Notice of Intent to Publish a Funding Opportunity Announcement for SPARC Clinical Studies of Peripheral and Spinal Neuromodulation Devices to Support New Indications and Human Functional Mapping (OT2 Clinical Trial Required)

Notice Number: NOT-RM-18-012

Key Dates

Release Date: March 2, 2018
Estimated Publication Date of Funding Opportunity Announcement: 04/27/2018
First Estimated Application Due Date: 06/28/2018
Earliest Estimated Award Date: 09/27/2018
Earliest Estimated Start Date: 09/27/2018

Related Announcements
NOT-RM-18-019

Issued by
Office of Strategic Coordination (Common Fund)

Purpose

The Office of Strategic Coordination (Common Fund) intends to publish a funding opportunity (FO) to solicit applications for a new initiative of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) program. This initiative is intended to support small clinical studies (e.g. Early Feasibility Studies) involving device-based neuromodulation, targeting peripheral nerves or the spinal cord to produce a therapeutic effect for diseases and conditions involving internal organs/functions (excluding the brain, sensory structures of the head, and voluntary muscles). Supported studies will be designed both to assess the safety and efficacy of neuromodulatory interventions and to collect additional physiology data to inform functional mapping.
 
This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and appropriate projects.

The funding opportunity is expected to be published in April 2018 with an expected application due date in June 2018. Applicant organizations may submit more than one application, provided each application proposes a distinct clinical study.

Awards under this funding opportunity will be issued as Other Transaction Agreements (OT2), which are not grants, contracts or cooperative agreements. Other Transactions awards will involve active NIH program management as described in the NIH Other Transaction Award Policy Guide for the SPARC Program. Furthermore, the OT funding mechanism provides SPARC with the flexibility to design unique collaborations with private sector entities that may not have experience with commonly used assistance mechanisms such as grants and cooperative agreements.

Research Initiative Details

The funding opportunity is associated with SPARC3, the SPARC initiative supporting translational partnerships among government, industry, researchers and other potential partners to produce proofs of concept for new nerve stimulation indications and to study functional neuromodulation in the context of human clinical studies. Prior funding opportunities under this initiative (RM-16-009 and RM-16-027) have supported pre-clinical studies of safety and efficacy of neuromodulation devices in animal models. The forthcoming funding opportunity represents a transition to the next phase of the initiative, supporting device-based nerve or spinal stimulation studies in human adults that are intended to provide proof of principle and initial clinical safety data and, in addition, to obtain functional data beyond the endpoints supporting short-term regulatory milestones. The clinical study is expected to provide information that cannot be practically obtained through additional non-clinical assessments.
 
Applications solicited under this funding opportunity will be expected to be managed by interdisciplinary teams that possess the necessary clinical, surgical, research design, and device engineering expertise. Interested commercial stakeholders may be involved either as collaborators on academic investigator-initiated applications or as direct leads. SPARC program provides template agreement documents (Collaborative Research AgreementConfidential Disclosure Agreement) to help facilitate formation of collaborations between academia and industry.
 
Successful applications will incorporate physiological data collection beyond the primary clinical endpoints to enhance functional understanding of the proposed intervention or other relevant anatomy and physiology. Such data collection may include various invasive or non-invasive measurements of neural activity or biomarkers for end-organ function. Applicants may consider taking advantage of acute or short-term procedures (e.g. implantation or pulse generator replacement surgeries) to collect human data that would be difficult to obtain chronically (e.g. long-term nerve recording). To increase the value of such data for the SPARC program, prospective applicants are encouraged to contact existing SPARC awardees involved in mapping efforts to identify the kinds of human data that would inform ongoing functional studies in animal models.
 
Clinical studies to be supported can be either IRB-approved Non-Significant Risk studies or Significant Risk studies requiring an Investigational Device Exemption (IDE) from the FDA. Necessary approvals to conduct a clinical study need to be obtained either prior to study initiation or within the first year (pre-clinical testing will not be supported in this funding opportunity). Applicants may be expected to show evidence that study design has been discussed with the FDA, for example by including feedback from pre-submission meetings or IDE submissions.
 
While general anticipated guidelines are provided above, we strongly encourage contacting SPARC program staff to discuss potential applications.

Funding Information

Estimated Total Funding TBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.310

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
City or township governments
Special district governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Danilo A. Tagle, Ph.D.
National Center for Advancing Translational Sciences
301-594-8064
SPARC_TPNI@mail.nih.gov