This NICHD grant aims to leverage its clinical research Network infrastructure for innovative, multisite, investigator-initiated clinical trials and observational studies. The purpose is to advance research relevant to infants, children, women, pregnant and lactating women, and persons with disabilities. This opportunity uses a bi-phasic (UG3/UH3), milestone-driven mechanism, where a successful start-up UG3 phase transitions to full implementation in the UH3 phase. This grant provides a platform for extramural investigators to pursue novel hypotheses. Applications should be investigator-initiated, multi-PD/PI submissions, partnering with an NICHD-supported Network Data Coordinating Center.
Opportunity ID: 357730
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-311 |
| Funding Opportunity Title: | Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Women, and Persons with Disabilities (UG3/UH3 – Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.313 — NIH Office of Research on Women’s Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Dec 16, 2024 |
| Last Updated Date: | Mar 31, 2025 |
| Original Closing Date for Applications: | Nov 15, 2027 |
| Current Closing Date for Applications: | Nov 15, 2027 |
| Archive Date: | Dec 21, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $6,250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Small businesses Native American tribal governments (Federally recognized) Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) County governments Public housing authorities/Indian housing authorities Independent school districts For profit organizations other than small businesses State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating women, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-311.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 |
|---|---|---|
| Description updated | Mar 31, 2025 | |
| Update title | Dec 16, 2024 | |
| Dec 16, 2024 |
DISPLAYING: Synopsis 3
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-311 |
| Funding Opportunity Title: | Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Women, and Persons with Disabilities (UG3/UH3 – Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.313 — NIH Office of Research on Women’s Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 3 |
| Posted Date: | Dec 16, 2024 |
| Last Updated Date: | Mar 31, 2025 |
| Original Closing Date for Applications: | Nov 15, 2027 |
| Current Closing Date for Applications: | Nov 15, 2027 |
| Archive Date: | Dec 21, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $6,250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public and State controlled institutions of higher education Small businesses Native American tribal governments (Federally recognized) Private institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Native American tribal organizations (other than Federally recognized tribal governments) County governments Public housing authorities/Indian housing authorities Independent school districts For profit organizations other than small businesses State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education City or township 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: |
The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating women, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-311.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 2
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-25-311 |
| Funding Opportunity Title: | Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Women, and Persons with Disabilities (UG3/UH3 – Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.313 — NIH Office of Research on Women’s Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 2 |
| Posted Date: | Dec 16, 2024 |
| Last Updated Date: | Mar 31, 2025 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Nov 15, 2027 |
| Archive Date: | Dec 21, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $6,250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Independent school districts County governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education City or township governments Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities |
| 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 Organizations) are not eligible to apply. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating individuals, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-311.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-25-311 |
| Funding Opportunity Title: | Leveraging Network Infrastructure to Conduct Innovative Research for Women, Children, Pregnant and Lactating Individuals, and Persons with Disabilities (UG3/UH3 – Clinical Trial Optional) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.313 — NIH Office of Research on Women’s Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Dec 16, 2024 |
| Last Updated Date: | Dec 16, 2024 |
| Original Closing Date for Applications: | – |
| Current Closing Date for Applications: | Nov 15, 2027 |
| Archive Date: | Dec 21, 2027 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $6,250,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | State governments Independent school districts County governments Native American tribal governments (Federally recognized) For profit organizations other than small businesses Small businesses Native American tribal organizations (other than Federally recognized tribal governments) Private institutions of higher education City or township governments Special district governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public housing authorities/Indian housing authorities |
| 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 Organizations) are not eligible to apply. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Notice of Funding Opportunity (NOFO) is to leverage NICHD clinical research Network infrastructure relevant to infants, children, women, pregnant and lactating individuals, and persons with disabilities to conduct innovative, multisite, investigator-initiated clinical trials and observational studies. This NOFO will utilize a bi-phasic (UG3/UH3), milestone-driven mechanism consisting of a start-up phase (UG3) and a full enrollment and clinical trial implementation phase (UH3). Applications submitted in response to this NOFO must address specific aims and milestones for both the UG3 and UH3 phases. A UG3 project (phase I) that meets its milestones will be administratively considered by NICHD and prioritized for transition to the UH3 award (phase II). This NOFO provides an opportunity to leverage NICHD clinical research Network infrastructure as a platform for investigator-initiated innovative hypotheses by any investigator in the extramural community. Applications must be submitted as investigator-initiated, multi-Project Director/Principal Investigator (PD/PI) grant applications in conjunction with the respective NICHD-supported Network Data Coordinating Center (DCC), or equivalent as determined by the NICHD. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/pa-files/PAR-25-311.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 |
Related Documents
Folder 357730 Full Announcement-PAR-25-311 -> PAR-25-311-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-I | Use for due dates on or after January 25, 2025 | PKG00289673 | Feb 15, 2025 | Nov 15, 2027 | View |
Package 1
Mandatory forms
357730 RR_SF424_5_0-5.0.pdf
357730 PHS398_CoverPageSupplement_5_0-5.0.pdf
357730 RR_OtherProjectInfo_1_4-1.4.pdf
357730 PerformanceSite_4_0-4.0.pdf
357730 RR_KeyPersonExpanded_4_0-4.0.pdf
357730 RR_Budget10_3_0-3.0.pdf
357730 PHS398_ResearchPlan_5_0-5.0.pdf
357730 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357730 RR_SubawardBudget10_30_3_0-3.0.pdf
357730 PHS_AssignmentRequestForm_4_0-4.0.pdf
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