November 23, 2021
PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
This Notice of Special Interest (NOSI) calls for research to enhance capability of establishing a translational research resource platform for innovative drug discovery and development tools for maternal precision therapeutics.
The purpose of this NOSI is to provide an opportunity for researchers funded by the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub to jumpstart activities for a future translational research resource platform to advance maternal precision therapeutics. The NICHD intends to publish a Request for Applications for fiscal year 2023 for a full translational research resource platform.
The administrative supplement funds are intended to support research activities with innovative study designs and leveraging existing resources through collaborations with existing NICHD networks to generate preliminary data, collect samples, develop robust models, and/or analytic tools for a maternal translational research resource platform.
Background
The accumulation of data and biosamples from ongoing research networks have increased the need to create a research resource platform for translational research to advance safe and effective precision therapeutics in pregnant and lactating women. Despite progress made in pharmacology research in pregnant persons in recent years, knowledge gaps remain unaddressed and there is a paucity of tools to guide precision therapeutic treatment. There is lack of infrastructure for a resource platform to advance fundamental knowledge towards innovative therapeutics-focused translational research to advance safe and effective therapy in pregnant and lactating persons.
The NICHD Strategic Plan 2020 values the importance of research resources and infrastructure that help investigators advance fundamental knowledge towards safe and effective treatments for all. The recommendations of the Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) also recognizes the importance of infrastructures to perform translational research in pregnant and lactating persons.
The MPRINT Hub recently established by NICHD focuses on aggregating, presenting, and expanding the available knowledge, tools, and expertise in maternal and pediatric therapeutics. Activities supported through this administrative supplement will expand current efforts of the MPRINT Hub and focus on the development of a translational research resource platform for maternal precision therapeutics.
Research Objectives
This NOSI informs Program Directors/Principal Investigators (PDs/PIs) of the MPRINT Hub Center awards (P30 and P50s) of the opportunity to submit administrative supplement requests through the NIH Parent Funding Opportunity Announcement, PA-20-272, “Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)”.
Interested applicants are encouraged to expand current efforts from their parent grants to form new collaborations within or outside of the MPRINT Hub and leverage existing resources and expertise from NICHD supported research networks such as MFMU, NRN, NuMoM2b, IMPAACT, etc. Applicants are also encouraged to explore collaborations with groups that are experienced in the use of public-private partnerships to advance the qualification of drug development tools, such as the Foundation for the NIH’s Biomarker Consortium (https://fnih.org/our-programs/biomarkers-consortium). An administrative supplement proposal must demonstrate its potential capability, applicability, and high impact for the translational research resource platform serving for scientific community while it must be within the scientific scope of the parent grant.
Area of research include, but are not limited to:
- Assemble multi-study biosample and data collections to accelerate real world data (RWD) based translational research assessing safety, effects, and clinical therapeutic outcomes;
- Discover and validate biomarkers of novel therapeutic potentials or predicting adverse pregnancy outcomes;
- Develop common analytic lab platforms and perform analysis of existing biosamples for high priority questions;
- Generate data and support filing for regulatory qualification of a biomarker with the FDA;
- Develop innovative strategies to identify and fill gaps in biosample and data collections;
- Develop models/algorithms evaluating potential targets and toxicities of novel therapeutic strategies for pregnant and lactating persons.
Award Project Period
Administrative supplements are limited to 12 months.
Award Budget
NICHD intends to commit $2,000,000 in FY2022 to fund awards under this Notice. Supplement budget requests must reflect the actual needs of the proposed project.
Supplement budget requests may include an expansion of Opportunity Pool or Support Pool activities of the MPRINT Hub.
Applicants may request additional funds for projects that address research priorities of the HEAL initiative , the NIH's Strategic Priorities for COVID-19 Research, or
for HIV/AIDS research. Availability of funds for such projects will depend on FY22 appropriations and interested applicants are encouraged to discuss with Program staff.
The earliest anticipated start date is May 1, 2022.
Eligible Individuals (Program Director/Principal Investigator)
To be eligible, individual(s) must hold an active NIH grant at the time of the award. For supplements to parent awards that include multiple PDs/PIs, the supplement may be requested by any or all of the PDs/PIs (in accordance with the existing leadership plan) and submitted by the awardee institution of the parent award.
The PD/PI, or contact PD/PI in applications using the multiple PD/PI option, must be a PI/PD of an MPRINT Hub center. Investigators who are not affiliated with a MPRINT Center’s Institution may co-direct a project in partnership with an MPRINT investigator.
Application and Submission Information
Applications for this initiative must be submitted using the following opportunity or its subsequent reissued equivalent.
- PA-20-272 - Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
All instructions in the SF424 (R&R) Application Guide and PA-20-272 must be followed, with the following additions:
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- Application Due Date – March 3, 2022, by 5:00 PM local time of applicant organization.
- For funding consideration, applicants must include “NOT-HD-21-051” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.
- Requests may be for up to 1 year of support only.
- The Research Strategy section of the application is limited to 6 pages.
- All applications must be submitted electronically using a single-project application form package.
- It is strongly recommended that the applicants contact Dr. Zhaoxia Ren (zren@mail.nih.gov) to confirm the proposed request fits within the scientific scope of this Notice.
Administrative Review Process
NICHD will conduct administrative reviews of submitted applications and will support the most meritorious applications for consideration, pending availability of funds.
Criteria:
- Is the work proposed within the scope of the active award?
- Will the work proposed focused on activities that will ultimately lead to the development of a translational research resource platform?
- Is the proposed project technically feasible within the budget and funding period?
- Is the overall strategy, methodology, and analysis proposed in the supplement application appropriate to accomplish the activities in the proposed project period?
Zhaoxia Ren, M.D., Ph.D.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-9340
E-mail: zren@mail.nih.gov
and Human Services (HHS)
