Opportunity Information: Apply for RFA AI 13 008
Apply for RFA AI 13 008
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Preclinical Innovation Program (PIP) (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 Mar 7, 2013 and posted on Mar 7, 2013.
- Applicants must submit their applications by Aug 1, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,500,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $400,000.00 in funding.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification) Private institutions of higher education For profit organizations other than small businesses State governments Small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Public and State controlled institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) County governments City or township governments Public housing authorities/Indian housing authorities Independent school districts Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education.
- 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 Preclinical Innovation Program (PIP) (R01) is a National Institute of Allergy and Infectious Diseases (NIAID), NIH funding opportunity designed to push forward non-vaccine biomedical prevention (nBP) research aimed at preventing HIV acquisition and transmission. The central goal is to keep a strong, sustainable pipeline of early-stage prevention candidates moving toward later development by supporting projects that are intentionally high-risk and highly innovative. In practice, this means NIAID is looking for research that explores new or under-used ideas rather than incremental extensions of well-established approaches, with a strong emphasis on generating the kind of preclinical evidence and enabling technologies needed to advance promising prevention concepts.
A major focus of the program is on building and diversifying HIV prevention strategies beyond vaccines, including microbicides, pre-exposure prophylaxis (PrEP) approaches, and Multipurpose Prevention Technologies (MPT). MPT concepts are particularly relevant when they aim to address more than one sexual and reproductive health need at the same time (for example, preventing HIV while also preventing other infections or unintended pregnancy), though the FOA framing emphasizes HIV prevention. PIP also places heavy weight on the development and refinement of drug delivery systems (DDS) that can make prevention products practical, acceptable, and effective in real-world use. The announcement highlights both pericoital methods (products used around the time of sex) and sustained-delivery approaches, and it explicitly includes work on single agents as well as combination products and combination strategies.
On the delivery side, PIP is broad and encourages multiple formulation and platform directions, including gels and films, intravaginal rings (IVRs), and systemic or long-acting routes such as oral products, implants, and injections. This reflects a recognition that adherence and user preference are often decisive for prevention effectiveness, and different populations and settings may need different delivery formats. Applications can therefore be built around creating or improving a candidate nBP agent, pairing a candidate with a new delivery platform, advancing combination products, or developing supporting technologies that remove key bottlenecks in preclinical development (for example, technologies that improve delivery performance, stability, tissue targeting, safety assessment, or other enabling steps that help a candidate move forward).
Administratively, this FOA is offered as an R01 research project grant under Funding Opportunity Number RFA-AI-13-008, within the NIH health research activity areas tied to allergy, infectious diseases, microbiology, and infectious disease research (CFDA 93.855 and 93.856). It was posted March 7, 2013, with an application due date of August 1, 2013, and it was later archived September 1, 2013. The program’s estimated total funding level was $3.5 million, with an award ceiling of $400,000 (as listed in the opportunity record), and it does not require cost sharing or matching.
Eligibility is intentionally expansive. Beyond standard academic institutions, eligible applicants include for-profit and nonprofit organizations (including those without 501(c)(3) status), small businesses, state and local government entities, tribal governments and tribal organizations, public housing authorities, school districts, and special district governments. The FOA also explicitly includes a wide range of institution types such as HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations. Importantly, foreign organizations and foreign institutions are eligible to apply, non-U.S. components of U.S. organizations are eligible, and foreign components are allowed consistent with NIH policy, which signals that NIAID anticipated and welcomed global expertise and collaborations relevant to HIV prevention.
Finally, PIP is described as the replacement for the earlier Microbicide Innovation Program, and the FOA cautions investigators to read the new announcement carefully for key differences rather than assuming it mirrors the older program. In practical terms, that statement signals that while microbicides remain within scope, the updated program is broader in framing (covering non-vaccine prevention more generally), more explicit about delivery platforms and sustained-release systems, and oriented toward maintaining an overall pipeline of candidates and enabling technologies rather than focusing narrowly on any single product category. For full details, NIH linked the complete FOA at http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-13-008.html, and technical access issues were directed to the NIH Office of Extramural Research webmaster contact listed in the posting.
Frequently Asked Questions (FAQs)
What is the Preclinical Innovation Program (PIP) (R01)?
The Preclinical Innovation Program (PIP) (R01) is a National Institute of Allergy and Infectious Diseases (NIAID), NIH funding opportunity intended to advance non-vaccine biomedical prevention (nBP) research aimed at preventing HIV acquisition and transmission. It supports preclinical work that helps move early-stage prevention candidates toward later development.
What is the main goal of PIP?
The central goal is to maintain a strong, sustainable pipeline of early-stage HIV prevention candidates by supporting projects that are intentionally high-risk and highly innovative, with an emphasis on generating preclinical evidence and enabling technologies that can move promising concepts forward.
What kinds of projects does PIP prioritize?
PIP prioritizes research that explores new or under-used ideas rather than incremental extensions of well-established approaches. The program emphasizes innovation, high-risk concepts, and the creation of preclinical data and tools needed to advance prevention candidates.
