Analytical and/or Clinical Validation of a Candidate Biomarker for Pain (R61/R33 Clinical Trial Optional)

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Funding Opportunity ID:309098
Opportunity Number:RFA-NS-18-046
Opportunity Title:Analytical and/or Clinical Validation of a Candidate Biomarker for Pain (R61/R33 Clinical Trial Optional)
Opportunity Category:Discretionary
Opportunity Category Explanation:
Funding Instrument Type:Grant
Category of Funding Activity:Education
Food and Nutrition
Health
Income Security and Social Services
Category Explanation:
CFDA Number(s):93.121
93.213
93.233
93.273
93.279
93.286
93.313
93.361
93.393
93.399
93.837
93.838
93.839
93.840
93.846
93.847
93.853
93.865
93.866
93.867
93.879
Eligible Applicants:State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For profit organizations other than small businesses
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility:Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession.
Agency Code:HHS-NIH11
Agency Name:Department of Health and Human Services
National Institutes of Health
Posted Date:Sep 19, 2018
Close Date:Mar 12, 2020
Last Updated Date:Sep 19, 2018
Award Ceiling:$0
Award Floor:$0
Estimated Total Program Funding:
Expected Number of Awards:
Description:The overarching purpose of this Funding Opportunity Announcement (FOA) is to promote the validation of strong candidate biomarkers and endpoints for pain that can be used to facilitate the development of non-opioid pain therapeutics from discovery through Phase II clinical trials. Specifically, the focus of this FOA is on advanced analytical and clinical validation of pain biomarkers, biomarker signatures, and/or endpoints using retrospective and/or prospective methods. It is assumed 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. Research supported by this FOA will ultimately demonstrate that biomarker or endpoint change is reliably correlated with variables such as clinical outcome, pathophysiologic subsets of pain, therapeutic target engagement or response to a pain therapeutic; in addition, biomarker response will demonstrate specificity to the pain condition or therapeutic as demonstrated at multiple clinical sites. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers, biomarker signatures and endpoints of pain to application in clinical trials (Phase II clinical trials and beyond) and in the spectrum of clinical practice.
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