It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions. Applications that do not comply with these instructions may be delayed or not accepted for review.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

A distinction can be drawn between knowledge deficits and novel research opportunities. While novel research presents an opportunity to advance scientific understanding, knowledge deficits often lie within heterogeneously studied areas that are not considered novel and often occur due to variation in underlying biology across development or inter-individual differences. It is the objective the Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub to address both knowledge deficits and novel research through knowledge aggregation and dissemination through the MPRINT Knowledge and Research Coordination Center (KRCC), and via novel research around knowledge deficits conducted by the MPRINT Centers of Excellence in Therapeutics (CETs). These components of the MPRINT Hub will function collaboratively to build a cohesive and integrated national resource to facilitate and catalyze research and drug development in maternal and pediatric therapeutics. For the MPRINT Hub, an additional aspect is assuring that research, both novel and for knowledge deficits, is focused on the goal of improving regulatory science and the drug development process.

While there has been a dramatic increase in biomedical knowledge and a growing number of potential disease targets, there remains significant unmet needs in the treatment of children across the spectrum of pediatric development and of women attempting to conceive, during pregnancy, the post-partum period, and throughout lactation. There is a clear need to improve upon past and current approaches to the study of pharmacology and therapeutics in maternal, post-partum, and pediatric populations. Additionally, individuals in these populations with mental or physical disabilities are often excluded from therapeutics research, leading to a paucity of data for their treatment. The goal of precision medicine is to give the right drug to the right person for the right condition at the right time. To enable this approach, there must be an increase in the understanding of the underlying biological heterogeneity relevant to therapeutics across the continuum of pediatric development and during and around pregnancy.

For the purpose of this FOA maternal and pediatric therapeutics is defined to encompass:

• Therapeutic treatment of obstetric and breastfeeding conditions;
• Physiological changes that occur in a woman’s body during pregnancy, the post-partum period, and during lactation that impact the distribution or effects of administered therapeutics;
• Passage of drug from mother to fetus during pregnancy and to child during breastfeeding, including the effects of those drugs on the fetus or child;
• Therapeutic treatment of pediatric disease, particularly where there are unique pediatric conditions or pharmacodynamic differences from adult disease;
• Physiological changes that occur across the entire spectrum of pediatric development from birth through adolescence that impact the distribution or effects of administered therapeutics.

There are significant barriers to the extension and application of transformative biomedical advances to enable and provide precision medicine to maternal and pediatric populations, including those with disabilities. One barrier is the lack of a centralized resource for high quality, curated knowledge of maternal and pediatric therapeutics that includes the inter-individual variability in underlying biological processes that influence drug disposition and action. Another barrier is the development and integration of research approaches and tools to both facilitate the closing of knowledge deficits, enhance regulatory science, and to facilitate clinical trials in maternal and pediatric populations. Enhancing the availability of knowledge, regulatory science, and drug development tools will facilitate safer, more inclusive, and more cost-effective trials to increase knowledge around use of existing drugs and enable novel drug development. The MPRINT Hub will be a national resource to aggregate, present and expand the available knowledge, tools, and expertise in maternal and pediatric therapeutics to the broader research and drug discovery and development communities.

This FOA invites applications for research projects and core resources that will serve as Centers of Excellence in Therapeutics (CETs) within the MPRINT Hub. The MPRINT Hub will create a broadly accessible, integrated platform in maternal and pediatric therapeutics research to facilitate research, regulatory science, drug development, and synergy across the broader scientific community. Within the MPRINT Hub, the CETs will address key knowledge deficits in maternal and pediatric pharmacology and therapeutics through the conduct of cutting edge clinical, translational, basic, and/or data sciences research that fills knowledge and tool gaps in maternal and pediatric pharmacology. The outputs of the CETs should enable and catalyze new research and drug development opportunities in areas of high unmet medical need in maternal and pediatric therapeutics and enhance the inclusion of individuals with disabilities. To maximize scientific exchange and accelerate research in that field, all information, data, protocols, resources, and methods developed by MPRINT CET investigators will be shared within the MPRINT Hub and with the research community at large.

As it is anticipated that the underlying science will change over time, the maximum total funding period for any P50 award, including potential future renewals, is 10 years

The research activities of the MPRINT CETs will comprise a multidisciplinary approach to address key knowledge deficits in maternal and pediatric therapeutics. CETs may have more than one research theme. Each responsive application will include studies relating to both maternal and pediatric therapeutic science, although individual Research Projects or Support Cores may have either a maternal or pediatric focus. Responsive applications must have at least one predominantly clinical project and all basic, translational, and/or data science projects must be linked to the clinical project(s) of the CET. The results, tools, and resource of the MPRINT CETs will accelerate the pace of maternal and pediatric therapeutics research and drug development to ultimately improve the care of patients by undertaking key activities in the field. Examples of key activities include, but are not limited to:

