NOT-RM-25-002: Notice of Clarification of Requirements and Non-responsive Activities in RFA-RM-24-012, In Vivo Non-Invasive Optical Imaging Approaches for Biological Systems (UG3/UH3 Clinical Trials Not Allowed)

Notice of Clarification of Requirements and Non-responsive Activities in RFA-RM-24-012, In Vivo Non-Invasive Optical Imaging Approaches for Biological Systems (UG3/UH3 Clinical Trials Not Allowed)

Notice Number:

NOT-RM-25-002

Key Dates

Release Date:

January 7, 2025

Related Announcements

December 02, 2024 - In Vivo Non-Invasive Optical Imaging Approaches for Biological Systems (UG3/UH3 Clinical Trials Not Allowed. See RFA-RM-24-012.

Issued by

Office of Strategic Coordination (Common Fund)

Purpose

The purpose of this notice is to clarify the requirements and non-responsive activities in RFA-RM-24-012

Part 2. Section I. Notice of Funding Opportunity Description

Requirements

Currently reads:

This NOFO will support projects that develop novel in vivo optical imaging utilizing light as the imaging modality. Here, light is defined as radiation ranging from ultraviolet to infrared on the electromagnetic spectrum. The imaging technique must be capable of providing unique in vivo imaging information from live tissues using non- or minimally invasive technical strategies. Development of the device must first demonstrate a significant increase in tissue depth non-invasively; following development, the device may be used in applications that are non-invasive, minimally invasive, or in surgical settings. The advancement, when compared to existing in vivo non-invasive technologies, must provide a significant objective increase in penetration depth while maintaining or improving other performance features such as spatial and temporal resolution and contrast. The proposed device or technology must capture relevant physiological changes and timescales for biological events, e.g., heartbeat, action potential. The specific technology must provide imaging across scales, (e.g., sub-cellular to cellular; or cellular to tissue) relevant to the tissue of interest. Detailed plans for partnerships to continue technology maturation beyond the NIOI project period, including but not limited to commercialization, startups, follow-on funding from advanced developers, etc. are encouraged.

NIOI will use a two-stage, phased award mechanism to develop and validate integrated approaches for non-invasive or minimally-invasive, in vivo optical based imaging. Phase I (UG3, years 1-2) is expected to encompass designing hardware that integrates novel forms of optical imaging data acquisition and processing and developing prototypes that overcome light-scattering barriers in complex biological systems. Phase II (UH3, year 3) is expected to focus on optimization and performance testing. By the close of the third year of funding support, it is expected that developed technologies will have been evaluated for performance in a relevant biological system and will have demonstrated the capability to effectively capture images across multiple scales (e.g. micro to macro scale) relevant to the tissue of interest.

Transition from UG3 to UH3: An administrative review of each funded UG3 project will be conducted by NIH Program staff in year two to decide whether it will be considered for transition from the UG3 phase to the UH3 phase. To be eligible for transition, a project must have successfully met the stated milestones of the UG3 Phase.

Updated to read (changes in bold italics):

NIOI will use a two-stage, phased award mechanism to develop and validate integrated approaches for non-invasive or minimally-invasive, in vivo optical based imaging. Phase I (UG3, years 1-2) is expected to encompass designing hardware that integrates novel forms of optical imaging data acquisition and processing and developing prototypes that overcome light-scattering barriers in complex biological systems. Phase II (UH3, year 3) is expected to focus on optimization and performance testing. By the close of the third year of funding support, it is expected that developed technologies will have been evaluated for performance in a relevant biological system and will have demonstrated the capability to effectively capture images across multiple scales (e.g., sub-cellular to cellular; or cellular to tissue) relevant to the tissue of interest.

Part 2, Section I. Notice of Funding Opportunity Description

Non-Responsive Activities

Currently reads:

Applicants that propose a device that relies on surgical manipulation of the tissue and transgenic approaches to achieve increased imaging depth will not be considered and the application will be withdrawn prior to review.

Applicants that propose the use of gamma-rays, x-rays, microwaves, or radio waves will not be considered responsive to the NOFO and the application will be withdrawn prior to review.

Applicants proposing the use of non-mammalian or non-mammalian organisms will not be considered responsive to the NOFO and the application will be withdrawn prior to reviews.

Updated to read (changes in bold italics):

Applicants that propose a device that relies on surgical manipulation of the tissue or transgenic approaches to achieve increased imaging depth will not be considered and the application will be withdrawn prior to review.”

Applicants that propose the use of gamma-rays, x-rays, microwaves, or radio waves will not be considered responsive to the NOFO and the application will be withdrawn prior to review.

Applicants proposing the use of non-mammalian tissues or non-mammalian organisms will not be considered responsive to the NOFO and the application will be withdrawn prior to reviews.

Inquiries

Please direct all inquiries to:

Jonathan D. Pollock, Ph.D.
[email protected]
301-435-1309