Opportunity Information: Apply for PAR 11 216
Apply for PAR 11 216
- The National Institutes of Health in the education health sector is offering a public funding opportunity titled "Early Phase Clinical Trials in Imaging and Image Guided Interventions (R21)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.394 Cancer Detection and Diagnosis Research 93.395 Cancer Treatment Research.
- This funding opportunity was created on Feb 19, 2014 and posted on May 24, 2011.
- Applicants must submit their applications by Feb 19, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $250,000.00 in funding.
- Eligible applicants include: County governments Native American tribal organizations (other than Federally recognized tribal governments) Special district 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 City or township governments Private institutions of higher education State governments Others (see text field entitled Additional Information on Eligibility for clarification) Small businesses Public housing authorities/Indian housing authorities Public and State controlled institutions of higher education Independent school districts Native American tribal governments (Federally recognized) For profit organizations other than small businesses.
- 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 Foreign (non U.S.) components of U.S. Organizations are allowed.
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Opportunity Summary:
The NIH funding opportunity PAR-11-216, titled "Early Phase Clinical Trials in Imaging and Image Guided Interventions (R21)," is designed to help researchers run early, pilot-stage clinical trials in cancer imaging and image-guided interventions. The focus is on generating the first meaningful human data needed to judge whether a new imaging-related idea is safe, feasible, and promising enough to justify larger and more definitive studies later. In practical terms, this FOA supports Phase I and Phase II style efforts that are still exploratory, where investigators are trying to establish initial safety, refine methods, and gather preliminary signals of efficacy or clinical usefulness.
A central goal of the program is the preliminary evaluation of imaging agents, including early testing of safety and early indications that an agent performs as intended in people. Beyond imaging agents, the FOA also explicitly covers assessment and early clinical testing of imaging systems and related technologies. That includes image processing approaches, image-guided therapy methods, contrast kinetic modeling, 3-D reconstruction, and other quantitative imaging tools that can improve detection, diagnosis, treatment planning, treatment delivery, or monitoring in cancer care. The announcement is broad enough to encompass both hardware and software innovations, as long as the work is grounded in clinical trial activity aimed at early human evaluation rather than purely preclinical development.
Because these projects are early in the pipeline, the FOA anticipates that many studies will require hands-on patient monitoring and associated laboratory studies to understand safety, performance characteristics, and biologic or technical correlates. In other words, it is not limited to simply collecting images; it supports the practical clinical-trial infrastructure and the supporting measurements that are often necessary to interpret imaging findings, optimize protocols, and establish whether the approach is ready for expansion.
The R21 mechanism signals an exploratory and developmental intent: the program is meant to help investigators cross the gap from promising concept to initial clinical evidence. If an imaging or image-guided intervention approach looks successful in these early trials, the FOA frames the next step as validation in larger, more definitive studies. Those follow-on efforts could be pursued through competitive R01 applications or conducted in broader clinical trial settings such as Specialized Programs of Research Excellence (SPOREs), Cancer Centers, and/or Cooperative Groups. In that sense, PAR-11-216 functions as an early clinical stepping stone that can de-risk innovations and position them for scaling.
From an administrative standpoint, this is a discretionary grant opportunity administered by the National Institutes of Health. It falls under the health and education activity area and is tied to CFDA programs 93.394 (Cancer Detection and Diagnosis Research) and 93.395 (Cancer Treatment Research, reflecting the dual diagnostic and interventional relevance of imaging and image guidance. The award ceiling listed is $250,000, and the opportunity states that there is no cost sharing or matching requirement, meaning applicants are not required to provide non-federal matching funds as a condition of the award.
Eligibility is intentionally broad and includes many organization types: public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), small businesses, for-profit entities other than small businesses, local and state governments, independent school districts, public housing authorities/Indian housing authorities, special district governments, and tribal governments (both federally recognized and other than federally recognized). The eligibility details also call out a range of institution categories and communities, including HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, and regional organizations. Foreign participation is also allowed in specific forms: non-U.S. entities (foreign organizations) may apply, and foreign components of U.S. organizations are permitted, as are U.S. territories or possessions. This breadth reflects NIH's interest in attracting strong clinical imaging trial proposals from a wide set of capable research environments.
The opportunity was posted May 24, 2011, with key dates indicating it is now archived (archive date March 19, 2014). The original closing date was March 13, 2014, with a current closing date listed as February 19, 2014, indicating the solicitation is no longer open for new applications under those deadlines. For historical reference and full details, the FOA points to the NIH Guide announcement page at http://grants.nih.gov/grants/guide/pa-files/PAR-11-216.html, and it provides NIH Office of Extramural Research contact information (FBOWebmaster@OD.NIH.GOV) for technical access or linking issues.
Frequently Asked Questions (FAQs) - NIH PAR-11-216 (R21)
What is NIH PAR-11-216?
