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PAR-18-548 Clinical Validation of a Candidate Biomarker for Neurological Disease (U44 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to encourage applications from Small Business Concerns (SBCs) to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond). 

Application Due Dates: February 14, 2020; and July 20, 2020, by 5:00 PM local time of applicant organization.
*** Note new SBIR/STTR Standard Due Dates. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

AIDS Application Due Dates: May 7, 2020 ; and September 7, 2020, by 5:00 PM local time of applicant organization.
*** Note new SBIR/STTR Standard Due Dates.  SBIR/STTR Applications due on Standard Due dates will no longer be accepted on AIDS Due dates unless otherwise indicated.

PAR-18-549 Analytical Validation of a Candidate Biomarker for Neurological Disease (U44 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to support applications from Small Business Concerns (SBCs) to perform rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines.  Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.  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.  The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond).

Application Due Dates: February 14, 2020; and July 20, 2020, by 5:00 PM local time of applicant organization.
*** Note new SBIR/STTR Standard Due Dates. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

AIDS Application Due Dates: May 7, 2019; and September 7, 2020, by 5:00 PM local time of applicant organization.
*** Note new SBIR/STTR Standard Due Dates.  SBIR/STTR Applications due on Standard Due dates will no longer be accepted on AIDS Due dates unless otherwise indicated.

PAR-18-550 Analytical Validation of a Candidate Biomarker for Neurological Disease (U01 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous analytical validation of candidate biomarker measures or endpoints in a manner that is consistent with FDA guidelines.  Analytical validation establishes that the performance characteristics of the biomarker measurement or endpoint are acceptable for its intended use.  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.  The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond).

Application Due Dates: February 14, 2020; and July 20, 2020, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

AIDS Application Due Dates: May 7, 2019; and September 7, 2020, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

PAR-18-664 Clinical Validation of a Candidate Biomarker for Neurological Disease (U01 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to support rigorous clinical validation of a candidate biomarker using retrospective and/or prospective methods in a manner that is consistent with the purpose of the biomarker. This FOA assumes that: 1) a candidate biomarker has already been identified, 2) an analytical method has been developed and validated that is consistent with the purpose of the biomarker and 3) a working hypothesis regarding context of use is in place. The goal of this FOA is to facilitate the advancement of robust and reliable biomarkers of diseases that fall within the mission of NINDS to application in clinical trials and practice (Phase II clinical trials and beyond).

Application Due Dates: February 14, 2020; and July 20, 2020 , by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on these dates.

AIDS Application Due Dates: May 7, 2020; and September 7, 2020, by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on these dates.

 

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

 

Expiration Date: September 8, 2020

Non Pain