• Performing non-clinical and clinical research to understand the mechanisms underlying changes of drug response and disposition during pregnancy, the post-partum period, and breastfeeding;
• Identifying and studying fit-for-purpose biomarkers for safety, early prevention, and effective treatment of pregnancy-related diseases/conditions;
• Systematically exploring and categorizing the functions of drug transporters in drug disposition and action, including the impact of pediatric ontogeny and the physiological changes occurring during pregnancy, placental development, and in mammary tissue during lactation;
• Developing assays and analytic procedures that have the sensitivity, reproducibility, and value to inform therapeutics development and use for maternal and pediatric conditions;
• Establishing predictive non-clinical models including animal studies, biomimetic systems, and computational models to predict age-specific therapeutic response and toxicity, focusing on a particular therapeutic area;
• Expanding in silico models that can provide critical knowledge about drug dispositional changes in pregnancy, fetal pharmacology, and lactation;
• Using artificial intelligence and machine learning approaches to mine and analyze large scale datasets (e.g., biobanks, electronic health records) to inform on outcome measures of drug exposure and assess the safety and toxicity of drugs used for maternal and pediatric conditions.

Activities of the MPRINT CETs will be undertaken with input from a Steering Committee composed of MPRINT Hub awardees in addition to feedback from the MPRINT Hub’s External Program Consultants (EPCs) and the NICHD.

Research Projects

CETs must propose at least two and no more than three Research Projects. Research Projects may be clinical, basic/translational, or data science projects, as described below. At least one proposed Research Project must be a clinical research project.

Clinical Research Project: A minimum of one clinical research project must be proposed in each CET application. The clinical research project does not have to be a clinical trial. Clinical research projects may focus on children, women, or both and should include participants with disabilities. However, if there is a focus on either women or children within the clinical research project, additional research on the other group must be proposed in a separate research project within the CET. The clinical research project(s) must NOT focus on drug studies designed to change clinical practice or labeling, but rather on general questions in maternal and pediatric therapeutics whose findings will accelerate multiple other research projects. For opportunities for clinical trials to inform practice change and/or result in labeling changes, please visit the NICHD’s website (https://www.nichd.nih.gov/health/clinical-research). Proposed projects may include, but are not limited to:

• Discover or validate fit-for-purpose biomarkers for disease risk or progression, patient stratification based on disease heterogeneity, prediction of adverse events, or monitoring or predicting drug response in pediatric or obstetric indications;
• Identify, define, and develop age- or pregnancy stage-appropriate outcome measures to assess disease progression and potential drug efficacy or toxicity;
• Explore interactions between human microbiomes and drug disposition and effect in pregnant and lactating women and children;
• Research of developmental changes likely to have clinically significant effects on drug metabolism and transport in children, incorporating pharmacogenomic knowledge around individual heterogeneity.

Basic/Translational Research Project: The inclusion of a basic or translational research project is optional. Basic/translational research project must be thematically linked to a clinical research project. Basic/translational research projects may include human subjects research but not clinical trials. Proposed projects may include, but are not limited to:

• Elucidation of basic mechanisms for drug disposition and response in maternal and pediatric populations;
• The development of new animal, biomimetic, or computational models to aid in therapeutic discovery and/or development;
• De-orphanization of transporter proteins that are known to be expressed at high levels during pediatric development, in the placenta, or in mammary tissue during lactation.

Data Science Research Project: The inclusion of a data science research project is optional. A data science research project must be thematically linked to a clinical research project. Data Science Research Projects will work closely with the MPRINT KRCC to avoid duplication of efforts and enhance the overall missions of the MRPINT Hub. Proposed projects may include, but are not limited to:

• Electronic health record databases mining to identify drug effects that may identify potential repurposing of therapeutics;
• The development of new, computational models that predict therapeutic response, risk, or drug dosing based on genotype and age-specific status;
• Analytical or visualization tools to help mine and understand the corpus of knowledge around maternal and pediatric therapeutics.

Administrative Core

The Administrative Core will provide oversight, support and management of Research Projects and Support Cores within each CET and provides for coordination of communication, collaborations, and dissemination of knowledge and tools with other components of the MPRINT Hub. The Administrative Core will house appropriate administrative/business management staff and oversight mechanisms and will coordinate closely with the MPRINT KRCC’s Logistics Core to assure consistent oversite across the entire MPRINT Hub. Additionally, the Administrative Core will oversee a Resource Pool of funds to be used to augment or create a new Support Core.

The Administrative Core of each CET will support outreach, dissemination, and training by working and coordinating with the MPRINT KRCC’s Outreach, Dissemination, and Training Core. As national resources for maternal and pediatric therapeutics, the MRPINT CETs have roles in training of new researchers by establishing and maintaining a training environment for predoctoral students and postdoctoral fellows as well as clinical fellow investigators in maternal and pediatric therapeutics research. Each CET must coordinate and integrate the training programs across the MPRINT Hub with a goal of aiding the development of a new cadre of cross-disciplinary scientists in maternal and pediatric therapeutics. Utilization and adaptation of existing training programs are encouraged.

