Key Dates

Related Announcements

NOT-HD-21-017 - Notice of Change to Funding Opportunities for NOT-EB-20-017, "Notice of Special Interest (NOSI): Synthetic Biology for Biomedical Applications"

PA-20-183 - NIH Research Project Grant (Parent R01 Clinical Trial Required)

PA-20-185 - NIH Research Project Grant (Parent R01 Clinical Trial Not Allowed)

PAR-20-084 - NIBIB Trailblazer Award for New and Early Stage Investigators (R21 Clinical Trial Optional)

PAR-19-367 - Maximizing Investigators' Research Award (R35 - Clinical Trial Optional)

PAR-20-117 - Maximizing Investigators Research Award (MIRA) for Early Stage Investigators (R35 - Clinical Trial Optional)

PA-18-482 - NICHD Exploratory/Developmental Research Grant (R21 - Clinical Trial Optional)

NOT-EB-20-022 - Notice of Special Interest (NOSI): Administrative Supplement for Providing Travel Support for Awardees to Attend the Annual NIH Synthetic Biology Consortium Meeting (Admin Supp)

NOT-EB-21-021 - Notice of Change to NOT-EB-20-017

Issued by

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Institute on Aging (NIA)

National Institute of Allergy and Infectious Diseases (NIAID)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of General Medical Sciences (NIGMS)

National Center for Complementary and Integrative Health (NCCIH)

National Cancer Institute (NCI)

National Human Genome Research Institute (NHGRI)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to announce that the National Center for Complementary and Integrative Health (NCCIH), the National Cancer Institute (NCI), the National Institute of Aging (NIA), the National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), the National Institute of General Medical Sciences (NIGMS), and the National Human Genome Research Institute (NHGRI) are encouraging new applications to advance research activities relevant to synthetic biology.

Background

One of the great challenges in biomedical research is to be able to quantitatively predict, test, and harness the complex dynamics of biological systems. Synthetic biology is the design and construction of new biological parts and systems, and the re-design of existing and natural biological systems for specific purposes. In contrast to the traditional genetic engineering approach, which usually focuses on individual genes and proteins, synthetic biology adopts a more systematic approach targeting entire pathways, networks, and whole organisms with quantitative control and modulation. Gaining new insights into the complex and dynamic biological pathways of designer cells and tissues and developing cell-based and cell-free diagnostics and therapies are at the frontiers of biomedical science. Enabling these de novo biological systems will require the ability to design and build complex pathways with endogenous or novel functions and with predictable and quantitative responses to endogenous or environmental signals. Achieving this paradigm will allow the testing of hypotheses on complex biological systems and the development of novel therapeutic strategies and diagnostic capabilities. To improve the reach and impact of engineering biology on human health, an integrative research plan based on collaborations of synthetic biologists with computational scientists, cell biologists, engineers, geneticists, developmental biologists, and/or physician scientists is strongly recommended.

Research Objectives

The overarching goal(s) of this Notice are to:

1. develop tools and technologies to control and reprogram biological systems.
2. apply synthetic biology approaches for the development of biomedical technologies.
3. increase the fundamental understanding of synthetic biology concepts as they relate to human health.
4. gain fundamental biological knowledge through the application of synthetic biology approaches.

NCCIH Statement of Interest

NCCIH supports a diverse portfolio of natural products research. This includes the use of systems biology technology to better understand the biosynthesis and beneficial functions of natural products. This includes support for development and application of synthetic biology approaches to assess mechanisms of action and causal effects of beneficial microbes in human. NCCIH encourages applications to this initiative aimed at elucidating biosynthetic pathways for high value, plant based, natural products and developing ways to improve their production in either native or heterologous hosts.In the context of this initiative, high value, plant based, natural products are defined as those which have well established therapeutic properties for humans. Use of systems biology for the engineering and production of compounds which are not known from a natural source are considered low priority for NCCIH.

Examples of research of interest to NCCIH include, but are not limited to:

• Use of synthetic biology tools to identify biosynthetic gene clusters or pathways responsible for the biosynthesis of plant based natural products
• Use of synthetic biology tools to improve production of plant based natural products from their native sources
• Use of synthetic biology tools to assemble biosynthetic machinery and optimize yield for plant based natural products into heterologous hosts
• Synthetic microbiome and probiotics to sense host-gut microbiome interactions and improve human health

NCI Statement of Interest

The National Cancer Institute (NCI) supports a broad-based portfolio of cancer research and development projects encompassing basic, translational, clinical, and epidemiological inquiries.This includes support for the development and application of novel enabling technologies in a broad range of cancer research. NCI strongly encourages multidisciplinary collaborations between synthetic biologists and cancer biologists or translational cancer researchers in developing novel solutions to tackle critical cancer problems. Some general examples that are relevant to this FOA include, but are not limited to:

