Notice of Special Interest of NCCIH in PAR-22-097/098, "Global Brain and Nervous System Disorders Research Across the Lifespan (R01/R21 Clinical Trial Optional)
Notice Number:
NOT-AT-24-001

Key Dates

Release Date:

March 28, 2023

First Available Due Date:
November 15, 2023
Expiration Date:
December 10, 2024

Related Announcements

PAR-22-097 - “Global Brain and Nervous System Disorders Research Across the Lifespan

PAR-22-098 - “Global Brain and Nervous System Disorders Research Across the Lifespan”

Issued by

National Center for Complementary and Integrative Health (NCCIH)

Purpose

Purpose

The purpose of this NOSI is to inform potential applicants of the National Center for Complementary and Integrative Health's (NCCIH) participation, effective immediately, in PAR-22-097Global Brain and Nervous System Disorders Research Across the Lifespan” and companion notice of funding opportunity   PAR-22-098 “Global Brain and Nervous System Disorders Research Across the Lifespan” NCCIH will not support a clinical trial through this announcement.  

NCCIH-specific Program Considerations

The National Center for Complementary and Integrative Health (NCCIH) is interested in supporting basic, mechanistic and translational research on natural products and their therapeutic potential to treat nervous system disorders, in particular with relevance to pain management through the Global Brain Program.

The chemical space occupied by metabolites derived from a variety of natural products, such as terrestrial plants, marine, animal and microbial taxa, continues to be an effective source of novel bioactive agents, particularly when developed in conjunction with combinatorial chemistry and cutting-edge high throughput screening.  Integrating novel chemical space with increasingly complex multi-omics and biological signature data has become possible due to recent advances in spectroscopic instrumentation coupled with network-based computational approaches.  Global biodiversity hotspots represent a rich source for therapeutics benefiting from such novel chemical space. Therefore, leveraging natural products from biodiverse sources holds great promise for the development of new lines of therapeutic agents.

NCCIH’s interests in PAR-22-097 and PAR-22-098 aim to support collaborative investigative teams to explore and identify natural products across the globe with potential for treating a variety of brain or nervous system disorders, such as pain, and investigate their underlying mechanisms of action.

Given the global focus of this funding opportunity, work conducted in biodiversity hotspots is expected to promote conservation and bio-resource planning. Proposed organism collection must have a local Access and Benefit Sharing agreement in place prior to an award and be consistent with guidelines set forth in the U.N. Convention on Biological Diversity and Bonn Guidelines on Access  to Genetic Resources and Fair and Equitable Sharing of the Benefits Arising out of their Utilization. Applicants are encouraged to work with existing natural product libraries (https://www.nccih.nih.gov/grants/natural-product-libraries) in addition to the low- and middle-income country (LMIC)  to synergize extract availability, ensure public availability of voucher specimens in the LMIC and U.S. partnering institution, and build on prior local Access and Benefit Sharing agreements, if available. All benefit sharing agreements need be approved by NIH program staff and legal points of contact before work begins to ensure an appropriate balance of proprietary, collaborative and public needs. It is strongly recommended that all parties to agreements have separate, competent legal counsel to represent their interests. LMIC institutions that do not have access to appropriate counsel may consider contacting Public Interest Intellectual Property Advisors (PIIPA: http://www.piipa.org/) for assistance. Spectroscopic and genomic data are expected to be deposited in appropriate databases, in particular the Natural Products Magnetic Resonance Database NP-MRD, consistent with the NIH Data Management and Sharing Policy

Applicants are strongly encouraged to consult with the NCCIH Scientific Research staff contact prior to developing and submitting an application.

Applications considered nonresponsive or out of NCCIH Scope:

  • Studies of macronutrients or micronutrients for nutritional benefits.
  • Studies proposing to focus on synthetic derivatization of a natural product lead compound previously isolated.
  • Studies of disease mechanism
  • Investigational New Drug (IND) enabling studies. 
  • Manufacture of therapeutic agents for clinical use or development of bioassays for clinical use.
  • Applications related to chemotherapy or cancer related pain conditions.

Application and Submission Information

This notice applies to due dates on or after November 15, 2023 and subsequent receipt dates through December 10, 2024. 

Applications submitted for this initiative should use the following notice of funding opportunity (NOFO) or any reissues of this announcement through the expiration date of this notice.

  • PAR-22-097 - "Global Brain and Nervous System Disorders Research Across the Lifespan (R01/R21 Clinical Trial Optional)”
  • PAR-22-098 - “Global Brain and Nervous System Disorders Research Across the Lifespan (R21 Clinical Trial Optional)”

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

  • For funding consideration, applicants must include “NOT-AT-24-001” (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.

Although NCCIH is not listed as a Participating Organization in all the NOFOs listed above, applications for this initiative will be accepted.

Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed notice of funding opportunity with the following additions/substitutions:

Scientific/Research Contact(s)

For general inquiries or studies related to this NOSI, please contact:

Patrick Still, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Telephone: 301-682-1895
Email: patrick.still@nih.gov