Opportunity Information: Apply for RFA AI 08 057
Apply for RFA AI 08 057
- 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 Nov 28, 2008 and posted on Nov 28, 2008.
- Applicants must submit their applications by Mar 13, 2009. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $5,000,000.00 to eligible and selected applicants.
- Eligible applicants include: County governments Independent school districts Public and State controlled institutions of higher education City or township governments State governments For profit organizations other than small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses 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 Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) is a National Institutes of Health funding opportunity led by the National Institute of Allergy and Infectious Diseases (NIAID) with co-funding from the National Institute of Mental Health (NIMH). It is set up to push forward the development of new, safe topical microbicides and combination microbicide approaches designed to prevent sexual transmission of HIV. The core idea is to fund teams that can connect preclinical work (such as formulation, mechanism studies, and safety testing) with early, exploratory clinical studies, and to do so in a way that is integrated and iterative, meaning that results from one stage are expected to inform and refine the next rather than sitting in separate silos.
The program uses a U19 cooperative agreement mechanism, which signals that NIH expects substantial scientific and programmatic involvement during the life of the award compared with a standard investigator-initiated grant. Applicants are expected to propose a multi-project structure that brings together multiple disciplines and capabilities under one umbrella. At a minimum, an application must include at least two distinct research projects plus an Administrative Core to manage coordination, communication, oversight, and overall program integration. The intent is to support a pipeline-style effort where coordinated projects can move candidate microbicides forward more efficiently, from laboratory and preclinical evaluation into carefully designed early clinical assessments.
A notable eligibility and structure requirement is that at least one component of the overall program (either a research project or a scientific core) must be led by, or substantially involve, a private-sector company. This company can be for-profit or nonprofit, small, and either domestic or foreign, and it should be in a relevant industry area such as pharmaceuticals, chemicals, bioengineering, or biotechnology. This requirement is meant to strengthen translation and product development readiness by ensuring that industry expertise, manufacturing or formulation know-how, regulatory experience, or other practical development capacities are embedded directly in the funded program rather than treated as an afterthought.
Each funded award is also expected to have a Scientific Advisory Panel (SAP). The SAP is not required to be in place at the time of application, but it must be constituted after award and no later than 12 months into the project period. This panel is intended to provide independent scientific input, help with strategic decision-making across the integrated projects, and keep the overall program aligned with the goal of advancing viable microbicide candidates and strategies.
Funding for this initiative was projected at a total of $5.0 million in fiscal year 2010, with NIAID providing the bulk of the support ($4.5 million) and NIMH contributing $0.5 million. The NIH anticipated making two to three new awards under this announcement, reflecting an expectation of a small number of relatively comprehensive, multi-component programs rather than many small standalone grants.
In administrative terms, this was a discretionary NIH opportunity (Funding Opportunity Number RFA-AI-08-057) within health-related research activity areas. It is linked to CFDA programs covering mental health research (93.242) and allergy/immunology, transplantation, microbiology, and infectious diseases research (93.855 and 93.856). There was no cost sharing or matching requirement. The announcement was posted on November 28, 2008, with an original and current closing date of March 13, 2009, and it was archived on April 13, 2009, meaning it is a historical opportunity rather than an open competition today.
The eligible applicant pool was broad and included many types of organizations: state, local, and tribal governments; public and private institutions of higher education; nonprofits (including those with and without 501(c)(3) status); small businesses and other for-profit entities; public housing authorities; and various special categories such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, U.S. territories or possessions, and foreign (non-U.S.) entities and regional organizations. This breadth aligns with the program’s emphasis on assembling multidisciplinary consortia that can cover the scientific, clinical, operational, and development expertise needed for topical microbicide advancement.
Overall, IPCP HTM was designed to fund tightly coordinated, multi-project teams that can move potential topical HIV prevention products forward through an integrated set of preclinical and early clinical activities, with built-in administrative coordination, NIH collaboration through the cooperative agreement model, formal external scientific advising via the SAP, and required participation from at least one private-sector company to strengthen the path toward real-world product development.
FAQs: Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM)
What is the IPCP HTM funding opportunity?
The Integrated Preclinical/Clinical Program for HIV Topical Microbicides (IPCP HTM) is a National Institutes of Health (NIH) funding opportunity led by the National Institute of Allergy and Infectious Diseases (NIAID), with co-funding from the National Institute of Mental Health (NIMH). It was designed to accelerate development of new, safe topical microbicides and combination microbicide approaches intended to prevent sexual transmission of HIV.
