Opportunity ID: 350827

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-23-314
Funding Opportunity Title: Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.394 — Cancer Detection and Diagnosis Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Nov 01, 2023
Last Updated Date: Oct 15, 2024
Original Closing Date for Applications: Oct 14, 2026
Current Closing Date for Applications: Oct 15, 2025
Archive Date: Nov 14, 2025
Estimated Total Program Funding:
Award Ceiling: $250,000
Award Floor:

Eligibility

Eligible Applicants: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
City or township governments
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
For profit organizations other than small businesses
Private institutions of higher education
Public housing authorities/Indian housing authorities
County governments
Independent school districts
Small businesses
State governments
Public and State controlled institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Native American tribal governments (Federally recognized)
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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name: National Institutes of Health
Description:

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and validation of molecular/cellular/imaging markers (referred to as “markers” or “biomarkers”) and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously.The UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays.

Link to Additional Information: https://grants.nih.gov/grants/guide/pa-files/PAR-23-314.html
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH Grants Information

grantsinfo@nih.gov
Email:grantsinfo@nih.gov

Version History

Version Modification Description Updated Date
expired and re-issued as PAR-25-075 Oct 15, 2024
Nov 01, 2023

DISPLAYING: Synopsis 2

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-23-314
Funding Opportunity Title: Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.394 — Cancer Detection and Diagnosis Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 2
Posted Date: Nov 01, 2023
Last Updated Date: Oct 15, 2024
Original Closing Date for Applications: Oct 14, 2026
Current Closing Date for Applications: Oct 15, 2025
Archive Date: Nov 14, 2025
Estimated Total Program Funding:
Award Ceiling: $250,000
Award Floor:

Eligibility

Eligible Applicants: Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Special district governments
City or township governments
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
For profit organizations other than small businesses
Private institutions of higher education
Public housing authorities/Indian housing authorities
County governments
Independent school districts
Small businesses
State governments
Public and State controlled institutions of higher education
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Native American tribal governments (Federally recognized)
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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name: National Institutes of Health
Description:

Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and validation of molecular/cellular/imaging markers (referred to as “markers” or “biomarkers”) and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously.The UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays.

Link to Additional Information: https://grants.nih.gov/grants/guide/pa-files/PAR-23-314.html
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH Grants Information

grantsinfo@nih.gov
Email:grantsinfo@nih.gov

DISPLAYING: Synopsis 1

General Information

Document Type: Grants Notice
Funding Opportunity Number: PAR-23-314
Funding Opportunity Title: Assay Validation of High Quality Markers for Clinical Studies in Cancer (UH3 Clinical Trials Not Allowed)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Education
Health
Category Explanation:
Expected Number of Awards:
Assistance Listings: 93.394 — Cancer Detection and Diagnosis Research
Cost Sharing or Matching Requirement: No
Version: Synopsis 1
Posted Date: Nov 01, 2023
Last Updated Date: Nov 01, 2023
Original Closing Date for Applications:
Current Closing Date for Applications: Oct 14, 2026
Archive Date: Nov 19, 2026
Estimated Total Program Funding:
Award Ceiling: $250,000
Award Floor:

Eligibility

Eligible Applicants: Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Small businesses
Special district governments
County governments
Independent school districts
Native American tribal organizations (other than Federally recognized tribal governments)
Public housing authorities/Indian housing authorities
Others (see text field entitled “Additional Information on Eligibility” for clarification)
State governments
Private institutions of higher education
For profit organizations other than small businesses
City or township 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
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; Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Additional Information

Agency Name: National Institutes of Health
Description: Through this Notice of Funding Opportunity (NOFO), the National Cancer Institute (NCI) intends to accelerate the adoption and validation of molecular/cellular/imaging markers (referred to as “markers” or “biomarkers”) and assays for cancer detection, diagnosis, prognosis, monitoring, and prediction of response or resistance to treatment, as well as markers for cancer prevention and control. This NOFO will also support the validation of pharmacodynamic markers and markers of toxicity. Applicants to this NOFO must have an assay(s) whose performance has been analytically validated in specimens similar to those for the intended clinical use of the marker(s) and assay(s). As chemotherapies and/or radiation therapies are increasingly combined with immunotherapies to enhance the durability of anti-cancer responses, assays for measuring multiple markers, including immune markers, can be developed and validated simultaneously.
The UH3 mechanism will support the clinical validation of established assays for up to 3 years using specimens from retrospective or prospective clinical trials or studies. This NOFO may be used to validate existing assays for use in other trials, observational studies, or population studies. Efforts to harmonize clinical laboratory tests, including investigation into the performance and reproducibility of assays across multiple clinical laboratories, are also appropriate for this funding opportunity. Projects proposed for this NOFO will require multi-disciplinary interaction and collaboration among scientific investigators, oncologists, statisticians, and clinical laboratory scientists. This NOFO is not intended to support early-stage development of technology or the conduct of clinical trials but is intended for validation of assays to the point where they could be integrated into clinical trials/studies as investigational assays.
Link to Additional Information: https://grants.nih.gov/grants/guide/pa-files/PAR-23-314.html
Grantor Contact Information: If you have difficulty accessing the full announcement electronically, please contact:

NIH Grants Information
grantsinfo@nih.gov
Email:grantsinfo@nih.gov

Folder 350827 Full Announcement-PAR-23-314 -> PAR-23-314-Full-Announcement.pdf

Packages

Agency Contact Information: NIH Grants Information
grantsinfo@nih.gov
Email: grantsinfo@nih.gov
Who Can Apply: Organization Applicants

Assistance Listing Number Competition ID Competition Title Opportunity Package ID Opening Date Closing Date Actions
FORMS-H Use for due dates on or after January 25, 2023 PKG00283676 Jan 19, 2024 Oct 16, 2024 View

Package 1

Mandatory forms

350827 RR_SF424_5_0-5.0.pdf

350827 PHS398_CoverPageSupplement_5_0-5.0.pdf

350827 RR_OtherProjectInfo_1_4-1.4.pdf

350827 PerformanceSite_4_0-4.0.pdf

350827 RR_KeyPersonExpanded_4_0-4.0.pdf

350827 RR_Budget_3_0-3.0.pdf

350827 PHS398_ResearchPlan_5_0-5.0.pdf

350827 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf

Optional forms

350827 RR_SubawardBudget30_3_0-3.0.pdf

350827 PHS_AssignmentRequestForm_3_0-3.0.pdf

2025-07-11T13:47:19-05:00

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