Opportunity Information: Apply for RFA AI 10 006
Apply for RFA AI 10 006
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (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, Immunology and Transplantation Research 93.856 Microbiology and Infectious Diseases Research.
- This funding opportunity was created on Jul 30, 2010 and posted on Jul 29, 2010.
- Applicants must submit their applications by Nov 17, 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 $5,500,000.00 to eligible and selected applicants.
- Eligible applicants include: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities State governments Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education Small businesses Public and State controlled institutions of higher education County governments Others (see text field entitled Additional Information on Eligibility for clarification) City or township governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses Special district governments Independent school districts Native American tribal governments (Federally recognized).
- 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 Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19) is a National Institutes of Health (NIH) funding opportunity led by the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with the National Institute of Mental Health (NIMH). It is designed to push forward the development of topical microbicides intended to prevent sexual transmission of HIV, including both single-agent products and combination approaches. The key emphasis is on an integrated, iterative pipeline that connects preclinical work (such as formulation development, laboratory and animal studies, and other translational testing) with exploratory clinical studies, so that results from one stage can rapidly inform and refine the next. In other words, the program is structured to support teams that can move candidate products forward in a coordinated way rather than funding isolated projects that do not clearly feed into an overall product-development path.
This FOA uses the U19 cooperative agreement mechanism, which signals a multi-project structure and substantial scientific involvement by the NIH beyond what is typical for a standard grant. Applicants are expected to propose a coordinated set of projects that function as one program. At a minimum, each application must include at least two research projects plus an Administrative Core. The Administrative Core is meant to hold the whole program together by managing communication, coordination, decision-making, reporting, and overall program governance. The FOA also requires real participation from the private sector: at least one component of the application, either a research project or a scientific core, must come from a private sector company, whether for-profit or nonprofit. That requirement is meant to strengthen product-development realism by ensuring that industry or product-focused partners are directly involved in the work, not just consulted informally.
The announcement notes that this particular release includes significant modifications compared with earlier versions of the IPCP HTM program, and it cautions applicants that these changes could affect whether an application is considered responsive. In practical terms, that means applicants needed to read the FOA carefully and ensure that their proposed structure, partners, and scope match the updated expectations, especially around integration across disciplines and the preclinical-to-clinical progression. The FOA was published alongside a related opportunity, RFA-AI-10-007, which solicited competitive revisions for existing IPCP HTM awards. Together, the two opportunities represented NIH's coordinated plan for continuing and updating this microbicide development effort, supporting both new programs and revised ongoing ones.
Funding under this FOA is categorized as discretionary and falls under health-related activity areas, including mental health research and infectious disease research. There is no cost-sharing or matching requirement. NIH anticipated total funding around $6 million in FY 2010 across both this FOA (RFA-AI-10-006) and the companion competitive revision FOA (RFA-AI-10-007), with an estimated total funding level listed as $5.5 million for this specific opportunity record. The announcement does not guarantee a specific number of awards in the text provided, but it frames the program as supporting a limited set of larger, multi-project collaborative awards rather than many small independent grants.
Eligibility was intentionally broad, reflecting the consortium-driven, multidisciplinary nature of the work. Eligible applicants included a wide range of U.S. entities such as nonprofit organizations (including 501(c)(3) and non-501(c)(3)), public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, and special district governments. It also extended eligibility to small businesses and other for-profit organizations, and it explicitly included various mission-focused institution types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, and U.S. territories or possessions. Importantly, the eligibility list also included non-U.S. entities and foreign organizations, as well as regional organizations, which aligns with the global relevance of HIV prevention research.
Key dates show that the opportunity was posted in late July 2010, originally due in late October 2010, and then extended to a current closing date of November 17, 2010, before being archived in December 2010. The official NIH listing identifies the opportunity number as RFA-AI-10-006, and it provides a link to the full announcement on the NIH grants website for complete requirements and instructions. For access or technical issues, the contact point listed is the NIH Office of Extramural Research (OER) webmaster.
FAQs: Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19) - RFA-AI-10-006
What is this funding opportunity?
The Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) (U19) is an NIH funding opportunity designed to advance the development of topical microbicides intended to prevent sexual transmission of HIV. It supports both single-agent candidates and combination approaches, with an emphasis on coordinated product development.
Which NIH institutes are leading this program?
The opportunity is led by the National Institute of Allergy and Infectious Diseases (NIAID) in partnership with the National Institute of Mental Health (NIMH), under the National Institutes of Health (NIH).
