The Department of Health is offering a grant to provide investigators with consultative resources for planning single or multi-site clinical trials in pediatric drug development. This grant aims to address gaps in pediatric pharmacology, align with BPCA priorities, and support non-traditional trial designs. Investigators can access expertise through the Pediatric Trials Network and the BPCA Data Coordinating Center to develop well-designed trials focusing on pediatric therapeutics. The deadline for this opportunity is on March 17, 2023.
Opportunity ID: 325997
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | PAR-20-161 |
| Funding Opportunity Title: | Catalyzing Innovation in Pediatric Pharmacology Clinical Trial Design and Resource Access (X01 Clinical Trial Not Allowed) |
| 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: | 93.865 — Child Health and Human Development Extramural Research |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Apr 02, 2020 |
| Last Updated Date: | Apr 02, 2020 |
| Original Closing Date for Applications: | Mar 17, 2023 |
| Current Closing Date for Applications: | Mar 17, 2023 |
| Archive Date: | Apr 22, 2023 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | County governments Small businesses Special district governments Public and State controlled institutions of higher education For profit organizations other than small businesses 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 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 Independent school districts Others (see text field entitled “Additional Information on Eligibility” for clarification) Private institutions of higher education City or township governments State governments 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: | The purpose of this funding opportunity announcement (FOA) is to provide investigators with access to a consultative resource for planning activities and concept development for single or multi-site investigator initiated clinical trials that address gaps in pediatric drug development and that align with priorities identified in the Best Pharmaceuticals for Children Act (BPCA) Program. The FOA will support the development of clinical trials concepts of future well-designed clinical trials that require non-traditional designs in pediatric therapeutics with the opportunity to expand novelty and/or innovation. Investigators will have access to the expertise in pediatric drug development trial designs by utilizing the consultative services provided by the Pediatric Trials Network (PTN) and the BPCA Data Coordinating Center. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/pa-files/PAR-20-161.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
FBOWebmaster@OD.NIH.GOV Email:FBOWebmaster@OD.NIH.GOV |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
Folder 325997 Full Announcement-PAR-20-161 -> PAR-20-161-Full-Announcement.pdf
Packages
| Agency Contact Information: | NIH OER Webmaster FBOWebmaster@OD.NIH.GOV Email: FBOWebmaster@OD.NIH.GOV |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-F | Use for due dates on or before January 24, 2022 | PKG00260723 | Aug 14, 2020 | Jan 24, 2022 | View | |
| FORMS-G | Use for due dates on or before January 24, 2023 | PKG00270572 | Nov 22, 2021 | Jan 24, 2023 | View | |
| FORMS-H | Use for due dates on or after January 25, 2023 | PKG00278503 | Nov 16, 2022 | Mar 17, 2023 | View |
Package 1
Mandatory forms
325997 RR_SF424_2_0-2.0.pdf
325997 PHS398_CoverPageSupplement_5_0-5.0.pdf
325997 RR_OtherProjectInfo_1_4-1.4.pdf
325997 RR_KeyPersonExpanded_2_0-2.0.pdf
325997 PHS398_ResearchPlan_4_0-4.0.pdf
325997 PHSHumanSubjectsAndClinicalTrialsInfo_2_0-2.0.pdf
Optional forms
325997 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 2
Mandatory forms
325997 RR_SF424_5_0-5.0.pdf
325997 PHS398_CoverPageSupplement_5_0-5.0.pdf
325997 RR_OtherProjectInfo_1_4-1.4.pdf
325997 RR_KeyPersonExpanded_4_0-4.0.pdf
325997 PHS398_ResearchPlan_4_0-4.0.pdf
325997 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
325997 PHS_AssignmentRequestForm_3_0-3.0.pdf
Package 3
Mandatory forms
325997 RR_SF424_5_0-5.0.pdf
325997 PHS398_CoverPageSupplement_5_0-5.0.pdf
325997 RR_OtherProjectInfo_1_4-1.4.pdf
325997 RR_KeyPersonExpanded_4_0-4.0.pdf
325997 PHS398_ResearchPlan_5_0-5.0.pdf
325997 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
325997 PHS_AssignmentRequestForm_3_0-3.0.pdf
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