Partnerships for Countermeasures Against Select Pathogens (R01) | RFA AI 17 026

Frequently Asked Questions (FAQs)

What is the Partnerships for Countermeasures Against Select Pathogens (R01) opportunity?

It is an NIH funding opportunity run through NIAID titled "Partnerships for Countermeasures Against Select Pathogens (R01)" (RFA-AI-17-026). It is intended to move promising medical countermeasures closer to real-world use against select emerging infectious diseases and pathogens through milestone-driven, preclinical development projects.

Which NIH institute is responsible for this program?

The opportunity is run through the National Institute of Allergy and Infectious Diseases (NIAID), as part of NIH.

What stage of research and development is this FOA meant to support?

The focus is on milestone-driven preclinical development of a lead candidate countermeasure (therapeutic, vaccine, or a closely related countermeasure). It is positioned as development-style work intended to mature and better characterize a candidate and prepare it for later-stage development, rather than early discovery research.

Is this opportunity intended for early discovery or exploratory research?

No. The description emphasizes that it is not aimed at early discovery research. Instead, it supports targeted development activities that strengthen readiness for later-stage development.

What kinds of products or candidates are appropriate for this program?

The program is designed to advance a lead candidate therapeutic, vaccine, or closely related countermeasure intended to address select emerging infectious diseases and pathogens.

What does "milestone-driven" mean in the context of this opportunity?

Applications are expected to be structured around clear, measurable milestones with defined deliverables, timelines, and go/no-go decision points. Progress is expected to be evaluated against stated objectives rather than open-ended aims.

What is required regarding milestones in the application?

A central requirement is that the application must be built around clear, measurable milestones. This reflects an expectation of disciplined project management and objective progress tracking.

What is the Product Development Strategy attachment and is it required?

The FOA requires a Product Development Strategy attachment. This signals that NIAID expects a development-style proposal that resembles a product pipeline plan, including timelines, deliverables, and go/no-go decision points.

What types of preclinical development activities are expected under this program?

Examples described include de-risking activities such as efficacy studies in appropriate models, dose optimization, formulation work, preliminary safety or toxicology planning, manufacturability considerations, and other enabling steps typical of advancing a lead countermeasure.

Are efficacy studies and model-based testing relevant to this FOA?

Yes. The opportunity description explicitly references efficacy studies in appropriate models as an example of the kinds of preclinical steps used to de-risk and advance a lead candidate.

Does the program support formulation or dose optimization work?

Yes. Formulation work and dose optimization are specifically mentioned as examples of targeted development activities that may be part of advancing the lead candidate.

Does the FOA expect planning for safety or toxicology activities?

Yes. The description references preliminary safety or toxicology planning as an example of enabling preclinical development steps.

Does the FOA consider manufacturability or scale-up issues?

Yes. Manufacturability considerations are explicitly cited as part of the kinds of development-focused activities that help a candidate become more mature and development-ready.

What is the role of partnerships in this funding opportunity?

Partnerships are a defining feature. The FOA aims to encourage collaborations that combine academic or government research strengths with industry development expertise to advance preclinical countermeasure candidates more efficiently and credibly toward eventual clinical development.

Is an industry partner required?

Yes. Applications must demonstrate substantive investment by at least one industrial participant. The project cannot be purely academic in execution or support under the stated expectations.

What does "substantive investment" by an industrial participant mean here?

It means meaningful engagement and tangible commitment from at least one industry partner. The description notes that this could include financial support, in-kind contributions, access to specialized capabilities, manufacturing or scale-up know-how, regulatory development experience, proprietary platforms, or other resources that materially strengthen the path to a viable product.

Can an industry partner contribute in ways other than cash?

Yes. The description indicates that substantive investment may include in-kind contributions and other tangible resources such as specialized capabilities, manufacturing know-how, regulatory experience, or proprietary platforms.

What grant mechanism is used for this opportunity?

The award mechanism is an R01 research project grant.

What is the funding category and program area?

It is categorized as discretionary funding within the health area, with CFDA 93.855.

What is the maximum award amount listed for this opportunity?

The listed award ceiling is $1,050,000, described as the maximum budget level anticipated under the announcement.

When was this opportunity created and when did it close?

The opportunity was created on August 21, 2017, and had an original closing date of January 12, 2018.

Is the number of expected awards stated in the information provided?

No. The posting references expected awards, but a specific number is not provided in the source data described here.

Who is eligible to apply?

Eligibility is broad and includes many organization types commonly allowed under NIH grants. Examples listed include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities and Indian housing authorities; tribal organizations that are not federally recognized tribal governments; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; and other entities.

Are U.S. territories or possessions eligible applicants?

Yes. U.S. territories or possessions are explicitly included among eligible applicant categories.

Are non-U.S. (foreign) entities eligible to apply?

Yes. Non-U.S. (foreign) entities are explicitly listed as eligible in the information provided.

Are minority-serving institutions and community-based organizations included in eligibility?

Yes. The FOA explicitly calls out categories such as Historically Black Colleges and Universities, Hispanic-serving Institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions, and also includes faith-based or community-based organizations.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are explicitly included among the additional eligible applicant categories listed.

What is the overall goal of this program?

The stated goal is to push lead countermeasure candidates past earlier research stages into a more development-ready state through applied, translational preclinical work, strong milestone-based project management, and real industry participation that increases the likelihood of eventual deployment or advancement toward clinical evaluation.