What types of products are in scope?
The FOA focuses on topical microbicides aimed at preventing sexual transmission of HIV. The scope explicitly includes both single-agent products and combination approaches.
What is the main program emphasis?
The central emphasis is an integrated, iterative pipeline that tightly links preclinical activities (for example, formulation development, laboratory and animal studies, and other translational testing) with exploratory clinical studies, so results from one stage can quickly inform and refine the next stage.
Does the FOA support isolated or standalone projects?
The program is structured to support coordinated teams that can move candidate products forward in a connected product-development path, rather than funding isolated projects that do not clearly feed into an overall development pipeline.
What funding mechanism is used?
This FOA uses the U19 cooperative agreement mechanism. It is a multi-project structure and indicates substantial NIH scientific involvement beyond what is typical for a standard grant.
What does a "cooperative agreement" imply for applicants?
Based on the information provided, the U19 cooperative agreement signals that NIH will have substantial scientific involvement in the program, and applicants should plan for an actively coordinated, NIH-engaged effort rather than a fully independent investigator-driven award.
What is the minimum required structure of an application?
At a minimum, each application must include at least two research projects plus an Administrative Core.
What is the Administrative Core expected to do?
The Administrative Core is intended to hold the program together by managing communication, coordination, decision-making, reporting, and overall program governance.
Is private sector participation required?
Yes. The FOA requires real participation from the private sector. At least one component of the application (either a research project or a scientific core) must come from a private sector company, whether for-profit or nonprofit.
How can a team meet the private sector requirement?
A team can meet the requirement by including at least one application component that comes from a private sector company. The component can be either a research project or a scientific core.
Why does the FOA require private sector involvement?
The stated purpose is to strengthen product-development realism by ensuring industry or product-focused partners are directly involved in the work, rather than serving only as informal consultants.
Were there changes from earlier versions of the IPCP HTM program?
Yes. The announcement states that this release includes significant modifications compared with earlier versions and cautions applicants that changes could affect whether an application is considered responsive.
What does "responsive" mean in the context provided?
In practical terms, the FOA warns that applicants need to read the updated requirements carefully and ensure their proposed structure, partners, and scope align with the revised expectations, particularly around integration across disciplines and the preclinical-to-clinical progression.
Is this FOA connected to any other NIH opportunity?
Yes. It was published alongside a related opportunity, RFA-AI-10-007, which solicited competitive revisions for existing IPCP HTM awards. Together, the two opportunities reflected NIH's coordinated plan to continue and update the microbicide development effort.
What is the opportunity number for this FOA?
The official NIH opportunity number is RFA-AI-10-006.
What is the funding category or type of funding?
Funding under this FOA is categorized as discretionary.
Which activity areas does the FOA fall under?
The FOA falls under health-related activity areas, including mental health research and infectious disease research.
Is cost-sharing or matching required?
No. The information provided states there is no cost-sharing or matching requirement.
How much funding was anticipated?
NIH anticipated total funding of around $6 million in FY 2010 across both this FOA (RFA-AI-10-006) and the companion competitive revision FOA (RFA-AI-10-007). The specific opportunity record lists an estimated total funding level of $5.5 million for this opportunity.
How many awards were expected?
The provided text does not guarantee a specific number of awards. It describes the program as supporting a limited set of larger, multi-project collaborative awards rather than many small independent grants.
Who is eligible to apply?
Eligibility is broad and includes many U.S. entity types such as nonprofit organizations (including 501(c)(3) and non-501(c)(3)), public and private institutions of higher education, state and local governments, tribal governments and tribal organizations, public housing authorities, independent school districts, and special district governments. It also includes small businesses and other for-profit organizations, and specifically names institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, faith-based and community-based organizations, and U.S. territories or possessions.
Are non-U.S. or foreign organizations eligible?
Yes. The eligibility list includes non-U.S. entities and foreign organizations, as well as regional organizations.
What were the key dates for submission?
The opportunity was posted in late July 2010, originally due in late October 2010, and then extended to a closing date of November 17, 2010. It was archived in December 2010.
Where can applicants find the full announcement and instructions?
The official NIH listing provides a link to the full announcement on the NIH grants website for complete requirements and application instructions.
Who is listed as the contact for access or technical issues?
For access or technical issues, the listed contact is the NIH Office of Extramural Research (OER) webmaster.
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