Support Cores

CETs must propose at least one and not more than two initial Support Cores. Support Cores are intended to support the Research Projects within the proposed CET and will provide support services to other components of the MPRINT Hub, if applicable. Support Cores, if applicable, may also be made available as a national resource. Support Cores do not necessarily need to be fully ready to operate at the start of the CET and may include efforts to develop and implement their functions during the first two years of the CET awards. However, preliminary data supporting feasibility of achieving functional Cores by the third year of awards must be shown.

Types of Support Cores may include, but are not limited to:

• Support for small volume or blood spot assays to support drug studies in children and neonates;
• Development and implementation of techniques and approaches to precisely and rapidly determine drug levels in breast milk in a non-clinical setting;
• Collect human tissue samples and associated phenotype information relating to pediatric development or pregnancy and lactation, including the development of quality control metrics;
• Establish predictive cell-based, ex vivo, animal, or biomimetic models of disease or drug response that account for heterogeneity of disease and individual variation in genetics and developmental trajectory.

A Steering Committee (SC) will be formed to provide overall direction and guidance for the MPRINT KRCC (RFA-HD-21-025) and CET awardees collectively the MPRINT Hub. The Chair(s) of the SC will be selected by the NICHD from the PDs/PIs of the MPRINT Hub awardees. The MPRINT SC will establish procedures for the function of the Hub, including monthly SC teleconferences and, as necessary, convene working groups of the SC for specific purposes. Such working groups should be composed of at least one PD/PI from an MPRINT Hub award, at least one senior/key personnel from each MPRINT Hub awardee, and ex officio NIH members as well as other necessary MPRINT Hub members, external scientists, and/or External Program Consultants (EPCs), as needed. At least once yearly, the Steering Committee and other key personnel are expected to convene an in-person meeting (or virtual equivalent) to review scientific progress, highlight key Hub activities, and communicate with NICHD staff. The MPRINT Hub will establish strong working relationships with other related efforts, including collaborative projects, and will share scientific approaches and data prior to publication. NIH staff from other NIH-funded networks may participate as ex officio members in the MPRINT Hub SC and/or its working groups.

External Program Consultants will be selected by the NICHD to review the functioning and progress of the Hub and ensure the Hub is operating optimally and efficiently. EPCs will be appointed by the NICHD on a yearly basis and may include, but is not limited to, persons with expertise in data sciences, clinical pharmacology, pediatric subspecialties, maternal health, clinical trial design and analysis, developmental biology, and regulatory sciences. EPCs may be members of other Federal Agencies such as the Food and Drug Administration, Centers for Medicare and Medicaid Services, or others as deemed necessary by the NICHD. The NICHD, after consulting with the EPCs, may request modification to research projects or cores across the MPRINT Hub, including re-prioritization of effort among research projects and/or cores across the MPRINT Hub.

Evaluation of the MPRINT Hub by EPCs will include, but is not limited to:

• Progress of member Center programs;
• Proposed new research efforts within scope of the approved program;
• Collaborative needs either within or outside the MPRINT Hub;
• Evaluation and adjustment of the process used to solicit, evaluate, and select Opportunity Pool projects;
• Need to redirect efforts of member Centers based on emergent science, lack of productivity, or underutilization of resources by the broader scientific community.

Applications that are not responsive to this funding announcement:

Projects listed below are not within the scope of this funding announcement.  Applications proposing out of scope projects are not responsive to this FOA and will not be reviewed.

• Applications that propose studies primarily for the purpose of changing clinical practice or resulting in labeling changes;
• Applications that propose to conduct drug discovery efforts such as target identification, screening, or medicinal chemistry;
• Applications focused on pre-clinical drug development activities such as IND-enabling studies;
• Applications that do not propose a Clinical Research Project;
• Applications focused on medical devices that do not directly relate to therapeutics;
• Projects not focused on maternal and pediatric pharmacology and therapeutics research as defined above;
• Mechanistic research on understanding normal biology or disease processes that is not clearly directed towards understanding knowledge deficits related to therapeutics.

Pre-application Informational Webinar

An informational webinar for this announcement and its companion announcement will be held on Thursday, October 8th, 2020 at 1 PM - 3 PM, Eastern time. Potential applicants are encouraged to attend. Frequently Asked Questions from the webinar will be made publicly available. The FAQs and additional information on the webinar can be obtained at - https://www.nichd.nih.gov/about/org/der/branches/opptb/mprint. The webinar is optional and not required for application submission.