PAR-11-216 is an NIH funding opportunity titled "Early Phase Clinical Trials in Imaging and Image Guided Interventions (R21)." It supports early, pilot-stage clinical trials focused on cancer imaging and image-guided interventions, with the goal of producing the first meaningful human data needed to decide whether an approach is safe, feasible, and promising enough to justify larger studies.
What is the main purpose of this funding opportunity?
The main purpose is to help researchers bridge the gap between a promising imaging or image-guided intervention concept and initial clinical evidence in people. The FOA emphasizes generating early human data on safety, feasibility, and early signals of performance or clinical usefulness that can justify follow-on, more definitive studies.
What kinds of clinical trials does this FOA support?
This FOA supports early phase, exploratory clinical trial activity aligned with Phase I and Phase II style efforts. These are pilot or developmental trials where investigators are establishing initial safety, refining methods, and gathering preliminary indications that an imaging agent, system, or image-guided approach is working as intended in humans.
Is this opportunity focused only on imaging agents?
No. While a central goal is preliminary evaluation of imaging agents (including early safety testing and early indications of intended performance in people), the FOA also explicitly covers imaging systems and related technologies, including hardware and software innovations, when grounded in early human clinical trial activity.
What types of technologies are included beyond imaging agents?
The FOA includes early clinical testing and assessment of imaging systems and related technologies such as image processing approaches, image-guided therapy methods, contrast kinetic modeling, 3-D reconstruction, and other quantitative imaging tools intended to improve cancer detection, diagnosis, treatment planning, treatment delivery, or monitoring.
Does the FOA support software-based or quantitative imaging methods?
Yes. The FOA is broad enough to include software and quantitative methods (for example, image processing, modeling, reconstruction, and quantitative imaging tools), as long as the work is grounded in clinical trial activity aimed at early evaluation in humans rather than purely preclinical development.
Does this funding cover only image collection, or also clinical trial infrastructure?
It is not limited to collecting images. The FOA anticipates that many early studies will require hands-on patient monitoring and associated laboratory studies to understand safety, performance characteristics, and biologic or technical correlates. It supports practical clinical-trial needs and supporting measurements that help interpret imaging findings and optimize protocols.
What does the R21 mechanism indicate for this program?
The R21 mechanism signals an exploratory and developmental intent. In this context, it is meant to help investigators generate early clinical evidence that can de-risk an innovation and position it for larger, more definitive validation studies later.
What happens after an R21 project shows promising results?
The FOA frames the next step as validation in larger and more definitive studies. Follow-on efforts could be pursued through competitive R01 applications or conducted in broader clinical trial settings such as Specialized Programs of Research Excellence (SPOREs), Cancer Centers, and/or Cooperative Groups.
What is the award ceiling for PAR-11-216?
The listed award ceiling is $250,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement, meaning applicants are not required to provide non-federal matching funds as a condition of the award.
Which agency administers this grant opportunity?
This is a discretionary grant opportunity administered by the National Institutes of Health (NIH).
What activity area does this opportunity fall under?
It falls under the health and education activity area.
Which CFDA programs are associated with this opportunity?
The FOA is tied to CFDA 93.394 (Cancer Detection and Diagnosis Research) and CFDA 93.395 (Cancer Treatment Research), reflecting imaging's relevance to both diagnostic and interventional cancer research.
Who is eligible to apply?
Eligibility is broad and includes many organization types, including public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), small businesses, for-profit entities other than small businesses, local and state governments, independent school districts, public housing authorities/Indian housing authorities, special district governments, and tribal governments (both federally recognized and other than federally recognized).
Are specific institution types or communities called out as eligible?
Yes. The eligibility description explicitly calls out categories and communities such as HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities, Alaska Native and Native Hawaiian Serving Institutions, faith-based and community-based organizations, and regional organizations.
Are foreign organizations or international components allowed?
Yes. Non-U.S. entities (foreign organizations) may apply. Foreign components of U.S. organizations are permitted, and U.S. territories or possessions are also allowed.
Is PAR-11-216 currently open for applications?
No. The opportunity is archived (archive date March 19, 2014). The key dates provided indicate deadlines in early 2014, and it is no longer open for new applications under those deadlines.
When was this funding opportunity posted?
The opportunity was posted on May 24, 2011.
What were the listed closing dates?
The information provided notes an original closing date of March 13, 2014, and a current closing date listed as February 19, 2014, indicating the solicitation is closed and archived.
Where can someone find the original NIH Guide announcement for this FOA?
The NIH Guide announcement page is listed as: http://grants.nih.gov/grants/guide/pa-files/PAR-11-216.html.
Who should be contacted for technical access or linking issues related to the FOA page?
The FOA provides NIH Office of Extramural Research contact information for technical access or linking issues: FBOWebmaster@OD.NIH.GOV.
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