Opportunity Information: Apply for RFA AI 10 011

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Microbicide Innovation Program (MIP VI) (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 20, 2010 and posted on Apr 20, 2010.
  • Applicants must submit their applications by Jul 9, 2010. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • The funding agency has allocated a total of $2,500,000.00 to eligible and selected applicants.
  • Eligible applicants include: Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township governments Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities State governments For profit organizations other than small businesses Small businesses Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification) County governments Public and State controlled institutions of higher education Private institutions of higher education.
  • 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 VI) (RFA-AI-10-011) is a National Institutes of Health opportunity, issued through NIAID, focused on accelerating the development of topical microbicides that could help prevent HIV and other sexually transmitted infections (STIs) associated with increased HIV acquisition risk. The program is geared toward early-stage, innovation-driven work that can move new ideas from basic and preclinical research into a clearer development pathway. In practice, it is aimed at expanding the pipeline of candidate microbicides and strategies by supporting both the discovery of new products and the tools and models needed to evaluate them more effectively.

The scientific scope is broad but centered on topical products and topical prevention strategies. Applications are encouraged that pursue the discovery and characterization of microbicides used alone or in combination, especially those directed against HIV or STIs that can facilitate HIV transmission. The FOA also highlights the need for new rational targets and new approaches, meaning it is interested in projects that go beyond incremental improvements and instead open up new mechanisms, formulations, delivery concepts, or multi-agent prevention designs. Another major emphasis is on emerging technologies and models that improve how the field assesses safety, efficacy, and acceptability, which can include novel assays, preclinical models, testing platforms, or other evaluation methods that make decision-making faster and more reliable. Importantly, the opportunity explicitly welcomes complex prevention strategies that incorporate microbicides applied vaginally, rectally, and/or on the penis, signaling an interest in prevention concepts tailored to different routes of sexual exposure and real-world use.

Funding is provided through the NIH R21/R33 Phased Innovation Award mechanism. This is a milestone-driven, two-stage structure designed to help strong but exploratory concepts prove feasibility before receiving larger support. The R21 phase supports the initial exploratory and developmental work needed to establish whether a new microbicide candidate, strategy, or enabling research direction is viable. If the R21 milestones are met, the project may transition into the R33 phase, which provides follow-on support to further develop the R21 outcomes and, where appropriate, begin moving the work into the preclinical-to-clinical development pipeline. A key administrative point is that applicants must apply for the combined R21/R33 phased award; the FOA does not accept applications requesting only the R21 phase or only the R33 phase. The announcement anticipates that roughly 50 of the R21 awards will transition to the R33 phase, underscoring that progression is expected but contingent on achieving the proposed milestones.

From an administrative and eligibility standpoint, this is a discretionary grant opportunity with an estimated total funding level of $2.5 million for the announcement. There is no cost sharing or matching requirement. Eligibility is intentionally expansive, including a wide range of public and private organizations. Eligible applicants include state, county, city/township, and special district governments; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses); independent school districts; public housing authorities/Indian housing authorities; and tribal governments and tribal organizations. The eligibility section also notes additional eligible groups such as historically Black colleges and universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, faith-based and community-based organizations, eligible federal agencies, U.S. territories/possessions, and non-U.S. (foreign) entities and regional organizations, reflecting the global nature of HIV/STI prevention research.

Key dates in the announcement show it was posted and created on April 20, 2010, with an original and current closing date of July 9, 2010, and an archive date of August 9, 2010. The CFDA program references listed include 93.242 (Mental Health Research Grants), 93.855 (Allergy, Immunology and Transplantation Research), and 93.856 (Microbiology and Infectious Diseases Research), which aligns with NIAIDs infectious disease prevention mission and the interdisciplinary nature of microbicide development. The full announcement was made available through the NIH Grants Guide at the provided link, and contact support for access or technical issues is routed through the NIH Office of Extramural Research webmaster.

Microbicide Innovation Program (MIP VI) (RFA-AI-10-011) FAQs

What is the Microbicide Innovation Program (MIP VI)?

MIP VI (RFA-AI-10-011) is a National Institutes of Health (NIH) funding opportunity issued through the National Institute of Allergy and Infectious Diseases (NIAID). It focuses on accelerating the development of topical microbicides intended to help prevent HIV and other sexually transmitted infections (STIs) that are associated with increased risk of HIV acquisition.

What is the main goal of this funding opportunity?

The main goal is to expand and strengthen the pipeline of microbicide candidates and prevention strategies by supporting early-stage, innovation-driven projects. The program aims to help move new ideas from basic and preclinical research toward a clearer development pathway.

Which NIH institute is associated with this opportunity?