See Section VIII. Other Information for award authorities and regulations.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Higher Education Institutions

• Public/State Controlled Institutions of Higher Education
• Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

• Hispanic-serving Institutions
• Historically Black Colleges and Universities (HBCUs)
• Tribally Controlled Colleges and Universities (TCCUs)
• Alaska Native and Native Hawaiian Serving Institutions
• Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

• Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
• Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

• Small Businesses
• For-Profit Organizations (Other than Small Businesses)

Governments

• State Governments
• County Governments
• City or Township Governments
• Special District Governments
• Indian/Native American Tribal Governments (Federally Recognized)
• Indian/Native American Tribal Governments (Other than Federally Recognized)
• U.S. Territory or Possession

Other

• Independent School Districts
• Public Housing Authorities/Indian Housing Authorities
• Native American Tribal Organizations (other than Federally recognized tribal governments)
• Faith-based or Community-based Organizations
• Regional Organizations

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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

• Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
• System for Award Management (SAM) Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
• NATO Commercial and Government Entity (NCAGE) Code Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
• eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons.If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

The application forms package specific to this opportunity must be accessed through ASSIST or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

It is critical that applicants follow the Multi-Project (M) Instructions in the SF424 (R&R) Application Guide, except where instructed in this funding opportunity announcement to do otherwise and where instructions in the Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Zhaoxia Ren, MD, P.D
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-9340
Email: zren@mail.nih.gov

Available Component Types	Research Strategy/Program Plan Page Limits
Overall	12
Administrative Core	6
Research Project	12
Support Core	6

Additional page limits described in the SF424 Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the SF424 (R&R) Application Guide, and should be used for preparing a multi-component application.

The application should consist of the following components:

• Overall: required; maximum of one
• Administrative Core: required; maximum of one
• Research Project: required; minimum of two; maximum of three
• Support Core: required; minimum of one; maximum of two

When preparing your application, use Component Type Overall .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete entire form.

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Follow standard instructions.

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this FOA) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

Specific Aims: Describe the aims of the overall MPRINT CET and outline how the different Research Projects and Cores will contribute to these aims. State how the Research Projects and Cores will promote the NICHD’s 2020-2024 Strategic Plan (https://www.nichd.nih.gov/about/org/strategicplan), in particular (1) research theme five’s focus on advancing safe and effective therapeutics for pregnant and lactating women and children, including those with disabilities; and (2) the NICHD’s scientific stewardship of promoting an inclusive scientific workforce that fosters research training and facilitated data sharing.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation, and Approach. 

Significance: Focusing on the MPRINT CET as a whole address:

• The importance of the problems and critical barriers to advancing drug development in maternal and pediatric therapeutics that the proposed MPRINT CET will focus on;
• How the resources of the proposed CET will improve scientific knowledge, technical capability, and ultimately enable maternal and pediatric drug development projects;
• How the concepts, methods, technologies, and/or approaches that drive maternal and pediatric pharmacology will be changed if the proposed aims are achieved.

Innovation: Considering the MPRINT CET as a whole, show how the proposed resources will:

• Serve to shift current maternal and pediatric clinical research and/or clinical trial paradigms through use and generation of novel tools, approaches, methodologies, or modeling;
• Accelerate translational research across the spectrum of pediatric disease and maternal conditions, with a strong focus on understanding disease heterogeneity;
• Provide an environment and resources to enhance cutting-edge clinical research and trials by bringing together investigators from various fields to identify and address the gaps in delivering precision dosing to maternal and pediatric populations;
• If applicable, demonstrate scientifically productive interactions across related NICHD and NIH, FDA, VA, or other federally funded resources, clinical networks, or projects.

Approach: Applicants should address, at a minimum, the following aspects:

• Describe how all of the Research Projects and Cores of the MPRINT CET complement each other and will work together;
• Describe the mechanisms that will ensure the coherence of the CET and maintain a multidisciplinary focus and leverage team science;
• Describe preliminary organizational work, experience with maternal and pediatric therapeutics research, potential for developing or contributing to new and exciting research, and specific plans for implementation of the new program;
• Discuss the interrelation of the MPRINT CET to other activities in the applicants institution(s) (e.g., other relevant research projects) and the extent of institutional, departmental, and interdepartmental cooperation and support (charts and tables may be included);
• Describe how the MPRINT CET will ensure that the necessary infrastructure is in place to facilitate broad data and resource sharing, consistent with the goals of the program;
• Discuss plans to incorporate MPRINT CET research activities in to educational and training opportunities within the CET’s institution(s) and, by working with the MPRINT KRCC’s Outreach, Dissemination, and Training Core, the broader scientific community;
• Clearly state the overall MPRINT CET deliverables, timelines, and milestones and how they align with the goals of the MPRINT Hub;
• Describe how the MPRINT CET will reprioritize and adjust activities, timelines, and milestones on an annual basis (in the RPPR) based on feedback from the MPRINT Hub SC, External Program Consultants, and NICHD staff.

The NICHD may negotiate changes to the MPRINT KRCC deliverables, timelines, and milestones as well as the process for their reprioritization prior to award.

Letters of Support: A letter from each participating institution stating its commitment to support the proposed CET and its integration into ongoing activities at the applicant's institution should be provided.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

All applications, regardless of the amount of direct costs requested for any one year, must address a Data Sharing Plan for the full KRCC in the Overall component of the application.

