Opportunity Information: Apply for PAR 16 381
The Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases (X02) opportunity (Funding Opportunity Number PAR-16-381) is a National Institutes of Health (NIH) initiative from the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). It is designed as a pre-application step for the NIAMS RISK program and is aimed at surfacing highly innovative, non-traditional ideas within NIAMS mission areas, particularly skin and rheumatic diseases. The central theme is enabling research that challenges prevailing assumptions or standard approaches, especially when the underlying idea is promising but may look too uncertain, unconventional, or early-stage for more typical NIH funding routes.
This opportunity emphasizes high-risk, high-reward science. NIAMS is explicitly encouraging applicants to follow up on unusual observations, test imaginative hypotheses, explore creative concepts, and propose new paradigms that significantly depart from current theories or standard practice. In practical terms, the program is built to make room for ideas that reviewers might otherwise label as "too risky," "premature," "controversial," or "unconventional" under standard mechanisms. The intent is to accelerate novel lines of investigation that could open new directions for understanding disease mechanisms or developing new translational strategies relevant to NIAMS-supported conditions.
From a scope perspective, the RISK initiative is focused on disease-relevant translational research, but it draws a firm boundary at first-in-human work. It supports translational studies up to, but not including, first-in-human studies. It also makes clear that the associated RISK R61/R33 funding announcements are not intended to support clinical trials. So, the work is expected to be mission-relevant and translational in nature, but still preclinical or otherwise short of human clinical testing, and not structured as a clinical trial.
The funding instrument type is a grant, and the activity category is Health (CFDA number 93.846). The listing identifies this as a discretionary opportunity. While the source data does not provide an award ceiling or expected number of awards, it does provide key timing information: the opportunity was created on 2016-08-01, with an original closing date of 2016-10-04. Because this is an X02 pre-application opportunity, the main practical takeaway is that it functions as an entry point intended to help NIAMS identify and encourage the most compelling high-risk concepts for potential progression within the broader RISK pipeline.
Eligibility is broad across many U.S.-based organization types. Eligible applicants include state, county, city or township 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; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other eligible entities. The opportunity also calls out additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.
At the same time, the opportunity is explicit about foreign restrictions. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply. Non-domestic components of U.S. organizations are also not eligible. In addition, foreign components, as defined in the NIH Grants Policy Statement, are not allowed. The net effect is that the applicant and the work proposed under this opportunity must remain within allowable U.S.-based institutional and project structures, without foreign components.
Overall, this X02 pre-application opportunity fits researchers and organizations that have a strong, disease-relevant idea in skin or rheumatic diseases that is genuinely outside the mainstream and may not yet have the level of preliminary evidence that traditional mechanisms often demand. The program is intentionally built to capture and nurture bold translational concepts before they are ready for human testing, while avoiding clinical trial support and excluding foreign components.Apply for PAR 16 381
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases (X02)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.846.
- This funding opportunity was created on 2016-08-01.
- Applicants must submit their applications by 2016-10-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases (X02) - PAR-16-381
What is this funding opportunity?
This is the NIH "Pre-Application: Research Innovation for Scientific Knowledge (RISK) for Skin and Rheumatic Diseases (X02)" opportunity (Funding Opportunity Number PAR-16-381), offered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
What is the purpose of the X02 pre-application?
The X02 is a pre-application step for the NIAMS RISK program. Its goal is to surface highly innovative, non-traditional ideas within NIAMS mission areas, particularly skin and rheumatic diseases, and to help NIAMS identify and encourage the most compelling high-risk concepts for potential progression within the broader RISK pipeline.
What kind of research is NIAMS trying to encourage through this program?
NIAMS is emphasizing high-risk, high-reward science. The opportunity is intended for ideas that significantly depart from current theories or standard practice, including proposals that challenge prevailing assumptions, follow up on unusual observations, test imaginative hypotheses, explore creative concepts, or propose new paradigms.
How does this program differ from more typical NIH funding routes?
This opportunity is designed to make space for ideas that might be judged too uncertain, unconventional, early-stage, controversial, or premature under standard NIH mechanisms, even when the underlying concept is promising.
