This NIH HEAL Initiative grant is for research exploring the impact of opioids, potentially combined with other substances, on placenta function and neurodevelopment. The studies should focus on pregnancy and the first year of life. This grant requires experimental designs that prospectively assign human participants to conditions to assess biomedical and/or behavioral outcomes. Such studies are considered Basic Experimental Studies with Humans (BESH) by NIH, falling within the definition of clinical trials, though they must not propose clinical outcomes or products. Applications involving animal models or observational human studies should apply under a separate, companion funding opportunity.
Opportunity ID: 343292
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-HD-23-032 |
| Funding Opportunity Title: | HEAL Initiative: Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Basic Experimental Studies with Humans Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Grant |
| Category of Funding Activity: | Health Income Security and Social Services |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.213 — Research and Training in Complementary and Integrative Health |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Aug 29, 2022 |
| Last Updated Date: | Aug 29, 2022 |
| Original Closing Date for Applications: | Dec 07, 2022 |
| Current Closing Date for Applications: | Dec 07, 2022 |
| Archive Date: | Jan 12, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Independent school districts Public and State controlled institutions of higher education Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses For profit organizations other than small businesses County governments City or township governments Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal governments (Federally recognized) Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Native American tribal organizations (other than Federally recognized tribal governments) Private 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: | This Funding Opportunity Announcement (FOA) invites grant applications to study the impact of opioids, alone or in combination with other substances of misuse, on placenta function and neurodevelopment during pregnancy and in the first year of life using experimental designs that prospectively assign human participants to conditions (i.e., experimentally manipulate independent variables) and that assess biomedical and/or behavioral outcomes in humans to understand fundamental aspects of phenomena related to opioid exposure during pregnancy. NIH considers such studies as Basic Experimental Studies with Humans (BESH), or prospective basic science studies involving human participants that meet the NIH definition of basic research and fall within the NIH definition of clinical trials (see, e.g., NOT-OD-19-024). Applications should not propose a goal of clinical outcomes or products. Applications that propose studies including model animal research or observational studies involving humans should submit under the companion FOA, RFA-HD-23-030, “Opioid Exposure and Effects on Placenta Function, Brain Development, and Neurodevelopmental Outcomes (R01 Clinical Trials Not Allowed). |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-HD-23-032.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 |
|---|---|---|
Related Documents
There are no related documents on this grant.
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-G | Use for due dates on or before January 24, 2023 | PKG00276609 | Nov 07, 2022 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00277876 | Nov 07, 2022 | Dec 07, 2022 | View |
Package 1
Mandatory forms
343292 RR_SF424_5_0-5.0.pdf
343292 PHS398_CoverPageSupplement_5_0-5.0.pdf
343292 RR_OtherProjectInfo_1_4-1.4.pdf
343292 PerformanceSite_4_0-4.0.pdf
343292 RR_KeyPersonExpanded_4_0-4.0.pdf
343292 PHS398_ResearchPlan_4_0-4.0.pdf
343292 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
343292 RR_Budget_3_0-3.0.pdf
343292 RR_SubawardBudget30_3_0-3.0.pdf
343292 PHS398_ModularBudget_1_2-1.2.pdf
343292 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
343292 RR_SF424_5_0-5.0.pdf
343292 PHS398_CoverPageSupplement_5_0-5.0.pdf
343292 RR_OtherProjectInfo_1_4-1.4.pdf
343292 PerformanceSite_4_0-4.0.pdf
343292 RR_KeyPersonExpanded_4_0-4.0.pdf
343292 PHS398_ResearchPlan_5_0-5.0.pdf
343292 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
343292 RR_Budget_3_0-3.0.pdf
343292 RR_SubawardBudget30_3_0-3.0.pdf
343292 PHS398_ModularBudget_1_2-1.2.pdf
343292 PHS_AssignmentRequestForm_3_0-3.0.pdf
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