Applicants should indicate their willingness to abide by all data deposition, quality control metrics, standardization, metadata requirements, data and software release, and public copyright license policies developed by the MPRINT Hub SC and approved by NICHD staff. A primary goal of the MPRINT Hub is to facilitate discoveries of the broad scientific community for the improvement of public health. Restrictive licensing and sharing practices for Hub-generated data, tools, and resources could substantially diminish their value and public benefit. Accordingly, awardees should manage data, resources, protocols, tools, and software in a way that achieves this goal. The NICHD expects that the awardees, through the MPRINT Hub SC, will develop such policies, methods, and standards in concert with the NICHD. These policies, methods, and standards will remain consistent with NIH-wide and NICHD policies on data and resource sharing.

Specific Plan for Data Sharing: Consistent with achieving the goals of this program, the NICHD expects that information such as collected data, technical protocols, and any other metadata collected under this FOA is to be deposited as appropriate into existing, publicly available data repositories that are easily accessible, and in machine readable format. For human data, the NICHD encourages the use of the Data and Specimen Hub (DASH), a centralized resource for researchers to store and access de-identified data from studies funded by NICHD. Where appropriate, applicants should identify such repositories and plans for deposition. For datatypes that lack suitable public repositories, applicants should indicate their willingness to identify an appropriate alternative solution that is consistent with achieving the goals of the program. Data should also be made available as appropriate via the MPRINT Hub Knowledge Base and Portal that will serve as the central access point for information regarding data, critical tools, and reagents being developed by the MPRINT Hub. If applicable, applicants must abide by the NIH Genomic Data Sharing Policy (https://osp.od.nih.gov/scientific-sharing/genomic-data-sharing/) and should indicate their agreement to it in the data sharing plan.

Specific Plan for Protocol, Tool, and Reagent Sharing: In accomplishing the goals of the MPRINT Hub, it is likely that investigators will develop protocols, tools, and reagents that would be of broad use in the research community. The NICHD intends that protocols, tools, and reagents generated by the MPRINT Hub be broadly available and distributed at minimal cost, and without undue intellectual property constraints, so that they can be as widely used as possible, thus enabling downstream investigations in maternal and pediatric therapeutics. For all applications where applicable, the applicant should discuss plans for sharing and distribution of non-data resources that will be generated by the proposed project, including models, protocols, biomaterials, and reagents.

Specific Plan for Sharing Software: A software dissemination plan is expected in applications that are developing software. There is no prescribed single license for software produced in this project; however, reviewers will be asked to evaluate the software sharing and dissemination plan based on its likely impact. Applicants are asked to propose a plan to manage and disseminate the improvements or customizations of their tools and resources by others. This proposal may include a plan to incorporate the enhancements into the official core software, may involve the creation of an infrastructure for plug-ins, or may describe some other solution. A dissemination plan guided by the following principles is thought to promote the largest impact:

•   The software should be freely available to biomedical researchers and educators in the non-profit sector, such as institutions of training, research institutions, and government laboratories.
•   The terms should permit the dissemination and commercialization of enhanced or customized versions of the software, or incorporation of the software or pieces of it into other software packages.
•   The software should be transferable such that another individual or team can continue development in the event that the original investigators are unwilling or unable to do so.
•   The terms of software availability should include the ability of researchers outside of the MPRINT Hub and its collaborating projects to modify the source code and to share modifications with other colleagues. An applicant should take responsibility for creating the original and subsequent official versions of a piece of software.

Applicants should also be familiar with the NIH statements regarding intellectual property of resources developed with Federal funds (NIH Research Tools Policy (http://grants.nih.gov/grants/intell-property_64FR72090.pdf) and other related NIH sharing policies at http://sharing.nih.gov).

Prior to funding, NICHD Program Staff may negotiate modifications to the Sharing Plan with the applicant.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).

All instructions in the SF424 (R&R) Application Guide must be followed.

All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Administrative Core.

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

•   In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
•   In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
•   Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
•   If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.
•   The Core Leader should have demonstrated leadership and administrative skills. Specifically, the Project Leader should be able to organize and administer the resources created by the CET in such a way that they may be shared within the MPRINT CET as well as with other interested scientists. Demonstrated leadership in training junior investigators is desirable.
•   The contact Program Director/Principal Investigator of the proposed MPRINT CET should also be the Administrative Core Project Leader; sufficient time should be devoted to the core to ensure that the aims are met and required functions are carried out efficiently. The PD/PI’s biographical sketch should present evidence of scientific expertise relevant to the themes of the MPRINT CET and demonstrate the capacity for the leadership of a the MPRINT CET.
•   The administrative requirements of the MPRINT CET will necessitate the assistance of an administrator with business management expertise. It is important that such an individual be identified and be directly involved with the fiscal and administrative aspects of the MPRINT CET application and grant. The administrator should be able to provide consultation in matters of fiscal administration and be familiar with NIH grant-related compliance policies.
•   An Associate Director may be named who will be involved in the administrative and scientific efforts of the CET. If this is a multi-PD/PI application, this should be one of the non-contact PD/PIs.

