The National Institutes of Health is offering this grant to support research mitigating preanalytical variability in biospecimens, crucial for clinical assay development. This funding will investigate how diverse preanalytical conditions—collection, processing, and storage—impact the accurate quantification of emerging, clinically relevant biomarkers. Studies encompass various biospecimen types like tumor tissues, ‘liquid biopsies,’ and bodily fluids. The primary goal is to enhance understanding of these effects across different testing platforms. Ultimately, this grant aims to expedite biomarker clinical assay development via evidence-based standardization of biospecimen handling practices, ensuring more reliable and validated assays.
Opportunity ID: 336237
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-049 |
| Funding Opportunity Title: | Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial 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: | 93.393 — Cancer Cause and Prevention Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Oct 21, 2021 |
| Last Updated Date: | Nov 02, 2021 |
| Original Closing Date for Applications: | Sep 13, 2023 |
| Current Closing Date for Applications: | Sep 13, 2024 |
| Archive Date: | Oct 13, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments For profit organizations other than small businesses Private institutions of higher education Public and State controlled institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments City or township governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Special district governments |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) will support extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies, blood biospecimens utilized as liquid biopsies”, or other biospecimens as described in this FOA. Extramural research funded under this FOA may include investigations of preanalytical variability associated with the procurement and study of small biopsies (core biopsies, small excision samples), blood utilized for “liquid biopsies”, tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, or bodily fluids like sweat, urine, CSF, breast milk and saliva. Investigator-designed experiments will explore how different biospecimen preanalytical conditions affect emerging and clinically relevant biomarkers quantified by a variety of testing platforms. The results from this research program will improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen collection, processing, and storage procedures. The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-049.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
| updated close date as per NOT-CA-22-008 | Nov 02, 2021 | |
| Oct 21, 2021 |
DISPLAYING: Synopsis 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-049 |
| Funding Opportunity Title: | Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial 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: | 93.393 — Cancer Cause and Prevention Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Oct 21, 2021 |
| Last Updated Date: | Nov 02, 2021 |
| Original Closing Date for Applications: | Sep 13, 2023 |
| Current Closing Date for Applications: | Sep 13, 2024 |
| Archive Date: | Oct 13, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Small businesses Native American tribal governments (Federally recognized) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education County governments For profit organizations other than small businesses Private institutions of higher education Public and State controlled institutions of higher education Independent school districts Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) State governments City or township governments Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Special district governments |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
This Funding Opportunity Announcement (FOA) will support extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies, blood biospecimens utilized as liquid biopsies”, or other biospecimens as described in this FOA. Extramural research funded under this FOA may include investigations of preanalytical variability associated with the procurement and study of small biopsies (core biopsies, small excision samples), blood utilized for “liquid biopsies”, tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, or bodily fluids like sweat, urine, CSF, breast milk and saliva. Investigator-designed experiments will explore how different biospecimen preanalytical conditions affect emerging and clinically relevant biomarkers quantified by a variety of testing platforms. The results from this research program will improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen collection, processing, and storage procedures. The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-049.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
DISPLAYING: Synopsis 1
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-22-049 |
| Funding Opportunity Title: | Integrating Biospecimen Science Approaches into Clinical Assay Development (U01 Clinical Trial 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: | 93.393 — Cancer Cause and Prevention Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Oct 21, 2021 |
| Last Updated Date: | Oct 21, 2021 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Sep 13, 2023 |
| Archive Date: | Oct 19, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education Small businesses Public housing authorities/Indian housing authorities Independent school districts For profit organizations other than small businesses Native American tribal governments (Federally recognized) City or township governments Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Special district governments 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 |
| 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. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | This Funding Opportunity Announcement (FOA) will support extramural research to investigate and mitigate challenges facing clinical assay development and subsequent analytical validation due to preanalytical variability in tumor tissue biopsies, blood biospecimens utilized as liquid biopsies”, or other biospecimens as described in this FOA. Extramural research funded under this FOA may include investigations of preanalytical variability associated with the procurement and study of small biopsies (core biopsies, small excision samples), blood utilized for “liquid biopsies”, tissue swabs, tissue secretions, pleural and esophageal aspirates, feces, or bodily fluids like sweat, urine, CSF, breast milk and saliva. Investigator-designed experiments will explore how different biospecimen preanalytical conditions affect emerging and clinically relevant biomarkers quantified by a variety of testing platforms. The results from this research program will improve the understanding of how analytical quantification of clinically relevant biomarkers is affected by variation in biospecimen collection, processing, and storage procedures. The overall goal is to expedite biomarker clinical assay development through evidence-based standardization of biopsy handling practices. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-22-049.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Related Documents
Folder 336237 Full Announcement-PAR-22-049 -> PAR-22-049-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270425 | Dec 11, 2021 | Jan 24, 2023 | View | |
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00269453 | Dec 11, 2021 | Jan 24, 2022 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00277956 | Nov 04, 2022 | Sep 13, 2024 | View |
Package 1
Mandatory forms
336237 RR_SF424_5_0-5.0.pdf
336237 PHS398_CoverPageSupplement_5_0-5.0.pdf
336237 RR_OtherProjectInfo_1_4-1.4.pdf
336237 PerformanceSite_4_0-4.0.pdf
336237 RR_KeyPersonExpanded_4_0-4.0.pdf
336237 PHS398_ResearchPlan_4_0-4.0.pdf
336237 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
336237 RR_Budget_3_0-3.0.pdf
336237 RR_SubawardBudget30_3_0-3.0.pdf
336237 PHS398_ModularBudget_1_2-1.2.pdf
336237 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
336237 RR_SF424_2_0-2.0.pdf
336237 PHS398_CoverPageSupplement_5_0-5.0.pdf
336237 RR_OtherProjectInfo_1_4-1.4.pdf
336237 PerformanceSite_2_0-2.0.pdf
336237 RR_KeyPersonExpanded_2_0-2.0.pdf
336237 PHS398_ResearchPlan_4_0-4.0.pdf
336237 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
336237 RR_Budget_1_4-1.4.pdf
336237 RR_SubawardBudget30_1_4-1.4.pdf
336237 PHS398_ModularBudget_1_2-1.2.pdf
336237 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
336237 RR_SF424_5_0-5.0.pdf
336237 PHS398_CoverPageSupplement_5_0-5.0.pdf
336237 RR_OtherProjectInfo_1_4-1.4.pdf
336237 PerformanceSite_4_0-4.0.pdf
336237 RR_KeyPersonExpanded_4_0-4.0.pdf
336237 PHS398_ResearchPlan_5_0-5.0.pdf
336237 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
336237 RR_Budget_3_0-3.0.pdf
336237 RR_SubawardBudget30_3_0-3.0.pdf
336237 PHS398_ModularBudget_1_2-1.2.pdf
336237 PHS_AssignmentRequestForm_3_0-3.0.pdf
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