• Developing novel synthetic biology methods and tools relevant to cancer research and cancer management
• Using synthetic biology methods to develop novel cell, tissue, and animal based model systems to study the fundamental mechanism of cancer development, progression, and/or response to treatment
• Using synthetic biology methods to develop and evaluate novel diagnostic, preventive, and therapeutic approaches relevant to human cancer

NHGRI Statement of Interest

The National Human Genome Research Institute (NHGRI) supports a broad portfolio of genomics-based projects to accelerate scientific and medical breakthroughs that improve human health. This is driven by cutting-edge genomics research and technology development. For the purposes of this NOSI, NHGRI encourages synthetic biology approaches relevant to genomics. Research or tools development that are only applicable to one or a small number of genomic loci, diseases, or biological systems are generally beyond the scope of NHGRI.

Examples of research of interest to NHGRI include, but are not limited to:

• Synthetic genomic tools and approaches for genome-wide study of genome organization and function.
• High-throughput approaches utilizing synthetic tools and devices for functional genomic analysis.
• Novel methods and tools for the design and synthesis of nucleic acid molecules with defined sequences.

Applicants interested in synthesis of nucleic acids should also see RFA-HG-20-014, Novel Synthetic Nucleic Acid Technology Development, which is focused on novel technologies and instrumentation to improve the development of synthetic constructs and synthetic nucleic acid capabilities.

A complete list of NHGRI supported research domains can be found at: https://www.genome.gov/research-funding.

NHGRI will not accept applications in response to this NOSI that propose a clinical trial.

NIA Statement of Interest

The National institute on Aging (NIA) supports multiple portfolios on diverse aspects of aging, from social and behavioral research to the basic biology of aging, encompassing epidemiological, clinical, translational, behavioral, neurobiological and basic studies. This includes support for the development and application of novel enabling technologies in a broad range of aging research. In joining this NOSI, NIA encourages multidisciplinary collaborations between synthetic biologists and investigators from all aspects of aging research to develop novel synthetic biological tools and approaches.

Areas of interest to NIA include, but are not limited to:

• Develop biosynthetic reporters of the hallmarks of aging for laboratory animals or for lab animal and human-derived organoid and cell culture systems.
• Develop tools and technologies to control and reprogram aging systems for accelerated or delayed aging.
• Apply synthetic biology approaches for the development of biomedical technologies to track geroscience-based interventions in preclinical studies.
• Develop synthetic biology tools and technologies applicable to multiple morbidities in aging populations.
• Apply synthetic biology approaches for re-programming and re-wiring the aging and/or diseased neural systems.

NIAID Statement of Interest

The NIAID mission is to conduct and support basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. NIAID has a unique mandate, which requires the Institute to respond to emerging public health threats. Synthetic biology technology represents a foundation to improve our ability to prevent, diagnose, and treat infectious and immune-mediated diseases and to better understand complex host immune responses to such diseases. NIAID encourages collaboration between synthetic biologists and infectious disease scientists and/or immunologists for either basic or translational applications.

Examples of research of interest to NIAID include, but are not limited to:

• Basic research including novel cell, tissue, and animal-based model systems to better understand the complexities of infectious disease and immune disorders, and/ or immune responses in such diseases/disorders
• Tools and technologies to facilitate design and development of novel sensors, therapeutics, antibodies, or vaccine approaches to overcome roadblocks in infectious disease diagnosis, prevention, treatment and eradication/cure
• Translational and clinical studies for precise detection, targeting and treatment of a wide range of infectious and immunological diseases, including remodeling of the disease microenvironment

NIBIB Statement of Interest

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is interested in projects focused on the development of modular platform technologies to enable a new paradigm of biomedical intervention. Through this FOA, the NIBIB seeks applications with a particular emphasis on technologies to enable synthetic biology approaches or that are driven by synthetic biology approaches.

Examples of research of interest to NIBIB include, but are not limited to:

• Engineered biological circuits for implementing regulation and decision-making strategies in biological and biomimetic systems
• Engineered cells and tissues for therapeutic and diagnostic applications
• Sensors, processors, actuators, and other modules for biological control
• Biosensor assays for analyte detection and contrast agents and probes for imaging

A complete list of programmatic interests in NIBIB can be found at:https://www.nibib.nih.gov/research-funding.

Furthermore, the NIBIB mission does not include the development of new technologies to address basic research questions in cellular processes, functions, and structure. For research leading to the development of such technologies, applicants should consult the National Institute of General Medical Sciences (NIGMS).

NOTE: For applications submitted to this NOSI that propose clinical trials, 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 the early stage technology development in the submitted application. 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.

NICHD Statement of Interest

NICHD is interested in projects that focus on understanding the biological processes that control typical and atypical embryonic development, and the cellular, morphological, and molecular mechanisms that underlie susceptibilities and causes of structural birth defects.