Budget forms appropriate for the specific component will be included in the application package.

A significant time commitment (3.0 person months) should be made between the Project Leader and an Associate Director, with each person having no less than 1.2 person months.

Domestic and foreign travel of personnel directly related to the core and scientific activities of the MPRINT CET is allowable. Budgeting should include travel and lodging for representatives of the MPRINT CET to attend:

• Annual meetings of the MPRINT Hub PDs/PIs;
• Annual meetings of administrators, core leaders, training core leaders, data managers, and other key personnel;
• Ad hoc meetings called by the MPRINT Hub or the NICHD to discuss research findings and plan cooperative projects, to promulgate data sharing, and to discuss standardization of procedures within the MPRINT Hub.

An allotment of funds for a Support Pool must be budgeted in the Administrative Core budget. A brief description of the first-year Support Pool uses for the first year of MPRINT CET funding will be requested as Just-in-Time information through the eRA Commons shortly before the award of successful applications. Future-year Support Pool activities should be submitted with the annual Research Performance Progress Report (RPPR). Facilities & Administrative costs will be provided in accordance with these budgets. Support Pool projects may have a project term between 1 and 3 years. Support Pool projects may be awarded to investigators outside of the home institution. Applicants should budget for a total of $150,000 total costs under the other expenses within the administrative core budget as a separate line in the composite budget. Support Pool funds will be restricted from use until approved by the NICHD. This line item should be a Direct Cost amount such that when combined with its associated Indirect Costs the total is $150,000 in Total Costs.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Clearly state:

• How the Administrative Core will contribute to the goals of the MPRINT CET;
• Outline interactions of the core with each of the other components of the Center;
• Provide an overview of how the Admin Core will set the overall direction of the MPRINT CET and ensure optimal utilization of MPRINT CET resources;
• How the CET will identify emerging needs for uses of the Support Pool to facilitate the MPRINT Hub's role as a national resource in pediatric and maternal clinical pharmacology;
• Explain how the CET Administrative Core will coordinate with the other MPRINT CETs and the MPRINT KRCC (RFA-HD-21-025) to provide overall administrative coordination and oversite for the MPRINT Hub.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach.

Significance: Explain the role of the Administrative Core in the MPRINT CET and how it will interact with other components of the MPRINT Hub in establishing the MPRINT Hub as a central resource for national activities in maternal and pediatric therapeutics research. 

Innovation: For the purposes of the Administrative Core, innovation is defined as the business and management approaches that will promote seamless and efficient operation of the MPRINT CET and interactions with other components of the MPRINT Hub and does not need to include novelty.

Approach: Describe how the MPRINT CET’s Administrative Core structure will support, at a minimum, the following:

• Oversight of research and grants administrative processes (including preparation of annual RPPR)s;
• Coordination and integration of the other MPRINT CET Research Projects and Cores components and activities;
• Fund and support logistics for meetings specific to the proposed MPRINT CET;
• Work with the MPRINT KRCC’s Logistics Core to initiate and facilitate development of MPRINT Hub policies, such as for publication and internal data sharing, and other needed policies as determined by the MPRINT Hub SC;
• Manage MPRINT CET interactions by organizing at need or recurring teleconferences or web-based interactions, and by recording the minutes or reports resulting from these interactions;
• Work with the MPRINT KRCC’s Logistics Core to maintain and make accessible to NICHD and MPRINT Hub awardees all significant Consortium-related documents, including policies, guidelines, and records and meeting minutes generated by the various MPRINT Hub’s committees, working groups, and consultants;
• Applicants should also describe how their team proposes to administer Support Pool funds, addressing, at a minimum, the following aspects:
• How the MPRINT CET will work with the MPRINT Hub’s Steering Committee, NICHD staff, and potential other funding partners to identify emergent needs on a yearly basis;
• How the MPRINT CET will allocate funds from the Support Pool to meet the demands of external investigators;
• How subcontracts will be overseen and integrated into the overall MPRINT Hub.
• Define the deliverables, timelines, and milestones for the Administrative Core and how they align with the goals of the MPRINT Hub;
• Articulate how the MPRINT CET’s Administrative Core will reprioritize and adjust activities, deliverables, timelines, and milestones on an annual basis (in the RPPR) based on feedback from the MPRINT Hub SC, External Program Consultants, and NICHD staff.

The NICHD may negotiate changes to the MPRINT KRCC Admin Core deliverables, timelines, and milestones as well as the process for their reprioritization prior to award.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

The Resource Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities in this component of the application.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed

When preparing your application, use Component Type Research Project .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required? However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components?

