Key Dates

Related Announcements

• October 9, 2020 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional). See NOFO PA-20-272

Issued by

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Eye Institute (NEI)

Purpose

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) and other participating ICs announce the availability of administrative supplements for supporting the optimization, calibration, and dissemination of imaging phantoms that have been developed by investigators as part of the parent awards. This is part of a comprehensive effort to address the need for well-calibrated phantoms across different imaging modalities to improve repeatability, reproducibility, and quantification of imaging technologies and devices.

Background

Medical imaging plays an important role in screening, diagnosis, characterization, and treatment of diseases and therapy response monitoring.  Phantoms are specialized devices that mimic human anatomy or tissue properties and play a crucial role in various aspects of medical device and imaging technology development. Standardized and reproducible phantoms are critical tools to quantitatively test and characterize biomedical imaging and medical device performance under different operating parameters. These phantoms can assist in quality assurance and control during technical development of biomedical imaging technologies to accelerate innovation and reduce the need for ad-hoc test methods which remain a burden for innovators. Recognizing the roles phantoms play and the importance of sharing them, NIBIB is currently supporting the NIST/NIBIB Imaging Phantom Lending Library in which phantoms are made available, as a public resource, to the medical imaging community.

This administrative supplement NOSI will provide support to NIH-funded investigators to optimize, validate, calibrate, and curate qualified imaging phantoms already developed or acquired as part of their currently funded project for the purpose of being disseminated via the NIST/NIBIB Imaging Phantom Lending Library. This effort will enable diverse communities such as academia and industries (e.g. medical device and pharmaceutical companies) to use reliable and high-quality phantoms for quantification of biomedical imaging data as well as testing and validation of imaging technologies. This will further minimize the need for interested communities to invest in their own phantom development. By reducing time and costs for quantitative assessment of medical imaging technologies this effort can ultimately benefit patients, improve clinical trials, drug development, biomarker discoveries and clinical decision-making.

Parent grants that develop and use phantoms as part of their original scientific aims may be eligible for the supplemental funding under this NOSI if the supplement proposes to include and perform additional steps but are needed to make the phantoms ready for dissemination. Applicants may propose to perform tasks along the optimization, validation, and calibration pipeline that will use the parent project's existing phantoms.

Applications in response to this administrative supplement NOSI that propose the development of new imaging phantoms that are not included within the parent grant will not be considered. The proposed phantoms through this administrative supplement will be disseminated for public use through the NIST/NIBIB Medical Imaging Phantom Lending Library and must, at a minimum, include comprehensive documentation, instructions, and Standard Operating Procedures (SOPs) including:

1. A detailed technical description of the phantom, including bill of materials, commercial sources of chemical reagents and phantom components, phantom geometry, and a list of phantom material properties or other characteristics that have been measured or evaluated.
2. A description of the phantom’s intended purpose.
3. A description of the phantom’s scope of use and limitations.
4. Standard Operating Procedure (SOP) documentation describing methods for material formulation and preparation, phantom fabrication and assembly, and storage/handling requirements.
5. A description of testing that was performed to support use of the phantom within its intended purpose. This may include, but is not limited to stability, repeatability, or reproducibility testing; use of phantoms to evaluate medical devices and/or imaging systems; or comparisons to in vivo measurements.
6. Supporting documentation such as instructions for use, digital models or files (e.g., 3D printing files), related code or algorithms, and/or peer-reviewed publications describing preparation and/or use of the phantom.
7. Inclusion of curation methods and plans (assessment of stability, archives, etc.).

Eligibility and Eligible Individuals (Program Director/Principal Investigator):

• Projects through this administrative supplement opportunity are to be led by a current recipient of one of the participating ICs within this NOSI.  
• The parent award must be an active grant or cooperative agreement (R00, R01, R21, R35, R37, R41, R42, R43, R44, U01, P41, P01, P30, P50, U19, U24, or U54) with one of this NOSI’s participating IC as a primary assignment.
• The proposed administrative supplement must use or develop imaging phantoms as part of the research plan within the parent grant.
• At the time of a supplemental award, the parent award must have at least 1 year of active support remaining. The parent award must not be in a no cost extension period.
• For supplements to parent awards that include multiple program directors/principal investigators (PD/PIs), the supplement may be requested by any or all of the PD/PIs on that award (in accordance with the existing leadership plan) and must be submitted by the recipient institution of the parent award.
• Collaboration with scientists from different disciplines such as material science that aligns with the purpose of NOSI is encouraged.
• Collaborations with foreign institutions are allowed, but investigators must provide a justification for the collaboration. Please note that some foreign collaborations will require U.S. State Department approval by the NIBIB or other participating ICs, and that may delay receipt of funding.

