Notice Number: NOT-DE-17-010

Key Dates
Release Date: June 22, 2017

Issued by
National Institute of Dental and Craniofacial Research (NIDCR)

Purpose

The purpose of this Notice is to inform the applicants that effective July 6, 2017, NIDCR will no longer be participating in PAR-16-242, " Bioengineering Research Grants (BRG) (R01)"

Modifications are as follows:

Part 1. Overview Information

Participating Organization(s)
National Institutes of Health (NIH)

Components of Participating Organizations
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of Neurological Disorders and Stroke (NINDS)

Part 2. Full Text of Announcement
Section I. Funding Opportunity Description

IC-Specific Interests
NCI: The mission of the National Cancer Institute is to reduce the burden of cancer.  Toward that end it encourages grant applications for funding on research to gain understanding and achieve mitigations and solutions to cancer problems.  Interests in understanding, mitigations, solutions, and dissemination of knowledge and methods cover: cancer basic knowledge on what it is, causes and prevention, risk factors, screening, diagnosis and staging, monitoring, prognosis, symptoms, finding care givers and treatment facilities, types of treatment, side effects, clinical trials including information for caregivers and patients, cancer drugs, complementary and alternative medicine, among other interests.  More details on cancer, types, research, grants and training, news and events, and about NCI may be found at http://www.cancer.gov.  Communication with the NCI about your project concept is encouraged (See Section VII. below for Agency Contacts).

NIAID: Within the goals of this FOA, NIAID is particularly interested in the following areas:
Quantitative, predictive models of complex interactions of the immune system during development; in response to pathogens or vaccines; during the initiation, development and/or progression of immune-mediated diseases (i.e., allergy, asthma, autoimmune disease, solid organ or pancreatic islet beta cell transplant rejection); and/or for early stage development of interventions for immune-mediated diseases.
Novel bioengineering approaches, including imaging, for analysis of immune cell phenotype and function in response to infectious and/or immune-mediated diseases in target organs and tissues; for delivery of immunomodulatory agents, adjuvants, or antigens; or development and/or characterization of novel biomaterials with immunostimulatory/adjuvant properties.
Biodosimetry biomarkers, technologies and devices to inform triage and treatment strategies of large populations following a radiological or nuclear incident.
Home-based, self-administered tests for detection of HIV in the acute phase of infection.
Simple and accurate assay to quantify the persistent HIV reservoir.
In vitro tissue models for infectious diseases that mimic human biological structures, recapitulate pathophysiology, and incorporate components critical to pathogenesis and host response; these models could be simple enough for use in basic science or sufficiently robust for use in preclinical studies of candidate therapeutics or vaccines.
Multiplex integrated sample-to-answer platforms to rapidly diagnose infectious diseases and identify the causative pathogen and its drug sensitivities.
NIAID will not support any clinical trials through this FOA. Investigators seeking support for clinical trials should refer to NIAID’s Investigator-Initiated Clinical Trials website.

NIAMS: In addition to mission-relevant R01 projects, the National Institute of Arthritis and Musculoskeletal and Skin Diseases would specifically like to stimulate and promote research in building complex 3-dimensional in vitro human musculoskeletal and skin tissue models to study developmental biology, physiology, and disease pathogenesis of musculoskeletal tissues and skin as well as for drug discovery and toxicity studies.  NIAMS is not interested in applications that are developing 3D tissues for transplantation, or engineering non-human tissue models, or developing simple 3-D models that do not go significantly beyond those currently in use, such as human skin equivalents composed of only normal keratinocytes and fibroblasts.
Additionally, NIAMS will not support exploratory or clinical trials of any nature through this mechanism. Applications proposing a clinical trial must be submitted to one of the following NIAMS FOAs specifically designed for clinical trials found at http://www.niams.nih.gov/Funding/Clinical_Research/clinical_main.asp.
NICHD: The NICHD mission is to ensure that every person is born healthy and wanted, that women suffer no harmful effects from reproductive processes, and that all children have the chance to achieve their full potential for healthy and productive lives, free from disease or disability, and to ensure the health, productivity, independence, and well-being of all people through optimal rehabilitation. The NICHD is interested in supporting bioengineering research that advances the development of technology and medicine to accomplish this mission. Examples of areas of research interest include, but are not limited to: a) the development of novel technologies, both imaging and non-imaging, which accelerate the ability to safely and non-invasively assess human placental development and function in real time across pregnancy; b) pediatric specific technologies and equipment used by emergency and trauma care personnel; and, c) innovations in diagnostic methods such as advanced imaging, fluid biomarkers, or genetic profiling to assess rehabilitation intervention readiness.  For additional information about specific scientific programs of research interest to a Branch in the NICHD, please visit http://www.nichd.nih.gov.

NINDS: NINDS will not accept applications under this announcement that include clinical trials (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-15-015.html). A clinical trial is a prospective biomedical or behavioral research study of human subjects designed to answer specific questions about safety, tolerability, efficacy and/or effectiveness of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions. Other human subjects research can be submitted and NINDS may decline funding of any application that includes human subjects for programmatic or administrative reasons. Applicants considering projects involving human subjects research are strongly encouraged to contact Scientific/Research staff.
Applications proposing non-clinical studies concluding in a clinical trial should be submitted to one of the following NINDS CREATE Devices FOAs specifically designed for pre-clinical and pilot clinical studies for therapeutic devices (http://www.ninds.nih.gov/funding/areas/translational_research/CREATE-Devices.htm).
Applications proposing a clinical trial must be submitted to one of the following NINDS FOAs specifically designed for clinical trials (http://www.ninds.nih.gov/research/clinical_research/index.htm#tab3-panel)
See Section VIII. Other Information for award authorities and regulations.

Inquiries

Please direct all inquiries to:

Nadya Lumelsky, Ph.D.
National Institute of Dental and Craniofacial Research
Telephone: 301-594-7703
Email: nadyal@nidcr.nih.gov