Targeted Prevention for Tickborne Diseases (R01 Clinical Trial Not Allowed) | RFA AI 19 037

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is the NIH Targeted Prevention for Tickborne Diseases (R01 Clinical Trial Not Allowed) program, Funding Opportunity Number (FON) RFA-AI-19-037. It is a discretionary NIH grant program in the health category (CFDA 93.855) intended to advance new ways to prevent Lyme disease and other tick-borne illnesses.

What is the primary goal of the program?

The main goal is to move forward prevention-focused research, especially the development of vaccines and other strategies that stop infections from occurring in the first place. The emphasis is on generating strong scientific evidence that can move a prevention approach closer to real-world use.

Is this opportunity focused on treatment or prevention?

It is focused on prevention. Applications are expected to target approaches that prevent Lyme disease or other tick-borne diseases rather than treating illness after exposure.

What does the R01 mechanism mean for the type of project expected?

An R01 is generally used to support substantial, hypothesis-driven research projects. For this opportunity, that typically means projects that can produce robust preclinical or translational evidence supporting a vaccine or prevention strategy, while staying within the boundaries stated in the announcement.

Are clinical trials allowed under this FOA?

No. The title includes "Clinical Trial Not Allowed," meaning applications should not propose clinical trials as defined by NIH.

What kinds of activities are appropriate since clinical trials are not allowed?

Based on the description provided, appropriate activities generally stay on the discovery, design, optimization, and non-trial evaluation side of prevention development. Examples mentioned include antigen discovery, immunogen design, platform optimization, laboratory and animal model testing, identification of correlates of protection, and development of delivery systems or adjuvants, as well as other non-clinical-trial studies that strengthen the scientific and technical basis for prevention.

Does the opportunity only support vaccine research?

No. Vaccines are a major emphasis, but the program also supports other prevention strategies aimed at stopping infection before it occurs, as long as the work remains consistent with the scope described and does not include clinical trials.

How targeted does the project need to be to Lyme disease or tick-borne diseases?

The opportunity emphasizes "targeted prevention," so proposals are expected to be directly connected to preventing Lyme disease or other tick-borne diseases. Projects that broadly study ticks or pathogens without a clear prevention endpoint are not aligned with the stated emphasis.

Who is the sponsor of this opportunity?

The sponsor is the National Institutes of Health (NIH).

What type of award is being offered?

The award is structured as an NIH grant using the R01 research project format.

What is the CFDA number associated with this opportunity?

The CFDA number listed is 93.855.

When was this solicitation created and when did it close?

The creation date provided is 2019-04-02, and the original closing date provided is 2019-08-06, indicating this was a time-bound solicitation released in 2019.

Is the award ceiling provided?

No. The information provided does not specify an award ceiling.

Is the expected number of awards provided?

No. The information provided does not specify the expected number of awards.

Where would applicants normally find details like budget limits or project period expectations?

The provided summary indicates that budget limits, project period expectations, programmatic priorities, and detailed scientific scope are typically found in the full Funding Opportunity Announcement (FOA) text. Those specifics are not included in the information provided here.

What types of organizations are eligible to apply?

Eligibility is broad. The listed eligible applicants include many U.S. governmental entities and academic institutions, as well as nonprofit and for-profit organizations (including small businesses).

Which U.S. government entities are explicitly listed as eligible?

The eligible applicant list includes state, county, city or township, and special district governments, as well as independent school districts.

Are higher education institutions eligible?

Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible.

Are tribal governments and tribal organizations eligible?

Yes. Federally recognized Native American tribal governments are listed, along with tribal organizations that are not federally recognized governments. The announcement also highlights Indian/Native American tribal governments that are not federally recognized as an additional eligible category.

Are nonprofits eligible, including those without 501(c)(3) status?

Yes. The eligible applicant list includes nonprofits with or without 501(c)(3) status (excluding institutions of higher education within those nonprofit categories, as stated in the description provided).

Are for-profit entities eligible?

Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also included as eligible applicants.

Are public housing authorities eligible to apply?

Yes. Public housing authorities/Indian housing authorities are listed as eligible applicants.

Are faith-based or community-based organizations eligible?

Yes. The announcement explicitly highlights faith-based or community-based organizations as additional eligible applicant categories.

Are federal agencies eligible?

Yes. Eligible federal government agencies are explicitly highlighted as an additional eligible category.

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

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

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

Yes. Non-U.S. entities (foreign organizations) are explicitly listed among the additional eligible applicant categories, suggesting the program is open to international participation.

Are minority-serving institutions specifically encouraged or listed as eligible?

They are explicitly included among the highlighted eligible categories. The description lists Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and other diverse institutional categories.

What does the "Others" eligibility category mean?

The summary notes an "Others" category that NIH sometimes uses to capture additional eligible entity types beyond the standard lists. The exact meaning or scope of "Others" is not further defined in the provided information.

What diseases are in scope for prevention research?

The program targets prevention of Lyme disease and other tick-borne illnesses. The emphasis is on approaches that can prevent infection.

What is the overall takeaway for prospective applicants?

This opportunity is best suited for organizations proposing substantial R01-level research that advances practical, science-backed prevention tools against Lyme disease and other tick-borne diseases, with a strong emphasis on vaccine and prevention strategy development and a clear requirement that the proposed work must not include clinical trials.