Opportunity Information: Apply for RFA AI 09 021
Apply for RFA AI 09 021
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Microbicide Innovation Program (MIP V) (R21/R33)" 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, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Apr 15, 2009 and posted on Apr 15, 2009.
- Applicants must submit their applications by Jul 10, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $200,000.00 in funding.
- Eligible applicants include: County governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses For profit organizations other than small businesses State governments Native American tribal governments (Federally recognized) Independent school districts Special district governments Public and State controlled institutions of higher education Private institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities City or township 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) 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 Microbicide Innovation Program (MIP V) (R21/R33) is a National Institutes of Health (NIH) funding opportunity (RFA-AI-09-021) aimed at accelerating new ideas and early-to-mid stage development work in topical microbicides for the prevention of HIV and other sexually transmitted infections (STIs). Led by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH), with support from the NIH Office of Research on Womens Health (ORWH), the program is designed to push the field beyond incremental advances by backing projects that open up new prevention concepts, new biological targets, and better ways to evaluate whether candidate products are safe, effective, and likely to be used in real-world settings.
A central focus of the program is the discovery and characterization of microbicide candidates, whether they are single agents or combination approaches. The solicitation emphasizes interventions directed against HIV as well as STIs that are associated with increased HIV acquisition risk, recognizing that preventing or controlling co-infections can meaningfully reduce HIV transmission dynamics. Applications are expected to be grounded in preclinical and basic research, meaning the work should generate compelling mechanistic or proof-of-concept data, improve understanding of how candidate microbicides work, and strengthen the scientific basis for selecting the most promising products for further development.
Another major priority is advancing the tools used to test microbicides. The FOA calls for identification and promotion of emerging technologies, models, or evaluation platforms that can improve how researchers assess microbicide safety, efficacy, and acceptability. In practice, this could include innovative laboratory assays, ex vivo tissue systems, animal or surrogate models, formulation and delivery evaluation methods, or behavioral and acceptability assessment approaches that help predict adherence and real-world use. The underlying goal is to make early testing more informative and more efficient so weak candidates can be screened out sooner and strong candidates can be advanced with better justification.
The opportunity also explicitly welcomes complex prevention strategies that incorporate microbicides applied via different anatomical routes, including vaginal, rectal, and/or penile applications. This reflects an interest in prevention strategies that match the diversity of exposure routes and user needs, and encourages applicants to think beyond a single-product, single-route framework. Proposals that integrate multiple components into a coherent prevention strategy, while still being feasible within a preclinical to early development context, align with the program's intent to generate practical and scalable prevention options.
Mechanistically, this funding opportunity uses the NIH R21/R33 phased innovation structure. In general terms, that structure supports an initial exploratory or developmental phase (R21) intended to establish feasibility and produce key early data, followed by a second phase (R33) that can support more advanced development if predefined milestones are met. The practical takeaway is that applicants are expected to propose a milestone-driven plan, where progress in the early phase justifies a transition to the next stage rather than treating the project as an open-ended research effort.
From an administrative perspective, this is a discretionary grant program in the health research area, tied to CFDA numbers spanning mental health research and infectious disease and immunology research (93.242, 93.855, and 93.856). The posted and creation date for the announcement were April 15, 2009, with an original and current closing date of July 10, 2009, and an archive date of August 10, 2009. The listed award ceiling is $200,000, and there is no cost sharing or matching requirement stated in the opportunity summary.
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants include public and private institutions of higher education, nonprofits with and without 501(c)(3) status, small businesses, other for-profit organizations (with certain distinctions noted), and a wide range of government entities (state, county, city or township, special district, and independent school districts). The eligibility language also extends to tribal governments and tribal organizations, public housing authorities/Indian housing authorities, U.S. territories or possessions, and regional organizations. The FOA further notes eligibility for institutions serving specific populations (for example, Historically Black Colleges and Universities, Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions), as well as faith-based or community-based organizations, eligible federal agencies, and foreign (non-U.S.) entities.
For applicants seeking the full details, the NIH provided an official announcement link through the NIH grants guide, and included contact directions for technical access problems via the NIH Office of Extramural Research (OER) Webmaster (FBOWebmaster@OD.NIH.GOV). Overall, the MIP V (R21/R33) solicitation is best understood as a targeted push to generate and mature high-impact microbicide concepts, strengthen the evidence base for candidate selection, and modernize the preclinical and early assessment toolkit needed to bring topical HIV/STI prevention products closer to real-world use.
Frequently Asked Questions (FAQs): Microbicide Innovation Program (MIP V) (R21/R33) - RFA-AI-09-021
What is the Microbicide Innovation Program (MIP V) (R21/R33)?
The Microbicide Innovation Program (MIP V) (R21/R33) is a National Institutes of Health (NIH) funding opportunity (RFA-AI-09-021) focused on accelerating new ideas and early-to-mid stage development work in topical microbicides to prevent HIV and other sexually transmitted infections (STIs).