Which disease areas are the focus?
The opportunity is targeted to NIAMS mission areas, with particular emphasis on skin and rheumatic diseases.
Is the work expected to be basic science, translational, or clinical?
The RISK initiative is focused on disease-relevant translational research, with a clear boundary at first-in-human work. The supported scope is translational studies up to, but not including, first-in-human studies.
Are first-in-human studies allowed under this opportunity?
No. The opportunity explicitly supports translational studies up to, but not including, first-in-human studies.
Are clinical trials supported?
No. The associated RISK R61/R33 funding announcements are not intended to support clinical trials, and the work under this initiative is not meant to be structured as a clinical trial.
What is the central theme or guiding idea behind the RISK initiative?
The central theme is enabling research that challenges prevailing assumptions or standard approaches, especially where the idea is promising but might appear too risky or unconventional for typical NIH funding pathways.
What is the funding instrument and activity category?
The funding instrument is a grant. The activity category is Health, with CFDA number 93.846.
Is this opportunity discretionary?
Yes. The listing identifies this as a discretionary opportunity.
Does the listing provide an award ceiling or the expected number of awards?
No. The provided information does not include an award ceiling or the expected number of awards.
What are the key dates mentioned for this opportunity?
The opportunity was created on 2016-08-01, and the original closing date is listed as 2016-10-04.
Who is eligible to apply (in general terms)?
Eligibility is broad across many U.S.-based organization types, including government entities, institutions of higher education, nonprofits, for-profits (including small businesses), tribal entities, public housing authorities, and other eligible entities, as well as several specifically named institution categories and U.S. territories or possessions.
Which government entities are eligible?
Eligible government applicants include state governments; county governments; city or township governments; special district governments; and independent school districts.
Are colleges and universities eligible?
Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education. The opportunity also calls out multiple institution categories such as HBCUs, TCCUs, and other serving-institution types.
Are nonprofit organizations eligible?
Yes. Eligible applicants include nonprofits with 501(c)(3) status (other than institutions of higher education) and nonprofits without 501(c)(3) status (other than institutions of higher education).
Are for-profit organizations eligible?
Yes. Eligible applicants include for-profit organizations other than small businesses, as well as small businesses.
Are tribal governments and tribal organizations eligible?
Yes. Eligible applicants include federally recognized Native American tribal governments and tribal organizations other than federally recognized governments.
Are U.S. territories or possessions eligible?
Yes. The opportunity explicitly includes U.S. territories or possessions among additional eligible applicant categories.
Are faith-based or community-based organizations eligible?
Yes. The opportunity specifically identifies faith-based or community-based organizations as additional eligible applicant categories.
Are federal agencies eligible to apply?
Yes. The opportunity includes eligible federal agencies among additional eligible applicant categories.
Are foreign (non-U.S.) organizations eligible to apply?
No. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply.
Can a U.S. organization apply if it has a non-domestic (foreign) component?
No. Non-domestic components of U.S. organizations are not eligible under this opportunity.
Are foreign components allowed in the proposed project?
No. Foreign components (as defined in the NIH Grants Policy Statement) are not allowed. The applicant and the work proposed must stay within allowable U.S.-based institutional and project structures, without foreign components.
What types of ideas are a good fit for this X02 pre-application?
This opportunity is intended for organizations and researchers with disease-relevant ideas in skin or rheumatic diseases that are genuinely outside the mainstream and may not yet have the level of preliminary evidence that traditional mechanisms often expect, while still being translational and preclinical (not first-in-human and not a clinical trial).
What types of reviewer concerns is this program trying to address?
The program is explicitly designed to provide a pathway for concepts that might otherwise be labeled too risky, premature, controversial, or unconventional under standard review expectations, despite having a promising underlying idea.
How does this X02 relate to the broader RISK program?
Based on the information provided, the X02 functions as an entry point into the NIAMS RISK program. It is intended to help NIAMS identify and encourage compelling high-risk concepts for potential progression within the broader RISK pipeline, including the related R61/R33 announcements.
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