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Project Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims:

• State if this is a Clinical Research Project , Basic/Translational Research Project , or a Data Science Research Project and provide a rationale for how the Specific Aims fit within that category of project;
• Clearly state how the Research Project will contribute to the overall goals of the MPRINT CET and interact with other components;
• Address how the Research Project will address barriers to the conduct of maternal and/or pediatric therapeutics research and/or conduct of drug development projects in these populations;
• State the scientific objectives of the Research Project.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation and Approach. 

Significance: Explain, at a minimum:

• The role of the Research Project in the CET as a whole;
• How this project will remove barriers to the conduct of maternal and/or pediatric therapeutics research and/or the conduct of drug development projects;
• If addressing barriers in pediatrics, explain how this Research Project relates to the priorities of the Best Pharmaceuticals for Children Act (https://www.nichd.nih.gov/sites/default/files/inline-files/2020PriorityListFeb20.pdf).

Innovation: For the Research Project, show how the proposed research seeks to shift current therapeutics research or clinical trial paradigms through use of novel concepts, approaches, methodologies, instrumentation, or interventions.

Approach: Applicants should address, at a minimum, the following aspects:

• Provide preliminary data indicating the applicants ability to conduct the proposed research project;
• Clearly define how the barriers to maternal and/or pediatric therapeutics research or drug development projects are preventing the advancement of the field;
• Describe the research that the Research Project will undertake and how this research directly relates to barriers in the field;
• Provide examples of therapeutics research and or drug development projects that are not currently possible and will be enabled after the completion of the proposed research project;
• If including pediatric research, explain how this Research Project relates to the priorities of the Best Pharmaceuticals for Children Act (https://www.nichd.nih.gov/sites/default/files/inline-files/2020PriorityListFeb20.pdf);
• Detail how this Research Project will utilize Support Cores within the CET;
• Detail how this Research Project will interact with and leverage the proposed efforts in other Research Projects of the CET;
• Define the deliverables, timeline, and milestones for the Research Project and how they align with the goals of the MPRINT Hub;
• Articulate how the MPRINT CET Research Project will reprioritize and adjust activities, deliverables, timeline, and milestones on an annual basis (in the RPPR) based on feedback from the MPRINT Hub SC, External Program Consultants, and NICHD staff.

The NICHD may negotiate changes to the MPRINT KRCC Admin Core deliverables, timelines, and milestones as well as the process for their reprioritization prior to award.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

The Resource Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities in this component of the application.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

When preparing your application, use Component Type Support Core .

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions, as noted.

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

Enter Human Embryonic Stem Cells in each relevant component.

Human Subjects: Answer only the Are Human Subjects Involved? and 'Is the Project Exempt from Federal regulations? questions.

Vertebrate Animals: Answer only the Are Vertebrate Animals Used? question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

• In the Project Director/Principal Investigator section of the form, use Project Role of Other with Category of Core Lead and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

Specific Aims: Clearly state how the core will contribute to the goals of the MPRINT CET and outline interactions of the Core with its Research Projects and other Cores.   

Demonstrate exactly how the proposed Support Core would augment or enhance the present capabilities of investigators using MPRINT CET resources and to enhance or create research at the CET home institution and the wider research community.

Research Strategy: Organize the Research Strategy into sections on: Significance, Innovation, and Approach. There should be a detailed discussion of the research that will or could use the resources of Support Cores. Clearly address the deliverables, timelines, and milestones for the Support Core, how they align with the goals of the MPRINT Hub, and how the Core will reprioritize and adjust activities, deliverables, timelines, and milestones on an annual basis (in the RPPR) based on feedback from the MPRINT Hub SC, External Program Consultants, and NICHD staff.

The NICHD may negotiate changes to the MPRINT KRCC Admin Core deliverables, timelines, and milestones as well as the process for their reprioritization prior to award.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide, with the following modification:

The Resource Sharing Plan submitted to the Overall component of the application must include elements to address all proposed activities in this component of the application.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

When involving human subjects research, clinical research, and/or NIH-defined clinical trials follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered Yes to the question Are Human Subjects Involved? on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies) using ASSIST or other electronic submission systems. Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time. If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

This initiative is not subject to intergovernmental review.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

For information on how your application will be automatically assembled for review and funding consideration after submission go to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) and component Project Leads must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management (SAM). Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Only the review criteria described below will be considered in the review process. Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the proposed CET to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Reviewers will consider each of the review criteria below in the determination of scientific merit and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a Center that by its nature is not innovative may be essential to advance a field.

Does the proposed CET address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the Center are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Specific to this FOA: Will addressing the problems and critical barriers the project proposes to focus on result in a significant advancement of the concepts, methods, technologies, and/or approaches for both maternal and pediatric pharmacology? Will the resources and knowledges of the proposed CET improve scientific knowledge, technical capability, and enable maternal and pediatric therapeutics research and drug development?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy?  For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the Center? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

Specific to this FOA: Is the plan for how all of the investigators will work across the proposed CET sufficient to assure cohesive interactions? Is there sufficient preliminary evidence the investigators can work together?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

Specific to this RFA: Will the proposed CET serve to shift current maternal and pediatric clinical research and/or clinical trial paradigms through use and generation of novel tools, approaches, methodologies, or modeling? Will it bring together investigators from various fields to identify and address the gaps in delivering precision dosing to maternal and pediatric populations?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice? 