Which NIH institutes lead or support this funding opportunity?
The program is led by the National Institute of Allergy and Infectious Diseases (NIAID) and the National Institute of Mental Health (NIMH), with support from the NIH Office of Research on Women's Health (ORWH).
What is the main goal of this funding opportunity?
The main goal is to move the microbicide field beyond incremental advances by supporting projects that introduce new prevention concepts, new biological targets, and improved ways to evaluate whether candidate products are safe, effective, and likely to be used in real-world settings.
What types of research are expected under this program?
Applications are expected to be grounded in preclinical and basic research. The work should generate mechanistic or proof-of-concept data, improve understanding of how candidate microbicides work, and strengthen the evidence base for selecting the most promising products for further development.
What kinds of microbicide candidates does the FOA emphasize?
The solicitation emphasizes discovery and characterization of topical microbicide candidates, including both single agents and combination approaches.
Is the program focused only on HIV prevention?
No. While HIV prevention is central, the FOA also emphasizes STIs that are associated with increased HIV acquisition risk. The program recognizes that preventing or controlling co-infections can reduce HIV transmission dynamics.
Does this opportunity support improving microbicide testing and evaluation tools?
Yes. A major priority is advancing the tools used to test microbicides, including the identification and promotion of emerging technologies, models, or evaluation platforms to improve assessment of safety, efficacy, and acceptability.
What are examples of evaluation tools or platforms mentioned in the opportunity summary?
Examples include innovative laboratory assays, ex vivo tissue systems, animal or surrogate models, formulation and delivery evaluation methods, and behavioral/acceptability assessment approaches that help predict adherence and real-world use.
Why does the FOA emphasize better early testing methods?
The stated goal is to make early testing more informative and more efficient so weaker candidates can be screened out sooner and stronger candidates can be advanced with better justification.
Are multiple anatomical routes of microbicide application in scope?
Yes. The opportunity explicitly welcomes complex prevention strategies that incorporate microbicides applied via different anatomical routes, including vaginal, rectal, and/or penile applications.
Does the FOA encourage multi-component or complex prevention strategies?
Yes. Proposals that integrate multiple components into a coherent prevention strategy, while remaining feasible within a preclinical to early development context, align with the program's intent.
What does the NIH R21/R33 phased innovation structure mean for applicants?
The R21/R33 structure supports an initial exploratory or developmental phase (R21) to establish feasibility and generate key early data, followed by a second phase (R33) for more advanced development if predefined milestones are met.
Are milestones required in the application?
Yes. The practical expectation described is a milestone-driven plan where progress in the early phase supports transition to the next stage, rather than an open-ended research effort.
What is the award ceiling listed for this opportunity?
The listed award ceiling is $200,000.
Is cost sharing or matching required?
No. The opportunity summary states there is no cost sharing or matching requirement.
What is the CFDA information associated with this program?
The opportunity is tied to CFDA numbers spanning mental health research and infectious disease and immunology research: 93.242, 93.855, and 93.856.
When was this funding opportunity posted, and what were the key dates?
The posted and creation date were April 15, 2009. The original and current closing date was July 10, 2009. The archive date was August 10, 2009.
What is the general type of grant program described?
It is described as a discretionary grant program in the health research area.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic and non-domestic organizations. Eligible applicants include public and private institutions of higher education, nonprofits (with and without 501(c)(3) status), small businesses, other for-profit organizations (with certain distinctions noted), and a wide range of government entities.
Which government entities are listed as eligible?
Eligible government entities include state, county, city or township, special district, and independent school districts. The eligibility language also extends to tribal governments and tribal organizations, public housing authorities/Indian housing authorities, and eligible federal agencies.
Are U.S. territories or regional organizations eligible?
Yes. The eligibility language includes U.S. territories or possessions and regional organizations.
Are foreign (non-U.S.) organizations eligible to apply?
Yes. The FOA notes eligibility for foreign (non-U.S.) entities.
Does the FOA mention eligibility for institutions serving specific populations?
Yes. The eligibility language specifically notes categories such as Historically Black Colleges and Universities, Hispanic-Serving Institutions, Tribally Controlled Colleges and Universities, and Alaska Native and Native Hawaiian Serving Institutions.
Are faith-based or community-based organizations eligible?
Yes. The FOA states that faith-based or community-based organizations are eligible.
Where can applicants find the official announcement details?
The NIH provided an official announcement link through the NIH Grants Guide.
Who should be contacted for technical access problems related to the announcement?
For technical access problems, the NIH provided contact directions via the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV.
How should this opportunity be understood at a high level?
The solicitation is positioned as a targeted push to generate and mature high-impact topical microbicide concepts, strengthen the evidence base for selecting candidates, and modernize preclinical and early assessment tools to bring HIV/STI prevention products closer to real-world use.
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