distribution, safety, tolerability, and protective potential, generating knowledge that informs later design and optimization. Product development activities aimed at pushing a specific candidate or delivery system through preclinical or clinical development are outside the FOA's intended scope.
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