Notice Number: NOT-EB-18-008

Key Dates
Release Date: March 7, 2018

Issued by
National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Purpose

The purpose of this Notice is to inform potential applicants that the National Institute of Biomedical Imaging and Bioengineering (NIBIB) will participate, effective immediately, in PAR-18-009
"Academic-Industrial Partnerships to Translate and Validate in vivo Cancer Imaging Systems (R01 Clinical Trial Optional)."

The following changes and updates are made to PAR-18-009 (shown in italics) to reflect NIBIB's participation in this FOA.

Part 1. Overview Information

Components of Participating Organizations
National Cancer Institute (NCI)
National Institute on Dental and Craniofacial Research (NIDCR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)

Catalog of Federal Domestic Assistance (CFDA) Number(s)
93.394, 93.395, 93.396, 93.242, 93.847, 93.286

Part 2. Section I. Award Information

Specific Research Objectives and Scope:

The mission of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) is to improve health by leading the development and accelerating the application of biomedical imaging and bioengineering tools, methods, devices, and technologies for the prevention, detection, quantification, treatment, and monitoring of disease. The technology may focus on translation of methods, devices, and tools for pre-clinical research, pediatrics, and retrospective data analysis.

For this Funding Opportunity Announcement, NIBIB will only support applications proposing early-stage clinical trials through Phase I, first-in-human, safety, feasibility or other small clinical trials that inform early-stage technology development. NIBIB will not support applications proposing Phase II, III, IV or pivotal clinical trials or trials in which the primary outcome is efficacy, effectiveness or a post-market concern. Applicants are strongly encouraged to contact the NIBIB Scientific Contact listed in this FOA for guidance in advance of submitting an application that includes human subjects research to ensure their proposed project is in compliance with new NIH human subjects research and clinical trials policies (https://grants.nih.gov/policy/clinical-trials.htm) and consistent with the types of clinical trial applications that NIBIB supports.

NIBIB will not consider application requests of $500,000 or more for direct costs in any year.

Part 2. Section VII. Agency Contacts

Scientific/Research Contact(s)
Behrouz N. Shabestari, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-6771
Email: behrouz.shabestari@nih.gov

Financial/Grants Management Contact(s)
Kwesi Wright, MBA
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4789
Email: wrightnk@mail.nih.gov

Inquiries

Please direct all inquiries to:

Behrouz N. Shabestari, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-6771
Email: behrouz.shabestari@nih.gov