Is this program focused on HIV vaccines?
No. PIP is specifically designed to push forward non-vaccine biomedical prevention (nBP) research aimed at preventing HIV acquisition and transmission.
What prevention approaches are within scope under non-vaccine biomedical prevention (nBP)?
The opportunity highlights a broad range of non-vaccine HIV prevention strategies, including microbicides, pre-exposure prophylaxis (PrEP) approaches, and Multipurpose Prevention Technologies (MPT).
What are Multipurpose Prevention Technologies (MPT), as described in this opportunity?
MPT concepts are described as technologies aiming to address more than one sexual and reproductive health need at the same time, such as preventing HIV while also preventing other infections or unintended pregnancy, while maintaining an emphasis on HIV prevention.
Does PIP support drug delivery system (DDS) development?
Yes. PIP places heavy weight on the development and refinement of drug delivery systems (DDS) that make prevention products practical, acceptable, and effective in real-world use.
Does the program include pericoital and sustained-delivery prevention methods?
Yes. The announcement highlights both pericoital methods (used around the time of sex) and sustained-delivery approaches.
Are single-agent and combination products eligible?
Yes. The program explicitly includes work on single agents as well as combination products and combination strategies.
What delivery platforms and formulations are encouraged?
PIP encourages multiple formulation and platform directions, including gels and films, intravaginal rings (IVRs), and systemic or long-acting routes such as oral products, implants, and injections.
Can an application focus on improving adherence and acceptability through product design?
Yes. The opportunity frames adherence and user preference as key factors in prevention effectiveness and recognizes that different populations and settings may require different delivery formats.
What types of application strategies are mentioned as examples?
Applications may be built around creating or improving a candidate nBP agent, pairing a candidate with a new delivery platform, advancing combination products, or developing supporting technologies that remove key bottlenecks in preclinical development.
What kinds of "supporting technologies" are considered relevant?
The opportunity provides examples of enabling technologies that could address bottlenecks such as delivery performance, stability, tissue targeting, safety assessment, and other enabling steps that help a candidate move forward in preclinical development.
What is the funding mechanism for this opportunity?
This funding opportunity is offered as an NIH R01 research project grant.
What is the Funding Opportunity Number (FOA/RFA) for this program?
The Funding Opportunity Number is RFA-AI-13-008.
Which NIH institute is sponsoring this opportunity?
The opportunity is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.
What NIH activity areas are associated with this FOA?
The opportunity is tied to NIH health research activity areas related to allergy, infectious diseases, microbiology, and infectious disease research.
What CFDA numbers are associated with this funding opportunity?
The record lists CFDA 93.855 and 93.856.
When was this funding opportunity posted and when were applications due?
It was posted on March 7, 2013, and the application due date was August 1, 2013.
Is this FOA still active?
No. The opportunity record indicates it was archived on September 1, 2013.
What was the estimated total funding level for the program?
The estimated total funding level was $3.5 million.
What was the award ceiling listed for this opportunity?
The opportunity record lists an award ceiling of $400,000.
Is cost sharing or matching required?
No. The opportunity indicates that it does not require cost sharing or matching.
Who is eligible to apply?
Eligibility is described as expansive, including for-profit and nonprofit organizations (including those without 501(c)(3) status), small businesses, state and local governments, tribal governments and tribal organizations, public housing authorities, school districts, and special district governments, among other institution types.
Are specific institution types explicitly mentioned as eligible?
Yes. The FOA explicitly includes a wide range of institutions, including HBCUs, Hispanic-serving institutions, AANAPISIs, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and faith-based or community-based organizations.
Are foreign organizations eligible to apply?
Yes. The FOA states that foreign organizations and foreign institutions are eligible to apply.
Are non-U.S. components of U.S. organizations allowed?
Yes. The FOA indicates that non-U.S. components of U.S. organizations are eligible.
Are foreign components permitted under this FOA?
Yes. The FOA notes that foreign components are allowed consistent with NIH policy.
How does PIP relate to the earlier Microbicide Innovation Program?
PIP is described as the replacement for the earlier Microbicide Innovation Program. The FOA cautions investigators to read the new announcement carefully for key differences rather than assuming it mirrors the older program.
Does the updated program still include microbicides?
Yes. The information provided indicates that microbicides remain within scope, while the updated program is broader and covers non-vaccine prevention more generally.
What are the key ways PIP is broader than the earlier program, based on the description provided?
Based on the description, the updated program is broader in framing (covering non-vaccine prevention), more explicit about delivery platforms and sustained-release systems, and oriented toward maintaining an overall pipeline of candidates and enabling technologies rather than focusing narrowly on a single product category.
Where can applicants find the full FOA text?
The full FOA was linked at http://grants.nih.gov/grants/guide/rfa-files/RFA-AI-13-008.html.
Where were technical access issues directed?
Technical access issues were directed to the NIH Office of Extramural Research webmaster contact listed in the posting.
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