Notice Number: NOT-RM-15-010

Key Dates
Release Date: April 2, 2015
Response Date: April 30, 2015

Issued by
Office of Strategic Coordination (Common Fund)

Purpose

The National Institutes of Health (NIH) is seeking input on SPARC-relevant data. SPARC (Stimulating Peripheral Activity to Relieve Conditions) (http://commonfund.nih.gov/sparc/index) is a new program to deliver detailed, integrated functional and anatomical neural circuit maps in multiple organ systems. These maps will be directly leveraged to develop and pilot novel electrode designs, with corresponding stimulation protocols and minimally invasive surgical procedures, to improve existing neuromodulation therapies or pursue new indications. SPARC will provide the scientific foundation required to catalyze the development of new and/or more efficacious therapies utilizing closed-loop neuromodulation to modulate end-organ system function. This will be accomplished primarily by generating detailed functional maps of end-organ systems in appropriate animal models, while validating the relevance of these maps for human translation. The NIH is interested in understanding how cellular and tissue based responses form the underlying mechanisms of neural control networks. SPARC is primarily focused on autonomic nervous system control of, and sensory feedback from, internal organs, but interests may extend beyond these to other organs that show promise for development of neuromodulation therapies.

Pending the availability of funds, SPARC is being implemented in FY 2015 by the NIH Common Fund which supports cross-cutting programs that are expected to have exceptionally high impact. The SPARC program is a high-risk, goal-driven endeavor to provide insights into the neural control of organ function, and lay the foundation for development of neural control devices to precisely treat a wide variety of diseases and conditions.

NIH seeks input from the biomedical research community, potential biotechnology and pharmaceutical company partners, and other members of the public on this new program. Through the SPARC program, the NIH tentatively plans to support interdisciplinary teams of investigators to deliver neural circuit maps of several organ systems, novel electrode designs, minimally invasive surgical procedures, and stimulation protocols. Driven by end goals of improving existing and developing new neuromodulation therapies, the program will be iterative and dynamic, with the novel technologies informing mapping efforts, and the mapping results defining new technology requirements.

Current plans for SPARC include potential initiatives to:

• Deliver detailed, integrated functional/anatomical neural circuit maps in multiple organs or organ systems for understanding the underlying mechanisms of control; develop/pilot novel electrode designs, surgical procedures, and stimulation protocols leveraging insights from the functional maps (see NOT-RM-14-016 for details).
• Develop next-generation technology for stimulating and recording of visceral nerves and tissues, e.g., optogenetics, stimulating/recording electrodes, cell-type specific tracing (see NOT-RM-14-017 for details). The SPARC program is currently soliciting applications to develop new and/or enhance existing tools and technologies tailored to elucidate the neurobiology and neurophysiology underlying autonomic control of internal organs in health or disease, to inform next generation neuromodulation therapies (see RFA-RM-15-002 for details).
• Partner with industry and FDA to explore utility of existing, approved devices to address new, small-market indications (see NOT-RM-14-015 for details).
• Assemble data from all SPARC initiatives into a coordinated data resource, develop user-friendly computational tools, and incorporate new computer modeling methods (subject of this current RFI).

This RFI, in conjunction with the SPARC Strategic Planning: Biology & Technology Workshop held February 25 and 26, 2015, is intended to gather information and may lead to a subsequent funding opportunity announcement; however, this RFI should not be construed as a funding opportunity. Additional information, including current and future funding announcements for SPARC, can be found at:  http://commonfund.nih.gov/sparc/index).