What is the main goal of the program?
The program aims to move candidate topical microbicides forward through a coordinated pipeline that connects preclinical research (such as formulation work, mechanism studies, and safety testing) with early, exploratory clinical studies. A key expectation is that these stages are integrated and iterative, so findings in one stage inform and refine the next.
What type of NIH award mechanism does IPCP HTM use?
IPCP HTM uses the U19 cooperative agreement mechanism. This reflects NIH’s expectation of substantial scientific and programmatic involvement during the life of the award compared with a standard investigator-initiated grant.
What does “integrated and iterative” mean in this program?
It means the preclinical and clinical parts of the program are not treated as separate silos. Instead, results from formulation, mechanism, or safety work are expected to shape early clinical study design, and outcomes from early clinical assessments are expected to feed back into further preclinical refinement and decision-making.
What is the required overall application structure?
Applicants are expected to propose a multi-project structure that brings multiple disciplines and capabilities under one umbrella. At a minimum, an application must include at least two distinct research projects plus an Administrative Core.
What is the purpose of the Administrative Core?
The Administrative Core is intended to manage coordination, communication, oversight, and overall program integration across the multiple projects and any cores included in the U19 structure.
How many research projects are required at minimum?
At least two distinct research projects are required, in addition to the required Administrative Core.
Is private-sector participation required?
Yes. At least one component of the overall program (either a research project or a scientific core) must be led by, or substantially involve, a private-sector company.
What types of private-sector companies can fulfill the requirement?
The company may be for-profit or nonprofit, may be small, and may be domestic or foreign. It should be in a relevant industry area such as pharmaceuticals, chemicals, bioengineering, or biotechnology.
Why does the program require a private-sector company to be involved?
The requirement is meant to strengthen translation and product development readiness by embedding industry expertise directly into the funded program. This can include manufacturing or formulation know-how, regulatory experience, and other practical development capabilities.
What is the Scientific Advisory Panel (SAP), and is it required?
Each funded award is expected to have a Scientific Advisory Panel (SAP). The SAP is intended to provide independent scientific input, support strategic decision-making across the integrated projects, and help keep the overall program aligned with advancing viable microbicide candidates and strategies.
Does the SAP need to be formed at the time of application?
No. The SAP is not required to be in place at the time of application, but it must be constituted after award and no later than 12 months into the project period.
How much funding was projected for this initiative?
Total projected funding was $5.0 million in fiscal year 2010, with NIAID providing $4.5 million and NIMH contributing $0.5 million.
How many awards did NIH anticipate making?
NIH anticipated making two to three new awards under this announcement, indicating an expectation of a small number of comprehensive, multi-component programs.
What is the Funding Opportunity Number for this announcement?
The Funding Opportunity Number is RFA-AI-08-057.
Which NIH institutes were involved in funding and leadership?
NIAID led the opportunity, and NIMH provided co-funding.
Which CFDA programs are associated with this opportunity?
This opportunity is linked to CFDA 93.242 (mental health research) and CFDA 93.855 and 93.856 (allergy/immunology, transplantation, microbiology, and infectious diseases research).
Was cost sharing or matching required?
No. There was no cost sharing or matching requirement stated for this opportunity.
When was the opportunity posted, and what were the closing dates?
The announcement was posted on November 28, 2008. The original and current closing date was March 13, 2009.
Is this opportunity currently open?
No. The opportunity was archived on April 13, 2009, which indicates it is a historical opportunity rather than an open competition today.
Who was eligible to apply?
The eligible applicant pool was broad and included state, local, and tribal governments; public and private institutions of higher education; nonprofits (including those with and without 501(c)(3) status); small businesses and other for-profit entities; public housing authorities; and other categories such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, U.S. territories or possessions, and foreign (non-U.S.) entities and regional organizations.
Were foreign organizations eligible?
Yes. Foreign (non-U.S.) entities and regional organizations were included in the eligible applicant pool, and private-sector company participation could also be domestic or foreign.
What kinds of activities were expected to be included in the research pipeline?
Activities described for the integrated pipeline included preclinical efforts such as formulation, mechanism studies, and safety testing, along with early, exploratory clinical studies designed to assess candidates in humans at an early stage.
What is the overall program concept in plain terms?
The program was designed to support tightly coordinated, multi-project teams that can move potential topical HIV prevention products from lab and preclinical evaluation into carefully designed early clinical assessments, with active NIH involvement through a cooperative agreement, formal external advising through the SAP, and required private-sector participation to strengthen real-world product development potential.
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