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the proposed CET? Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the Center involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and

2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this RFA: Do all of the Research Projects and Cores of the MPRINT CET complement each other and will they work together? Are their adequate mechanisms in place to ensure the coherence of the CET and maintain a multi-disciplinary focus while leveraging team science? Are appropriate, evaluative, and quantitative deliverables and milestones provided with clear metrics and plan for annual reprioritization? Will the proposed deliverables and milestones facilitate accomplishing the overall goals of the MPRINT Hub?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

Specific to this RFA: How well is the proposed CET integrated into other activities at the applicant's institution and does it leverage existing efforts in maternal and/or pediatric pharmacology? Is there strong commitment from the applicant's institution to support the proposed CET?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed? Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate? If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial? If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

As applicable for the Center proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

When the proposed Center involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Not Applicable

Not Applicable

Not Applicable

As applicable for the Center proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Not Applicable

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: 1) Data Sharing Plan; 2) Sharing Model Organisms; and 3) Genomic Data Sharing Plan.

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

As applicable for the CET proposed, reviewers will evaluate the following items while determining scientific and technical merit for the entire application, and in providing an impact score for the Research Project but will not give separate scores for these items.

• Are the qualifications, experience, and commitment of the Project Lead and other personnel appropriate?
• If successful, will this project remove barriers to the conduct of maternal and/or pediatric therapeutics research and/or the conduct of drug development projects?
• Does this Research Project interact and leverage with other Research Projects in the proposed CET and is its utilization of proposed Cores appropriate?
• Are appropriate, evaluative, and quantitative deliverables and milestones provided with clear metrics and plan for annual reprioritization?
• Will the proposed deliverables and milestones facilitate accomplishing the overall goals of the MPRINT Hub?

As applicable for the CET proposed, reviewers will evaluate the following items while determining scientific and technical merit for the entire application, and in providing an impact score for the Support Core but will not give separate scores for these items.

• Are the qualifications, experience, and commitment of the Core Lead and other personnel appropriate?
• Is it clear that the Support Core will augment or enhance the present capabilities of investigators using MPRINT CET resources and enhance or create research at the CET home institution and the wider research community?
• Are the technical approaches proposed in the Support Core appropriate?
• Are appropriate, evaluative, and quantitative deliverables and milestones provided with clear metrics and plan for annual reprioritization?
• Will the proposed deliverables and milestones facilitate accomplishing the overall goals of the MPRINT Hub?

As applicable for the CET proposed, reviewers will evaluate the following items while determining scientific and technical merit for the entire application, and in providing an impact score for the Administrative Core but will not give separate scores for these items.

• Are the qualifications, experience, and commitment of the Core Lead and other personnel appropriate?
• Have the applicants provided evidence of their ability and plans to oversee and coordinate the proposed MPRINT CET?
• Are the plans to identify needs and uses for and award the Support Pool funds clear and appropriate?
• Are appropriate, evaluative, and quantitative deliverables and milestones provided with clear metrics and plan for annual reprioritization?
• Will the proposed deliverables and milestones facilitate accomplishing the overall goals of the MPRINT Hub?

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s), convened by NICHD, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications:

• May undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.
• Will receive a written critique.

Appeals of initial peer review will not be accepted for applications submitted in response to this FOA.

Applications will be assigned to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the National Advisory Child Health and Human Development (NACHHD) Council. The following will be considered in making funding decisions:

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.
• Evidence that the applicant and investigators are committed to policies as established by the SC including confidentiality, sharing of information and resources, cooperative interaction, and functioning as a national resource.
• Evidence of previous productive, cooperative, collaborative interaction.
• Assurance that there is approximately equal distribution of study between maternal pharmacology and pediatric pharmacology across the MPRINT Hub.

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Awardee-selected Support Pool projects require prior approval by NIH prior to initiation.

• The awardee institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The awardee institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General  and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex.  This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. HHS provides guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency.  Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at https://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.
• Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment.  Please see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html; https://www2.ed.gov/about/offices/list/ocr/docs/shguide.html; and https://www.eeoc.gov/eeoc/publications/upload/fs-sex.pdf. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• Recipients of FFA must also administer their programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws.  Collectively, these laws prohibit exclusion, adverse treatment, coercion, or other discrimination against persons or entities on the basis of their consciences, religious beliefs, or moral convictions.  Please see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.  

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. 

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 Award Term and Conditions for Recipient Integrity and Performance Matters.

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Zhaoxia Ren, MD, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-402-9340
Email: zren@mail.nih.gov

Sherry Dupere, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Telephone: 301-451-3415
Email: duperes@mail.nih.gov

Bryan Clark, MBA
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-435-6975
Email: clarkb1@mail.nih.gov

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.