Application and Submission Information

Applications for this initiative must be submitted using the following opportunity.

• PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:

• Application Due Date(s) August 1st, 2024, by 5:00 PM local time of applicant organization
• For funding consideration, applicants must include NOT-EB-24-009 (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
• Application budget cannot exceed a maximum total cost of $200,000 but no more than the amount of the current parent award.
• To be eligible, at least one full year of active support on the parent award must remain at the time of supplemental funding (i.e., not a no-cost extension period) - the proposed project period cannot exceed that of the parent award.
• The Research Strategy section of the application is limited to 6 pages. The Specific Aims page is not included in this page limit
• In addition to the review considerations found in PA-20-272, the following administrative review criteria will also be considered in the evaluation of the submission
  • Clear statement of the phantom’s impact on improving repeatability, reproducibility, and quantification of biomedical imaging technologies and medical devices, clinical translation, or patient care and outcomes
  • Demonstrate reliability, robustness, and usability of the phantoms in research and clinical settings and their clinical and translational significance.
  • Demonstrate phantom’s utility for its intended purpose (for example, for imaging system calibration or inter-comparison of performance between different devices
  • Clearly defined tissue type(s) or organ(s) the phantom is intended to simulate.
  • Identification of required phantom specifications for the intended application, including but not limited to geometry, material properties, and their ability to mimic specific tissue(s) of interest.
  • Inclusion of quantitative technical objectives that can be used to evaluate the success of the phantom in the context of relevant imaging methodology and medical device development, and/or clinical use. This includes data or procedure to confirm the feasibility of the phantom to enable objective and quantitative assessment of imaging technology, tool, and device performance.
  • Demonstrate system performance and functionality against commercially relevant quantitative milestones.
  • Rigor of the phantom design with adequate plans to address relevant biological variables that phantom represents, such as sex, age, gender, as well as physiological and pathological variations.
  • Realistic scope of work, given the time and budget requested.
  • Statement confirming that the phantom (including relevant data and models) will be deposited to the Phantom Library after publication and in accordance with the NIH data sharing policy.
• It is allowable for institutions to waive indirect costs, but not required.
• Requests for no-cost extensions of the parent grant to accommodate a supplement will not be permitted; however, a no-cost extension of the supplement will be considered if the parent grant is still active.
• The administrative supplement awards pursuant to this opportunity are contingent upon the availability of funds from participating institutes and the receipt of a sufficient number of meritorious requests.  
• NIH staff will consider the ability of the proposed supplement activities to increase or preserve the parent award’s overall impact within the original scope of award as appropriate. Participating ICs within this NOSI will conduct administrative reviews of applications and will support meritorious applications submitted for consideration based on the availability of funds and programmatic priorities. NIH staff will consider the potential impact of the phantoms on the development and standardization of biomedical imaging technologies and medical devices, and the dissemination potential through the Phantom Library. The criteria that will be considered during the administrative review include:
• All applications, including those for multi-project activity codes, must be submitted electronically using a single-project application form package
• Applicant organizations may submit more than one application, provided that each is sufficiently distinct from any other administrative supplement currently under consideration by the awarding NIH Institute or Center. Only one application per parent award may be submitted
• List any senior/key personnel who have important roles (e.g., researchers leading the entire aim of the supplement or other official supplement responsibilities) in the supplement as Co-Investigators
• A separate progress report for these supplements is required under section G.1, Special Reporting Requirements, as part of the Research Performance Progress Report (RPRR) of the parent grant. The progress report for the supplement should describe what was accomplished under the supplement for the reporting period. 

Applicants are strongly encouraged to discuss their application with the scientific/research contacts listed in this NOSI prior to submission and to notify the program contact at the NIH Institute or Center supporting the parent award that a request has been submitted in response to this NOFO in order to facilitate efficient processing of the request

Applications that are not in compliance with the terms of this NOSI will not be considered for funding.

Inquiries

Afrouz Anderson, Ph.D.
Division of Applied Science and Technology
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-4558
Email: [email protected] 

Amberlynn A. Reed, MPH 
National Eye Institute (NEI)
Telephone:  301-503-1050
Email:  [email protected]