Key Dates

Related Announcements

PA-20-260 - PHS 2020 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed

PA-20-265 - PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

Issued by

National Center for Complementary and Integrative Health (NCCIH)

Purpose

The purpose of this Notice of Special Interest (NOSI) is to support small businesses for stimulation of technological innovation in natural products research. For the purposes of this NOSI, natural products include prebiotic, probiotic, herbal, botanical, microbial, and animal sources as well as extracts or constituents derived from them. Natural products offer a diverse reservoir of biologically active components. The single chemical entities, as well as their mixtures in natural product extracts, have a long history of use as drugs, drug precursors, and/or complementary health adjuvants. However, methodologies for the identification of bioactive natural products and their mechanism(s) of pharmacological action are often inadequate or too time consuming to be compatible with modern screening platforms. Potentially, many existing biotechnologies could be adapted to improve natural products research. Innovative methods may utilize genomics, bioengineering, bioinformatics, synthetic and molecular biology, and/or nanotechnology. These new and innovative methodologies and technologies should increase the efficiency of research in this field.

Background

Natural products can be essential sources of medicines. In many parts of the world, people still rely on traditional formulas made from natural products as the primary source of medicine. The modern pharmaceutical industry is also dependent on nature, with as many as 50 percent of all drugs based on natural products or derived from a natural product origin. Clearly, natural products offer excellent sources of health-promoting medicines. Thus, it is extremely important that we enhance our capacity to achieve a solid scientific understanding of their potential health benefits.

Nonetheless, substantial problems exist in identifying and understanding natural products and their bioactivity. While the potential for natural products in health and well-being is clear, the challenges that hamper the full utilization of these resources are many, with the greatest hurdle simply being the enormous amounts of time and effort required for characterization of the chemical complexity in these mixtures and the mechanisms by which natural products exert their biological activity. While advances have been made to help overcome these hurdles, there exist many new and innovative untapped technological resources that can improve natural products research methodologies.

Research Objectives

With this NOSI via the omnibus solicitation, NCCIH is proposing to focus on areas that could significantly improve progress in natural products research. This NOSI is intended to help move useful technologies into the commercial marketplace by inviting grant applications from small businesses for further development of such technologies that are relevant to the missions of the sponsoring NIH institutes and centers. The supported research and development will likely include making the tools more robust and easier to use.

Areas of interest include, but are not limited to, those listed below:

• Technologies aimed at the rapid removal of nuisance compounds in the crude extracts of natural products (innovative chromatographic technologies, resins, catch-and-release–type systems, etc.)
• Technologies aimed at the development of highly sensitive phenotypic/high content bioassays including capacity to identify potential synergistic mechanisms (image-based cellular assays, multiple-endpoint analysis based on phenotypic changes, bioengineering chemically sensitive strains, etc.)
• Development of gut microbiome monitoring assays for quantifying their safety and functional host interactions
• Development of novel analytical tools and technologies to study the microbiome, including its composition, genetics, and bioactivity
• Technologies aimed at the creation and exploitation of model systems for the expression of natural product constituents in high-product-yielding hosts (broad spectrum heterologous or homologous expression hosts, stimulation of biosynthetic pathways, mutation, etc.)
• Technologies aimed at predicting and/or quantifying risks of natural product–drug interactions (in vitro interaction assays or kits, in silico technologies, etc.)
• Advanced bioinformatic technologies that can improve upon the accuracy or efficiency of annotating features in complex metabolomic datasets
• Bioinformatic technologies capable of identifying bioactive natural products or their metabolites in complex mixtures without the need for bioactivity-guided isolation.

Topics that are not responsive to this NOSI include:

• Approaches applicable to only one organism, biosynthetic pathway, and/or natural product are of limited scope
• Optimization of large-scale production of specific natural products
• Chemical synthesis of natural products
• Approaches based on collection or storage of natural products for screening

Application and Submission Information

This Notice applies to due dates on or after September 05, 2020 and subsequent receipt dates through September 05, 2023.

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

• PA-20-260- PHS 2020 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed
• PA-20-265-PHS 2020-2 Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Not Allowed)

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 funding consideration, applicants must include “NOT-AT-20-015” (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.

Applications nonresponsive to terms of this NOSI will not be considered for the NOSI initiative.

Inquiries

Scientific/Research Contact(s)

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

Financial/Grants Management Contact(s)

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