Research topics that are of interest to NICHD that fall within the scope of this NOSI include, but are not limited to:

• Construction and utilization of transgenic synthetic biology tools and approaches in animal model systems for the systematic and quantitative study of embryonic developmental processes such as:
  • Tools for functional validation of principles of gene regulatory network architectures in animal models
  • Tools for durable, persistent, tunable gene expression and gene regulatory network activity for the study of embryonic developmental processes in whole animals
  • Synthetic gene regulatory networks that model and simulate stage- and tissue-specific developmental processes and allow for engineering of cell fate commitment and differentiation
  • In vivo lineage tracing and/or engineering tools, such as circuit-based memory switches and recorders of transient events experienced by a cell during lineage specification
• Engineered animal and human pluripotent cells and organoids to advance birth defects research
• Synthetic biology tools for in vivo measurement of biophysical parameters critical for embryonic morphogenesis
• Synthetic biology tools to advance research on endogenous tissue regeneration
• Utilization of synthetic biology approaches and tools to develop diagnostic, prognostic, predictive, or therapeutic synthetic biomarkers for use in populations and conditions of interest to the NICHD
• Generation of synthetic biology constructs to deliver therapeutic payloads to targeted tissue niches or cell types for the treatment of a condition of interest to the NICHD

NIGMS Statement of Interest

The National Institute of General Medical Sciences (NIGMS) supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS welcomes applications that fall within its mission to address fundamental research questions. NIGMS encourages technologies and approaches related to synthetic biology that include, but are not limited to:

• establishing in vivo or cell-free means of producing useful biological materials for discovery, development, or manufacture (e.g., natural products)
• producing models for the characterization and testing of complex cellular and metabolic processes (e.g., the microbiome)
• development of safer, more effective, targeted early stage delivery strategies, including the synthetic readout and control systems for controlled release of molecules of interest
• synthetic reporter systems for single cell level genotype-phenotype characterization
• genome-editing tools for the reliable and reproducible construction of synthetic control networks
• transforming basic and applied biomedical research into new technologies (e.g., biosensors)

The Institute places great emphasis on supporting investigator-initiated research grants. For this NOSI, NIGMS will not accept applications that include research which meets the NIH definition of a clinical trial.

Application and Submission Information

Applicants must select the IC and associated FOA to use for submission of an application in response to this NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative. In addition, applicants using NIH Parent Announcements (listed below) will be assigned to those ICs on this NOSI that have indicated those FOAs are acceptable and based on usual application-IC assignment practices.

This notice applies to due dates on or after January 19, 2021 and subsequent receipt dates through January 18, 2024.

Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice.

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

• For this NOSI, NIGMS will not accept applications that include research which meet the NIH definition of a clinical trial nor applications to PA-20-183.
• For funding consideration, applicants must include NOT-EB-20-017 (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.

Applicants planning to submit an application in response to this NOSI are strongly encouraged to contact and discuss their proposed research/aims with an NIH Program Officer listed on this NOSI well in advance of the grant receipt date.

Inquiries

Please direct all inquiries to:

Scientific/Research Contact(s):

Hye-Sook Kim, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-496-5825
Email:[email protected]

Jiayin (Jerry) Li, M.D., Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6210
Email:[email protected]

Solita Chiayeng Wang, Ph.D.
National Cancer Institute (NCI)
Telephone: 240-276-6624
E-mail: [email protected]

Stephanie A. Morris, Ph.D.
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-5738
Email: [email protected]

Ronald Kohanski, Ph.D.
National Institute on Aging (NIA)
Telephone: 301-496-6402
Email: [email protected]

Reed Shabman, Ph.D.
Division of Microbiology and Infectious Diseases (DMID)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 301-761-6433
Email: [email protected]

Brigitte Sanders, DVM, PhD
Division of AIDS (DAIDS)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3209
Email: [email protected]

Conrad Mallia, Ph.D.
Division of Allergy, Immunology, and Transplantation (DAIT)
National Institute of Allergy and Infectious Diseases (NIAID)
Telephone: 240-627-3491
Email:[email protected]

Jermont Chen, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 240-552-0939
Email:[email protected]

Tuba Fehr, Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-7030
Email: [email protected]

Michelle R. Bond, Ph.D.
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Peer Review Contact(s):

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s):

Shelley Carow
National Center for Complementary and Integrative Health (NCCIH)
Telephone:301-594-3788
Email: [email protected]

Amy Bartosch
National Cancer Institute (NCI)
Telephone: 240-276-6375
Email: [email protected]

Deanna L. Ingersoll
National Human Genome Research Institute (NHGRI)
Telephone: 301-435-7858
E-mail: [email protected]

Eva Lawson-Lipchin
Grants and Contracts Management Branch
National Institute on Aging (NIA)
Telephone: 301-435-2020
Email: [email protected]

Ruthann McAndrew
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-496-8521
Email: [email protected]

Bryan S. Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: [email protected]