Notice of Intent to Publish a Funding Opportunity Announcement for Analytical and Clinical Validation of Biomarkers, Biomarker Signatures, and Endpoints for Pain Indications (R61/R33)

Notice Number:NOT-NS-18-074

Key Dates

Release Date: July 23, 2018
Estimated Publication Date of Funding Opportunity Announcement: 09/12/2018
First Estimated Application Due Date: 11/14/2018
Earliest Estimated Award Date: 06/01/2019
Earliest Estimated Start Date: 07/01/2019

Related Announcements
None

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The NINDS, with other NIH Institutes and Centers participating in the HEAL (Helping to End Addiction Long-term) Initiative, intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for research on the analytical and clinical validation of biomarkers, biomarker signatures, and endpoints for pain indications. The goal of this FOA will be to support the analytical and clinical validation of candidate biomarkers for use in the discovery and development of non-opiate alternatives to the treatment of pain conditions using retrospective and/or prospective methods. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) assay technology has already been developed, and 3) a working hypothesis regarding context of use is in place.

Public Law 115-141, the Consolidated Appropriations Act of 2018 (signed March 23, 2018) includes a requirement that grantees from for-profit applicant organizations must provide a 50% match and/or in-kind contribution of all federally awarded dollars under the grant award (direct costs, as well as facilities and administrative costs) for research related to opioid addiction, development of opioid alternatives, pain management and addiction treatment.

Matching Requirement: A grantee from a for-profit organization funded under this funding opportunity announcement must match funds or provide documented in-kind contributions at a rate of not less than 50% of the total-Federally awarded amount, as stipulated by Public Law 115-141, the Consolidated Appropriations Act of 2018.The applicant will be required to demonstrate that matching funds and/or in-kind contributions are committed or available at the time of, and for the duration of, the award. Applications must identify the source and amount of funds proposed to meet the matching requirement and how the value for in-kind contributions was determined. All matching funds and/or in-kind contributions must be used for the portion of allowable project costs not paid by Federal funds under the grant award.  NIH will not be the recipient, nor serve as a pass-through entity, of any such matching funds and/or in-kind contributions required under this announcement.  See 45 CFR 75.306 for additional details.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

This FOA is expected to be published in September 2018 with an expected application due date in November 2018.

This FOA will utilize the bi-phasic, milestone driven R61/R33 mechanism. Details of the planned FOA are provided below.

Research Initiative Details

This Notice encourages investigators with expertise and insights on biomarkers and endpoints for specific pain indications to begin to consider applying for this new FOA.

This FOA will support rigorous analytical and clinical validation of promising candidate biomarkers for pain indications to provide the tools necessary for the development of non-opiate therapeutics for the treatment of pain conditions.

A biomarker is a defined characteristic that is measured as an indicator of normal biological processes, pathogenic processes or responses to an exposure or intervention, including therapeutic interventions.  Biomarker modalities are diverse, and can include genetic, protein, cellular, metabolomic, imaging and physiologic endpoints.

An endpoint is an outcome or event used to objectively measure the effect of a therapeutic or other intervention being studied.  A precise definition of an endpoint typically specifies the type of assessments made, the timing of those assessments, the assessment tools used, and possibly other details, as applicable, such as how multiple assessments within an individual are to be combined.

The scope of this FOA does not include discovery, which will be supported through another funding opportunity announcement supporting the Discovery of Biomarkers, Biomarker Signatures, and Endpoints for Pain Indications, which will be published shortly.  

Rather, this FOA supports the Validation Phase of biomarker and endpoint development, where analytical validation of the assay or detection technology is completed, along with increasingly rigorous clinical validation. The degree of evidence required to provide the necessary confidence in biomarker or endpoint validation depends upon the context of use for the biomarker or endpoint. As the context of use moves from research to accepted utility in clinical practice (i.e., as a diagnostic or predictor of therapeutic response), the required degree of validation evidence is increased and must include prospective, multi-site validation data.

Multidisciplinary collaboration among scientific investigators, assay developers, clinicians, bioinformatics and statistical experts, consultants, and clinical laboratory staff must be an integral part of the application, and investigators with such expertise should also begin considering applying for this FOA. Projects proposed for this FOA will also utilize multi-site design as applicable, and standardized data stewardship to ensure that data is reusable and accessible.

Funding Information

Estimated Total Funding TBD
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers 93.853

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)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Mary Ann Pelleymounter, PhD.
National Institute of Neurological Disorders and Stroke
301-451-4551
mary.pelleymounter@nih.gov