The opportunity is issued through NIAID (National Institute of Allergy and Infectious Diseases) under NIH.

What types of products or strategies are in scope?

The scientific scope is broad but centered on topical products and topical prevention strategies. The FOA encourages projects involving the discovery and characterization of microbicides used alone or in combination, particularly those targeting HIV or STIs that can facilitate HIV transmission.

Does the program only support HIV-focused microbicides?

No. While HIV prevention is central, the opportunity also emphasizes STIs that are associated with increased HIV acquisition risk, especially where preventing or addressing those STIs may reduce HIV transmission risk.

Are combination products or multi-agent approaches encouraged?

Yes. Applications are encouraged that pursue microbicides used alone or in combination, including multi-agent prevention designs.

What does the FOA mean by seeking “new rational targets” and “new approaches”?

The FOA highlights interest in projects that go beyond incremental improvements. It signals interest in work that introduces new mechanisms, targets, formulations, delivery concepts, or other innovative approaches that could open up new directions for topical HIV/STI prevention.

Does the program support tools and models, or only product candidates?

It supports both. In addition to discovering new microbicide products and strategies, the program emphasizes enabling technologies and models that improve how safety, efficacy, and acceptability are assessed. Examples mentioned include novel assays, preclinical models, testing platforms, or other evaluation methods designed to make decision-making faster and more reliable.

What routes of application or exposure are included in the scope?

The opportunity explicitly welcomes complex prevention strategies that incorporate microbicides applied vaginally, rectally, and/or on the penis. This reflects interest in prevention concepts tailored to different routes of sexual exposure and real-world use.

What funding mechanism is used for this opportunity?

Funding is provided through the NIH R21/R33 Phased Innovation Award mechanism. This is a milestone-driven, two-stage award structure designed to support feasibility work first and then provide follow-on support for projects that meet their milestones.

What is the purpose of the R21 phase in this program?

The R21 phase supports initial exploratory and developmental work to establish feasibility of a new microbicide candidate, prevention strategy, or enabling research direction.

What happens in the R33 phase?

If the R21 milestones are met, the project may transition to the R33 phase. The R33 provides follow-on support to further develop the R21 outcomes and, where appropriate, begin moving the work toward the preclinical-to-clinical development pipeline.

Do applicants have to propose milestones?

Yes. The award is described as milestone-driven, and transition from R21 to R33 is contingent on achieving the proposed milestones.

Can an applicant apply for only the R21 phase or only the R33 phase?

No. A key administrative requirement is that applicants must apply for the combined R21/R33 phased award. The FOA does not accept applications requesting only the R21 phase or only the R33 phase.

Is transition from R21 to R33 automatic?

No. Transition is expected for many projects but is contingent on meeting the proposed milestones. The FOA anticipates that roughly 50 of the R21 awards will transition to the R33 phase.

What is the estimated total funding level for this announcement?

The announcement lists an estimated total funding level of $2.5 million.

Is cost sharing or matching required?

No. The opportunity states there is no cost sharing or matching requirement.

What types of organizations are eligible to apply?

Eligibility is broad and includes many public and private organization types, including state, county, city/township, and special district governments; public and private institutions of higher education; nonprofits with or without 501(c)(3) status; for-profit organizations (including small businesses); independent school districts; public housing authorities/Indian housing authorities; and tribal governments and tribal organizations.

Are specific institution types (like HBCUs or HSIs) listed as eligible?

Yes. The eligibility section also notes groups such as historically Black colleges and universities, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based and community-based organizations, among others.

Are non-U.S. (foreign) organizations eligible?

Yes. The eligibility information includes non-U.S. (foreign) entities and regional organizations, reflecting the global nature of HIV/STI prevention research.

Are U.S. territories and possessions included in eligibility?

Yes. The eligibility section mentions U.S. territories/possessions.

Are federal agencies eligible to apply?

Yes. The eligibility section includes eligible federal agencies.

What are the key dates for this opportunity?

The announcement was posted/created on April 20, 2010. The original and current closing date is July 9, 2010. The archive date is August 9, 2010.

Where was the full announcement published?

The full announcement was made available through the NIH Grants Guide at the link referenced in the opportunity information.

Which CFDA program references are associated with this opportunity?

The CFDA program references listed include 93.242 (Mental Health Research Grants), 93.855 (Allergy, Immunology and Transplantation Research), and 93.856 (Microbiology and Infectious Diseases Research).

What kind of support contact is listed for access or technical issues?

Contact support for access or technical issues is routed through the NIH Office of Extramural Research webmaster.

Is this described as a discretionary grant opportunity?

Yes. The opportunity is described as a discretionary grant opportunity.

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