Information Requested

This RFI invites input from the scientific community, potential industry partners, and other members of the public on all aspects of the program. Small businesses with appropriate technologies are especially encouraged to provide input. Please provide perspectives, pertinent references (and hyperlinks if referencing databases/repositories), as well as names of key experts related to any of the following topics, though your comments are not limited to these topics:

• Biology Perspectives
  • Any existing biological datasets that will be valuable/informative for the SPARC program.
  • Theories and constructs for anatomical maps, computational models, methodological tools, and statistical inferences within the autonomic nervous system.
  • Data processing and data interoperability hurdles for generating anatomic maps to elucidate the neurobiology and neurophysiology underlying autonomic control of internal organs in health or disease.
  • Informatics tools that may enhance the ability to improve understanding of the biology and the mapping of the peripheral nervous system.
  • Translating non-SPARC-based data analysis tools to SPARC-focused biological research.
  • Capabilities necessary for data sharing on neuroanatomy and neuromodulation of organ function.
  • Technology data needs for developing the mapping of the PNS and relevant aspects of the CNS.
  • Technology data needs for defining target areas in neuromodulation in the PNS and the end organs supplied by the PNS.
  • Data acquisition and metadata capabilities needed to develop anatomical and functional maps of the PNS.
  • Existence and/or value of comparative datasets that deal with animal models and human data.
  • Examples of physiology of nerve and organ function and the types of data and metadata currently existing or required in neuroanatomy of organ function.

• Technology Perspectives
  • Existing datasets of legacy technologies for neurophysiological studies and neuromodulation.
  • Computational models and benchmarked parameters to drive the design of tools tailored for specific neurophysiological studies.
  • Data processing and interoperability hurdles for tools being developed to study neuroanatomy or neuromodulation of organ function.
  • Informatics tools (and gaps) for enhancing the development of technologies for studying neuroanatomy, neural control, and neuromodulation of organ function.
  • Translating non-SPARC-based data analysis tools to SPARC-focused technology development.
  • Capabilities necessary for data sharing on technologies for mapping neuroanatomy, and neuromodulation of organ function.
  • Keeping track of failures and one-off successes for neuromodulation approaches.
  • Biological data needs for non-invasive or invasive, electrical or non-electrical approaches to neuromodulation and mapping of peripheral nervous system.
  • Safeguards necessary to encourage sharing of data on one-off, proof-of-concept, and/or failed neuromodulation treatment technologies.

• Data Informatics Perspectives
  • Current knowledgebase of common data elements (CDE) and data schema in the various organ systems and technologies within the purview of the SPARC.
  • Ontology and provenance tools development within the organs and organ systems that comprise the SPARC initiative. These include neural input / output, functional or biomarker measurements describing the organ systems, etc.
  • Types of user-friendly computational tools that can enable a healthy exchange of research results within a coordinated data enterprise and encourage the development of teams-based, hypothesis-driven ideas.
  • Data coordination and standardization efforts that currently exist for these organs and organ systems, and issues related to such efforts.
  • Protocols that can be shared and/or can be standardized for mapping neuroanatomy and neuromodulation.
  • Data informatics tools and resources for ensuring measurement and data reproducibility of neuroanatomy mapping and neuromodulation in the context of SPARC.
  • Big data informatics approaches that can be used to manage and analyze SPARC data.

How to Submit a Response

To ensure consideration, responses must be received by April 30, 2015, and must be submitted to [email protected]. NIH will provide automated confirmation of response submission, but respondents will not receive individualized feedback.

Responses to this RFI are voluntary and may be submitted anonymously. Please do not include any personally identifiable or other information that you do not wish to make public. Proprietary, classified, confidential or sensitive information should not be included in your response. Comments may be compiled for discussion and may appear in related reports. Any personal identifiers (names, e-mail addresses, etc.) will be removed when responses are compiled.

This RFI is for informational and planning purposes only and should not be construed as a solicitation or as an obligation on the part of the United States (US) Government to provide support for any ideas submitted in response to it. Please note that the US Government will not pay for the preparation of any information submitted, or for its use of that information.

References:
1. Birmingham, K., et al., Bioelectronics Medicine: a research roadmap. Nature 13: 399-400, 2014.

Inquiries

Please direct all inquiries to:

Vinay M. Pai, Ph.D.
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4781
Email: [email protected]